the national statement on ethical conduct in research

Understand the principles of Human Research Ethics

Are you supporting or planning to engage in research with or about people, their data or their tissue? A new, self-paced learning module now available on Canvas entitled Human Research Ethics introduces its values, principles and review.

The module provides information to help you design a human research project and understand how ethics reviewers will consider your design against the guidance provided in the National Statement on Ethical Conduct in Human Research .

Based on, and directly cross referencing with the National Statement, the module outlines why research ethics review was introduced internationally. It introduces the key agencies and documents associated with Australian ethics review and points out important changes in 2023 National Statement. These include a refined risk matrix approach and the requirements of granting an exemption from ethics review.

Merrilee Kessler, UTS Research Ethics Coordinator said that UTS commissioned this module for its research community.

“We wanted to provide a course that introduced the key research ethics concepts such as risk and benefit, consent, recruitment and data management, in a way that helps researchers understand the language and intent of ethics review,” she said.

The module highlights the kinds of responses needed in an ethics application to show that the research design meets the expectations of the National Statement. It looks at current issues like AI, social media in research and Big Data.

“It also includes research that UTS doesn’t come across as often, but which provides great scope for ethical investigation, such as Genomic research and Animal-to-human xenotransplantation,” Merrilee explained.

We wanted to provide a course that introduced the key research ethics concepts such as risk and benefit, consent, recruitment and data management

Keith Heggart, UTS researcher and ethics reviewer, was one of the first to complete the module.

“I think it’s important for early career researchers to understand that going through the ethics process is not just a matter of ticking the right boxes and filling in the right forms. Instead, it’s a thoughtful, nuanced engagement with ideas like justice, beneficence and risk,” he said.

“Done well, careful completion of the ethics approval process improves research projects. This course does a great job of carefully explaining this point, and as such, I recommend it for all early career researchers - and experienced ones too!”

Done well, careful completion of the ethics approval process improves research projects.

Contributing to research excellence

Importantly, the Human Research Ethics module covers key aspects of the UTS Research Outcomes Capability Framework | RES Hub (uts.edu.au) including those relating to:

Research life cycle: Best practice in research project management from research ethics and integrity, policy and procedures, data management policy and systems to IP management and security.
Research leadership: Confidence to champion research integrity and best practice in research project management, mentor successfully and deliver ethical and robust research with integrity.
Creativity and innovation: Knowledge of ‘human-centred’ research methods and practices.
Indigenous led knowledges and research: Knowledge and understanding of Indigenous Research Ethics (e.g. AIATSIS, NHMRC, community protocols) and the ability to ensure that research processes and outputs will not harm Indigenous peoples and communities.

“We also look at the relevant UTS policies, procedures and systems,” added Merrilee.

“At the end of the course, participants will have the ability to identify and manage risk and appropriately manage data – including by planning for re-use and reproducibility, archiving and sharing with appropriate audiences.”

About the Human Research Ethics Module

Human Research Ethics takes approximately two hours to complete and can be accessed as many times as needed once an account has been opened.

A Certificate of Completion is available for download.

Access the training at https://canvas.uts.edu.au/enroll/GEKRK8

Find ethics training and support

Visit the Ethics Sharepoint site - Research Ethics and Integrity - Home (sharepoint.com)
Make an appointment to attend clinics for Animal Ethics, General Research Ethics or Health Related Research - Ethics clinics (sharepoint.com)
Register for Good Clinical Practice (GCP) training- GCP training page

Need more information? Get in touch with the Research Ethics team by email [email protected]

RES Hub acknowledges and pays respect to the Gadigal people of the Eora Nation, the Boorooberongal people of the Dharug Nation, the Bidiagal people and the Gamaygal people, upon whose ancestral lands where UTS now stands.

We pay respect to their Elders; past, present, emerging and future as the traditional custodians of Country and knowledge for this land. We recognise their continued connection to the land and waters and the continuation of their cultural, spiritual, and educational practices. We extend this respect to all Aboriginal and/or Torres Strait Islander peoples who visit RES Hub.

As a place for the UTS community to connect and collaborate, RES Hub acknowledges the long-standing traditional practices of these communities in gathering to share experience, knowledge, and history. RES Hub acknowledges that sovereignty was never ceded. This is and always will be Aboriginal Land.

Due to major building activity, some collections are unavailable. Please check your requests before visiting. Learn more .

National statement on ethical conduct in human research 2007 (updated May 2015) / developed jointly by National Health and Medical Research Council, Australian Research Council, Australian Vice-Chancellors' Committee

National edeposit
https://www.nhmrc.gov.au/guidelines-publications/e72
[Canberra : National Health and Medical Research Council], 2007
Canberra : National Health and Medical Research Council, [2015]
1 online resource (iv, 95 pages)
"2007 (Updated May 2015)"
"NHMRC Publication reference: E72"
Originally published in 2007.
Includes index.
Also available online. Available on the NHMRC website on 26/4/07 at: http://www.nhmrc.gov.au/publications/synopses/_files/e72.pdf.
Human experimentation in medicine -- Australia
Medical ethics -- Australia
Research ethics -- Australia
Research -- Moral and ethical aspects -- Australia
National Health and Medical Research Council (Australia), issuing body
Australian Research Council
Australian Vice-Chancellors' Committee

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Update to the national statement on Ethical Conduct in Human Research

A critical document governing clinical trials in Australia, the National Statement on Ethical Conduct in Human Research ( National Statement ), has been updated for the first time in 5 years. The new 2023 National Statement commences on 1 January 2024.

A number of significant changes have been made in the National Statement 2023, including:

fully revising the guidance on risk and benefits from a three-level risk model to a continuum-based model with two broad categories and
multiple updates to the guidance on research governance and ethics review.

Clinical trials continue to expand in Australia, with over 18 000 trials recruiting 8.7 million participants in Australia. [1] The National Statement is the foundational guide in the ethics approval process for those clinical trials in Australia—outlining the ethical principles and standards to which drug and device developers, researchers, ethics committees, and institutions must adhere when planning, conducting, and reviewing their clinical trials.

Stakeholders in research & development in life sciences should familiarise themselves now with these updates, which will affect study design, ethics approval procedures and risk assessment for future clinical trials of medicines and devices.

Clinical trials in Australia

What is the National Statement?

Changes to the National Statement’s position on risk

Changes to the National Statement’s position on research governance and ethics reviews

Summary of changes to the National Statement

Clinical trials play a crucial role in advancing the Australian health sector by driving medical innovation, ensuring patient safety, and improving healthcare outcomes. These trials provide a structured and controlled environment for testing new medical interventions, such as drugs, medical devices, and treatment protocols, before they are introduced into mainstream medical practice.

The economic investment in Australian trials is substantial, with an estimated $1.4 billion of public and private funding committed in 2019” - Medical Journal of Australia [2]

The Australian Government actively encourages clinical trials in Australia, including through the Research & Development Tax Incentive for industry. [3] Clinical trials are a cornerstone of the Australian health industry, providing not only medical insights but also substantial economic opportunities. By conducting trials for new medical interventions, Australia attracts international pharmaceutical and biotech companies to invest in research and development activities within the country.

The National Statement sets out the criteria by which Human Research Ethics Committees ( HRECs ) authorise, monitor, and review clinical trials. For the majority of clinical trials in Australia, HREC assessment is the key approval process for commencement of a clinical trial in Australia. [4]

HRECs review research proposals for research and clinical trials that involve human participants (or data relating to individuals) to ensure that they are ethically acceptable. Before a clinical trial can begin, the sponsor (usually the organisation or company conducting the trial) must submit a comprehensive research proposal to an accredited HREC. The proposal includes details about the trial's objectives, methods, participant recruitment, informed consent process, potential risks and benefits, and more.

When researchers submit a clinical trial proposal to an HREC for review, the committee evaluates the proposal based on the ethics principles outlined in the National Statement. The committee’s role is to assess whether the trial's design, methods, and protocols align with these principles. The HREC's responsibilities don't end with approval. It continues to monitor the trial's progress to ensure ongoing ethics compliance. If any changes to the trial are proposed after approval, these changes may need to be reviewed and approved by the HREC before implementation.

The need for ethics review of research involving human participants was recognised in the 1960s and continues to be seen by the Federal Government as a pre-requisite to any Federal funding of medical research.

The National Statement has regularly been updated since 1999. In fact, the NHMRC has already flagged further review and public consultation on Section 4 of the National Statement that provides guidelines on the ethical considerations specific to certain participants, such as pregnant women, children, and Aboriginal and Torres Strait Islander Peoples.

Introduction of a new continuum-based risk model

The current three-level risk model (negligible risk, low risk, and greater than low risk) has now been replaced with a continuum-based model from lower risk to higher risk: [5]

the national statement on ethical conduct in research

Source: National Health and Medical Research Council, National Statement 2023 , Chapter 2.1, p 12.

The National Statement 2023 makes it clear that research in which the risk for participants or others is greater than discomfort level and involves a risk of harm is not low risk research and should be considered higher risk. All higher risk research requires review by an HREC.

Amendments clarify that processes for reviewing research may differ according to the levels of risk

Recognising that risk in research exists on a continuum, the National Statement 2023 says that institutions may choose to:

differentiate between levels of lower risk or between levels of higher risk for review or monitoring purposes and
develop review processes to accommodate these different levels of risk, while taking care to respect the principle of proportionate review.

Amendments clarify what is considered harm versus discomfort, burden, and inconvenience

The National Statement 2023 now recognises that harm can be experienced individually or collectively.

including anxiety-related psychological harm such as re-traumatisation and
removing the explicit reference to cultural harm
re-asserts that discomfort is considered less serious than harm and explains that discomfort can involve physical or psychological impacts, such as minor side-effects of medication, discomfort related to non-invasive examinations or tests (for example, measuring blood pressure), and mild anxiety associated with an interview
explains that where a person’s reactions might exceed discomfort and become distress, this should be viewed as the potential for harm
explains that some participants may be at higher risk of harm or discomfort arising from research and that this increased risk of harm or discomfort can express itself in different ways at different times and to different degrees and
recognises that participation in research can also impose burdens or inconvenience (such as time given up and travel costs) on those involved in research but that these should not be considered a type of harm or discomfort and therefore should not be viewed as a risk. Nevertheless, the impact of any of these burdens or inconvenience on participants should be considered by researchers, institutions and HRECs and balanced against the potential benefits of the research.

Amendments clarify that the assessment of risk is a shared responsibility of institutions, review bodies, and researchers

The National Statement 2023 emphasises that researchers, institutions, and ethics review bodies are all engaged in the risk assessment process. It also reminds researchers, institutions, and ethics review bodies that the assessment of risk informs the determination of the appropriate level of review for a research project by the institution and reviewers’ judgments about whether risks are justified by potential benefits.

It also clarifies that:

in assessing the risks of a research project, researchers, institutions and ethics review bodies should only consider the risks that may result from the research, as distinct from the risks participants would be exposed to if they were not participating in the research and
that developing and promoting clear policies for the processes for assessment of risk and review of research are an institutional responsibility.

The new National Statement makes a number of changes in Section 5 regarding research governance and ethics reviews, the first of which is to align this section with the changes made in Chapter 2.1 on risk. For example, the new introductions to section 5 and Chapter 5.1 make it clear that developing and promoting clear policies for the processes for assessment of risk and review of research are an institutional responsibility.

The guidelines for ethics review exemptions have been updated

Some research may be eligible for exemption from ethics review. Previously, institutions could choose to treat as exempt from ethical review research that involved ‘negligible risk’ or involved the use of existing collections of data or records that contain only non-identifiable data about human beings. This has now been updated.

The new guidelines also make it clear that research that involves the use of data that includes personal information without consent cannot be granted an exemption from ethics review. [6]

The decision whether to grant an exemption is made by the institution responsible for the research, and when there is no institution providing oversight of the research, the decision needs to be made by an ethics review body.

The criteria for the minimum membership of an HREC has been updated

Specifically, in addition to the existing requirements [7] , the National Statement 2023 now requires:

two people who bring a broader community or consumer perspective and who have no paid affiliation with the institution (previously the requirement was for ‘at least two lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work’)
a person who performs a pastoral care role in a community including, but not limited to an Aboriginal and/or Torres Strait Islander elder or community leader , a chaplain or a minister of religion or other religious leader (changes in italics) and
a qualified lawyer , who may or may not be currently practicing and, where possible, is not engaged to advise the institution on research-related or any other matters (changes in italics).

Further guidance on the membership of HRECs and ethics review bodies

Additional members of HRECs

On top of the minimum members an HREC is required to have, institutions may appoint additional members and these members may represent minimum membership categories (for example, an additional community member, lawyer or researcher) or have experience or expertise relevant to the work of the committee. [8]

HREC membership pools

As before, institutions are encouraged to establish a pool of appointed HREC members to draw on as needed. [9]

Diversity & expertise

New guidelines have also been added on membership diversity and expertise.

For example, the guidelines now require HRECs and other ethics review bodies to ensure that, as far as practicable, the membership at each meeting has diversity, including gender diversity. [10]

Institutions that establish HRECs should also ensure that at least one third of those participating in each meeting are from outside of the institution. [11]

Access to expertise

The guidelines have also added further guidance on how institutions ensure that its ethics review bodies have access to the expertise needed to enable it to properly review research. [12] This may require going outside of the review body’s membership for review of individual research projects to seek assistance from individuals with:

specialised scientific or scholarly expertise (including research methods)
specialised technical expertise, such as statisticians or data security, storage and safety specialists
expertise related to participant groups, including participant advocates and
expertise related to research contexts, such as clinical or community care.

Aboriginal and Torres Strait Islander expertise

The National Statement 2023 adds a new requirement that HRECs that review research concerning Aboriginal and Torres Strait Islander people or communities should appoint one or more members who have knowledge of research with Aboriginal and Torres Strait Islander Peoples or who are familiar with relevant cultural knowledge, if such a person has not already been appointed to the committee. [13]

Delegation by HRECs

Finally, the National Statement 2023 now allows an HREC to delegate some of its responsibilities to its chairperson, one or more of its members, a sub-committee, or its administrative officers. However, it is clear that actions taken by these delegates are not equivalent to decisions by the HREC and some of these actions would need to be ratified by an HREC. [14]

Additional guidance on ethics review policy and processes

The National Statement 2023 states that institutions can establish their own processes for ethics review of research or use the review processes of another institution or external ethics review body . [15]

This also includes overseas review bodies . When institutions are considering accepting the outcome of another institution’s ethics review process, including a review conducted by an overseas review body, the Statement recommends they follow the updated guidelines in Chapter 5.5 that aim to minimise the duplication of ethics reviews. [16] These guidelines include the following changes of particular interest:

Wherever more than one institution has a governance responsibility to ensure that ethics review of a human research project has taken place, each institution has the further responsibility to adopt a review or authorisation process that minimises any unnecessary duplication of ethics review. [17]
Institutions that will serve as individual sites for a multi-centre research project should make every effort to avoid multiple ethics reviews of the same research project, other than specialised review that may be required. [18]
Institutions should determine the criteria that must be satisfied for them to accept an ethics review conducted by an entity external to the institution, including overseas review bodies. [19]
all sites at which the research will be conducted
any information on local site circumstances that is relevant to the ethics review
any other body that will be considering ethical issues related to the research and
any previous decisions to approve, re-consider or deny approval of the research by another review body in Australia or elsewhere. [20]
Researchers who wish to submit evidence of ethics approval by an external ethics review body in support of single ethics review should be aware of existing national or international programs, protocols, policies, standards, and guidance that may be relevant to the institutional decision to accept the review. [21]

Other changes

The NHMRC has also:

made a structural revision to the National Statement by separating the responsibilities of HRECs and other ethics review bodies, which are now contained in Chapter 5.2, and the responsibilities of researchers, which are now contained in Chapter 5.3 and
made it clear that the failure to comply with the requirements of the National Statement may result in the HREC being removed from the list of HRECs registered with NHMRC.

Existing Applications for ethics review

Applications that have already been submitted to an HREC prior to 1 January 2024 when the new National Statement takes effect that are under review or have not yet been reviewed can be considered under the current version of the National Statement.

All stakeholders in the research and development ecosystem should familiarise themselves with the amendments in time for commencement of 2023 National Statement next year. This includes making any necessary adjustments to policies, processes, or individualised application or project description templates in readiness for 1 January 2024. This is particularly important for current and future Medical Research Future Fund (MRFF) grant recipients as MRFF grant agreements require compliance with the National Statement.

Prior to the 1 January commencement date, the NHMRC will also be making minor changes to the Human Research Ethics Application.

Further updates are proposed to Section 4

Stakeholders should also consider NHMRC’s proposed changes to Section 4 of the National Statement, which covers the ethical considerations specific to certain groups of participants, such as pregnant women, children, and people with cognitive impairment, an intellectual disability, or a mental illness. The NHMRC have released drafts of an updated Section 4 , a National Statement preamble, an updated purpose, scope and limits statement, and section 1 , as well as explanatory materials . Submissions are being sought from all interested parties in relation to the proposed changes.

The closing date for submissions is 15 September 2023.

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Informed consent and plain language

In this section

PICF and plain language resources

We have a number of templates and resources to help you write your PICF and other participant-facing materials in plain language.

Informed consent

The National Statement on Ethical Conduct in Human Research says that if you want people to take part in your research project, you need to get their informed consent. They should:

voluntarily agree to take part in your project and
understand what your project involves.

To help people understand your project, you should give them information in plain language .

You also need to record the fact that each person has consented to take part in your project. You can record consent in a number of ways, depending on the:

nature, complexity and level of risk of your project and
personal and cultural circumstances of the person.

Some common ways of recording consent are:

written – for example, the person signs a Participant Information and Consent Form
verbal – for example, you ask the person whether they agree to take part in your project and record their response in writing or on an audio device
implied – for example, the person gives consent by filling out and returning a survey.

Children and young people

Research with children and young people under 18 years of age raises particular issues around informed consent. Usually, you need to get consent from:

the child or young person and
the parent or guardian.

When you are seeking consent from a child or young person, you need to think about:

their capacity to understand what the research involves and
the complexity of the research, and its potential risks and benefit.

You should respect the developing capacity of children and young people to be involved in decisions about their participation in research - see Chapter 4.2 of the National Statement . In some cases, parental consent may not be necessary. For example, a 17 year-old with good literacy skills may be able to consent to low-risk research.

If the child cannot consent, you should still involve them in appropriate discussions about the research. A Child Information Sheet could help you do this. See our resources for guidance.

Think about your participant's needs

You may be seeking informed consent from an individual whose needs do not suit the templates on our website, for example, the parent of a deceased child. If this is the case, please contact our office for advice. We will help you make sure that your written materials, and your recruitment processes, are appropriate for that individual.

Opt out approach

The National Statement says that you should respect people's capacity to make their own decisions. This normally means that people should give express consent to take part in your project. Sometimes it may be justifiable to use an alternative approach. This might be appropriate if you are running a large scale, low risk project and it is not feasible to get express consent from each person.

Using an opt out approach means that participants are included in the research unless they give their express decision to be excluded. Their decision must be informed. Therefore, you still need to give them information about your project. Once you have done this, you can assume that they are willing to take part in your project unless they say they do not want to.

If you want to use an opt out approach, you must get permission from a Human Research Ethics Committee. You need to make a strong argument that:

your project poses little or no risk to participants and
the risk of not seeking express consent is outweighed by the public benefit or interest of the research.

This is only appropriate if people can make an informed choice about participation. This requires that:

you give people written information about the project
people receive this information, and are able to read and understand it
people are able to act on the information to decline participation.

It may be appropriate for you to use different types of consent for different parts of your project. For example, you might seek explicit written consent for participation in clinical research. You might then use an opt out approach if you are seeking to use people’s information as part of a registry.

The opt out approach is unlikely to constitute consent if you are applying Commonwealth privacy legislation to the handling of sensitive information, including health information. In some cases, it may not be feasible for you to get a participant’s explicit consent to use their information, but you cannot achieve the purpose of your research by using non-identifiable information. In these cases, you must comply with the guidelines under section 95 or section 95a of the Privacy Act 1988. If you are seeking to use an opt out approach to which sections 95 or 95a apply, only a HREC can grant this approval.

For more information about an opt out approach, see Chapter 2.3, 2.3.5 - 2.3.6 of the National Statement.

Waiver of consent

In some cases, you may be able to use tissue or data without getting express consent from the individuals involved. In order to do so you will need to seek a waiver of consent. The National Statement on Ethical Conduct in Human Research states that a waiver of consent can only be granted by a fully constituted Human Research Ethics Committee (HREC). The HREC can only grant a waiver if sufficient justification is provided, and the necessary criteria are met. For more information about this, see Chapter 2.3 of the National Statement .

You can access the list of projects that the RCH HREC has granted a waiver of consent for.

Withdrawing from research

You should make your withdrawal processes as simple as possible. When designing your research, consider how your participants prefer to communicate. For example, they may like to communicate verbally or by text message. If so, your withdrawal processes should reflect this.

At the time of consent, you should tell people about the consequences of withdrawing from the research. You should also outline this in your Participant Information and Consent Form (PICF). See sections 2.2.6(g) and 2.2.20 of the National Statement .

If a participant does want to withdraw from the research project, engage them in a conversation so they understand the implications of withdrawal. This should be in line with your consent discussion and PICF. You can clarify exactly what they are withdrawing from. For example:

Are they willing for you to you continue using their already collected data or do they wish for it to be securely destroyed if possible?

Do they want to know what the study found?

Would they mind being contacted about future research projects?

If they were on an investigational product, do they understand it may be in their best interests to be followed for safety?

In some cases, it may be appropriate to explore the reasons they want to withdraw. While they are not obliged to give you this information (see section 2.2.19 of the National Statement) if they are willing to share then it may help improve the current project or help you design future research projects.

Make sure you record the participant’s withdrawal. If they withdraw verbally, keep a file note of your conversation including the date and the people involved in the discussion, in addition to the information above.

Final letter - communicating your research results

The National Statement advises that you should communicate your research results to participants in a timely manner, and in clear and accessible language: see section 3.1.72 . The RCH HREC expects that in most cases you should do this by sending participants a final letter.

You should use our resources to help you draft your final letter:

Example final letter - with study results
Example final letter, study stopped early - with no study results

When you've drafted your final letter, email it to [email protected] . Please:

include your study number in the subject heading of the email
let us know whether your study is single site or multi-site . If your study is multi-site, clearly list the full names of all the sites in the email
make sure you send a clean copy of the letter in Word format . We cannot provide advice on PDF letters.

Our Plain Language Adviser will give you feedback on your letter. When the letter is suitable for participants, the Plain Language Adviser will issue you with an approval certificate.

Please do not submit the final letter on ERM.

For more information, refer to the Final letter guidelines .

Plain Language Adviser

If you need help extra help writing in plain language, you can contact the Plain Language Adviser (PLA), who is based in Research Ethics and Governance. The PLA will be of particular assistance to new researchers. However, experienced researchers may also wish to seek assistance from the PLA.

The PLA can review documents for participants, including PICFs, newsletters and letters, and provide advice on how to make them clearer. Before you arrange for your documents to be reviewed, please:

review the resources on our website, particularly the Example PICF
proofread your documents
obtain an ERM number , and quote this in the subject-line of your emails to us
make sure your documents are clean copies in Word - please, no PDFs or track changes
provide the PLA the protocol for your project - the PLA will use this for background information. They will not provide feedback on your protocol.

Please contact our office to request or arrange a review or make a time to discuss the resources and education materials available: [email protected]

When should I get consent from the parent/guardian?

In general, you should get consent from the parent/guardian if the young person is under 18 years of age. Sometimes you should seek the young person’s consent as well. See the next question.

Can a young person consent to taking part in research?

The young person’s capacity to provide informed consent will depend on:

the nature and complexity of the research project, and
the young person themselves. The capacity to understand and consent to taking part in research varies from young person to young person. You should assess this on a case-by-case basis. Remember that a young person’s capacity can change over time.

You should offer young people over 12 years of age the opportunity to consent if they are capable and mature enough to do so. This is in addition to their parent/guardian’s consent.

In some cases, you can get consent solely from a young person who is a mature minor, and not their parent/guardian. If you are seeking to do this, you need to provide the ethics committee with justification in line with sections 4.2.8 and 4.2.9 of the National Statement .

If a young person does not have capacity to consent, you should still involve them in discussions about the project. You may also wish to give them an information sheet about the project.

Can I use an assent form?

The term 'assent' has no legal standing in Australia and is not recognised in the National Statement . The Australian Paediatric Research Ethics and Governance Network (APREG) guidelines on consent reiterate that assent forms are not appropriate. For this reason the RCH HREC will not approve an assent form.

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2007 National Statement on Ethical Conduct in Human Research

PMID: 21762341
DOI: 10.1111/j.1445-5994.2011.02528.x

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2007 National Statement on Ethical Conduct in Human Research: not worth the paper it is written on? Smith M. Smith M. Intern Med J. 2011 Jan;41(1a):73. doi: 10.1111/j.1445-5994.2010.02420.x. Intern Med J. 2011. PMID: 21265969 No abstract available.

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The style and content of the information provided in the consent process needs to be suitable for the target group in terms of comprehension and literacy levels and cultural norms. Whatever process is chosen, the core information needs to be presented in a way that can be understood by the person being recruited.

The means of recording consent should also be appropriate to the participant group and the nature of the information being collected. Generally, you avoid collecting identifiable information if it is not necessary. This means consent may be:

Tacit e.g. for anonymous surveys. In this case you would state clearly in the information provided that return of the survey is taken as indicating consent; or
Verbal, if written consent is not meaningful (e.g. due to literacy) or inappropriate – just make sure you have a record of obtaining this consent (e.g. audio recording or diary note); or
Written; or
A combination of the above. A project may have multiple consent processes reflecting different stages of the project and/or different participant groups.

Examples of appropriate Participant Information Sheet and Consent Form documents are available below, along with checklist guides for what to include in these documents, however no ‘template’ exists – they are different for every study. To access any UOW Human Research Ethics templates (e.g. Application Form templates) please see our Forms, guidelines and policies page.

UOW r esources for preparing Participant Information Sheets and Consent Forms

Checklists for Participant Information Sheets and Consent Forms
Consent Form Guidelines
Examples of Alternative Methods of Consent

Please note that whilst these documents download in pdf form, you can "Save As" a Word document with Adobe and use as a template.

UOW examples of Participant Information Sheets

Participant Information Sheet – Email format
Participant Information Sheet – Letter format
Participant Information Sheet – Question and answer format
Participant Information Sheet – Standard format

UOW examples of Consent Forms

Consent Form - Email Format
Consent Form - Standard Format

Other sources of examples of consent documentation include:

NSW Health - standardised documents for clinical trials: trials involving genetic testing and collection of human tissue, and for tissue banking or storage of tissue samples.
NSW Department of Education: the SERAP guidelines include examples of contact letters, participant information sheets and consent forms for research involving schools.
NHMRC - has released templates for genetic studies, clinical interventional studies, non-interventional medical studies and health/social science research.
Murdoch Children’s Research Institute – has developed pamphlets for parents to explain the informed consent process. These are to be provided in addition to the participant information sheet.

Chapter 4.2 of the National Statement on Ethical Conduct in Human Research deals with research involving children and young people in detail. The HREC is looking for the ethics application to demonstrate understanding of this, in particular that consent processes ensure that participants who are children understand what is being asked of them, and that they can choose not to participate, to the extent that their stage of development allows. If there are expected to be barriers to comprehension (e.g. due to language) the process must also be designed to address this.

Consent processes usually involve a combination of written and verbal elements, depending on the project.

For very young children best practice is to provide a simple explanation of the activity, and obtain verbal assent. Formal written consent is obtained from the parent/carer.

For upper primary aged children, age appropriate information documents should be provided and the consent process designed to encourage adults (usually the parent/carer) to discuss the research with the child before consent is obtained. Parent/carer and child sign off are commonly included on the same form. For useful guidance, see the handbook on Understanding Consent in Research Involving Children.

Adolescents, particularly where over 14, should complete an autonomous consent process. Parents/carers should be informed of the research and in most cases parent/guardian consent should also be sought. There are some circumstances where a case can be made for relying solely on the consent of the young person (see National Statement 4.2.8 – 4.2.9).

For a detailed discussion of the legal considerations see Laws relating to the giving of consent for persons with impaired capacity to provide informed consent to participate in research in each Australian State and Territory, 2017.

Please refer to the current UOW Research Integrity guidance regarding the use of GenAI in research.

Participants can be harmed by breaches of their privacy. Human Research Ethics Committees must consider the potential for this, and whether research proposals comply with national and state legislation regarding the handling of personal information. Any data which allows identification of an individual is 'personal information'.

The underlying principle in all of the legislation is that personal information should not be used for a purpose other than the one for which the data was collected without consent. The exceptions to this relating to research are:

When information is already in the public domain, with the exception of social media data, as per the information below.
In some cases identifiers may be removed by the data custodian and the data provided to a researcher. This generally requires approval by an HREC.
When an HREC has approved a request for a waiver of the privacy legislation. Strict criteria apply to granting a waiver. All four criteria must be met.

Criteria 1: The use or disclosure is reasonably necessary for research, or the compilation or analysis of statistics, in the public interest.

Criteria 2: You have taken reasonable steps to de-identify the information, or the purpose of the research cannot be served by using or disclosing de-identified information and it is impracticable to seek the consent of the person to the use or disclosure.

Criteria 3: If the information could reasonably be expected to identify individuals, the information is not published in a generally available publication.

Criteria 4: The use or disclosure of the health information is in accordance with the statutory guidelines on research.

Office of the Australian Information Commissioner
Privacy Act 1988 (Federal)
Australian Privacy Principles
Medical Research - Guidelines under Section 95 of the Privacy Act 1988: These Guidelines apply to medical research involving personal information obtained by Commonwealth agencies.
Medical Research - Guidelines approved under Section 95A of the Privacy Act 1988: These guidelines apply to health information that is collected, used or disclosed in the conduct of research and the compilation or analysis of statistics, relevant to public health or public safety, and in the conduct of health service management activities.

N SW State Government Legislation and Guidelines

There are two key pieces of privacy legislation specific to the use of personal information in NSW. Details can be found on the NSW Information and Privacy Commission website. The key legislation is:

Privacy and Personal Information Protection Act 1998 (NSW): The PPIP Act deals with how NSW public sector agencies manage personal information. Personal information refers to any information that relates to an identifiable person. For an overview of who is bound by PPIP and what it involves.
Health Records and Information Privacy Act 2002 (NSW): The HRIP Act governs the collection, storage, use and disclosure of health information in both the public and private sectors in NSW.
This includes hospitals whether public or private, doctors and other health care organisations. It also includes other organisations that have any type of health information. This can be as varied as a university that undertakes research or a gymnasium that records information about a person's health and injuries. For an overview of who is bound by HRIP and what it involves.

Researchers wishing to access health and medical records should consult the Statutory Guidelines on the use or disclosure of Health Information for Research Purposes

ANONYMITY AND CONFIDENTIALITY – WHAT’S THE DIFFERENCE?

It is important for researchers to understand the difference between anonymity, confidentiality and privacy as each term is distinct and has practical implications for the way in which participant data is collected, used and managed.

Participant consent is based on the information provided to them, most commonly via a written participant information sheet (PIS). If the information provided to participants explains that their data will, for example, be anonymous, when in fact the data is identifiable but confidential to the research team, researchers are likely to be in breach of their privacy obligations to participants and, as a result, their ethics approval.

Please see the key terms below to ensure that the information provided to your participants is accurate.

Privacy: a concept that relates to an individual’s control over information about them.

Anonymous data: data that can in no way be linked back to an individual participant. Data collected in interviews, yarns and focus groups can never be anonymous.

Confidential data: data that will only be identifiable to the research team.

Personal information: information or an opinion about an identified individual, or an individual who is reasonably identifiable. All reasonably identifiable information is considered personal information, and is governed by Australian and NSW Privacy Laws: The Privacy Act 1988; Privacy and Personal Information Protection Act 1998; Health Records and Information Privacy Act 2002.

Direct identifiers: identifiers that are unique to an individual. Examples include names, medical reference numbers, email addresses etc.

Indirect identifiers: variables that enable information to be connected until an individual can be identified. Whether data is indirectly identifiable depends on the context of the data collection (e.g. collecting demographic data from a relatively small sample size is likely to identify individual participants). Examples include demographic data such as date of birth, gender, postcode etc.

De-identified data: data that is no longer reasonably identifiable to an individual person. De-identification of data must be considered in context – it requires more than just removing direct identifiers, it is about ensuring that data is not reasonably identifiable in a given context.

A word diagram showing the overlap of confidentiality, privacy and anonymity for research purposes

Many online survey platforms (including Qualtrics) are set up to automatically collect participant IP addresses, which are then stored alongside each survey response. As IP addresses are unique identifiers and have the potential to identify responses, it is important to ensure that IP addresses are not collected when using online survey platforms. This is essential when participants have consented on the basis that the survey is anonymous.

When conducting anonymous surveys online, please select the appropriate security options to turn off the collection of IP addresses; the relevant information for Qualtrics can be found on the Qualtrics website , under ‘Anonymize Responses’.

The UOW Ethics Office is aware that IP addresses have historically been used to filter bot responses, or to remove duplicate human responses. As noted above, to collect an IP address is to collect reasonably identifiable information, and IP addresses should not be used as a default for bot detection. Qualtrics has published various fraud detection methods that can be applied for these purposes.

The ‘publicly available information’ exemption

Historically, it has been understood that when information, including identifying information, is already in the public domain, human ethics approval is not required for its use in research. Some examples include:

Publicly available statistics and datasets, e.g. Australian Bureau of Statistics , Australian Institute of Health and Welfare , Healthstats NSW , NSW Bureau of Crime Statistics and Research
Registries of births and deaths, e.g. NSW Registry of Births Deaths & Marriages
Court judgments, e.g. NSW Caselaw
Information in public archives, e.g. NSW State Archives
Information published in newspapers or media releases

However, the rise of social media and the creation of diverse online spaces – some of which are potentially accessible to anyone – has changed this discussion. While many social media posts/comments are in the public domain, they are not necessarily viewed as such for those who authored them. As many online spaces are highly private in nature, users may not reasonably expect to be observed or have their data collected for research purposes. As explained in the National Statement on Ethical Conduct in Human Research :

“Privacy concerns arise when the proposed access to or use of the data or information does not match the expectations of the individuals from whom this data or information was obtained or to whom it relates. These issues are especially complex in the context of the access to or use of information relating to individuals that is available on the internet, including social media posts… Data or information available on the internet can range from information that is fully in the public domain (such as books, newspapers and journal articles), to information that is public, but where individuals who have made it public may consider it to be private, to information that is fully private in character. The guiding principle for researchers is that, although data or information may be publicly available, this does not automatically mean that the individuals with whom this data or information is associated have necessarily granted permission for its use in research.” (Chapter 3.1, p 36)

For these reasons, human ethics approval is required to use data collected via social media for research purposes.

Social media spaces exist on a spectrum of publicness

A useful first step in considering these studies is to ask how public is the data? Is it so public (e.g. a Tweet from the Prime Minister) that it could reasonably be considered public information, and therefore not be subject to the ethical requirements applied to the use of social media data? Please note that the vast majority of social data proposed for use in research does not fall into this category.

For all other social media data proposed for use in research, the first step is to ensure that the data collection is lawful.

Legal requirements

It is important to understand the definition of ‘personal information’ when proposing to use social media data in research. NSW Privacy and Personal Information Protection Act 1998 defines personal information as ‘Information or an opinion…about an individual whose identity is apparent or can reasonably be ascertained from the information or opinion.’

In a research context, this means that just because someone’s name is not directly attached to the data collected about them, does not mean that the data is ‘de-identified’. Often, data without direct identifiers attached (e.g. names) is still reasonably identifiable, meaning it is still someone’s personal information. In the context of social media research, quotes are generally considered to be identifiable information.

What does this mean for researchers proposing to collect reasonably identifiable data from social media?

In this situation, researchers have three options to work through:

Restructure the research methodology to collect only de-identified information . Both NSW and National Privacy laws state that a person’s personal information can only be collected when ‘the collection of the information is reasonably necessary’ for a given purpose. In a research context, this means that if the research aims can be achieved by collecting and using de-identified information, then that approach must be taken. However, if the research aims cannot be met by using de-identified data, researchers should;
Obtain consent from that person to use their data for research purposes. If obtaining consent is not practicable, researchers can;
Apply for a waiver of consent. Researchers are able to apply for a waiver of consent from the HREC when they wish to use an individual’s personal information for research purposes without obtaining consent to do so.

In the instance that a waiver of consent is requested from the HREC, the research team must address each point below from section 2.3.10 of National Statement :

(a) Involvement in the research carries no more than low risk to participants.

(b) The benefits from the research justify any risks of harm associated with not seeking consent.

(d) There is no known or likely reason for thinking that participants would not have consented if they had been asked.

When responding to this point, researchers should consider the reasonable expectations of participants in this context. For example, how public is this information? What are the terms of use of the particular social media site being used? What is the nature of the space they are posting in?

(e) There is sufficient protection of their privacy.

When responding to this point, researchers should consider whether, by collecting this data, they are placing participants’ privacy at a greater risk than they it currently stands. Will the researchers publish data in a more public forum than it is currently available?

(f) There is an adequate plan to protect the confidentiality of data.

(g) In case the results have significance for the participants’ welfare there is, where practicable, a plan for making information arising from the research available to them.

(h) The possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled.

(j) The waiver is not prohibited by State, federal, or international law.

Ethical Considerations

It is important to note that meeting legal requirements does not mean that data collection is ethical. Whether proposing to collect reasonably identifiable information or completely de-identified information from social media, all researchers are required to address the following ethical considerations by completing the Research Using Social Media Data form (DOCX: 26 KB) . This form should be submitted to the HREC with your Application Form.

What information will be collected? Names? Quotes? Key words? Please be as specific as possible here to support the committee’s understanding of how identifiable the data is.

Will consent be obtained from users? If not, why?

What are the reasonable expectations of social media users in this context?

(1) How public is the information?

From which social media site is data being collected? What are the terms of use of this site?
Is it in a closed group? A public facing comment on Facebook? Or a more public site, like Twitter?
If from a closed group, how large is the group? Will group administrators (if any) consent? Will group members be told of the researcher’s presence? Will they consent?

(2) What is the nature of the space from which data will be collected?

This is an important consideration in determining the ethical acceptability of the data collection and relates primarily to respect for participants’ privacy.
Many online spaces are highly private/sensitive in nature and exist as a social support for a particular group of people. It is important to consider the invasiveness of the researcher’s presence – even when no identifiable information is to be collected. As the level of intrusiveness grows, so do the risks to privacy.
Researchers should keep in mind that the likely benefit of the research must justify the risks to participants (see National Statement 1.6 on Beneficence). This means that as the risks to privacy rise, so too must the likely benefit of the research.

The ethics of using social media data in research is a fast-changing space and it is important that researchers re-consult with this guidance through time.

Although researchers in NSW are not considered to be “mandatory reporters” of child abuse and neglect, Section 24 of the Children and Young Persons (Care and Protection) Act 1998 provides for any person to make a report if they suspect on reasonable grounds that a child is at significant risk of harm , such as:

Information from your own observations of the child’s physical condition or behaviour, something that the child might tell you, or information gained from any other person
You must be able to recognise and understand the abuse and neglect.

The extent of harm to a child’s safety, welfare and wellbeing that may prompt a report include:

The child’s basic physical or psychological needs are not being met or are at risk of not being met (neglect)
The parents/caregivers have not arranged and are unable or unwilling to arrange for necessary medical care for the child
The child has been or is at risk of being, physically or sexually abused or ill-treated
The child is living in a household where there have been incidents of domestic violence and, as a consequence, the child is at risk of serious physical or psychological harm
A parent/caregiver has behaved in such a way towards the child that the child has suffered or is at risk of suffering serious psychological harm.

Any report made under the Act can be made anonymously and the maker of the report is protected from actions such as breach of professional etiquette or ethics, professional conduct or defamation.

If there is a possibility that disclosures about child abuse or neglect could be made in the conduct of your research, you should include a brief statement explaining your reporting obligations on the Participant Information Sheet.

Chapter 4.6 of the National Statement on Ethical Conduct in Human Research addresses research which may potentially reveal illegal activities. It identifies the following research where information gathered could lead to legal consequences:

Research intended to study, and perhaps to expose, illegal activity
Research not specifically intended to discover illegal activity, but likely to do so
Research where illegal activity is discovered inadvertently and unexpectedly.

If, during the conduct of your research, a participant gives you information about a serious indictable offence (a crime punishable by five years or more imprisonment) you are required to report the information to police or the appropriate authority. This is only where the offender has not previously been investigated/prosecuted and/or convicted for the offence.

Researchers may also be required to provide information about illegal activity that is disclosed to them during the conduct of their research if it is ordered by a court (eg. subpoena or search warrant).

If your research has the potential to collect information about illegal activity by participants or others, you should:

Clearly outline on the Participant Information Sheet and during the consent process any limits on confidentiality that are associated with your reporting obligations under the law
Consider the use of pseudonyms, or the removal of links between names and data, for participants whose illegal activity may be revealed or discovered in research.

Researchers must be clear to their participants from the start as to the circumstances in which they will breach the confidentiality of the data that the participant provides and what the researcher will do to avoid having to disclose confidential information.

UOW Staff and Students who wish to conduct research overseas, or with overseas participants*, must seek Ethics approval before commencing their research.

For projects taking place in a country or province that has an ethics review process equivalent to the NHMRC standard of HREC review , the local approval may be accepted by the UOW HREC via an ‘ Acceptance of Approval by an External HREC ’ without the need to submit a full New Application. For example, receiving ethics approval from an IRB in the USA is highly likely to meet this requirement. If you think that your research may fall into this category, please contact the Ethics Office for further information.

For projects taking place in a country or province that does not have an ethics review process equivalent to an HREC review :

Where there exists a local process for the review of research, this local approval must be sought in addition to UOW HREC approval. A copy of the local human ethics approval must be provided to the UOW HREC before the research commences.
In countries or provinces where there is no local ethics approval process, this must be outlined in the application.

There are additional ethical considerations which may arise from the differing beliefs, customs and cultural heritage of overseas populations. Researchers must address these considerations in the Additional Form: Research Conducted Overseas which is to be submitted to the UOW HREC along with the UOW Application Form.

*Anonymous surveys which may include responses from people living overseas, but are not targeting overseas participants, are not likely to require this additional form. Please contact the Ethics Office if you would like further information.

Chapter 2.2 of National Statement on Ethical Conduct in Human Research details the general requirements for consent. The basic principle is that consent should be informed and voluntary. Academics wishing to conduct research on university student groups, whether to evaluate their own teaching or for other purposes, need to ensure that the research is designed so that the students do not perceive any obligation to agree to participate.

Key considerations to be mindful of are:

There is an inherent power imbalance between university students and academic staff. This is greater when the academic is, or is likely to be, teaching the students in question, either now or in the future. It is always preferable to conduct research on students you do not teach.
If the research activity will take place in class time, the activity must be directly aligned with the learning objectives of the subject and this should be clearly communicated to all students invited to participate. The decision not to participate must not have any negative impact on student’s learning outcomes from that class.
Students must receive adequate notice of the activity, to allow time to consider whether or not they wish to be involved.
Active consent is always required where you are using student generated content e.g. journals, blog posts, assessment results.
When seeking consent to use student generated content for research purposes (including assessment material), to mitigate the risk of coercing students to consent (or students perceiving a pressure to do so) students should only be approached for their consent once grades are released. Please note this also applies to situations where students are approached by researchers who are not involved in teaching the relevant subject.
Where the research is using student grades or student evaluations of a class, consideration should be given to how the identity of participants can be concealed from the teaching staff conducting the research. This may include having a third party de-identify the data, not analysing data until after subject results have been released, or both. Consideration should also be given to whether students are likely to encounter the relevant teaching staff in future subjects during their studies.
Where the research involves classroom observations but not recording information about individual students, opt out consent may be an option. Adequate information must be given to students to give them time to opt out. Consideration must be given to what these students do while the observations are happening, and how they can be excluded from the observations without making it obvious to others that they are being excluded or ostracising them from the rest of the class. Applications seeking opt out consent should explain how the proposed research meets each of the criteria for opt out consent as detailed in paragraph 2.3.6 of the National Statement. For useful guidance see the Scholarship of Teaching and Learning Human Research Ethics Resource Manual.

The NSW Ministry of Health website provides guidance on policies and links to forms to be used for applications involving NSW Health researchers, data or sites.

For NSW Health research the local HREC is not always the right HREC, this will depend on the location of the sites and the population involved in the study.

If your research is single site, or within a single Local Health District, you would normally use the local HREC.
If your research involves multiple Local Health Districts, you must use a Lead HREC.
If your research involves more than one jurisdiction participating in the National Mutual Acceptance Scheme the application can be lodged with a Certified Reviewing HREC.
Research involving Aboriginal and Torres Strait Islanders must also be reviewed by the NSW Aboriginal Health and Medical Research Council (AH&MRC) HREC .
Research using state wide data collections owned or managed by NSW Health must be reviewed by the NSW Population and Health Services HREC .
All human research projects undertaken with people in the correctional environment in NSW must be reviewed by the Justice Health HREC and the NSW Aboriginal Health & Medical Research Council HREC.

Current Governance Processes

Applications involving NSW Health sites or researchers must be approved by the administration of the relevant Local Health District, which reviews governance issues (e.g. resource availability) related to the applications. The governance application form is the Site Specific Assessment Form (SSA); it is generated automatically when you fill in a HREA form in REGIS.

Governance approval is additional to the HREC review, which looks at applications for their compliance with relevant ethical and privacy guidelines and laws.

National guidelines

The Australian Code for the Responsible Conduct of Research
National Statement on Ethical Conduct in Research Involving Humans
Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders
Keeping research on track II
AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research

International statements and agreements

World Medical Association, Declaration of Helsinki (2013)
Universal Declaration of Human Rights

Clinical research resources and guidelines

Therapeutic Goods Administration
Medicines Australia
Australian clinical trial handbook

Contact the Human Research Ethics Team

Ethics of Psychological Research

Animal Research
Conducting Research

Psychological Research

August 2023

This nine-hour course explores basic ethical concerns associated with scientific research, using specific historical examples to illustrate key issues. It begins by exploring the purposes served by codes of research ethics, highlighting their role in guiding researchers towards responsible conduct. A comprehensive account of the five general Ethical Principles and ten Ethical Standards of the American Psychological Association’s Ethics Code establishes a foundation for the course, particularly focusing on the specific elements of the APA code that apply to researchers, such as the operations of Institutional Review Boards and Institutional Animal Care and Use Committees, which play crucial roles in overseeing research involving human and nonhuman subjects.

The course emphasizes the protections offered by ethics codes for human participants, ensuring their safety and well-being throughout the research process. Ethical considerations in planning research studies using nonhuman animals are also thoroughly examined, with a focus on the importance of the three Rs (Replacement, Reduction, and Refinement) in animal research.

Students will explore the implications of WEIRD (Western, Educated, Industrialized, Rich, and Democratic) participants being overrepresented in psychological research, and how this affects the generalizability of findings. The course addresses problems in analysis and interpretation of results like p-hacking and HARKing (Hypothesizing After the Results are Known), explaining how replication and preregistration can mitigate these issues.

Real-life examples of ethical violations are used to apply theoretical knowledge, helping students identify the consequences of different types of fraud in research. Through this comprehensive exploration, students will be equipped with the knowledge and skills to conduct ethical research in psychology.

Learning objectives

Illustrate the history of ethical concerns about scientific research using specific examples.
Describe purposes served by codes of research ethics.
Explain the five general Ethical Principles of the APA Ethics Code.
Describe the issues addressed by the APA Ethical Standards that apply to researchers.
Explain how IRBs and IACUCs operate.
Outline the major ethical considerations in planning a research study using nonhuman animals.
Explain the importance of the three Rs in animal research.
Explain the protections ethics codes offer for human participants in research.
Describe the implications of WEIRD participants being overrepresented in psychological research.
Apply your knowledge of ethical violations with real-life research.
Identify the consequences of the different types of fraud in research.
Explain how replication and preregistration address the problems of p-hacking and HARKing.

This program does not offer CE credit.

More in this series

Introduces applying statistical methods effectively in psychology or related fields for undergraduates, high school students, and professionals.

August 2023 On Demand Training

Introduces the scientific research process and concepts such as the nature of variables for undergraduates, high school students, and professionals.

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August Newsletter

August 2024

Collaboration, Communication and Connection

The evolving landscape of human research with ai - putting ethics into practice, register now webinar on differing approaches to measuring and ensuring irb effectiveness.

Review the latest SACHRP Recommendations for the Ethical Review and Inclusion of LGBTQI+ Participants in Human Subjects Research

Visit our Collection of Luminaries Lectures Recordings

Commemorative event for the 50th anniversary of the national research act.

Virtual Research Community Forum September 9-10, 2024

AI is the talk of the town. Catch up on potential benefits and pitfalls of AI-assisted research. Learn about synthetic research and how electronic health records (EHR) could help accelerate important research! You will also get a chance to interact with staff and ask questions about their work at the Office of Research Integrity (ORI) and OHRP!

Wait no more. Register today for this educational event!

A maximum of 4.5 continuing education credits for Certified IRB Professional (CIP) can be claimed for each day of the event.

OHRP Exploratory Workshop (virtual) Thursday, September 19, 9:45 a.m. - 4:15 pm ET

Join an exciting panel of speakers to explore challenges in ethics, oversight, and governance in human research involving AI. Review our agenda at www.hhs.gov/ohrp/education-and-outreach/exploratory-workshop/2024-workshop/index.html .

No registration required. Simply save the date and join us on the day!

The HHS Office for Human Research Protections (OHRP) and the FDA Office of Clinical Policy (OCLIP) are co-hosting a live public webinar to hear from research ethics professionals and the public about differing approaches that may contribute to ongoing efforts to measure institutional review board (IRB) effectiveness in protecting human subjects in research. This virtual event will be held on Thursday October 17, 2024, from 12:00 – 2:00 PM ET .

For speaker information and event agenda, visit this page .

Spots are limited, so register now !

Review the latest SACHRP Recommendations for the Ethical Review and inclusion of LGBTQI+ Participants in Human Subjects Research

The document presents a comprehensive set of recommendations for the research community for conducting research related to LGBTQI+ communities. It responds to three primary objectives: (1) Ensuring the ethical protection of LGBTQI+ participants in research, (2) Promoting the advancement of LGBTQI+ research and working towards reducing health disparities within LGBTQI+ communities; and (3) Enhancing the knowledge and cultural understanding of research involving LGBTQI+ participants.

A small panel of experts spoke about some of the ethical and regulatory considerations for research related to LGBTQI+ populations at the public meeting of the Secretary’s Advisory Committee for Human Research Protections (SACHRP) on October 18, 2023. You can readily access their presentations and others in OHRP’s Luminaries Lecture Series . Available titles include:

Ethical and Regulatory Considerations for LGBTQI+ People in HHS HSR, Christina N. Dragon, MSPH, CHES
Risk & Benefit: IRB Review and LGBTQIA+ Research Participation, Amy Ben-Arieh, JD, MPH
Evidence-Based Recommendations for Ethical Research Practices with Sexual and Gender Minority Adolescents by Brian Mustanski, PhD

Webinars in the Luminaries Lecture Series are eligible for education credits for Certified IRB Professional (CIP).

On Friday, July 12, 2024, OHRP commemorated the 50th anniversary of the National Research Act with a live virtual event that reflected on the past, present, and future of research with human subjects. If you missed it, you can now watch the recording at https://www.hhs.gov/ohrp/education-and-outreach/national-research-act-50th-anniversary/index.html .

Save the date! Webinar Advancing Research Participation for LGBTQIA+ Individuals

A joint OHRP/NIH event on Wednesday, October 2, 12 – 2 pm ET.

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You will be bound by the destination website's privacy policy and/or terms of service when you follow the link.
HHS is not responsible for Section 508 compliance (accessibility) on private websites.

For more information on HHS's web notification policies, see Website Disclaimers .

Visiting Scholars and Students

Decorative banner for the Visiting Scholars and Visiting Students program page

The UC Berkeley Kavli Center for Ethics, Science, and the Public invites applications for visiting appointments from national and international scholars and graduate students in the sciences, humanities, social sciences, and professional fields who are interested in exploring ethical challenges, advancing solutions, or identifying ways of involving impacted communities and the public in science and technology and its governance.

Our center offers a unique environment where visitors can engage in a variety of center and university programs and events and become part of a multi-disciplinary intellectual community. Please be aware that visitors must secure their own funding for their stay.

The Kavli Center's Focus Areas

The Kavli Center aims to advance our understanding of the ethical and societal dilemmas born from scientific advancements; how scientists should be trained to account for these, how humanities, social sciences, professional fields, and the public can and should inform and guide these scientific advancements, and how they should be governed. Prospective visitors should be working on topics related to this vision (for more, see Vision ). The center comprises three elements: a “hub,” representing the core activities of the center, where all affiliates come together to address fundamental ethical questions across disciplinary boundaries; “spokes” linking these activities to specific scientific disciplines; and an “axle” connecting the center with the larger society it sits within. Current spoke sciences focus on genome editing, artificial intelligence, and neuroscience. These areas have enormous potential to benefit humanity but also raise questions of practical and existential ethical significance and may affect distinct communities differently. Bringing these three scientific fields together under one center enables the identification of shared challenges and the translation of solutions and lessons learned from one to another.

Areas of Particular Interest

We encourage applications from visitors working on a wide range of topics related to the center's work. We are particularly interested in those visitors with expertise in public, stakeholder, or community engagement who are interested in developing a collaboration, building capacity among scientists, or running an engagement with us around an ethical dilemma in one of our three scientific spokes.

Opportunities & Privileges

Connection with the Kavli Center, including access to the center's core faculty and fellows
Access to all Kavli Center events and programming including special opportunities such as pilot projects, engagement opportunities, and collaborations with the journalism school. The center periodically hosts diplomats or policy experts or has access to invitation-only events with high-level experts and officials. When visitors' expertise aligns, we regularly nominate or include them in such events.
UC Berkeley email account & Cal ID
Library borrowing privileges and research database access
Ability to audit UC Berkeley courses with the instructor’s permission
Access to campus events
Access to desk space and meeting rooms in 621 Sutardja Dai Hall

Expectations

Visiting Scholars and Students should...

Strive to cross disciplinary boundaries while visiting the Kavli Center.
Fully engage in the programming and activities of the center. This includes collaborating with our affiliated faculty or Ethics, Science, and the Public Fellows, participating in our Colloquium Series, and contributing to our seminars, workshops, and social events.
In addition to fully participating in the center, Visiting Scholars and Visiting Students must advance an area of study or research that will benefit from time in the center.

Duration of Visit

Visiting appointments are at least one month and up to one year, with a maximum cumulative appointment time of two years.

Visiting Scholars and Visiting Students are required to provide their own funding. The Kavli Center will consider modest supplemental funding for those exceptional applicants with financial hardship. Typically, financial support comes from visitors' home institutions, private foundations, or government grants.

$910 annual sponsorship charge (this fee is not pro-rated for stays shorter than a year).
University Services fees: Visiting Scholar $750 |Visiting Student Researcher $1000. Please visit the Visiting Scholar & Postdoc Affairs (VSPA) website for more details.
All international scholars coming to the Berkeley campus require a visa, typically the J-1 visa, and must pay a one-time, non-refundable processing fee of $650. Please visit the Berkeley International Office (BIO) for more details.
Most international applicants must pay the SEVIS fee and a Visa application fees when applying for the J1 Visa at a US Embassy abroad.

Types of Visiting Appointments

Visiting scholars.

A Visiting Scholar appointment allows individuals with a PhD (or the terminal degree in their field), typically earned more than 5 years ago, the chance to participate in short-term educational or research projects on the UC Berkeley campus under the supervision or sponsorship of a UC Berkeley faculty member; in this case, under the Kavli Center.

Scholars must maintain their primary academic position or other employment elsewhere while visiting Berkeley. Visiting Scholars are self-supported from external funding sources appropriate for the duration of the appointment. Remote appointments are not permitted. Read more about the University's definition and requirements for visiting scholars at the VSPA website .

Visiting Postdocs

While the Visiting Scholar appointment is intended for scholars who are 5 years out of their terminal degree, the Kavli Center will also consider visiting appointments for scholars with recent PhDs who hold an active postdoc appointment at another institution and wish to conduct research as a visitor at UC Berkeley. Visiting postdocs must be onboarded as a Visiting Scholar by exceptional approval by the campus.

Visiting Student Researcher

Visiting Student Researchers (VSR) are students currently pursuing a degree in a degree-granting program at another university (not in the University of California system), and possess at least a bachelor’s degree. VSRs do not enroll in UC Berkeley courses for credit. Remote appointments are not permitted; all visits must be conducted on campus.

Please note that students enrolled at any UC campus are ineligible for this type of appointment as they enjoy the benefits of reciprocity at UC Berkeley. Read more about the University's definition and requirements for visiting student researchers at the VSPA website .

How to Apply

To apply to be a Visiting Scholar or a Visiting Student, please follow the steps below.

Application

1) Kavli Center Application : Complete the Kavli Center's form ( https://tinyurl.com/2hpa39n3 ) to be considered for a visiting appointment. Promising applicants may be asked for a Zoom interview.

As part of the application, you will be asked to provide the following:

Faculty of interest: Please list any faculty with whom you are interested in studying/working while a visiting scholar or student.
Interest Statement: Briefly, describe the relevance of the Kavli Center for Ethics, Science, and the Public to your academic or professional development. Why are you interested in holding a visiting appointment?
Proposed plan of study : Please provide a brief (1-2 paragraphs) summary of the proposed plan of study/research while a visiting scholar at the Kavli Center for Ethics, Science, and the Public.

2) University Application : If the Kavli Center decides to extend an invitation to hold a visiting appointment, applicants will advance to filling out the University's paperwork, including the application through the VSPA and if needed, a visa application through BIO.

Relevant University Offices

Visiting scholars & postdoc affairs (vspa) office.

Those applicants selected through the Kavli Center's application process will subsequently work with the Visiting Scholars & Postdoc Affairs (VSPA) Office to complete the campus process. Procedures and university policies can be found at the VSPA website.

Berkeley International Office (BIO)

Information regarding visas as well as useful resources for international visitors can be found at the Berkeley International Office website .

Kavli Center-specific Application Review Time: we aim to provide a response within a month of receiving an application.

University Approval Timeline: for domestic applicants, the campus approval process typically takes three weeks once all paperwork is submitted. For international applicants, the approval process may take up to four months due to the need for out-of-country visa processing. We strongly recommend starting the application process as early as possible.

Please direct any questions to [email protected] .

Analyzing the ethical and societal impacts of proposed research

An interdisciplinary Stanford team has created and seeks to scale a new Ethics and Society Review (ESR) that prompts researchers seeking funding to consider the ethical and societal impacts of their research and how to mitigate potential harms.

Currently, Institutional Review Boards (IRBs) are the main form of ethical review for research done in the United States that involves human subjects. IRBs are groups designated to review and monitor research and ensure the rights and welfare of the people taking part in the study. According to the U.S. Food and Drug Administration’s regulations, IRBs have the authority to approve, deny, or require modifications to a research project, but their scope is limited to assessing the impact the of research on the individuals in the study.

The newly proposed ESR fills a critical need by considering how proposed research could have harmful effects on society as well as positive effects. Consider the effects for example of AI algorithms on fairness in sentencing or on who is prioritized for treatments, or the effects of a proposed technology on privacy. If there are negative risks or known negative effects, how might these be anticipated and mitigated?

Earlier this year, the ESR was tested in a pilot program that reviewed proposals submitted by researchers seeking funding from the Stanford Institute for Human-Centered Artificial Intelligence (HAI). The first faculty review panel included experts from fields including anthropology, communication, computer science, history, management science and engineering, medicine, philosophy, political science, and sociology. A paper published December 28 in the Proceedings of the National Academy of Sciences ( PNAS) details the findings and how the ESR could be applied in other areas of research and institutions elsewhere.

Here, four of the paper’s six co-authors, Michael Bernstein , associate professor of Computer Science in the School of Engineering ; Margaret Levi , the Sara Miller McCune Director of the Center for Advanced Study in the Behavioral Sciences (CASBS ); David Magnus , the Thomas A. Raffin Professor of Medicine and Biomedical Ethics at Stanford Medicine ; and Debra Satz , the Vernon R. and Lysbeth Warren Anderson Dean of the School of Humanities and Sciences discuss how the ESR came to be, why it’s needed, and the impact they hope it will have.

What is the process for the ethics and society review that you propose?

Bernstein: The engine that we usually associate with ethics review—the Institutional Review Board, or IRB—is explicitly excluded from considering long-range societal impact. So, for example, artificial intelligence projects can be pursued, published, and shared without engaging in any structured ethical or societal reflection. But even if many of these projects do not need to engage with IRBs, they need to apply for funding. The ESR is designed as a gate to funding: funding from collaborating grant programs isn't released until the researchers complete the ESR process.

Levi: The ESR depends on a partnership with a funding group that is willing to release funds to successful proposals only after the project investigators provide a statement outlining any problematic ethical implications or societal consequences of their research. Of particular interest to the review panel are mitigation strategies. If the outline is adequate, the funds are released. If the panel deems it necessary, there is iterated discussion with the panel to help figure out where there are problems, trade-offs that need to be addressed, and appropriate mitigation steps. This is more of a collaborative than a compliance model.

Why do we need an ethics review and why is the focus on potential impacts to society important?

Satz: Our current review processes do a good job of protecting individuals from unnecessary risks or harms. But some of our social problems do not show up directly as harms or risks to individuals but instead to social institutions and the general social fabric that knits our lives together. New technologies are upending the way we work and live in both positive and negative ways. Some of the negative effects are not inevitable; they depend on design choices that we can change.

Magnus: Because this is not part of the IRB process, it is easy for researchers to focus solely on the risks to individual participants without consideration of the broader implications of their research. For example, a project that was developing wearable robotic devices did a great job of considering all of the relevant risks that research participants would be exposed to and how to mitigate those. But they did not at all consider the literature on the importance of taking downstream implications of the technology (for example privacy issues that are likely to arise when implemented in real world settings that do not arise in the laboratory research setting) into account in the design process.

An interdisciplinary group of authors worked on this paper, how did that come about?

Satz: The problems posed by new technologies require input from many fields of knowledge, working together. The problems cannot be adequately addressed by ethicists or philosophers pronouncing from “on high”—removed from those creating and thinking about technology and science. We have found that deliberation among computer scientists, philosophers, political scientists, and others yields a deeper understanding of the challenges and provides better guidance for improving our practices.

Levi: All four of the faculty have been active—in different domains—in promoting standards for research that take into account ethical and societal implications, not just harms to individual subjects and participants. Within Stanford’s Ethics, Society, and Technology Hub , CASBS has been coordinating the implementation and evaluation of the ESR. Betsy Rajala , the program director of CASBS, and Charla Waeiss, a consultant to CASBS, have been the key players and are full partners in the writing of the PNAS paper.

Bernstein: What initially catalyzed this effort was an email that Debra Satz sent about a (rejected) grant that we were on, where she mentioned that IRBs were focused on risks to human subjects rather than risks to human society. Her comment gave words to much of the uncertainty I had faced in my career as a computer scientist, and it rattled around in my brain until I translated it into the basic concept of the ESR—ethics and societal review connected to grant funding. I quickly connected with Margaret Levi, who had been pursuing similar goals in the social sciences and had a strong interest in societal impacts of AI. We pitched it to the leadership of Stanford's HAI; they connected us with David Magnus, who has vast experience in ethics review, and the four of us were off to the races.

Did any of the results surprise you?

Bernstein: Two results surprised me. First, I expected substantial pushback from researchers along the lines of "you're adding red tape!" However, all the respondents to our survey were willing to submit to the ESR again in the future. Second, over half of researchers felt that the process had positively influenced the design of their research project. For a fairly lightweight process to benefit the design of half of projects was a huge—and very pleasant—surprise to me.

What’s next for the ESR?

Magnus: The biggest challenge is to find a way to make this scalable. It is one thing to do an ESR for 35 or 40 proposals, it is quite another to do 400 or 4,000. We hope this scaffolding will make it easier for researchers to think through the ethical and social issues raised by their research and identify strategies to mitigate any problems. [We also hope this process] becomes a routine part of research.

Levi: We also are eager to collaborate with other universities and firms to see how best to transfer our process broadly. In addition, we are considering ways to help researchers when they discover new ethical implications or societal consequences in the process of their research. In terms of improving the ESR, our plans are two-fold. First, we are determining ways to staff and support the faculty panels so that we are not misusing or over-demanding of faculty time. Second, and perhaps most importantly, we are building the scaffolding that will inform and transform thinking so that considering the ethical implications and societal consequences becomes second nature.

Related: Michael Bernstein , Associate professor of Computer Science

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Insights for College Transitions is a resource that emphasizes evidence-based strategies for practitioner-scholars who support first-year students and students in transition inside and outside the classroom. Articles on a variety of topics including those focusing on a broad range of college transition issues; innovative and creative programs to support student success; first-year pedagogical strategies; and organizational structures and institutional resources for supporting college success.

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Confidentiality. The editor and editorial staff of the National Resource Center will not disclose any information about a submitted manuscript to anyone other than the corresponding author, reviewers, potential reviewers, and other editorial advisers, as appropriate.

Disclosure and conflicts of interest. Unpublished materials disclosed in a submitted manuscript will not be used by the editor, the members of the editorial board, or the staff of the National Resource Center for their own research purposes without the author's explicit written consent.

Originality, plagiarism, and acknowledgment of sources. Authors will submit only entirely original works and will appropriately cite or quote the work and/or words of others, including their own prior publications. Publications that have been influential in determining the nature of the reported work should also be cited.

Ethical research practices. In some cases, manuscripts submitted to Insights may report on institutional research. Authors should affirm that they followed their institutional policies with respect to the collection and reporting of program assessment data (e.g., IRB approval) accompanying the manuscript.

Authorship of the manuscript. Authorship should be limited to those who have made a significant contribution to the writing or revision of the manuscript under consideration. All those who have made significant contributions should be listed as co-authors. The corresponding author ensures that all contributing co-authors and no uninvolved persons are included in the author list. The corresponding author will also verify that all co-authors have approved the final version of the manuscript and have agreed to its submission for publication. Individuals who contributed to the manuscript in a meaningful way but who fall short of the requirements for authorship may be listed in a separate acknowledgment.

Multiple, redundant, or concurrent publications. In general, manuscripts describing a student success practice using essentially the same structure and assessment data should not be published in more than one Insights issue or other publication outlet. Submitting the same manuscript to more than one Insights issue or other publication outlet constitutes unethical publishing behavior and is unacceptable. Manuscripts that have been published as copyrighted material elsewhere cannot be submitted. In addition, manuscripts under review by Insights should not be simultaneously submitted for review to other copyrighted publications.

Inclusive language. Authors should refer to the latest edition of the Publication Manual of the American Psychological Association for guidance on avoiding bias in their writing. In accordance with our commitment to inclusion, the National Resource Center believes it is unacceptable to use constructions that might imply prejudicial beliefs or perpetuate biased assumptions against persons on the basis of age, disability, gender, racial and ethnic identity, sexual orientation, socioeconomic status, or some combination of other personal factors. Instead, authors should use affirming and inclusive language. For example, first-year student rather than freshman should be used to describe a student in the first year of postsecondary study.

Fundamental errors in published works. When an author discovers a significant error or inaccuracy in their own published work, it is the author’s obligation to promptly notify the editor or publisher and to cooperate with the editor to retract or correct the manuscript in form of an erratum.

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NeurIPS Code of Ethics

The Code of Ethics aims to guide the NeurIPS community towards higher standards of ethical conduct as it pertains to elements of research ethics and the broader societal and environmental impact of research submitted to NeurIPS. It outlines conference expectations about the ethical practices that must be adopted by the submitting authors, members of the program and organizing committees. The Code of Ethics complements the NeurIPS Code of Conduct , which focuses on professional conduct and research integrity issues, including plagiarism, fraud and reproducibility concerns. The points described below also inform the NeurIPS Submission Checklist, which outlines more concrete communication requirements.

Potential Harms Caused by the Research Process

Research involving human subjects or participants:

Fair Wages: all human research subjects or participants must receive appropriate compensation. If you make use of crowdsourcing or contract work for a particular task as part of your research project, you must respect the minimum hourly rate in the region where the work is carried out.
Research involving human participants: if the research presented involves direct interactions between the researchers and human participants or between a technical system and human participants, authors are required to follow existing protocols in their institutions (e.g. human subject research accreditation, IRB) and go through the relevant process. In cases when no formal process exists, they can undergo an equivalent informal process (e.g. via their peers or an internal ethics review).

Data-related concerns:

The points listed below apply to all datasets used for submissions, both for publicly available data and internal datasets.

Privacy: Datasets should minimize the exposure of any personally identifiable information, unless informed consent from those individuals is provided to do so.
Consent: Any paper that chooses to create a dataset with real data of real people should ask for the explicit consent of participants, or explain why they were unable to do so.
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Societal Impact and Potential Harmful Consequences

Authors should transparently communicate the known or anticipated consequences of research: for instance via the paper checklist or a separate section in a submission.

The following specific areas are of particular concern:

Safety: Contributors should consider whether there are foreseeable situations in which their technology can be used to harm, injure or kill people through its direct application, side effects, or potential misuse. We do not accept research whose primary goal is to increase the lethality of weapons systems.
Security: Researchers should consider whether there is a risk that applications could open security vulnerabilities or cause serious accidents when deployed in real world environments. If this is the case, they should take concrete steps to recommend or implement ways to protect against such security risks.
Discrimination: Researchers should consider whether the technology they developed can be used to discriminate, exclude, or otherwise negatively impact people, including impacts on the provision of services such as healthcare, education or access to credit.
Surveillance: Researchers should consult on local laws or legislation before collecting or analyzing any bulk surveillance data. Surveillance should not be used to predict protected categories, or be used in any way to endanger individual well-being.
Deception & Harassment: Researchers should communicate about whether their approach could be used to facilitate deceptive interactions that would cause harm such as theft, fraud, or harassment, and whether it could be used to impersonate public figures and influence political processes, or as a tool to promote hate speech or abuse.
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Human Rights: We prohibit circulation of any research work that builds upon or facilitates illegal activity, and we strongly discourage any work that could be used to deny people rights to privacy, speech, health, liberty, security, legal personhood, or freedom of conscience or religion.
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Impact Mitigation Measures

We propose some reflection and actions taken to mitigate potential harmful consequences from the research project.

Data and model documentation: Researchers should communicate the details of the dataset or the model as part of their submissions via structured templates.
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Responsible release and publication strategy: Models that have a high risk for misuse or dual-use should be released with necessary safeguards to allow for controlled use of the model, e.g. by requiring that users adhere to a code of conduct to access the model. Authors of papers exposing a security vulnerability in a system should follow the responsible disclosure procedures of the system owners.
Allowing access to research artifacts: When releasing research artifacts, it is important to make accessible the information required to understand these artifacts (e.g. the code, execution environment versions, weights, and hyperparameters of systems) to enable external scrutiny and auditing.
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Violations to the Code of Ethics should be reported to [email protected] . NeurIPS reserves the right to reject the presentation of scientific works that violate the Code of Ethics. Notice that conference contributors are also obliged to adhere to additional ethical codes or review requirements arising from other stakeholders such as funders and research institutions.