Please note:

The Human Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked. This information is kept here for archival purposes only. For the current guidelines, Human Research Ethics Committees should refer to the National Statement on Ethical Conduct in Human Research 2007.

2. Human Research Ethics Committees

Research proposals involving human participants must be reviewed and approved by a Human Research Ethics Committee (HREC) which is established by and advises an institution or organisation regarding ethical approval for research projects. Requirements are set out for:

institutions or organisations in establishing HRECs;

researchers in submitting research proposals to HRECs; and

HRECs in considering and reaching decisions regarding those proposals and in monitoring the conduct of approved research.

Institutions and organisations in which research involving humans is undertaken must individually or jointly establish, adequately resource, and maintain an HREC composed and functioning in accordance with this Statement.

Institutions or organisations are required to set up Human Research Ethics Committees (HRECs). (For useful discussions of the Australian system of research ethics review, see the Research Law Collection under ' Research, regulation of ', page L45).

Where two or more institutions agree, one HREC may be used to review research conducted in each institution. HRECs need sufficient resources in staffing and equipment to complete all the tasks involved in reviewing research proposals and monitoring the conduct of approved research. Institutions need to have processes for appointing members of HRECs and establishing that the HREC is functioning in accordance with the National Statement.

An institution or organisation whose review of research fails to comply with the National Statement may be deemed ineligible to retain or receive funds for research from the National Health and Medical Research Council or the Australian Research Council. This consequence would require a decision by one of these two bodies.

The institution or organisation must, when establishing an HREC, set out its terms of reference including the scope of its responsibilities, relationship to non-affiliated researchers, accountability, mechanisms of reporting, and remuneration, if any, for members.

Terms of Reference

Terms of Reference should be clear, concise and accessible to committee members, researchers and non-members. They may include any of the following:

purpose of the HREC;
responsibilities within the institution or organisation, including legal responsibilities;
relationship to the organisation, as well as other parts of the organisation;
sub-committees and other HRECs within the institution;
scope of responsibility, including definition of research to be reviewed and relationships (if any) to non-affiliated researchers;
reporting to the institution (management, board and council);
composition of the committee;
minimal categories of membership;
appointment of members and terms of appointment;
reimbursement and payment, if any, to members;
induction and support of new members;
education and training;
procedures for:
- meetings
- recording decisions
- rules of functioning
- expedited review
- researchers and HREC applications
- monitoring ongoing research
- complaints
- investigations
- appeals
- hearings
  See also NS 2.13
suspension or discontinuation of research; and
providing compliance reports to the Australian Health Ethics Committee.

Individual institutions may decide to include additional items.

Institutions and organisations may appoint more than one HREC

In some situations an institution or organisation may form more than one HREC. This may be appropriate in large organisations, such as some universities and hospitals, where the volume of research proposals reviewed is extremely high and proposals originate from many different disciplines. In this arrangement, each HREC formed must be composed according to NS 2.6. Institutions need to clarify responsibilities of each such committee.

For a discussion of legal aspects of the formation and operation of HRECs, see the Research Law Collection under ' Human Research Ethics Committees ' on page L33.

HRECs with small workloads

The Report of the Review of the Role and Functioning of Institutional Ethics Committees (March 1996) suggests that where committees meet infrequently or review few proposals, concerns arise about the 'time spent serving on committees', as well as about maintaining the 'breadth and depth of experience needed by committee members to maintain an adequate level of review.' The report therefore invites committees with small workloads, such as those reviewing fewer than 50 research proposals a year, to 'consider the possibility of amalgamation' with another committee. [Footnote 9]

However, the report also acknowledges that there may be good reason for maintaining a committee even though the number of research projects reviewed is small. This would be appropriate if the research reviewed was of such a specialised nature that the necessary expertise would be difficult to replicate on a committee dealing with a wider range of proposals.

The institution or organisation (individually or jointly) must accept legal responsibility for decisions and advice received from the HREC and indemnify its members.

Whether an HREC operates in an advisory capacity only or has other authority, the institution or organisation is responsible for its advice or decisions.

Individual members of HRECs have legal as well as ethical responsibilities in relation to the protection of the interests of research participants. Therefore, they could be sued by, for example, an injured participant or an aggrieved researcher. [Footnote 10] Thus, institutions must indemnify each member of its HREC for liability for acts done in accordance with its terms of appointment. [Footnote 11]

Researchers without affiliation to an institution or organisation with an HREC must ensure that the project is approved by an established HREC. There should be an agreement between the institution or organisation and researchers that defines the approval, conduct and monitoring of research, and who carries legal responsibility for it.

All research involving humans conducted in Australia should be reviewed by a properly constituted HREC. When an institution or organisation decides to permit their HREC to consider and approve research with which it has no connection, there must be an appropriate formal agreement between the parties.

The primary role of an HREC is to protect the welfare and the rights of participants in research and the primary responsibility of each member is to decide, independently, whether, in his or her opinion, the conduct of each research proposal submitted to the HREC will so protect participants.

Members of HRECs are not appointed to represent any interest in the research processthat is, that of a researcher, other research interests or participants. Each member of the HREC has the same responsibility, in reaching a decision whether or not to approve a research proposal, to protect the welfare and rights of the research participants. The decision-making process can involve the assessment of competing considerations of the value of research and the risks to participants, but should not be seen as adversarial. [Footnote 12]

Each committee member is expected to reach a decision independently, that is, according to their judgment of all the material available, including the opinions of other HREC members and expert advice. A decision is independent in the sense that it is the committee member's decision and not that of any other person or entity.

Further discussion in this area can be found in the Research Ethics Collection under ' Human Research Ethics Committees: Approval of Research ', page E84.

Composition

The minimum membership of an HREC is seven members, being men and women, comprising:

a chairperson;

at least two members who are lay people, one man and one woman, who have no affiliation with the institution or organisation, are not currently involved in medical, scientific, or legal work, and who are preferably from the community in which the institution or organisation is located;

at least one member with knowledge of, and current experience in, the areas of research that are regularly considered by the HREC (eg. health, medical, social, psychological, epidemiological, as appropriate);

at least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people (eg. medical practitioner, clinical psychologist, social worker, nurse, as appropriate);

at least one member who is a minister of religion, or a person who performs a similar role in a community such as an Aboriginal elder; and

at least one member who is a lawyer.

Chairperson

The chairperson should be chosen for her or his ability to draw on the experience of all members, including lay members and those with specialist expertise, and to demonstrate respect for each member's view. The chairperson also has responsibility for managing the agenda and making sure that all relevant items are covered and adequately recorded.

Further guidance to the chairperson's role in relation to committee meetings can be found in other paragraphs of the National Statement. That role is likely to include:

considering whether the committee is sufficiently informed on all aspects of research protocols (2.8);
overseeing arrangements for meetings (2.15);
being satisfied that all views of absent minimum members have been received and considered (2.16);
presiding over decision-making (2.17);
inviting researchers to attend meetings (2.18);
seeking advice from experts (2.19);
monitoring conflicts of interest (2.19, 2.20);
overseeing recording of decisions (2.14, 2.30); and
establishing a complaints process (2.40)

The chairperson is likely to be called upon to perform duties beyond those related to HREC meetings. These could include overseeing procedures, monitoring approved research and receiving reports, and being involved in expedited review.

The Chairperson is likely to be called on to communicate with other HRECs in multi-centre research approval arrangements (3.4, 3.5), and to be required to represent the HREC within the institution and in discussions with researchers and other HRECs.

Lay members

The qualifications for lay members are their independence from the institution and their non-involvement in medical, scientific or legal work. Those recruited from the community in which the institution is located are more likely to understand that community and how its members would view involvement in research. And those who have no experience in professions associated with research on human beings are more likely to bring a truly lay perspective.

Person with knowledge of, and current experience in, areas of research regularly considered by the committee

There may need to be more than one member in this category. For instance, where a university HREC regularly considers educational, psychological, medical and sociological research, the HREC will need the opinions of members with relevant knowledge and experience in each field. [Footnote 13]

Person with knowledge of, and current experience in, the professional care of people

This category of member is included because such a person has contact with potential or typical participants in research and has insights into the possible impact of research on such people.

Minister of religion

The rationale for including a minister of religion is that this person 'holds the importance of humanity and human life above all else'. [Footnote 14] Through the experience of pastoral care and mixing widely throughout the community, a minister of religion is usually in a position to understand the views of many people. [Footnote 15]

A person who is a lawyer

This member should have professional qualifications but need not be currently in legal practice. The role of the lawyer on an ethics committee is to 'advise the committee on legal implications of research considered or decisions taken and whether formal legal advice is necessary'; the attributes required are 'good judgment and experience in dealing with people', as well as competence in 'critical thinking and experience in the clarification of issues'. [Footnote 16]

Further discussion of the membership categories can be found in the Research Ethics Collection under ' Human Research Ethics Committees: Membership: Minimum requirements ', page E71, and ' Appointment ' page E73.

The institution or organisation must ensure that the membership will equip the HREC to address all relevant considerations arising from the categories of research likely to be submitted to the HREC. For example, an experienced medical practitioner should be included if the HREC considers research protocols which involve any physically invasive procedures or medical interventions, (eg. surgical, pharmacological, physiological, technological, or nutritional intervention).

This paragraph adds detail to the basic institutional responsibility set out in NS 2.1. Where additional members are needed, NS 2.9 is relevant.

An HREC must ensure that it is sufficiently informed on all aspects of a research protocol, including its scientific and statistical validity, that are relevant to deciding whether the protocol is both acceptable on ethical grounds and conforms with this Statement. This may necessitate appointment of additional members with specific expertise.

HRECs need to be satisfied that the research design can produce valid results and can protect the welfare and rights of research participants. To be satisfied, an HREC may seek or receive advice from an individual, a scientific committee in its institution, an external expert, or it may include an additional person who has specific expertise in the particular type of research. For more information on research design, see the Research Ethics Collection, ' Research, design and purpose ' page E143.

It is not possible to provide a comprehensive list of relevant considerations for every research approval. However, the following matters will usually require consideration:

The project

Is there a clear hypothesis?
Is the research question useful? Is the research worthwhile?
Is the research likely to yield new information, enhance understanding or clarify existing uncertainty?
Has this, or similar, research been carried out before in the same, or similar, contexts?
Can the research proposal be supported by a systematic review of the literature that would demonstrate the importance of the research question and that it builds upon the results of previous research?
If indicated, have perspectives of potential participant groups, the wider community, or other disciplines been incorporated into the research proposal?
Are the aims of the proposal clear?
Does the value of the project appear to be adequate to justify its conduct with humans?

The researchers

Do the researchers have necessary qualifications, competence and experience?
Are there adequate arrangements to ensure that members of the research team are aware of relevant ethical and legal obligations?

The funding

What is the relationship between the source of funding and the aims of the project?
Does that relationship have any implications for the ethical conduct of the project, especially the recruitment of participants, the character of information sought or the freedom to publish the results?

Other HREC approval

Where applicable, are the reasons given by another HREC, either for approval or the imposition of conditions, consistent with the HREC's own opinion?

Research methodology

Are all aspects of the research methodology clearly described?
Is the HREC satisfied that the methodology is appropriate to the achievement of the aims of the project?

Recruitment of participants

Is it clear how participants will be recruited?
Do the recruitment methods respect participants' rights to the confidentiality of their affairs?
Are the proposed participants appropriate in number and kind?

Burdens of research

Are the burdens and risks of research to participants clearly identified and have appropriate measures been taken to minimise these?
Is the balance between the burdens and risks to participants and the aims and benefits of the project such as to warrant approval?

Incentives for participation

Are financial or other rewards proposed to be given to participants?
Are these of such a size or value that they may unduly influence the freedom of participants to withdraw or otherwise protect themselves from risks?

Consent

Are the ways in which participants will be approached clearly described?
Is the information to be provided to potential participants adequate in content and appropriate in form?
Do the proposed methods of securing consent to participate provide a) sufficient time to consider the decision; b) evidence that participants understood their choices, and c) sufficient opportunities to ask questions and re-consider?

Discontinuing participation

Are the ways in which participants are advised of their freedom to withdraw sufficient in content and frequency?

Information protection

Is it clear who will (and who will not) have access to information collected during the project?
Are the proposed storage and security measures adequate?
Are participants clearly informed that information they provide will be used only for the project?
What measures are proposed to protect the confidentiality of information in the course of the project and are these adequate to give the degree of protection promised to participants?
Are the manner and form in which results will be published clearly described, and do they adequately protect the confidentiality of information and privacy of participants?

Legal issues

Does the project involve subject matter or conduct which may give rise to legal vulnerability of participants or researchers? Are adequate precautions to be taken?

In addition to these recurrent issues, some research requires particular additional attention, either because of the vulnerability of the intended participants or the type of research. Research with vulnerable participants that needs additional consideration includes:

research involving children (see NS 4.1�4.4);
research involving participants with intellectual or mental impairment, including temporary impairment, for example as a result of alcohol or drug-induced intoxication (see NS 5.1�5.4);
research involving persons in highly dependent medical care situations (see NS6.1�6.10);
research involving persons in dependent or unequal relationships (see NS 7.1�7.3);
research involving collectivities (see NS 8.1�8.2);
research involving Aboriginal or Torres Strait Islander communities (see NS 9, which refers to NHMRC Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research [1991]).

Types of research requiring additional attention include:

research involving ionising radiation (NS 10)
research involving assisted reproductive technology (NS 11)
clinical trials (NS 12.1�12.13)
epidemiological research (NS 14.1�14.13)
research using human tissue samples (NS 15.1�15.9)
human genetic research (NS 16.1�16.16)
research involving deception (NS 17.1�17.2)
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If an institution or organisation appoints additional members it should ensure that the membership continues to reflect both the diversity of the categories of members listed in paragraph 2.6, including gender, and the relative proportion of institutional to non-institutional members.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

Appointment of members

The institution or organisation may recruit members for an HREC in such a manner and shall appoint them for such a period and on such terms and conditions as it determines.

Institutions and organisations may develop explicit policies to ensure that appropriate people are recruited to HRECs. In developing such policies, the points made in NS 2.6 about attributes, desired qualities of members and minimum categories of membership should be considered. See also the Research Ethics Collection under 'Human Research Ethics Committees: Membership: Minimum requirements', page E71.

The term of appointment of members is a decision for the institution. It may be advisable to include the time period in the written Terms of Reference. The benefit of maintaining some continuity of membership by overlapping terms of office could be considered.

Traditionally, members of HRECs have provided their services on a voluntary basis; some institutions offer 'sitting' fees, and others are required to pay fees by the legislation under which they operate. The appropriateness of payments to members of HRECs is an issue to be determined by individual institutions. [Footnote 17] The National Health and Medical Research Council supports the payment of reasonable expenses such as travel, parking and additional child care.

Members are to be appointed for their expertise and not in a representative capacity.

HREC members must reach their decisions independently, and not on behalf of or in accordance with any identifiable interest. See also NS 2.5.

Members must receive a formal notice of appointment and assurances that the institution or organisation will provide legal protection in respect of liabilities that may arise in the course of bona fide conduct of their duties as committee members.

Members need a full and clear statement of their responsibilities and any other information or documentation that will enable them to fulfil their roles. This should include copies of the National Statement, the Terms of Reference of the HREC and any previous reports on the committee's activities. It should also include any other relevant material about the committee's processes, procedures and protocols, and an up-to-date list of members' names and contact information, including the administrative support person and other relevant personnel.

Procedures

Institutions and organisations and their HRECs must establish working procedures concerning:

frequency of meetings;

preparation of agendas and minutes;

distribution of papers prior to meetings;

presentation of research protocols;

timely consideration and review of research protocols;

methods of decision making;

prompt notification of decisions;
reporting of adverse occurrences;
appropriate monitoring;
receiving complaints;
advising institution(s) or organisation(s) to discontinue a research project;
fees, if any, to be charged; and
confidentiality of the content of protocols and of committee proceedings.

For a discussion of meeting frequency, agendas and minutes, applications forms and methods of decision-making, see the Research Ethics Collection, ' Human Research Ethics Committees ', page E67-88.

Some commentary on the other items for working procedures appears in relation to the following paragraphs:

Distribution of papers before meetings - NS 2.15
Methods of decision-making - NS 2.17
Reporting of adverse occurrences - NS 2.37, 2.38
Monitoring - NS 2.33�2.38
Complaints - NS 2.39�2.43
Suspension of research - NS 2.44�2.45
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An HREC may approve, require amendment of, or reject a research proposal on ethical grounds. The HREC must record decisions in writing and should include reasons for rejection.

HRECs should inform researchers in writing of decisions and, in the event of rejections or recommended amendments, the reasons for those decisions.

Meetings of an HREC must be so arranged as to allow, wherever possible, all members to be fully informed by receipt of all relevant papers and the opportunity to attend.

The agenda, including copies of research proposals, should be distributed to all members prior to the meeting, allowing sufficient time for reading. Some committees also distribute a copy of relevant grant applications to members who are selected to lead the committee review process, while others distribute comments from members and responses from the researchers.

Committees benefit by regular attendance of members at all meetings. Members are then in a position to consider ethical issues within the context of a range of points of view. This promotes informed discussion and consensual resolution of conflicting views.

Where there is less than full attendance at a meeting, the Chairperson must be satisfied, before a decision is reached, that the minimum membership listed in paragraph 2.6 have received all papers and have had an opportunity to contribute their views and that these have been recorded and considered.

This paragraph is designed to ensure that all HREC decisions are the result of consideration of the views of each of the categories of members listed in NS 2.6.

HRECs need to establish procedures to enable members who are unable to attend a particular meeting to contribute, prior to that meeting, views on each protocol to be considered. Written comments may be communicated by any convenient method, including email or facsimile. The chairperson is responsible for ensuring that these views are recorded and considered at the meeting.

Some committees establish a quorum that needs to be met before the committee can proceed with a meeting. A quorum serves the important purpose of ensuring a degree of discussion, but needs to be realistic, taking into account the mechanism required by this paragraph.

An HREC should endeavour to reach decisions by general agreement. This need not involve unanimity, but failure to agree may require an extension of time to reconsider the research protocol and its possible amendment, especially when any member is not satisfied that the welfare and rights of participants are protected.

Committees are encouraged to respect the expression of a diversity of views and to allow the time necessary to review all concerns. [Footnote 18] Full consideration of all relevant perspectives fosters greater confidence in the committee's decisions and the advice it offers.

An HREC may invite the researcher(s) to be present for discussions of the research and may request amendments to the research protocol.

HRECs need to be sufficiently informed about each research protocol (NS 2.8). Interviewing researchers is one means to this end.

Some HRECs require all researchers presenting proposals to attend an interview, while others restrict such interviews to proposals involving contentious ethical issues, invasive or potentially risky procedures, or the need for clarification. Interviews provide opportunities for detailed assessment of the proposed research, for provision of information about its conduct, for clarifying the capacity of the researchers to fulfil their responsibilities and for negotiating possible amendments to research proposals. Interviews can contribute to a cooperative working relationship.

Communication between individual HREC members and researchers should be in accordance with procedures established by the HREC.

Confidentiality of protocols and proceedings

Documents are submitted to an HREC for the sole purpose of consideration and, if thought fit, approval. Generally speaking, HRECs should regard this as confidential material. They should take care to prevent it being disclosed outside of the HREC except for the purpose for which it was provided, for example obtaining an opinion from an expert. Where a committee thinks consultation within the research or wider communities is desirable, or where it wishes to share its experiences with other committees, it should seek the consent of the parties involved or omit potentially identifying information.

These strategies could also be applied when inviting interested researchers and others to attend committee meetings.

An HREC may seek advice and assistance from experts to assist with consideration of a research protocol, but must be satisfied that such experts have no conflicts of interest in relation to the research project under consideration arising from any personal involvement or participation in the research, any financial interest in the outcome or any involvement in competing research.

See also comments on NS 2.20 and the Research Ethics Collection, ' Conflicts of interest ', page E25.

An HREC shall ensure that no member of the committee adjudicates on research in which that member has any conflict of interest including any personal involvement or participation in the research, any financial interest in the outcome or any involvement in competing research.

When an HREC member has, or could be seen to have, a conflict of interest, that member should withdraw from the meeting when that project is being assessed. The absence of the member concerned should be recorded in the minutes. In addition, a committee member in this situation should not discuss the project with other members or attempt to influence the committee in any way. Where a member is an investigator, the HREC may choose to invite that member to answer questions about the project before the member withdraws from the meeting.

HRECs relying on the advice of sub-committees or advisory bodies should also seek assurance that members of these groups will declare any conflict of interest and comply with the process described above.

Institutions need to develop clear policies and definitions of conflicts of interest.

See also comments on paragraph 2.19 and the Research Ethics Collection, ' Conflicts of interest ', pp E25-27.

A researcher must disclose to the HREC the amount and sources or potential sources of funding for the research and must declare any affiliation or financial interest when proposing and when reporting the research. The HREC must consider the extent to which it should disclose that information about funding sources.

Researchers must disclose funding sources, affiliations or financial interests so that HRECs may consider whether there is any actual or perceived conflict between the researcher's personal and professional involvement in the proposed research. Disclosure of such conflict is a recognised means of protecting a person from later criticism. For this reason, the HREC must consider whether the affiliation or financial interest, or any payments to be received by the researcher, ought to be disclosed to the research participants. An explanation of the HREC's reasons for so deciding should be provided to the researcher.

Further discussion can be found in the Research Ethics Collection, Conflicts of interest , page E25-27.

Points to consider

What parties have interests in the specific research setting and exactly what are their interests?
Is a primary purpose of the research project commercial?
Does a researcher face a conflict of interest with regard to the obligations of, or pressures involved in, having more than one professional role in relation to a specific research project?
Is sponsorship from industry likely to limit scientific communication in order to protect proprietary information?
Have researchers fully disclosed any financial interests relating to the research project? Is any payment to researchers fair and not excessive?
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A researcher must include, in the research proposal, a statement of the ethical considerations involved in the proposed research and an HREC must be satisfied that the research protocol gives adequate consideration to participants' welfare, rights, beliefs, perceptions, customs and cultural heritage both individual and collective.

The ways in which HRECs can be satisfied that a researcher has given adequate consideration to the characteristics of participants are often illustrated in research with vulnerable populations. Further information can be found in the Research Ethics Collection, ' Children and young people, research involving ' page E5, ' Gay men and lesbians, research involving ', E43, ' HIV/AIDS, research involving ' page E57, or ' Terminally ill people, research involving ', page E161.

An HREC should not communicate directly with a research sponsor on matters relating to the protocol or ethics of a project, but the institution or organisation and the sponsor may have direct communication on matters relating to administration, indemnity and insurance.

Any undue influence, or appearance thereof, in HREC review of research is to be avoided. Normally, an HREC will communicate with the researcher or the institution who in turn will communicate with the sponsor, where necessary.

In some types of research, notably clinical trials, it will be important for the HREC to be aware of the regulatory requirements imposed on the research.

All documents and other material used to inform potential research participants should be approved by the HREC including plain language information sheets, consent forms, questionnaires, advertisements and letters of invitation.

It is important that potential participants in research are properly informed before they decide whether to participate. The process of recruiting participants begins with the first information they receive about the research, and HRECs need to recognise that this paragraph refers to ALL documentation used in those processes. These will include newspaper, radio, television or other public advertisements, and not only information sheets and consent forms.

Advocates and interpreters

Advocates

An HREC must consider whether an advocate for any participant or group of participants should be invited to the HREC meeting to ensure informed decision making and understanding by these participants.

Advocates may help an HREC decide on the best ways of providing information to potential participants and the most appropriate process by which potential participants can exercise their choice whether or not to participate.

Interpreters

Where research involves the participation of persons unfamiliar with the English language (or the language in which the research is to be conducted), an HREC must ensure that:

the participant information statement has been translated into the participant's language; and

an interpreter is present during discussions with the participants about the project. Normally the interpreter should be independent, but when the research proposed is of minimal risk, an English-speaking relative or friend may be acceptable.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

Expedited review for minimal risk research

An HREC may establish procedures for expedited review of research involving minimal risks to participants and in so doing may depart from the requirements of paragraphs 2.15, 2.16 and 2.17 and if so, must determine:

the class or classes of research to which an expedited review procedure is to apply;

the scope of the Chairperson's authority;

the delegation of tasks to sub-committees;

the relationship between the Chairperson of the full Committee, and the Chairpersons of such sub-committees; and

the method of reporting and ratification of decisions by the full Committee.

This involves a departure from the usual requirements that all materials are considered by all committee members who participate in decision-making. The justification for this type of review is that the research involves minimal risk to participants, not that speedy approval is needed. In this situation, the HREC delegates assessment of a proposal to a small number of reviewers. These reviewers are usually given the authority to approve a proposal subject to ratification by the full committee.

In some circumstances, often created by research funding time constraints, a faster review than is normally available is sought. Where the research involves more than minimal risk, there is not a clear justification for departing from the normal review process of an HREC meeting.

For further discussion of expedited review, see the Research Ethics Collection, ' Human Research Ethics Committees, Expedited review ', page E86.

Research with potential for physical or psychological harm should generally not be considered for expedited review. This includes drug trials, research involving invasive physical procedures and research exploring sensitive personal or cultural issues.

Other situations where review would not normally be expedited include where vulnerable populations are involved or where conflicts of interest may arise, such as those between the roles of clinician and researcher, or teacher and student. Expedited review is never justifiable solely on the grounds of a researcher's claim to the need for urgent review of their project.

Where the Chairperson of an HREC considers that research may involve a departure from any of the ethical principles in this Statement, the protocol must be considered by the full Committee and cannot be dealt with by expedited review.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

Recording of decisions

An HREC shall maintain a record of all research protocols received and reviewed, including:

name of responsible institution or organisation;

project identification number(s);

principal researcher(s);

title of project;

ethical approval or non-approval with date;

approval or non-approval of any changes to the protocol;

the terms and conditions, if any, of approval of any protocol;

whether approval was by expedited review;

whether the opinion of another HREC was considered;

action taken by the HREC to monitor the conduct of the research; and

the relevance, if any, of the Guidelines for the Protection of Privacy in the Conduct of Medical Research.

This record is important for HRECs' responsibilities for monitoring the conduct of approved research, the need for renewals of approval or amendments and statistical reporting to institutions and to the NHMRC (see NS 2.46�2.48).

For multi-centre research proposals the HREC shall also record, from information provided from the researcher (see paragraph 3.7):

details of other centres involved;

the approval status of the study at each centre; and

details of any amendments required at other centres.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

An HREC shall retain on file a copy of each research protocol and application for HREC approval, including any information sheets, consent forms or relevant correspondence, in the form in which they are approved.

The National Statement does not specify a period for which these records need to be kept. For research data, the Joint AVCC/NHMRC Statement and Guidelines on Research Practice recommends retention for a minimum period of five years, and 15 years for specific types of research such as clinical research. [Footnote 19] The time for which HREC records need to be retained may be determined by State or Territory legislation. Where there is no legislation, retention of HREC records for the same period as the data from the research project is advised.

Monitoring

An institution or organisation and its HREC have the responsibility to ensure that the conduct of all research approved by the HREC is monitored by procedures and/or by utilising existing mechanisms within the institution or organisation which will ensure the achievement of the goals for monitoring as determined by the institution or organisation and the HREC.

Monitoring is defined in the National Statement on page 64. Monitoring should be designed to establish that a research project is being or has been conducted in the

manner proposed to, and approved by, the HREC. The conclusion could then be drawn that protection of the welfare and rights of participants - the primary purpose of the National Statement and of HRECs - had been achieved.

In determining mechanisms for monitoring research, an HREC needs to take into account how they can be implemented within the institution. There may be existing institutional procedures that can be adapted or relied upon to achieve monitoring goals.

Further information can be found in the Research Ethics Collection under ' Monitoring research ', page E109.

The frequency and type of monitoring determined by an HREC should reflect the degree of risk to participants in the research project.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

As a minimum an HREC must require at regular periods, at least annually, reports from principal researchers on matters including:

progress to date or outcome in the case of completed research;

maintenance and security of records;

compliance with the approved protocol; and

compliance with any conditions of approval.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

An HREC may recommend and/or adopt any additional appropriate mechanism for monitoring including random inspections of research sites, data and signed consent forms, and/or interview, with their prior consent, of research participants.

HRECs may apply monitoring measures additional to, or in place of, the regular reports provided for under NS 2.35. Such additional measures should be designed to establish that the research is being or has been conducted as approved. They may focus on a specific element of the research, for example where a condition was attached on approval, or on a report publishing the results of the research.

Existing mechanisms within an HREC's institution or organisation may help. For example, quality control mechanisms could be modified to confirm that a research project is progressing as approved. Or it may be appropriate to set up specific on-site monitoring of the research process for a particular study. When an HREC decides that active monitoring of a research project is necessary, committee members will need to consider who is the most appropriate person to carry this out.

An HREC shall, as a condition of approval of each protocol, require that researchers immediately report anything which might warrant review of ethical approval of the protocol, including:

serious or unexpected adverse effects on participants;

proposed changes in the protocol; and

unforeseen events that might affect continued ethical acceptability of the project.

Serious adverse effect is defined in Appendix 3 to the Statement as any untoward medical occurrence that at any dose:

results in death
is life threatening
requires in-patient hospitalisation or prolongation of existing hospitalisation;
results in persistent or significant disability/incapacity; or
is a congenital anomaly/birth defect.

This definition is taken from the context of clinical trials.

An unexpected adverse effect is an adverse reaction, the nature or severity of which is not consistent with the applicable product information. HRECs need to be aware of the mechanisms for reporting such events that are part of multi-centre clinical trials and decide how they will assess the significance of reports they receive, particularly those from other research sites. HRECs should receive from researchers advice about the significance of the adverse events, their relation to the research and whether any amendments to the conduct of the research are required. Notes on and references to NS 12.2 about clinical trials contain further discussion.

An HREC shall, as a condition of approval of the research proposal, require researchers to inform the HREC, giving reasons, if the research project is discontinued before the expected date of completion.

If an HREC is advised of the early discontinuation of a research project, it can assess whether any research participant has been or will be disadvantaged as a result. It can also be made aware that the research will not fulfil its goals.

Complaints

An institution or organisation with an HREC shall establish mechanisms for receiving and promptly handling complaints or concerns about the conduct of an approved research project.

Further information can be found in the Research Ethics Collection, ' Complaints ', page E17. See also NS 2.40, 2.41 and 2.42 following.

An HREC must nominate a person to whom complaints from research participants, researchers, or other interested persons may be made in the first instance. This person or the HREC shall attempt to resolve these complaints.

At least one person should be designated to receive complaints, although two people may be necessary to carry out any investigation. Such a person may be the secretary or a member of the HREC, but is not required to be a member. 'Complaints officers' should be easily contactable, be seen to be easily approachable and have the authority to act promptly and appropriately. They should also be capable of dealing sympathetically with any concern that arises and be prepared to take action on the basis of verbal or written reports, whether these reports are from people who identify themselves or not. Adequate resources should be provided to allow complaints officers to carry out their functions.

2.41 Where a complaint made under paragraph 2.40 cannot be resolved, the HREC must refer the matter to a person nominated by the institution or organisation to handle and resolve such complaints.

If the person nominated under NS 2.40 is connected with, or a member of, the HREC, then the appointment of a person under NS 2.41 not associated with the HREC would reflect a desirable standard of transparency.

When information on the research is first provided to participants, the name or position and contact details of the person nominated by the HREC to receive complaints must be included together with the procedures for raising concerns or obtaining additional information on the research.

All details about how to make complaints should be given to all research participants as a routine part of the information they receive when they are deciding whether to participate or not. Collaborating researchers and research assistants also need to be informed. These details could be advertised throughout an institution and forwarded to any associated research bodies.

An institution or organisation shall also establish procedures for receiving and promptly handling concerns or complaints from researchers about the consideration of their research protocol by an HREC.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

Suspension or discontinuation of research

Where an HREC is satisfied that circumstances have arisen such that a research project is not being or cannot be conducted in accordance with the approved protocol and that, as a result, the welfare and rights of participants are not or will not be protected, the HREC may withdraw approval, inform the researcher(s) and the institution(s) or organisation(s) of such withdrawal, and recommend to the institution(s) or organisation(s) that the research project be discontinued, suspended, or that other necessary steps be taken.

The HREC's authority is normally limited to the withdrawal of ethical approval, notification of this decision to the researcher and the institution, and a recommendation to the institution that it take action to discontinue the research.

Institutions need to establish procedures to receive and act on such advice and recommendations.

A researcher must not continue the research if ethical approval has been withdrawn and must comply with any special conditions required by the HREC.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

Compliance reports to the NHMRC

The National Health and Medical Research Council (NHMRC), through the Australian Health Ethics Committee (AHEC), will audit the activities of HRECs to ensure compliance with this Statement.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

An institution or organisation and its HREC shall provide information from its records to the NHMRC on request.

This paragraph is regarded as sufficiently clear, and so no commentary has been added.

An institution or organisation and its HREC shall report annually to the NHMRC information relevant to its procedures including:

membership/membership changes;

number of meetings;

confirmation of participation by required categories of members;

the number of protocols presented, the number approved, and the number rejected;

monitoring procedures in place and any problems encountered; and

complaints procedures and number of complaints handled.

The present arrangements for this annual report are that Australian Health Ethics Committee (AHEC) of the NHMRC provides each HREC with a questionnaire for completion.

The process is regularly under review. HRECs are notified in advance of any additional information to be sought.

Current guidelines under section 95 of the Privacy Act 1988 (Cth) require AHEC to collect information about the use of those guidelines, http://scaleplus.law.gov.au

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