2008 National HREC Chairs Roundtable
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2008 National HREC Chairs Roundtable. Welcome. Aims of the day: To identify examples of good practice in strategies and procedures of research ethics review; and To facilitate and promote exchange of opinion, experience and ideas among HREC Chairs.

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2008 National HREC Chairs Roundtable

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2008 National HREC Chairs Roundtable


Aims of the day:

  • To identify examples of good practice in strategies and procedures of

    research ethics review; and

  • To facilitate and promote exchange of opinion, experience and ideas

    among HREC Chairs

Roles of review body chairs in human research ethics review in Australia

Professor Colin Thomson


Australian Health Ethics Committee

National Health and Medical Research Council

Australia’s human research ethics review system

Australia has had active human research ethics review committees for more than three decades

1976IEC review required by NHMRC

1987114 IECs

2008238 HRECs

Despite Ministerial review (1996), criticism in House of Representatives Cloning Inquiry report (2001), Essentially Yours (2003), & Latrobe and QuT instances in 2006/2007,

In 2004-5, HRECs reviewed 21,177 proposals and reported only 93 complaints (0.44%)(NHMRC)


  • Chairs of HRECs essential to established strengths

  • Central role in maintaining quality

  • Accumulated experience indispensable source of information and understanding

  • Round Table celebrates this in treating all chairs as equal in responsibility

  • To promote ethically good human research –

    • accord respect and protection due to participants

    • foster research of benefit to the community

Roles of HREC chairs

  • Assist institutions to fulfill responsibilities

  • Fulfill responsibilities, explicit & implicit, as Chair

  • Fulfill role as HREC members

Assist institutions to fulfil responsibilities


  • must see any human research they conduct/are responsible is ethically reviewed & monitored in accordance with National Statement. (NS 5.1.1)

  • may establish own processes for ethical review or use those of another institution. (NS 5.1.3)

  • satisfied that processes are in place for:

    (a) managing conflicts of interest (Chapter 5.4);

    (b) monitoring research (Chapter 5.5);

    (c) handling complaints (Chapter 5.6), and

    (d) ensuring accountability (Chapter 5.7) (NS 5.1.4)

Assist institutions to fulfil responsibilities

  • To enable assessment, prepare & make accessible regular reports on all ethical review processes. (NS 5.1.16)

  • To have auditing process to confirm that:

    • research is being reviewed at levels of review their criteria require (NS 5.1.17)

  • To ensure their HRECs

    • established/operate in accordance with NS (NS 5.1.25)

    • have access to expertise necessary to address ethical issues from categories of research it is likely to consider, including from outside HREC. (NS 5.1.33)

As Chair - experience & commitment

To have suitable experience

Other responsibilities will not impair the HREC’s capacity to meet obligations under NS (NS 5.1.30)

Good ethical review requires

  • shared commitment to the review process,

    Institutions to encourage shared commitment by promoting:

  • awareness of this NS among researchers; and

  • ready accessibility of review bodies and their staff to researchers. (NS 5.2.13)

As Chair: communication

Good ethical review requires

  • open communication between review bodies and researchers,

  • non-adversarial process.

    As misunderstandings often arise when only written communication used, review bodies should:

  • encourage informal communication with researchers, and

  • consider face-to-face meetings to resolve issues not resolved by written/telephone communication. (NS 5.2.14)

    Review body to clearly communicate decision to researcher/s:

  • Where approved, communication in writing (include email) & include explicit statement that proposal meets requirements NS.

  • Where amendments requested, communication written or informal & reasons for requested amendments.

  • Where proposal rejected, communication in writing (include email) and include reasons linked to NS (NS 5.2.22)

As Chair: meetings

  • To enable at least one member in each specified category to attend.

  • Papers enough in advance to enable members fully informed. (NS 5.2.28)

  • Decisions informed by exchange of opinions from each of minimum membership,

  • Ideally at meeting with those members present. (NS 5.2.29)

  • Where less than full attendance of minimum membership, Chairperson should be satisfied, before a decision is reached, that the views of minimum membership absent

    • have been received and

    • considered. (NS 5.2.30)

  • Endeavour to reach decisions by general agreement, not necessarily unanimity. (NS 5.2.31)

  • All documents/material used in recruiting potential research participants should be approved (NS 5.2.23)

As Chair: advocates, researchers, experts

Review body consider consulting participant advocate to assess if a proposal adequately provides for participants’ decision making and understanding. 5.2.17

Review body may invite researcher/s, and researchers may request, to be present for discussion of proposed research. 5.2.18

Review body may seek advice from experts to help

Experts bound by confidentiality & conflicts of interest requirements as review body members. NS 5.2.19

As Chair: conflicts of interest

Of researchers:

  • disclosure to participants & in report (except details? 5.4.6)

  • independent approach to participants or alternative researcher

  • disapproval

    Of HREC members:

  • disclose actual or potential CoI

  • personal involvement/participation in research or competing research

  • financial interest, affiliation

    Manage CoI’s of HREC members: e.g exclusion

As Chair: records

Review body to retain

  • copy of each research proposal & application for ethical approval, including all documents & relevant correspondence, in approved form 5.2.25

    Review body to record

  • specified details of all research proposals received & reviewed NS 5.2.24

  • decisions of, & reasons linked to NS for, approval, amendment or rejection in written or electronic form NS 5.2.26

    Where more than one review body has reviewed proposal, each body to record

  • details of other review body/ies involved;

  • the decision/s of each other review body; and

  • details of any amendments required by each other review body. 5.2.27

As an HREC member

Each member responsible for

  • deciding whether, in his or her judgement, a proposal submitted to the review body meets the requirements of NS and is ethically acceptable. (NS 5.2.2)

  • becoming familiar with NS & consult other guidelines relevant to specific proposals,

  • preparing for & attending scheduled meetings of review body,

  • if unavailable, providing opinions on ethical acceptability of proposals before meetings, subject to institutional policies on absences,

  • attending continuing education/training in research ethics at least every three years. (NS 5.2.3)

  • disclosing to review body any actual or potential conflict of interest, that bears on any research coming before the review body (NS 5.2.4)


  • Recognizes the community to which you belong

  • Offers opportunity to

    • discuss - and be instructed by - experience

    • explore ways to meet responsibilities

How do you sustain a HREC?

Lead Facilitator: A/Prof Lyn Angel

Why we chose this session to open the program

Nuts and bolts session

About management practices

Adapting to trends and changes – what have you done in the last two years which has altered the way you run and sustain your committee?

New and Senior Chairs attending with variable experience

Acknowledging the collective wisdom of Chairs with opportunities to tap into this wisdom.

Workload of secretariat

Workload of the HREC

Circulating increasingly large agendas to all members

Massive amounts of paper required to distribute

Length of meetings

Timing and frequency of meetings

Venue eg videoconferencing facilities


Communication between meetings


Succession planning

Institutional support

Others? Eg. Food.

Which of the following issues created difficulty in sustaining a HREC?Prioritise 3 and discuss

What strategies did you employ to overcome them?

How do you justify the strategies?

What principles do you use in developing strategies to overcome issues around ethical management?

Why do you do it this way?

Can it be applied across other sections or HREC’s or is it just going to work in your institution?

Conflict of Interests: real and perceived

Lead Facilitator: Dr Garry Pearce

The Code defines conflict of interest as follows:

A conflict of interest exists where there is a divergence between the individual interests of a person and their professional responsibilities such that an independent observer might reasonably conclude that the professional actions of that person are unduly influenced by their own interests (Section 7)

The National Statement states that:

While a conflict may relate to financial interests, it can also relate to other private, professional or institutional benefits or advantages that depend significantly on the research outcomes. (Section 5.4).

Section 5.4.1 of the National Statement requires that:

Institutions should establish transparent processes to identify and manage actual and perceived conflicts of interests involving:

(a) the institution itself;

(b) the researchers; or

(c) ethical review bodies, their members or advisors.

For a researcher, the National Statement notes that:

Sometimes a researcher who discloses the fact that he or she has a conflict of interest may have an ethically acceptable reason for not disclosing what the conflict is, for example, that this might breach another person’s privacy. The researchers may then remain involved in the research only if the review body is satisfied that the conflict can be managed without its nature being disclosed. (National Statement 5.4.6).

In relation to disclosing a conflict of interest the Code notes that:

Researchers frequently have a conflict of interest that cannot be avoided………An individual researcher should therefore expect to be conflicted from time to time, and be ready to acknowledge the conflict and make disclosures as appropriate. (Section 7.2).

“Identify a COI as a presentation from the table for case discussion- what it was, how it was dealt with”.

What systems are in place to deal with COI at the institutional level and at the HREC level?

Whom do COI involve – sponsors, institutions, researchers, HREC members?

When do they get the COI declaration forms signed?

How are COI best managed at the HREC level?

When do they get a person to leave the room and when do they bring them back? Do they always have to leave the room? Who decides?

How do Universities deal with COI arising from the commercial realities of research?

How do Health entities deal with pharmaceutical sponsorship COI in research?

Should a person from the same department review a study given that they are not participating in the study?

How detailed should COI declarations be?

Should we be doing more? How should this best be done?

Institutional support – what policies should be in place to assist the process?

Low Risk Research Review

Lead Facilitator: A/Prof Lyn Angel

How do the various institutions manage LRRR?

Is it (ie LRRR) a growing workload for universities and health sectors? We have no trend data to inform the discussion

What barriers are there to reviewing LRRR?

How are Institutions overcoming these barriers?

What is the least costly way of dealing with LRRR.

What systems have been put in place?

Related questions/issues:

i Undergraduate projects issues: how are these managed? Approved? By whom?

ii Honors students, projects undertaken by students on placement (clinical/education)?

What is the membership of LRRR oversight groups? Separate committee? Executive of the HREC?

Is training required?

How is this best done?

Should it be necessary for the HREC to ratify the LRR? (National Statement 2007 does not say that LRRR has to be ratified)

How much in the way of extra resources and workload is required to deal with LRRR?

What extra help is required in this area by Institutions to deal more effectively with LRRR?

Human research ethics review in Australia - where we’ve been, where we are and where we might go.

Professor Colin Thomson

Chair,Australian Health Ethics Committee

National Health and Medical Research Council

A history of Australian human research ethics review

1936Medical Research Endowment Fund Act creates Medical Research Endowment Fund.

Minister for Health determines use of fund for medical research & training

receives advice from National Health and Medical Research Council (NHMRC).

1964World Medical Assembly issues Declaration of Helsinki

1966NHMRC issues Statement on Human Experimentation that expressly draws on Declaration of Helsinki.

A history

1972 NHMRC Ethics in Clinical Research Subcommittee revises Statement & recommends medical ethics committee review - one outside member - of NHMRC grants involving human subjects.

1976Supplementary Note 1 added to the Statement, requires review by institutional ethics committee (IEC).

Scope of the Statement extended to all human subject research: medical, social and behavioural research.

IEC minimum membership:

  • Layman and laywoman not associated with institution

  • Minister of religion

  • Lawyer

  • Medical graduate with research experience

A history

1982Council established Medical Research Ethics Committee (MREC) to

  • keep under review ethical principles in human experimentation

  • facilitate, review & report on the work of IECs, & respond to questions raised by them.

  • Council policy that, to be eligible for Council research funds, institutions must conform to Supplementary Note 1 to Statement.

    1987 114 IECs in Australia

  • A history

    1987 - 1991

    Research Ethics Newsletter (MREC)

    Annual one-day IEC workshops

    1991 TGA legislation permits CTN trials to commence if favourable advice from IEC that would undertake monitoring

    1992 NHMRC Act - statutory corporation

    • AHEC formed

    • issue of "guidelines for the conduct of medical research involving humans”,

    • precisely as developed by Australian Health Ethics Committee (AHEC).

    A history

    1994 - concerns about

    • adequacy of ethical review under de-centralized drug research regime

    • monitoring by AHEC of IECs

    • adequacy of guidelines

    • trials about reproductive technology

    • innovative use of growth hormone

    A history

    1996 Ministerial review recommends

    • revision of national guidelines

    • manual or procedures for IECs

    • IECs address

      • multi-centre review &

      • procedures for information & voluntary consent

      • annual reports

    • institutions to appoint complaints officers, resource IECs

    • researchers use plain language in consent documentation

    A history

    1997NHMRC/AVCC Joint Statement on Scientific Misconduct guides institutions on handling research misconduct allegations.

    1999National Statement on Ethical Conduct in Research Involving Humans (NationalStatement)

    IECs now human research ethics committees (HRECs)

    • Parliamentary report on Human Cloning criticizes IECs as lacking public accountability, “in-house”

      National forum identifies urgent need to address duplication of ethical review

    A history

    • NHMRC Research Ethics Conference and Training Day

      (ALRC/NHMRC Essentially Yours; The Protection of Human Genetic Information in Australia, 2003, p 446

      “The Inquiry has concluded that there is a need to improve consistency, efficiency, transparency and accountability in HREC review . . “

    • NHMRC research ethics training program

    • NHMRC 2nd research ethics conference

      1st. HREC Chairs Rpundtable

    A history

    2006 LaTrobe University: phone interviews that revealed intimate details of the lives of partners of interviewees led to complaint that the review failed to identify some risks.

    http://www.abc.net.au/rn/healthreport/stories/2006/1680645.htm (at12/08/08)

    2nd HREC Chairs Roundtable

    • QUT: research participation of people with intellectual disability led to complaints that HREC failed to protect participants from risks.http://www.abc.net.au/news/opinion/items/200706/s1953217.htm (at 12/08/08)

      3rd NHMRC Research Ethics Conference, Continuing Education Day and 3rd HREC Chairs Roundtable

    A history

    2007Revised National Statement on Ethical Conduct in Human Research

    Australian Code for Responsible Conduct of Research replaces Joint Statement

    232 HRECs

    Another history

    • Research on Aboriginal and Torres Strait Islander people since early 1900’s

    • Perceived risks to white settlers of exotic tropical diseases

    • Testing theories about blood type & race & physiological reactions and capacities

    • No consent - identification by numbers on bodies or cards around necks

    • Helicopter studies; data raids

    • No alleviation of deepening disadvantage

    Another history

    • Research designed to meet needs of researchers, not participants

    • Exploitation of cultural property

    • Shared memories poisoned & deep suspicion of research and science

      1985 - fiery conference in Central Australia

    • Recognition of need to protect cultural integrity

    • Draft guidelines emphasised consultation, benefit and ownership

    • Used prescriptive rules to control investigator conduct in order to protect culture

    Another history


    • Maturing Aboriginal organizations, cultural confidence and resilience

    • Aboriginal organizations recognised potential value of research to address disadvantage

    • More Aboriginal researchers

    • Developing vision of cultural values

    • Engagement with research where those values realised

    Another history

    Emerging approaches:

    • For research to be ethically and culturally acceptable, must be of benefit to those involved

    • Benefit - and burden - to be of their definition and agreement

    • To be reciprocal with benefit to others from research

    • Essential prior consultation with involved people

    • Negotiated research plan

    Another history

    Confidence that

    • participants can assert research needs & protect themselves through relationship with researchers

    • best participant protection through negotiated relationship - and not only from approval from HREC.

    • researchers accept that only through relationship would they achieve research goals.

    Human research ethics review in Australia - where we’ve been, where we are and where we might go.

    Professor Colin Thomson

    Chair,Australian Health Ethics Committee

    National Health and Medical Research Council


    Revised Statement + SuppNotes

    2nd Research Ethics Conference, training day & HREC Chairs roundtable

    IEC newsletter, annual IEC workshops

    National Statement

    Statement on Human Experimentation & IEC review

    National Statement

    HREC training program

    MREC formed, IEC support

    Ministerial review

    2nd HREC Chairs Roundtable

    1st Research Ethics Conference &Training Day

    NHMRC policy decision


    1970 1980 1990 2000

    ALRC/NHMRC questions HRECs



    3rd Research Ethics Conference, training day & 3rd HREC Chairs Roundtable

    Cloning Report criticises HRECs

    Interim Guidelines

    protect cultural integrity

    consultation, benefit & ownership

    prescriptive rules to control investigators to protect culture


    Research on


    Risks to white settlers of exotic diseases

    Theories about blood type & race & physiological reactions and capacities

    No consent - identification by numbers on bodies or cards around necks

    Research meet researchers needs

    Shared memories poisoned & deep suspicion of research and science

    No alleviation of deepening disadvantage

    Values & Ethics


    State protection, access conditions, consent

    1920 1930 1940 1950 1960 1970 1980 1990 2000

    Aboriginal & Torres Islander health research

    Another history

    Effectiveness of Values & Ethics guidelines depends on establishing,

    between researchers & Aboriginal and Torres Strait Islander participants,

    a relationship through which the

    • scope,

    • methods &

    • outcomes of research

      are negotiated & determined.

    Influence of another history

    In National Statement, experience of potential participants should be used in

    • determination of research merit in some cases (1.1(a))

    • assessment of research risk (2.1.6)

    • planning some consent processes (2.2.15)

    • institutional assessment of low risk review (5.1.14)

    • deciding if research adequately provides for decision-making and understanding (5.2.17)

    The present – and the future

    Criticisms that Australian HREC review system

    is :

    • invisible

    • ineffective

    • inefficient

    • Inconsistent

      Future of human ethics review needs to include responses to these criticisms


    Faceless, lacking transparency and accountability

    To whom accountable:

    • Participants?

    • Funders?

    • Institutions?

    • Government?

    • The public?


    Ethics Review




    ARC etc







    Ethics review
















    National Statement

    I n s t i t u t i o n s



    Responses to “invisible”

    Challenging Ethical Issues in Contemporary Research on Human Beings, Repot to Minister (NHMRC website)

    Recognition or accreditation (later)

    Strengthen the annual report

    Annual report

    At present, no questions about how HRECs use NS clauses that protect participants, e.g. consent & waiver, risk assessment .

    Does accountability = demonstration

    • that NS process followed, or

    • that outcomes achieve goals of NS?

      How could an HREC show that :

    • NS process followed?

    • NS outcomes achieved?

      Annual repot revision related to broader NHMRC goals & functions & AHEC advisory role


    Principal Committees [includes AHEC]




    Operations Division

    Knowledge Development Division

    Program Management



    Health Evidence

    & Advice


    Research Investment

    Quality & Regulation

    Health & Research Ethics


    Fail to protect participants?

    Fail to follow National Statement?

    Controversial studies in 2006, 2007, BUT:

    2004-5 HREC reviews 21,177

    complaints about research conduct 62


    Challenging Ethical Issues in Contemporary Research on Human Beings, Report to Minister,NHMRC website

    follow direction suggested by Values and Ethics

    National Ethics Application Form (NEAF)

    recognition or accreditation (later)

    National Ethics Application Form (NEAF)

    • Version 2 available 25 August 2008.

    • Reduced in length & detail

    • Revised sequence

    • Amended to suit revised National Statement

    • Information and familiarization sessions


    Slow, unpredictable, bureaucratic, pedantic.

    Duplication of review of multi-site research.


    National Ethics Application Form (NEAF)

    Informal HREC recognitions

    State level multi-site initiatives

    Harmonisation of Multi-centre Ethics Review (HoMER)

    Recognition or accreditation (later)

    Research ethics review - multi-centre review I

    I N S T I U T I O N S






    N a t i o n a l S t a t e m e n t

    A s s o c i a t e r e s e a r c h e r s



    Problem method

    Research ethics review - multi-centre review II


    I N S T I U T I O N S





    Associate researchers

    Associate researchers

    N a t i o n a l S t a t e m e n t



    Mutual HREC recognition

    Research ethics review - multi-centre review III

    I N S T I U T I O N S





    National Statement



    Associate researchers

    Associate researchers



    Institutional recognition


    • AHMAC referral to NHMRC of task to develop a national harmonized system

    • Of States/territories initiatives

    • Enable single scientific and ethical review of national level studies

    • State/territory focus groups to

      • Advise local progress

      • Clarify key elements


    Will need to deal with:

    • Recognition of HRECs

      • scientific expertise

      • ethics

      • standards

    • Procedures for scientific and ethical review

    • Training of institutional officials & researchers

    • Allocation of proposals for review

    • IT system

    • Monitoring of approved proposals

    • Insurance & indemnity arrangements


    Contradictory or differing responses to same proposal

    Applying different standards (institutional history) or the same standard differently.


    Strengthen annual report

    National Ethics Application Form (NEAF)

    Recognition or accreditation

    Research ethics review - accreditation

    I N S T I T U T I O N S

    Accreditation criteria

    Accreditation agency

    National Statement

    National Agency

    Research ethics review - accreditation

    I N S T I T U T I O N S

    National Accreditation agency

    Accreditation criteria

    National Statement

    Recognition or accreditation

    • To what should accreditation apply:

      (i) committee?

      (ii) institution?

      (iii) program or system?

    • What should standards be?

    • Who should develop & determine standards?

    • Who should implement standards & how?

    • What should be consequences of non-compliance?


    Lead Facilitator: Dr Garry Pearce

    Some State Institutions eg NSW Health has already gone through an accreditation process as part of its single ethics review model 15/41 were accredited as “Lead Committees”.

    Should there be international accreditation of HREC’s for international multi site research?

    choose 1 or 2 of these questions to discuss at each table.

    • To what should accreditation apply: institutions, programs, HRECs?

    • What future accreditation standards should apply?

    • Who should set the standards?

    • Who should implement the standards by checking and reporting compliance?

      5.What should be the consequences of non-compliance?

    How much support is there for an accreditation process?

    Think of three arguments for and three arguments against accreditation.

    Minimising / Eliminating duplication of review

    Lead Facilitator: A/Prof Lyn Angel

    • What are local institutions doing to reduce duplication of review?

      •Looking for practical experience

      •What do you think should happen at regional, State, and National levels –

      should it be by choice ie voluntary or compulsion eg European Directive (all trials

      to be reviewed only once)? What would happen if the TGA used its powers to do

      similarly to Europeans?

    • Where would the levers for change for this to happen best come from?

      i.Eg Working Party to review and develop recommendations?


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