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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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
Roles of review body chairs in human research ethics review in Australia Professor Colin Thomson Chair 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 1976 IEC review required by NHMRC 1987 114 IECs 2008 238 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)
HREC CHAIRS • 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 Institutions: • 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)
Roundtable • 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 Membership Communication between meetings Training 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 1936 Medical 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). 1964 World Medical Assembly issues Declaration of Helsinki 1966 NHMRC 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. 1976 Supplementary 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 1982 Council 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 1997 NHMRC/AVCC Joint Statement on Scientific Misconduct guides institutions on handling research misconduct allegations. 1999 National 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 2007 Revised 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 2000-2003 • 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