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Australian Defence Human Research Ethics Committee


CP3-6-036, Campbell Park Offices, PO Box 7912, Canberra BC ACT 2610

AUSTRALIAN DEFENCE HUMAN RESEARCH ETHICS


COMMITTEE TERMS OF REFERENCE
OBJECTIVES
1. The Australian Defence Health Research Ethics Committee (ADHREC)
objectives are to:
a. protect the mental and physical welfare, rights, dignity and safety of
participants of research;
b. facilitate ethical research through efficient and effective review processes;
c. promote ethical standards of human research; and
d. review research in accordance with the National Statement on Ethical Conduct
in Research Involving Humans (NHMRC, 2007) (the National Statement)
(http://www.nhmrc.gov.au/guidelines-publications/e72).

FUNCTIONS
2. ADHREC functions are to:
a. provide independent, competent and timely review of research projects
involving humans in respect of their ethical acceptability;
b. provide oversight, monitoring and advice on ethical aspects of research
projects involving humans; and
c. promote awareness and understanding of human research ethics within
Defence and the broader community.

SCOPE OF RESPONSIBILITY
3. Research proposals involving humans will be reviewed by ADHREC where
the research involves epidemiological and public health research and/or research
involving social and psychological investigations, and:
a. is conducted on Defence members or other Defence personnel, their
information or tissue:
b. where research participants are to be recruited, either directly or indirectly,
through a service provided by Defence;
c. is conducted by Defence personnel;
d. is conducted on/in a Defence establishment; and/or
e. is sponsored, endorsed or funded in any part by Defence.
RELATIONSHIP TO OTHER PROCESSES OF RESEARCH REVIEW

Expedited review
4. Out of session review of a protocol will occur at the discretion of the Chair,
where appropriate. Where out of session review is required, the Chair and other
relevant members, as appropriate, will consider protocols and provide a report back to
the full committee at the next meeting on their recommendations.

Sub-committees
5. ADHREC may appoint such sub-committees as it sees fit to carry out a
scientific or technical review of a research proposal, or ethical review of minimal risk
research, submitted to the Committee. The Chair of any such sub-committee will be
appointed by Commander Joint Health (CJHLTH).
6. ADHREC may establish an Executive, consisting of at least the Chair and
Ethics Officer. Where provided by the standard operating procedures, the Executive
may undertake expedited review of research proposals between scheduled meetings at
the discretion of the Chairperson. The Executive may seek advice from other
Committee members, as appropriate, before reaching a decision. If approval is
granted, such approval shall be considered for ratification at the next Committee
meeting.
7. The Executive may consider other items of business that are considered to be
of minimal risk to participants such as appropriate adverse events, protocol reports,
minor amendments and the like. The minutes of any such meetings will be tabled for
ratification at the next Committee meeting.

Multi-centre research
8. To facilitate multi-centre research ADHREC may:
a. communicate with any other Human Research Ethics Committee (HREC);
b. provide its scientific/technical and/or ethical assessment of the research to
another HREC; and
c. accept the ethical review of the Department of Veterans’ Affairs Human
Research Ethics Committee (as appropriate), via administrative review to
ensure that any Defence specific requirements have been addressed.

RELATIONSHIP TO NON-AFFILIATED RESEARCHERS


9. ADHREC will conduct and monitor the ethical and scientific merit of research
protocols for researchers external to Defence where the research involves Defence
personnel.

INSTITUTIONAL ACCOUNTABILITY
10. ADHREC is accountable to CJHLTH in the conduct of its regular business.
The minutes of each ADHREC meeting shall be made available to CJHLTH upon
request.

Status of the ethics committee within the Department of Defence


11. ADHREC is an advisory committee of Defence specific to ethical issues for
research carried out as outlined in paragraph 3, including:
a. granting ethical approval
b. withholding ethical approval
c. withdrawing ethical approval.
12. Secretariat support of ADHREC is provided by the Directorate Health
Research Coordination.
13. In principle institutional approval and authorisation of research is to be
provided prior to ADHREC undertaking ethical review of proposed research.
Institutional approval or authorisation for the commencement of research can not be
granted by the relevant area/s unless ethical approval has been granted by ADHREC.

MECHANISMS OF REPORTING
14. ADHREC shall provide an annual report to the Chief of Defence Force (CDF),
which will include information on membership, the number of proposals reviewed,
the status of proposals, a description of any complaints received and their outcome,
and general issues raised.
15. The Director Health Research Coordination may from time to time bring to the
attention of the CJHLTH issues of significant concern, or CDF, as required.
16. ADHREC shall provide reports to the National Health and Medical Research
Council in accordance with the National Statement 5.7.4.
17. The ADHREC Terms of Reference, Standard Operating Procedures and
membership will be available upon request to the general public and will be posted on
Defence website.

MEMBERSHIP

Composition
18. The composition of ADHREC shall be in accordance with National Statement
5.1.30 and shall include at least:
a. a Chairperson
b. at least two lay people, one man and one woman, who have no affiliation with
Defence, and are not currently involved in medical, scientific, or legal work
c. at least one person with knowledge of, and current experience in, the
professional care, counselling or treatment of people
d. at least one person who performs a pastoral care role in a community (eg an
Aboriginal elder or minister of religion)
e. at least one lawyer, where possible one who is not engaged to advise Defence
f. at least two people with current research experience that is relevant to research
proposals to be considered at meetings they attend.
19. Additionally, two Defence health graduates (at least one being a medical
graduate) are to be appointed to the Committee.
20. To ensure the membership will equip ADHREC with the skills necessary to
address all of the relevant considerations arising from the categories of research likely
to be submitted, a pool of inducted members shall be maintained (National Statement
5.1.31).
21. Wherever possible one or more of the members are to be experienced in
analysing and reflecting on ethical decision-making (National Statement 5.1.32).
22. In accordance with section 5.1.29 of the National Statement there shall be
equal numbers of men and women (where possible) and at least one third of the
members must not be Defence personnel. Defence has an additional requirement that
a gender balance of 60/40 (male/female) be maintained for all Defence boards.

Remuneration of members
23. Members external to the Defence are offered a sitting fee for each meeting that
they attend. The value of the sitting fees will be determined by CJHLTH and
reviewed periodically.
24. All members will be reimbursed for legitimate expenses incurred in attending
Committee meetings or in otherwise carrying out the business of the Committee.
25. Members who are engaged in a Reservist capacity will be remunerated in
accordance with the ADF Pay and Conditions Manual (PACMAN) Volume 1 Chapter
3 ADF Salaries and bonuses Part 1 Salaries
(http://www.defence.gov.au/dpe/pac/V2_Ch3_Pt1.htm).

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