| 1.0 |
Preamble
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The Ethical Review Committee (ERC) shall be concerned
with ethical issues involved in proposals for research
on human subjects. The terms of reference have
taken into consideration recommendations of a sub-committee
of the Bio-ethics Group of Faculty of Health Sciences
(FHS) and particularly the report of the Royal
College of Physicians of London (1996) titled "Guidelines
on the Practice of Ethics Committees in Medical
Research Involving Human Subjects". The terms
have been derived mainly from principles and generalised
for application to both bio-medical and social
science research. A deliberate attempt has been
made to avoid detail, with the expectation that
experience will determine the need for revision
and elaboration.
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| 2.0 |
Terms of Reference
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| 2.1 |
All research projects involving human subjects,
whether as individuals or communities, including
the use of foetal material, embryos and tissues
from the recently dead, undertaken or supported
by Aga Khan University (AKU) faculty, staff or
students, wherever conducted, shall be reviewed
by the ERC before a study can begin.
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| 2.2 |
The duration of approval for a study shall be
limited. Any change in conditions that could affect
the rights of subjects during a study must be approved
for the study to continue.
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| 2.3 |
The Committee shall provide written guidelines
on ethical considerations for research involving
humans and review them at least once in two years.
The guidelines shall be based on but not restricted
to the following principles: |
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- Respect for an individual's capacity to make
reasoned decisions, and protection of those whose
capacity is impaired or who are in some way dependent
or vulnerable.
- The risks of the
proposed research in respect of expected benefits,
the research design and competence of the investigators
having been assessed.
- A proposal must
state the purpose of the research; the reasons
for using humans as the subjects; the nature
and degree of all known risks to the subjects;
and the means for ensuring that the subjects'
consent will be adequately informed and voluntary.
- The subjects of
research should be clearly aware of the nature
of the research and their position in respect
of it.
- Consent must be
valid. The participants must be sufficiently
informed and have adequate time to decide without
pressure. Consent must be obtained from the subjects,
preferably written.
- Subjects must be
able to easily withdraw from a research protocol
without giving reasons and without incurring
any penalty or alteration in their relationship
with providers of services.
- Further guidance
should be obtained from publications, such as
the World Medical Association Declaration of
Helsinki: Recommendations Guiding Medical Doctors
in Biomedical Research Involving Human Subjects
(1989), consultation with experts and other sources,
according to need.
- Specify procedures,
including periodic appraisal of the progress
of approved projects, for ensuring that subjects
of research are protected from harm, their confidentiality
is maintained, and their rights are respected.
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| 2.4 |
The Committee shall report annually or more frequently,
as necessary, to the URC and the Chief Academic
Officer.
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| 2.5 |
Method of Working
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| 2.5.1 |
The Committee will need substantial administrative
and secretarial assistance from the Research
Office.
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| 2.5.2 |
Authors of research proposals may be invited
to attend meetings of the ERC when their study
is being reviewed.
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| 2.5.3 |
Some business may be conducted by mail, but
reasonably frequent meetings are essential
to allow a committee ethos to develop.
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| 2.5.4 |
A quorum should include a layperson, a research
oriented member who is broadly familiar with
the proposed field of study, and a member of
each gender.
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| 2.5.5 |
Decisions will be made normally by consensus.
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| 2.5.6 |
The Chairman's approval may be given for
studies that pose no ethical problems. Such
approvals shall be reported to the next meeting
of ERC for ratification.
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| 2.5.7 |
Investigators are entitled to have an adverse
decision reviewed, and to make written and/or
oral representations to the Committee.
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| 2.5.8 |
The Committee may withdraw approval if it
is not satisfied with the conduct of the investigation.
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| 2.5.9 |
The ERC should approve amendments to protocols
that affect human subjects.
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| 2.5.10 |
Confidentiality of the Committee's proceedings
should be preserved.
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| 2.5.11 |
Members of the Committee should declare their
own interests, for example when testing of
the product of a company of which the member
is an advisor.
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| 2.5.12 |
Serious adverse events should be reported
promptly to the Chair.
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| 2.5.13 |
Members should not be paid; however, if honorarium
is necessary, then it should be modest.
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| 2.6 |
Membership
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| 2.6.1 |
Membership shall include representation from
researchers, the professional disciplines currently
found in the University, discerning public,
legal expertise, and both genders.
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| 2.6.2 |
The Chief Academic Officer shall appoint
the chair and members, in consultation with
the URC.
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| 2.6.3 |
The tenure of AKU members on ERC shall be
3 years which may be renewed for one term.
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| 2.6.4 |
The tenure of External Members on ERC would
be of one year which may be renewed
for another term of one year at the discretion
of the Chair ERC based on the attendance and
quality of input by the member. Further extension
would require URC's approval.
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| 2.6.5 |
For faculty, it is essential to select persons
who are not members of other research related
committees.
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| 2.6.6 |
The total number of members should not exceed
15, including the chair. In addition, there
will be one adjunct member from AKU-East Africa
and one from ISMC who would be called upon
as required by the Chair to give input for
projects falling into their respective areas
of expertise. |
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