Ethics Review Committee

Ethics Review Committee

Introduction

The Ethical Review Committee (ERC) shall be standing committee of Afzaal Memorial Thalassemia Foundation Research Office.

ERC Mandate

All research taking place at AMTF or by its faculty, staff or students at any site, which involves human participants or human data or material, whether as individuals or communities, including tissue, products, foetus or genetic material from human subjects, whether dead or alive, will need approval by the ERC before the research can commence.

Ethics Review Committee

Duties & Responsibilities of Committee

3.1 – The Ethics Review Committee (ERC) has responsibility to consider the ethical implications of proposed human research studies conducted at Foundation, or by staff or students at any site and determine whether or not they are acceptable on ethical grounds.

3.2 – The ERC shall

3.2.1 – Review and approve (with or without modification) or withhold approval, proposals for research on human participants or human data or material whether as individuals or communities, including tissue, products, foetus or genetic material from human subjects, whether dead or alive by Foundation’s faculty members, students or visiting scholars, and staff on the basis of ethical consideration.

3.2.2 – Advocate, encourage and monitor “best practice” ethical standards in research; protect subjects of research from unnecessary harm; preserve the rights of the subjects and provide reassurance, when required, to the public that this is being done.
3.2.3 – Undertake a regular review of the ongoing research for any unethical practices.
3.2.4 – Record in database, information pertaining to all research proposals including name, address and qualifications of Principal Investigator (s), the financial sponsor, title of the project, research methodology and research objectives.
3.2.5 – Provide guidance to AMTF faculty, staff and students regarding the ethics of conducting research involving human participants or human data or material.

3.2.6. 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 that are extracted from Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants WHO Library Cataloguing-in-Publication Data © World Health Organization 2011.

http://www.who.int/about/licensing/copyright_form/en/index.html)
3.2.6.1 – The appropriateness of the study design in relation to the objectives of the study, the statistical methodology (including sample size calculation), and the potential for reaching sound conclusions with the smallest number of research participants.
3.2.6.2 – Respect for an individual’s capcity to make reasoned decisions, and protection of those whose capacity is impaired or who are in some way dependent or vulnerable.
3.2.6.3 – The risks of the proposed research in respect of expected benefits, the research design and competence of the investigators having been assessed.
3.2.6.4 – 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 participants; and the means for ensuring that all ethical concerns are addressed, like protecting participants from harm, maintaining their confidentiality, and respecting their rights and choices.
3.2.6.5 – The participants of research should be clearly aware of the nature of the research and their role in it.

3.2.6.6 – Consent must be valid. The participants must be sufficiently informed and have adequate time to decide without pressure. Consent must be obtained from the participants or surrogates (if applicable) in writing, however, studies may be considered for exemption for a written consent by the ERC if the proposal is accompanied by an acceptable justification for not acquiring written consent.

3.2.6.7 – Participants 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.

3.2.6.8 – 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.

3.2.6.9 – ERC may ask for update on the progress of approved projects at any given time to ensure that participants of research are protected from harm, their confidentiality is maintained, and their rights are respected. This period will vary from study to study depending on the risk involved for participants and can be every three months or less for high risk studies like drug trials.

3.2.6.10 – The PI will be responsible to submit a report to ERC at the conclusion of the study.