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IRB (SOP)

Institutional Review Board (SOP)

This SOPs for the Council for Scientific and Industrial Research Ghana- Institutional Review Committee (CSIR-IRB) to govern the affairs and running of the IRB. Currently, most IRBs in the country are institutional base however, due to the absence of a National Ethical Guidelines, most IRBs adhere to International Guidelines thus the definition of a local setting may be limited to their institutional mandate of research even though most review international and multi-centered research as well.

Since CSIR has been mandated to coordinate all research activities in the country, it would be appropriate for it SOPs to have a wider coverage than limited to its 13 institutions. SOPs are written policies and procedures articulated and specified to govern IRB membership, the secretariats and the research community in carrying out their duties. To ensure efficient operation, the policies, rules, and written procedures will be reviewed periodically in the light of ongoing assessment of performance and outcomes to determine whether any revisions are needed.

Mission/Mandate
The IRB of the CSIR has been mandated for the review of studies in the fields of health and social sciences, including anthropology, sociology, and psychology according to the national act binding the CSIR. The research areas mostly under critical scrutiny include clinical trials of drugs or devices, epidemiological and parasitological studies, health care systems and delivery. Other areas include studies of social behavior, personal, opinions and attitudes.

Objective
The objective of this SOP is to contribute to effective functioning of Institutional Review Board (IRB) of the Council for Scientific and Industrial Research (CSIR), for quality and consistent ethical review mechanism of health and biomedical research.

How do we work?

Membership Composition and Representation

The composition of the CSIR-IRB will be in accordance with the ‘Common Rule’ (45 CFR 46) guidelines and other international guidelines and should be well represented in terms of gender balance. The current IRB composition is made of Health Policy Specialist, Health Planning and Sociologist, Medical Parasitologist and Molecular Epidemiologist, Legal practitioner, Social Worker, Community member/ Journalist, Veterinarian, Animal Breeder, and Bioethicist. This current representation is statutory but subject to revision when the need arises.

Terms and Conditions of Appointment

  • Members would be appointed and co-opted by the Director- General (D-G) of the CSIR.
  • The members would be drawn from different institutions and specialties to give a multi-sectorial, and multidimensional structure.
  • The duration of appointment is initially for a period of 4 years renewable.
  • Board members are required to submit their curriculum vitae to the administrator after nomination.
  • A member can be replaced in the event of death or long-term assignments outside the country or for any misconduct deemed unfit for a member.
  • A member can tender a resignation from the board with proper reasons to do so, which should be acceptable to the D-G, CSIR.
  • Re-imbursement or compensations for members would be in accordance to the institutional policy.

Compliance
The CSIR-IRB functions in compliance with but not limited to the following documents and guidelines:

  • Declaration of Helsinki (current version),
  • The Belmont Report,
  • The US Office of Human Research Protections 45 CFR 46,
  • The Council for International Organization of Medical Sciences (CIOMS)
  • ICH-GCP-E6 Section 1-4
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