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February 13, 2020 8209

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.

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.

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.

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.

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


Primary functions of the CSIR-IRB

Have an oversight responsibility over research on human subjects conducted under its authority that are scientific and ethically sound. Protect the rights and welfare of human subjects involved in research studies conducted under its authority. It would also promote ethically sound research in other research institutions and investigators to enhance compliant with the ethical standards and regulations governing human subject research. The IRB will review research protocols and related materials (e.g. informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research studies.

Responsibilities of the Chair

Conduct IRB meetings in accordance to all regulations. Determine submissions that are exempted from review. Perform an expedited review of research that meet the expedited criteria or assign another member to carry it out. Assign responsibilities and duties to the vice chair and other members. Supervise the Administrator to carry out his/her duties. Attend or assist any external review and meetings of the IRB. Provide statement of assurance when required in accordance to the regulations of governing IRB

Responsibilities of the Vice Chair

Shall perform the same duties as the chair in the absence of the chair Perform any assign responsibilities by the chair or the IRB

Responsibilities of the Coordinator

Facilitate provision of training and educational programme for new IRB members, continuing IRB members, and the greater science community of CSIR and Ghana. Attend or assist any external review and meetings of the IRB. Provide statement of assurance when required in accordance to the regulations of governing IRB. Supervise the Administrator to carry out his/her duties.

Responsibilities of the Administrator

  • Assist the institution to recruit new IRB members
  • Design and disseminate templates for IRB submission documents, including research protocols, informed consent materials, agreements and periodic and final reports.
  • Advise submitting investigators on preparing and submitting protocols for review according to SOPs.
  • Perform a pre-review of each submission of the IRB to ensure adherence to administrative submission requirements.
  • Correspond with all submitting researchers at all times throughout the submission and review process, while remaining independent of the researcher’s protocol operations.
  • Accept, verify completeness, duplicate and distribute all submitted items together with meeting agendas and all arranged meeting logistics to the appropriate IRB members for review.
  • Prepare and distribute agendas and minutes
  • Attend IRB meetings, take minutes during the meetings, and verify and distribute minutes in a timely manner.
  • The Administrator shall be responsible for the oversight of IRB documents, records and archives.
  • Undertake all administrative procedures in providing training and educational programs to new IRB members, continuing IRB members, and the greater science community of CSIR and Ghana. The training shall include programs about the basic principles of human subject protection, current literature and regulations and guidelines.
  • Support the Chair in preparing and providing a statement of assurance when required in accordance to the regulations guiding the establishment of the IRB.
  • Design and maintain a system for collecting and filing all IRB documents, including meeting minutes, member qualifications, protocol submission versions, deviations from approved protocols, and periodic and final reports.
  • Prepare and submit annual IRB operational budget and plan to the CSIR management with consultation with the coordinator.
  • Properly distribute and keep files of all correspondence.
  • Assist the Chair to conduct IRB meetings. Continually study and update staff about IRB operational regulations.
  • Be available for and attend any outside investigations or audits of the Board. Comply with requests during an investigation or audit.

Review Procedures

  • A Minimum of five meetings will be held per annum with members notified of each meeting, however, this is liable for revision depending on the work load. Agenda, previous minutes and application forms are to be circulated to board members two weeks prior to the meeting.
  • Not more than 15 new protocols will be reviewed at any meeting except for amendments, serious adverse effects and revisions.
  • All researchers submitting protocols for ethical review should be registered with a research institution in Ghana, where this is not the case, a proof is registration from an equivalent body in their home country. Where registration is not available, then a motivational letter and/or other supporting documents from a locally appropriate authority should accompany the application as evidence of competence.
  • All international collaborative researches should have a local Principal Investigator.
  • Student applications should be submitted under the responsibility of a qualified faculty member or in the name of the student co-signed by a qualified faculty supervisor.
  • Studies with substantial clinical component where the Principal Investigator is not a clinician should appoint a registered clinician as a Co-Investigator to the study.
  • All required information needed for a thorough and complete review of research proposal must be submitted including disclosure of researcher’s conflict of interest if any.

Application procedures-New Submissions

  • All proposals are to be submitted in the prescribed application forms.
  • All relevant documents to be enclosed with application forms such as: Information sheets, and Investigator’s brochure for clinical trials, Evidence of qualifications, evidence of current GCP training compulsory for clinical trial personnel.
  • Required number of hard copies and a soft copy of the research proposal, all relevant documents and the application forms in prescribed format to be submitted duly to the IRB Administrator.
  • The IRB only approves completed applications for ethical review. Before applications are submitted to the IRB, they will be pre-reviewed by the Administrator; any incomplete application will be returned to the Principal Investigator (PI) for completion before submission to the IRB.

Full board review procedures
All research proposals shall be reviewed in accordance with all regulations binding the CSIR-IRB. Approval and Disapproval of research would be based on ethical acceptability of the research including its Scientific validity, Social value, procedures for fair participant selection, favourable risk-benefit ratio, adequate Informed consent which is culturally appropriate and mechanisms to ensure voluntariness of participants, mechanisms to ensure respect for recruited participants and study community before, during and after research and the collaborative partnerships involved in the research.

For more details on these principles and their benchmarks, see publication of Emmanuel et al., 2004: What makes clinical research in developing countries ethical? The benchmarks for ethical review. Because this is a re-packaging of all the international ethic guidelines to provide a more specific and practical guidelines that can serve as a reminder or common reference for conducting and evaluating research. The review also takes into account any prior scientific review and other applicable laws.

Quorum/Meeting attendance
The minimum of 50% + 1 member are required to compose a quorum including at least one lay member and one non-affiliated member at scheduled or extraordinary meetings. Meetings will not be conducted when a quorum is not present. The Administrator will keep a record of attendance, indicating members who were present for the discussion of each application. IRB members are expected to attend a majority of scheduled meetings each year and are required to attend at least half of such meetings.

Conflict of interest
CSIR-IRB members shall declare any prior interest and/or involvement in any matter being discussed by the IRB to avoid conflict of interest in the IRB decision- making including review of protocols. During IRB meetings, the chair shall determine whether the member be excused for items for discussion or be allowed to remain and address questions when asked to do so but not vote or participate in final decision making on the matter in question.

All members should maintain absolute confidentiality of all discussions during the meeting. ‘Confidential information’ shall mean certain proprietary, personal, clinical or protocol-specific information which the BREC member acknowledges to be confidential. Such information includes all protocols relating to research with human participants and associated documentation.

Expedited Review Process
Expedited review of a new project or previously approved project may be requested by the principal investigator at the time of submission of the application, by indicating the applicable criterion for expedited review. Alternatively, the Chairperson or Vice Chairperson may choose to process an application by expedited review. Expedited review will be carried out by the IRB Chairperson, Vice Chairpersons or by one or any CSIR-IRB member designated by the Chairperson.

The reviewer(s) may exercise all of the authorities of the IRB, except disapproval. If the reviewer(s) believe(s) that there is a reason for disapproval, or the nature of the project is not suitable for expedited review, the reviewer(s) will defer any decision, and submit the project to a full board review by the CSIR-IRB. For research studies based on expedited review, the Chairperson of the CSIR - IRB is required to adopt a method of keeping all members advised of research studies that have been approved by expedited review. In addition such information and any observations made by members should also be recorded in the minutes of a meeting.

Independent consultant/ co-opted reviewer
IRB may call upon subject experts as independent consultants who may provide special review of selected research protocols, if the need arises especially when the research involved greater than minimal risk. These experts may be specialists in ethical or legal aspects, specific diseases or methodologies, or represent specific communities; patient groups or special interest groups e.g. Cancer patients, HIV/AIDS positive persons or ethnic minorities. They are required to give their specialized views but do not take part in the decision making process which will be made by the members of the IRB.

Decision making/ Voting
The IRB would base its review decisions on coherent and consistent ethical principles outlined in international guidelines, human rights laws as well as the national laws and policies through thorough and inclusive discussion and deliberation process. All decisions will be taken in meetings by a consensus and not by circulation of project proposals. When general agreement was not reached, a consensus will be determined by voting however, when a tied is reached during voting, the Chair reserves the right to final decision in accordance to international guidelines. Decision of the CSIR-IRB may include the following:

Approval: If full ethical approval is granted, the investigator may only begin the research proposed in the protocol when it has been outlined in a letter.

Conditional Approval: Conditional approval of a protocol may be granted, requiring modifications in the protocol and/or patient information sheet and/or patient consent form before initiation or responses to specific inquiries by the Ethics Board. In this case, the investigator should submit a cover letter along with a modified submission form, protocol, consent form or supplemental information as requested with the changes highlighted.

No research may be started until all conditions have been met and full approval has been obtained. Where conditional approval is granted the Chairman and Administrator may review the modified submissions and grant approval subject to the affirmation of the Board at its following meeting.

Deferral: A deferred protocol must be revised and resubmitted to the Ethics Board.

Rejection: Protocols may be rejected by the Ethics Board. This may occur if a protocol has been deferred several times and the Board feels that the proposed research is not justified and/or poses severe or unnecessary risk to the subjects. The Ethics Board will not accept any further revisions to a rejected protocol.

Communication of decision
The Administrator should compile and communicate queries and decisions arrived by the board within two days after the date of review to appropriate investigators through an email and a formal letter in effect. Investigators in turns have one week within which to response to queries raised by the board in a formal presentation submitted to the IRB office.

Monitoring Of Human Subjects Research In Progress

Researchers responsibilities
The Investigator of the protocol may be asked to attend the review. It is the responsibility of the investigator to provide the Ethics Board with the appropriate information on the research protocol including initial information, notification of subsequent modifications, terminations and adverse reactions.

Notification of Amendment
When any revision to an approved research protocol or written consent form is proposed, the amendment must be brought to the attention of the Ethics Board for approval. Amendments to approved protocols may not be initiated until Ethics Board approval has been obtained.

Notification of serious adverse event (SAE)
All adverse events which may be related to the research must be brought to the attention of the Ethics Board within 7 days verbally and 14 days in writing from the date that the Investigator receives a formal written report of the event(s). SAE may include; procedural error involving a human subject enrolled in the study, Physical or emotional harm to the subject during the execution of the experimental protocol, breach of confidentiality or privacy or any untoward medical occurrence (unexpected or expected) that at any dose: results in death, is life threatening requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenial anomaly/birth defect.

Annual renewal and continuing renewal
Update reports of all studies must be forwarded to the Ethics Board on an annual basis. The Board must be notified when trials are completed or terminated.

Final report
A copy of the final report should be submitted to the Board as soon as it is available.

Documentation of informed consent

  • In most instances, the act of obtaining consent shall be validated on the written document that contains the information needed to give informed consent, i.e. the Subject Consent Form. The validation shall be implemented by the signature of the subject or the subject's legally authorized representative, and by the investigator obtaining the consent.
  • Subjects who are illiterate or physically unable to write may have the consent explained to them verbally and indicate approval or disapproval by other means. In such circumstances, it is essential to document the method of communication, the explanation given (and by whom), and the means by which the subject indicates his/her wish. An impartial third party must witness the entire consent process and sign the consent document. Videotaping the consent process is recommended.
  • In the case of a child being recruited as a subject of research (a child according to the constitution of Ghana is anyone younger than 18 years), an assenting signature of the subject of an age sufficient to comprehend the nature, risks and benefits of the study, shall be obtained on the Subject Consent Form, in addition to the signature of the legally authorized representative.

    The documentation shall be executed on three copies of the written consent document carrying the subject's legal name, the hospital case identification number (if within a hospital), and the date of execution. One copy of the executed document shall be given to the subject or subject's legal guardian, one copy shall be incorporated into the research documents kept by the investigators, and one copy shall be placed in the subject's hospital record. The Subject Consent Form shall be dated by the person or persons whose signature is required to be obtained.
  • Clinical investigators should be cautious when enrolling subjects who may not truly understand what they have agreed to do.

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