
Post Office Box M32, Ministries
Agostinho Neto Road, Council Close, Airport Residential Area, Accra - Ghana
+233-302-777651-4
info@csir.org.gh
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.
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
Compliance
The CSIR-IRB functions in compliance with but not limited to the following documents and guidelines:
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.
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
Shall perform the same duties as the chair in the absence of the chair Perform any assign responsibilities by the chair or the IRB
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.
Application procedures-New Submissions
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.
Confidentiality
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.
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
Informed consent process/elements
All written informed consent must include the following information;
Projects that may be eligible for Waiver/Exemption of the written Informed Consent Process.
The CSIR-IRB will consider waiving/exempting the requirement of obtaining written informed consent from a subject of research, if the nature of the research is not either violative and or invasive, and does not involve risks to the subjects that are greater than minimal. The following but not limited to these can be considered;
The following types of research considered having no more than minimal risk, and not involving children, foetuses, pregnant women, prisoners, mentally ill or cognitive impaired or intellectually disabled persons have been explicitly identified as eligible for expedited review:
Research considered eligible for exemption from review, but subject to expedited review by CSIR- IRB
Overseas regulatory agencies recognize certain types of research as having no or negligible risk to the subjects, and considered them to be eligible for exemption from review by institutional review boards. The CSIR-IRB will not grant exemption from review for such research, but will consider processing them by expedited review.
Institutional-type applications considered by CSIR-IRB as eligible for expeditedreview
Applications and proposals lacking definite plans for involvement of human subjects, such as institutional-type centre or training grants, will be eligible for expedited review. Any study involving human subjects under the umbrella of such grants will have to be reviewed subsequently by the CSIR-IRB, prior to its initiation.
Use of test articles
Under certain circumstances, a test article may have to be administered to a human subject in a life-threatening situation, when there is no standard acceptable treatment available, or the standard treatments have failed and the subject is not enrolled, or is not eligible to enroll in a research protocol involving the test article. The following criteria apply:
Stored tissues
ARCHIVING/RECORD KEEPING
Meeting Records
Agendas and minutes of the IRB meetings will be kept in files .They will be maintained indefinitely.
Member Records
Member’s records should include the term and status of each member, Curriculum Vitae, appointment document and information about training received. Such information should be maintained and updated as necessary and should be retained for at least 5 years after completion of the service of active members of the IRB.
Review of Documents
The Chair of the IRB must review all IRB documents annually or whenever there is a change of IRB Chair. The documents must be reviewed and signed, where appropriate, by the Chair.
Reviewed research protocol record
The Administrator must maintain an archive of files for all research projects approved by the IRB. Such files will be retained for at least three years after completion of the research. Each project folder will include the following types of documents, as conventional hard copies:
Initial Review Application Form – FORM A, Study Protocol, Investigator's Brochure, Subject Information Sheet – English, Subject Consent Form – English, Texts of advertisements for subject recruitment - English (where appropriate), Questionnaires/Interview Guides – English (where appropriate), Investigator’s short CV, Insurance policy document, Certification documents from other agencies, as mandated by federal regulatory agencies, IRB Approval Certificate, Research Progress Report Form – FORM B, Research Final Report, Protocol Amendment Application, Statements on significant new findings and Correspondence between CSIR-IRB and investigators of the project.
Relational Database
To facilitate tracking of the steps involved in accepting, reviewing and monitoring research projects involving human subjects and evaluation of its activities statistically, the CSIR- IRB will maintain a computerized relational database on all research projects submitted for review. It will be maintained indefinitely.
Agenda
The Administrator/Secretary prepares a draft agenda for each IRB meeting for consideration and approval by the IRB. The agenda for each meeting will include:
Minutes
The minutes of the meeting shall contain a record of the following:
Standard Templates for Investigators
CSIR-IRB Submission Cover Letter
CSIR-IRB Informed Consent Template
CSIR-IRB Assent Form Template
CSIR-IRB Initial Submission Form Template
CSIR-IRB Serious Adverse Event Form Template
CSIR-IRB Continuing Review Form Template
CSIR-IRB Amendment Form Template
CSIR-IRB Study Closure Template
Supporting Documents for Investigators
CSIR-IRB Guidance for Preparation of Study Protocol
CSIR-IRB Guidance Notes for Preparation of Informed Consent Documents
Information for Investigators and IRB Members
CSIR-IRB Standard Operating Procedures (SOPs)
Documents for IRB Members
CSIR-IRB Review Checklist
Documents issued by IRB to Investigators
Ethical clearance
Post Office Box M32, Ministries
Agostinho Neto Road, Council Close, Airport Residential Area, Accra - Ghana
+233-302-777651-4
info@csir.org.gh