IRB (SOP)

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

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.

• 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.

• • 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.
  
  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

    • 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.

• • Informed consent process/elements
    All written informed consent must include the following information;

    • statement that the protocol involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed and identification of any procedures, drugs or devices which are experimental and participants responsibilities.
    • Description of any reasonably foreseeable risks or discomforts to the subject.
    • Description of any benefits to the subject or to others that may reasonably be expected from the research, including payment or free treatment.
    • A disclosure of appropriate alternative procedures or courses of treatment, if applicable, that might be advantageous to the subject.
    • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
    • Have the title of the project/trial and the names of the investigators clearly printed on the top of the form.
    • The name of the person to contact for further information in the research.
    • Have space for signature/name/date of both the patient and witness/guardian, language interpreter, and the investigator (or investigator’s nominee).
    • Include the statement: I have read and understood the attached patient 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;

    • Research involving collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, in which the investigator records the information in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects, or if the sources of the information are publicly available.
    • Research involving normal educational practices.
    • Research involving use of educational tests, survey procedures, interview procedures or observation of public behaviour without revealing subjects' identity, placing them at risk of criminal or civil liability, or damaging their financial standing, employability or reputation.
    • Research Involving sensitive information which may include but is not limited to:
    • Information relating to sexual attitudes, preferences, or practices.
    • Information relating to the use of addictive products.
    • Information pertaining to illegal conduct.
    • Information that if released could reasonably be damaging to an individual's financial status , employability, or reputation within the community.
    • Information that would normally be recorded in a patient's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination.
    • Information pertaining to an individual's psychological well-being or mental health.
    • Research that anticipates but lacks definite plans for involvement of human subjects, such as institutional-type centre or training grants; 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.
    • Research that cannot practicably be carried out, if informed consent were to be obtained in advance, provided that the rights and welfare of the subjects will not be adversely affected; in this instance, arrangements shall be made to provide pertinent information to the subjects after their participation.

• • 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:

    • Review of previously approved research for changes without risk implication.
    • Surveys by interview or questionnaire on non-sensitive issues.
    • Collection of hair and nail clippings in a non-disfiguring manner; deciduous teeth, and permanent teeth if patient care indicates a need for extraction.
    • Collection of excreta and external secretions including sweat, un-annulated saliva, and placenta removed at delivery and amniotic fluid at the time of rupture of the membrane prior to or during labour.
    • Recording of data from subjects, using non-invasive procedures routinely employed in clinical practice (including use of physical sensors applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or invasion of the subject's privacy; procedures such as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echocardiography, and electro-ethnography, not including exposure to electromagnetic radiation outside the visible range, such as X-rays and microwaves).
    • Collection of blood samples by vein-puncture, in an amount not exceeding 450 milliliters in an eight-week period and no more than two times per week, from subjects, who are in good health and not pregnant.
    • Collection of supra-gingival and sub-gingival dental plaque and calculus provided the procedure is not more invasive than routine prophylactic scaling of the teeth, and is accomplished in accordance with accepted prophylactic techniques.
    • Voice recordings made for research purposes, such as investigations of speech defects.
    • Moderate exercise by healthy volunteers.
    • Study of existing data, documents, records, pathological specimens, or diagnostic specimens.
    • Research on individual or group behavior or characteristics of individuals, such as perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
    • Research on drugs or devices for which an investigational new drug exemption or investigational device exemption is not required.

    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:

    • To be used in a single subject by a physician licensed to practice medicine in Ghana
    • The subject is facing a life-threatening condition, for which there is no conventional treatment, or conventional treatments have failed.
    • The physician has legitimate access to a test article, and believes that there is a reasonable likelihood that it may be helpful in the life-threatening condition.
    • The subject to receive the test article will not be enrolled in a research study involving the test article employed.
    • If subsequent use of the test article is contemplated in the same subject or in others, a new project application to the CSIR-IRB is required in advance of that use. If these criteria are met, a physician may use the test article on a subject, without prior approval of the CSIR- IRB. In this instance, the physician is required to do the followings:
      i. Obtain written informed consent from the subject or subject's legal representative.
      ii. Use the test article on the subject.
      iii. Enter a description of the procedure in the patients’ medical record and attach a copy of the informed consent document.
      iv. Within five days of using the test article, submit to the CSIR-IRB the following information in writing: Identity and address of the responsible physician, name and hospital case number of the subject, name and source of the test article; investigational new drug/device (IND) number, how much, by what route and on what date the test article was administered, information about any adverse effects observed and copy of the informed consent document used.
    • The CSIR-IRB will process such notifications as an expedited review and issue an acknowledgement letter. Any subsequent use of the test article will be subject to prior full review and approval by the CSIR-IRB.

    Stored tissues

    • In cases where blood or tissue specimens are to be stored for future analyses, only CSIR-IRB approved analyses may be done
    • Investigator must provide details of provision made to protect the privacy of the donor and maintenance of confidentiality.
    • Specimen may not be shared with any third party unless approved by the IRB.
    • Separate consent form for storage of residual samples and genetic testing must be obtained.
    • When samples are to be exported, valid Material Transfer Agreement (MTA) should be obtained. (WHO MTA procedures recommended).

    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:

    • The date, time and venue of the meeting
    • Minutes of the previous IRB meeting
    • Matters arising at the previous meeting(s) that the IRB specifically asked to be considered again
    • Declarations of interest relating to items on the agenda
    • Applications for ethical review to be considered at the meeting, including the names of the lead reviewers
    • Any other business

    Minutes
    The minutes of the meeting shall contain a record of the following:

    • The members present and absent
    • Any interests declared and the decision of the Board on the participation of the member concerned
    • The submission of written comments by members
    • A summary of the main ethical issues considered
    • The decision of the IRB on the applications
    • In the case of an approval, any special approval conditions or additional advice to be given to the applicant
    • In the case of a rejection, a list of reasons for the decision
    • In the case of a conditional opinion, the additional information requested by the IRB and the arrangements for considering this information and issuing the final opinion of the IRB
    • When a decision is held in abeyance, the issues for further advice is required
    • When an unfavorable opinion is given on a notice of amendment, the reasons for the decision and any delegation of responsibility for giving the opinion of the IRB on a modified amendment
    • The outcome of any vote taken
    • Any formal dissent from the decision of the IRB by a named member, with reasons

    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