APIN INSTITUTIONAL REVIEW BOARD (IRB)
The APIN Institutional Review Board (IRB) is an administrative body established to primarily protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the APIN Public Health Initiatives. In other words, the IRB is charged to review all research involving human participants of its program and maintains the right of authority to approve, disapprove, monitor and require modifications in all activities that fall within this scope as specified by federal and international regulations as well as institutional policy.
The APIN IRB has 11 voting members of varying professional background. APIN IRB’s members constitution include non-scientific and non-APIN affiliated memberships providing a complete insight of legal, scientific, and social implications involved in research.
The APIN IRB is regulated by the National Health Research Ethics Committee, Nigeria and the Office for Human Research Protections, USA.
Standard Operating Procedures for APIN IRB
POLICYThe APIN Institutional Review Board (IRB), is an independent review body, set up by the APIN management, with authority to review all research protocols, emanating from APIN related program activities, APIN Staff, APIN supported sites and use of APIN program data.
The APIN IRB maintains a current federal wide assurance (FWA) and registration with the Nigerian National Health Research Committee (NHREC). It aligns its activities to the guidelines provided by the Nigerian National Health Research Ethics Committee (NHREC) and the United States Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA).
This Standard Operating Policies and Procedures (SOPs), is designed to provide a framework for the activities of the IRB, guide the conduct of the IRB members and ensure a standardized and uniform relationship between the IRB and other individuals and groups, including researchers, research subjects, institutions and regulatory authorities. The APIN IRB relies on these written procedures to ensure a constant protection of the subjects of human research, irrespective of changing situations, staff or interest.
1. Procedures for Review, Revision and Approval of SOPs
This SOP may be reviewed, to adapt to changes in NHREC, OHRP or FDA regulations and research practices. It may also be reviewed if there are significant observed gaps in the SOP or in response to internal policy changes approved by the APIN management. Each approved SOP will be reviewed every two years, usually at the onset of the tenure of a new IRB or may be determined two years from the last date of approval.
1.1 At the expiration of two years, after the last approved date of an SOP or if there is a determination that the SOP should be reviewed, the IRB administrator, notifies the IRB Chairman, and the SOP may be presented at a convened IRB meeting for review and approval by voting or general consensus.
1.2 The review and approval of the SOP is documented by the IRB Secretary or designee, who records the policy, its date of approval, and the members who gave the approval. The effective date is also determined by the IRB members and recorded, the reviewed policy becomes implementable automatically from the approved effective date.
2. Procedures for SOP Dissemination and Training
When a new SOP is approved or an existing SOP is reviewed, a hard copy of the new SOP is stored at the IRB office, electronic copies are to be disseminated to all IRB members, APIN management and Staff, within two weeks, by the IRB administrator or designee. An electronic copy must also be posted to the APIN website with a notification of the review.
2.1 New IRB members must review all SOPs and regulations and also complete all required human subjects training prior to accepting any IRB responsibilities, evidence of this training, must be documented and filed with the IRB administrator.
3. Procedures for Creating and Using IRB Forms
IRB forms may be created to ensure a uniformity and standardize the review of protocols, with accurate documentation of processes. Forms may include templates, checklists, application forms and notifications.
3.1. Forms are created and revised by IRB Administrators or designee.
3.2. Forms are approved by the IRB chairman.
3.3. Forms must align with this SOP and other IRB regulatory guidelines.
A) Alternate member
Alternates are not IRB members, they are appointed by an IRB member, to perform a designated role which the member should have ordinarily performed in the IRB. Alternates must have comparable training, skill and qualifications as members who they represent and must be certified fit to function in that role by the IRB chairman. Alternate members may contribute to protocol review, however they do not have voting rights in APIN IRB.
B) Non Scientific Member
A non-scientific IRB member, is a member, whose training, skills and work experience, is not related to the core scientific fields including medicine, biology and chemistry
C) Scientific Members
A scientific member, is a member whose training and work experience includes the core scientific fields. They may include academics, doctors, nurses and other biomedical health professionals.
D) Unaffiliated member/community representative
The community representative, is a member of the local community in which a research is to be carried out. The community representative, must be knowledgeable about the community and be in a position to speak on the interests of that community and must be willing to provide a representation of the perspective from the local community in the course of protocol review. The community representative may be a scientific or non-scientific personnel.
The APIN IRB, has the responsibility of ensuring that all research protocols received, are in line with; APIN institutional policies, Nigerian or international law as applicable, sound ethical and scientific principles and the highest standards of professional conduct. The IRB must ensure that it is in a position to determine this at all times and research is carried out according to its approved guidelines and global best practices.. The APIN IRB must not discriminate in any form in choosing its members, it may only retain members based on a consideration of skill, qualification, expertise and diversity. It must consist of at least five regular voting members, which must include at least one scientific member, one nonscientific member, a female, an Islamic cleric, a Christian cleric and a lawyer. A single member may perform a maximum of two of the listed roles. A minimum of one and maximum of two IRB members, must be staff of APIN, they are expected to act as liaison officers between the IRB and APIN management. The IRB must appoint a Chairman, an administrator and a secretary from its membership, to manage the activities of the IRB, for the duration of the IRBs tenure. The IRB should include members or appoint expert reviewers who are knowledgeable about the concerns of some research subjects, who may be vulnerable for example children, prisoners, pregnant women, handicapped or mentally disabled persons.
1. Procedure for appointing IRB members
The APIN CEO, is responsible for appointing members to the IRB. IRB Members are to be sourced from the academic and non-academic communities, at the discretion of the CEO. The IRB membership must be sufficiently diverse and fit for purpose. Participation of APIN staff in the IRB, shall be considered as part of their job functions, therefore it does not attract additional compensation with the exception of travel allowances and accommodation as applicable. IRB members who are not staff of APIN are entitled to an allowance/honorarium and accommodation, as applicable.
1.1 IRB membership is for a term of two years, at the end of each tenure, the APIN CEO may re appoint each IRB member for another two year term, based on positive performance.
2. Procedures for Appointment of the IRB Chair
The IRB Chairman, should be an individual that is accomplished in a particular field of endeavor and must be willing to undertake the additional activities required for an IRB chairman. He must be fully capable of managing the affairs of the IRB. The IRB chairman is appointed by the APIN CEO, for a two year tenure. The APIN CEO may appoint the IRB chairman, based on a previous amicable working relationship with APIN, IRB experience (if applicable), integrity, education, research experience, Professional and personal interests. The APIN CEO makes the appointment, of the IRB chairman through a letter of appointment sent to the chairman designee.
2.1 The performance of IRB members must be evaluated at least once a year by the IRB chairman or a designee. A member may be suspended or his appointment terminated, due to gross misconduct. The IRB chairman has the responsibility of suspending erring members, while termination is at the discretion of the full IRB committee.
2.2 Procedure for maintaining board member information The board members are to submit the following information to the IRB administrator; cv/resumes updated annually, signed confidentiality agreement and a signed conflict of interest declaration form. Other information include; members names, earned degrees, scientific status, representative capacity, employment information, experience relevant to the functions of the IRB.
3. Procedures for Maintaining Sufficient Resources
The APIN management shall provide meeting space and sufficient staff support to the IRB, The IRB administrative staff, will also be provided the resources and sufficient time to conduct IRB duties.
3.1 The adequacy of the APIN IRB is to be reviewed by the APIN management before the beginning of the tenure of each IRB.
The management of the membership of the IRBs and facilitation of member appointments, IRB related activities, communications, and other administrative details are the responsibility of the IRB administrator.
The APIN IRB has been granted the authority by the APIN management to review all research protocols emanating from APINs program activities, projects affiliated to APIN, APIN supported facilities, APIN database, APIN staff and APINs project partners. The IRB has the authority to disapprove, modify or approve studies based on a consideration of human subject protection. The IRB also requires the researcher to provide progress reports of approved research protocols at designated periods in the course of the research. The APIN IRB may place restrictions on some components of a study, and allow other components to go on subject to adherence to recommended guidelines. The IRB also has the authority to observe or appoint a third party to observe the consent process, and the conduct of the research. The IRB must in exercise of its oversight functions, conduct continuing review of protocols, at intervals not less than six months into the lifespan of the protocol or as determined by the IRB during initial protocol review. Researchers are required to submit a continuing review application and complete the self-assessment checklist, at least six months to the end of the period covered in the initial approval. In considering this request for continuation, the IRB is expected to review the initial criteria used to approve the protocol and assess the researchers’ adherence to protocol as approved. In reviewing a request for continuation of a protocol, the IRB may approve, disapprove, place restrictions or suspend a protocol. The IRB may also modify the protocol. The IRB chairman and administrator are authorized to sign any and all documents in connection with the review and approval of research projects involving human subjects which have been reviewed and approved by the APIN IRB. The IRB chair may designate signatory authority to qualified IRB members and IRB administrator as appropriate and in writing. In all cases individuals must sign with their personal and known signatures, Electronic signatures are considered valid. Authorization to sign any document may be done in writing by the IRB chairman.
1. Procedure for determining the scope of authority of the IRB
1.1 The APIN IRB may receive protocols from all APIN staff, partners and supported facilities.
1.2 The APIN IRB may receive protocols from researchers working on APIN programs
1.3 The APIN IRB may receive protocols requiring the use of data from APIN database.
2. Procedure for approval or disapproval of protocols
2.1 The APIN IRB may approve or disapprove protocols.
2.2 All researchers are expected to comply with the guidelines for submission of protocols.
2.3 Approvals by APIN IRB is for a duration of one year.
2.4 In the event that a study is not concluded within one year, the researcher, may apply for an extension or renewal of protocol.
2.5 Protocols must be reviewed by the APIN IRB, unless it qualifies for expedited review.
2.6 The decision of the APIN IRB must be communicated to the researcher, by e-mail within two weeks.
2.7 The notification letter to the researcher may contain additional guidelines, if approved, or detailed reason for a disapproval.
3. Procedure for obtaining progress reports and oversee conduct of approved protocols
3.1 Progress reports are to be submitted to the APIN IRB by all researchers
3.2 Progress reports are submitted six months into the tenure of an approved protocol, and at the end of the study or application for an extension.
3.3 The APIN IRB may through the administrator, send reminders to the Researcher, to submit progress report, through short message service (SMS) or e-mail.
3.4 Failure to submit progress reports may serve as sufficient grounds to suspend a research protocol.
3.5 The IRB administrator may create a system of tracking submission of progress reports, to ensure adherence.
3.6 The APIN IRB must perform oversight functions, as applicable on all approved research protocols, at least once in its life span or approved tenure.
4. Procedure for suspending a protocol
4.1 The APIN IRB may suspend its previous approval of a protocol
4.2 The APIN IRB may suspend a protocol, when the outcome is obvious or already known
4.3 There is a violation of protocol/ non-adherence to approved protocol.
4.4 Violation of terms of approval
4.5 The researcher has failed to renew or apply for an extension within four to six months to the expiration of the approved protocol
4.6 The APIN IRB may disapprove or suspend an approved protocol, based on a consideration of all or any of the following reasons; protection of human subjects of research, unanticipated risks to research subjects, poor scientific base of research, poor data management in the course of research, researchers are unqualified to conduct a proposed study, absence of informed consent, non-adherence to Nigerian or international laws, insensitivity to local customs, laws and traditions and any other factor that may not be in line with ethical conduct of research.
4.7 If a decision is made to suspend a protocol, the researcher must be notified by e-mail, within two weeks.
4.8 The notification letter to the researcher must contain detailed information on the decision of the IRB.
4.9 The APIN IRB chairman can initiate a protocol suspension, and present it to the convened IRB, for ratification, at the earliest opportunity.
4.10 If a protocol is suspended, the following must be notified; the researcher, APIN Management, Protocol sponsors, regulatory authorities. The researcher may not conduct any further activity associated with the protocol until the suspension is lifted.
5. Procedure for placement of restrictions on protocols
5.1 The APIN IRB may place restrictions on some components of a protocol.
5.2 The researcher may not progress further with those components of a protocol restricted by APIN IRB.
5.3 Authority to place restrictions is domiciled within the IRB or a committee designated to perform oversight functions on the protocol on behalf of the IRB.
5.4 If restrictions are placed on a protocol, the following must be notified; the researcher, APIN Management, Protocol sponsors, regulatory authorities. The researcher may continue with other components of the protocol which were not restricted.
6. Procedure for authorization of IRB communications
6.1 The results of IRB reviews and actions taken by the convened IRB, must be signed by the IRB Chair or designee and the IRB administrator.
6.2 Letters of notification to researchers on IRB decision must be signed by the IRB chairman and administrator.
6.3 Any action, letters, memos or emails between IRB and / or staff of APIN, that provides information, concerning the review of protocols by the IRB or staff, which do not imply or appear to imply approval of research protocol may be signed by the designated IRB member.
6.4 Any letters, memos or emails sent to agencies or individuals outside APIN, must be signed by the APIN CEO, IRB chair or designee.
6.5 Any letters, memos or email sent representing the decision of opinions of the IRB chair or his/her respective designees, may be signed by the IRB chair or designee, as long as the correspondence does not convey or imply approval of research projects.
IRB members are appointed to the IRB mainly for the protection of human subjects in research studies. IRB members have been trained in basic research ethics and are considered subject matter experts in their different core disciplines, however all members are expected to continually re-train and educate themselves on the Nigerian National code for research ethics and international current practices in research, in other to maintain the high standards expected from the IRB.
The APIN core values of integrity and excellence are expected at all times from members of the IRB, in the course of their duties. Although responsiveness and speed is encouraged during protocol review, IRB members must not facilitate protocol review at the expense of diligent consideration of the risks and interests of the human research subjects.
IRB members are expected to declare any conflicts of interest that may prejudice their judgment or influence their actions during the review of protocols.
1) Specific duties
1.1 Review of protocols
1.2 Ensure the sustenance of the IRBs reputation for fairness, diligence, independence, professionalism and timeliness in the review of protocols
1.3 Nonscientific members are expected to provide perspectives within their knowledge and skill level. They are expected to advise the IRB in this regard and recommend for additional expertize if there is a perceived need for more specialized advise to the IRB.
1.4 Scientific members are expected to provide perspectives within their knowledge and skill level. They are expected to advise the IRB in this regard and recommend for additional expertize if there is a perceived need for more specialized advise to the IRB.
1.5 The Lawyer is expected to provide legal advice and interpretation of legal language. S/He is expected to ensure that the IRB adheres to the laws of Nigeria in the discharge of its functions. S/He is expected to be the lead guardian of the rights of human research subjects.
1.6 Community representatives are expected to be members of the community under study, they provide perspectives from the community based on their intimate knowledge of the community under study.
2) Duties of the IRB Chair
2.1 The IRB chair is first a member of the IRB and he has same responsibilities and duties as members of the IRB, in addition to his role as the Chair.
2.2 The IRB chair conducts the IRB meetings and makes a report to the institutional officer at the conclusion of each IRB meeting.
2.3 The IRB members may elect an IRB vice chair, to assist the chair in performing his duties or act on his/her behalf whenever s/he is unavoidably absent from meetings.
2.4 The IRB chair may delegate any of his/her duties to any competent IRB member, as long as such action is documented in writing and transmitted to the IRB administrator for record purposes.
2.5 The IRB chair may conduct an expedited review of protocols.
2.6 The IRB chair may delegate the responsibility for expedited reviews to competent board members
2.7 The IRB chair represents the IRB in all relationships with external institutions and regulatory authorities.
2.8 The IRB chair is responsible for maintaining the standards contained in the guidelines of regulatory agencies.
3) IRB membership
3.1 The IRB shall be made up of 9 to 13 members.
3.2 The membership of the IRB must always be odd numbered
3.3 The IRB shall maintain diversity in its membership
3.4 The IRB must have an Islamic cleric, a Christian cleric, a nonscientific member and a female member.
3.5 Membership consideration for the IRB must always include competence, relevant qualifications and the diversity as listed in
3.6.IRB members are required to attend 75% of IRB meetings in a year.
4) Quorum for business
4.1 The IRB must have at least 60% of its members present, for any decision taken to be valid.
4.2 The IRB must have the chair or his designee present, the lawyer or his designee, the clerics or their designee present for meetings where protocols are to be reviewed.
4.3 All IRB members have equal voting rights.
4.4 The secretary may not vote but may be required to break a tie during voting.
5) Removal/suspension of membership.
5.1 Membership tenure may be terminated or suspended, due to misconduct or dereliction of duties.
5.2 Misconduct may include, non-declaration of conflict of interest, bias in protocol review, sexual misconduct, financial inducement etc.
5.3 The chairman may receive any complaints of misconduct and recommend appropriate sanctions to the IRB for voting.
5.4 A member may be disciplined by a majority vote of the IRB in a convened meeting
5.5 Any IRB member who has a case of alleged misconduct must be given an opportunity to defend himself before the IRB.
5.6 The IRB must vote on the Chairman or his designees’ recommendations.
5.7 The IRB member facing disciplinary proceedings, may attend IRB meetings but must recuse himself from all IRB activities related to his investigation, including voting, while he is under investigations
5.8 The decision of the IRB must be communicated to the member who is facing a disciplinary process within two weeks.
6) Removal/suspension of the IRB chair
6.1 The IRB chair may be removed/suspended for dereliction of duties or misconduct.
6.2 If an allegation is made against the IRB chair, and the IRB members vote to consider such allegation, the chair must recuse himself and step aside, he must leave the meeting for the IRB members to elect a pro term chair, to handle all IRB activities related to the investigation. The pro term chair is only functional whenever the disciplinary proceedings against the chairman is being considered.
6.3 The chair is to be allowed to continue performing all other functions of his office until he receives a formal communication from the IRB concerning their decision on the disciplinary proceedings against him.
7) Training Requirements
7.1 IRB members are expected to complete all the training requirements recommended by NHREC including the CITI training and bioethics training.
7.2 The APIN management may organize trainings for all IRB members once a year depending on the availability of funds.
A quorum is defined as more than half of the regular voting members of an IRB. A quorum consists of regular members or their alternate and includes at least an Islamic and Christian cleric, one member whose primary concerns are in scientific areas, and one member whose primary concerns are in nonscientific areas. (University of Utah IRB SOP 2018).
The IRB meets to review research protocols submitted to it, and to deliberate on all other matters that may affect the smooth running, efficiency and integrity of the IRB. The APIN IRB will meet every quarter, or at the instance of the Chairman. To review a protocol, the IRB must have a quorum.
1) Procedure for maintaining Quorum
1.1 Establishment of quorum is a core requirement for every IRB meeting.
1.2 It is the duty of the IRB administrator to take attendance and inform the IRB Chair when quorum is established.
1.3 An alternate member may attend in lieu of a permanent member.
1.4 A specialist or community representative may not be used to establish a quorum.
1.5 It is the responsibility of the IRB administrator to notify the Chair if quorum is lost, during a meeting, if this happens, all voting must be suspended until quorum is re-established.
2) Procedure for voting
2.1 At least 60% of members must vote, for an action by the IRB to be valid
2.2 Only members are allowed to vote, alternate members are not allowed to vote, but they may convey the votes of the members they represent to the IRB via electronic means or through a signed letter.
2.3 IRB members not physically present may participate in voting via teleconferencing or speaker phone. This must be to the hearing of all IRB members present.
2.4 The IRB administrator is responsible for counting the votes and is required to count to the hearing of all IRB members present.
2.5 All IRB decisions arrived at by voting in which all the procedures in this SOP where adhered to remain valid, and may only be revisited if there is an appeal of the IRB decision.
3) Procedure for managing conflict of interest
3.1 Conflict of interest declarations must be made at the beginning of every meeting in which protocols are to be reviewed.
3.2 Any IRB member, declaring a conflict of interest must be recused from voting during protocol review.
3.3 Undeclared conflicts of interest will attract sanctions by the IRB.
3.4 All conflicts of interest and recusals must be recorded by the IRB secretary in the Minutes of the IRB meeting.
3.5 Consultants and community representatives are also required to declare any conflicts of interest.
3.6 The IRB administrator is to ensure that all the IRB members, consultants and Community representatives understand the conflict of interest policy and sign on to it.
4) Procedure for maintaining IRB confidentiality Agreements
4.1 All IRB deliberations are confidential.
4.2 All IRB materials are confidential
4.3 Consultants and community representatives must sign the IRB confidentiality agreement
4.4 IRB members are not allowed to discuss IRB activities with a non IRB member, including Staff of APIN.
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For inquiries contact:
The Chair, APIN IRB, 10 Ndagi Mamudu close Jabi, Abuja, Nigeria.
The Chair, APIN Regulatory Affairs Committee
Tel: +234 9 7809377