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.
APIN IRB Review Guidelines for Investigators
IRB SCOPE AND AUTHORITY
All researchers are expected to comply with the guidelines for submission of protocols.
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.
Approvals by APIN IRB is for a duration of one year. In the event that a study is not concluded within one year, the researcher, may apply for an extension or renewal of protocol.
The IRB will 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. 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. Progress reports may also be demanded on request also.
Protocols will be reviewed by the APIN IRB, unless it qualifies for expedited review.
The decision of the APIN IRB is usually communicated to the researcher, by e-mail within two weeks. The notification letter to the researcher may contain additional guidelines, if approved, or detailed reason for a disapproval.
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. Electronic signatures are considered valid.
The APIN IRB may suspend a protocol, e.g. on instances when the outcome is obvious or already known or when there is a violation of protocol/ non-adherence to approved protocol.
Failure to submit progress reports may serve as sufficient grounds to suspend a research protocol and also when the researcher has failed to renew or apply for an extension within four to six months to the expiration of the approved protocol
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.
If a decision is made to suspend a protocol, the researcher will usually be notified by e-mail, within two weeks, the notification letter containing a detailed information on the decision of the IRB. Other parties that will be notified include the APIN Management, Protocol sponsors, regulatory authorities. The researcher may not conduct any further activity associated with the protocol until the suspension is lifted.
The APIN IRB may place restrictions on some components of a protocol. The researcher may not progress further with those components of a protocol restricted by APIN IRB. Appropriate communications will be made accordingly.
Submission of Protocols
Who to submit to
All submission should be made to the IRB administrator who is designated to receive protocols on behalf of the IRB, through secure electronic and physical means. The administrator will usually ensure that protocols are complete and all required information is provided by the researcher, before the protocols are presented to the IRB for review. The IRB relies on the documents submitted by the researcher to arrive at a decision. The research protocol must contain enough information, to enable the IRB make an informed decision on the ethics and science of the research.
Content requirements of Protocols
Each protocol must contain an ethical considerations section and amongst other information, clearly state how the following will be implemented:
• Confidentiality and storage of data • Data analysis • Secondary or future use of data • Translation of protocol to local language (where applicable) • Beneficence to participants • Non-maleficence to participants • Informed consent • Voluntariness
Currently, the APIN IRB may not charge for the review of your protocol. Please check with the administrator to confirm if yours qualifies for this.
The procedure for submission of protocols to the APIN IRB is as listed below. • Cover page containing the following information: Title of Research; full names, E-mail addresses, phone numbers, qualifications of investigators, supervisors name (where applicable), sponsors (where applicable), other collaborating institutions and investigators; Contact details of corresponding investigator who must be the projects principal investigator (PI) or local PI of the research, who must bear full responsibility for the research.
• Typewritten letter to be addressed to the Chairman, APIN Institutional Review Board, 10 Ndagi Mammudu close, Jabi, Abuja, Nigeria
• Completed application forms.
• One e-version sent as an E-mail to email@example.com
• Copies of the informed consent form.
• Principal investigators CV in NIH Bio sketch format
• Evidence of ethics training for all the Nigerian based researchers to be credited in the study where applicable (please see www.citiprogram.org)
• Supervisors attestation statement where applicable
• Relevant directorate clearance for APIN Operational Research (where applicable)
• Statements/letters of support from co-investigators and collaborators.
• Sponsors attestation statement/letter of sponsorship where applicable
• Materials Transfer agreement, in studies in which materials/data will be shipped out of Nigeria where applicable
• Copy of data use agreements, for third-party data users where applicable
• Clinical Trial Agreement (CTA) where the research is being conducted on behalf of a sponsor
All requirements should be sent to the Office of the APIN IRB at firstname.lastname@example.org.
To start your application process, download and fill require forms below (please refer to the National ART Data Collection Tools to fill Form B) and send application addressed to the “Chairman of APIN IRB” to email@example.com.
Making changes to Protocol
The IRB approves protocols based on available information, submitted by the investigator, at the time of approval, the researcher may not alter or modify a proposal, without notifying the IRB, except where necessary to eliminate immediate hazards to human subjects. Changes to protocols may be initiated by the researcher, his sponsors or collaborators, however the notification to the IRB must be received from the Principal investigator. The principal investigator must notify the IRB within thirty days of reaching an agreement to modify the protocol. The IRB will determine if the protocols changes remain in line with the initial criteria used for approval of the protocol or for exempting the protocol from IRB review. If an alteration is necessary to avert impending harm to study subjects, a full report is to be submitted to the IRB, by the principal investigator, outlining the circumstances, actions taken and plan to avert a reoccurrence.
Procedure for notifying the IRB of proposed changes
The investigator must write a formal letter to the IRB chairman within 30 days of notification of funder or determination of the need for protocol changes. The investigator must attach the approved protocol and highlight proposed changes for the IRB’s consideration. The IRB will usually convey its decision to the investigator within 30 days of receipt of the proposed changes.
Protocols that may be expedited
Expedited review is review of a protocol which presents minimal risk to the human subjects of the research. It is conducted by the IRB chair or his designee, who may approve an expedited review but may not disapprove. If the review is not in line with the criteria for approval, the IRB chair or his designee will have to present same to the convened IRB.
A research may meet the criteria for expedited review, if it meets the following criteria
• Minimal risk to research subjects.
• Involve only procedures listed in Federal Register Volume 63, No 216 (See link: https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm118099.htm).
• The research is not classified.
Some categories of research are exempt from IRB review, this determination is made by the IRB administrator and the research protocol is registered by the IRB, then sent to IRB for approval before the research can proceed. Determination of IRB exemption cannot be made by the investigator.
Criteria for IRB exemption
• Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless 1.)information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and 2.) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt as defined in this SOP, if 1.) The human subjects are elected or appointed public officials or candidates for public office; or 2.) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
• Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
• Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: Public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.
• Taste and food quality evaluation and consumer acceptance studies, 1.) if wholesome foods without additives are consumed or 2.) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Method of approval
Convened IRB reviews all protocols except protocols that qualify for expedited review. The voting procedure is by a simple majority which is 60% of IRB members in attendance.
Criteria for IRB approval • Risks to subjects are minimized: 1.) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and 2.) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
• Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
• Selection of subjects is equitable. In making this assessment the IRB will consider the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
• Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by the IRB
• Informed consent will be appropriately documented, in accordance with, and to the extent required by the IRB
• When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
• (HHS.gov 45 CFR 46 2018)
Criteria for disapproving a study.
Criteria for disapproval may include but is not limited to the following:
• The study violates any laws or regulations of Nigeria or APIN.
• Risks to subjects outweigh the benefits to them or society.
• Unnecessary risks are created.
• Selection of subjects is inequitable.
• Procedures for obtaining and documenting informed consent are inadequate.
• Payment or other offered inducements are likely to influence subjects’ judgment.
• The study is poorly or improperly designed such that meaningful conclusions cannot be derived.
• The study is promotional and not scientific in nature.
IRB Actions / Determinations
Approval as submitted. This is the approval of a protocol with all the accompanying documents. This is effective immediately such approval is given.
Approval pending receipt of administrative documents. This is approval that is only effective after the IRB receives administrative documents that may not have been included in the protocol for example, verification of training or CV of investigators. The IRB administrator withholds the approval until the documents are provided.
Approval upon receipt of required modifications. The IRB may grant an approval but with a recommendation of minor modifications. The approval is not transmitted to the investigator until the modifications are implemented. The IRB chair may review the modifications through expedited review and grant final approval.
Tabled. This occurs if the IRB does not have sufficient information to make a conclusive decision, or requests clarifications from investigators or substantial modifications. The IRB may table the protocol until it receives sufficient information to decide on the protocol.
Disapproval. The IRB may disapprove a study if it fails to meet any of the criteria for approval or meets the criteria for disapproval.
The IRB is authorized to suspend, terminate or disapprove a study. Terminations and suspensions will be reported to OHRP, APIN institutional officials, NHREC and FDA. Administrative hold placed by the investigator.
The hold is usually placed out of concern that the research activity is causing more harm than anticipated on the human subjects. The IRB on receipt of notice that a study is to be placed on administration, initiates an enquiry. The IRB in consultation with the investigator re assesses the risk benefit ratio and adherence to protocol. The IRB determines how and when the study participants will be notified that a study has been placed on administrative hold.
Investigators must: • Notify the IRB in writing that the investigator is voluntarily placing a study on administrative hold.
• Provide a description of the research activities that will be stopped. Research activities may include but are not limited to recruitment, screening/enrollment, research intervention/interaction, follow-up, or all research activities.
• Provide a list of all currently enrolled participants’ status within the study, and the proposed actions to be taken (if needed) to protect the rights and welfare of current participants during the administrative hold
• Provide a written description of actions that will be taken prior to IRB approval of proposed changes in order to eliminate apparent immediate harm.
The IRB designee who conducted the enquiry, is expected to write a report of his findings to the IRB chair, and recommends the appropriate action that should be taken. The IRB chair will then present the report to a convened IRB for consideration.
Termination will occur only after the convened IRB decides through voting by a simple majority. Possible actions to be taken by the IRB include but are not limited to the following;
• Continue interventions that are being administered to currently enrolled participants, especially when the intervention holds direct benefit to the participants or its cessation holds direct risk to the participants.
• Transferring currently enrolled participants to another institution engaged in the research, to ensure their continued participation.
• Transitioning currently enrolled participants to medical management outside the research context.
After the immediate interests of the participants have been taken care of above, the convened IRB may then decide to lift the suspension, continue or modify the suspension or terminate the study. The investigator will be communicated to through the Administrator citing the following in the notification:
• The activities to be stopped;
• Actions to be taken by the Investigator;
• An explanation of the reasons for the decision;
• A request to immediately notify the IRB Chair with a list of names of participants who might be harmed by stopping research procedures and a rationale as to why they might be harmed.
The investigator may appeal or respond to the convened IRB in writing.
The right to appeal is one of the rights guaranteed every investigator by APIN IRB. An investigator may appeal the following decisions:
• Revisions required by the APIN IRB
• APIN IRB determination of noncompliance to approved protocol.
• Disapproval or suspension of protocol
• Limitation placed on a protocol.
All correspondence related to the appeal process is stored using APIN IRB procedure for storing IRB data. If the appeal is rejected, the investigator has no further chance at appealing, hence appeal decisions are final.
All appeals must be written and addressed to the IRB chair. For research reviewed by expedited review, the same official that reviewed it originally if available may review the appeal.
For research reviewed by the convened IRB, the appeal is also reviewed by the convened IRB. The investigator must write a detailed justification for an appeal. If an appeal is rejected, the IRBs decision is final.