NIMR IRB
6, Edmond Crescent off Murtala Muhammed Way,
P.M.B. 2013 Yaba, Lagos.
Tel: +234 802 351 3399, +234 909 016 6992
Email: nimr_irb@yahoo.com, nimr-irb@nimr.gov.ng
Secretariat: 2nd floor, Room 207, Research Block, NIMR
IRB VISION
To promote high ethical standards and ensure that the rights, health and welfare of potential research participants are protected and that researchers are guided in conducting ethical research.
IRB MISSION
To ensure that research conducted in the Institute and in the health sector is independently reviewed in a fair and consistent manner. To review protocols to ensure the ethical conduct of research. To develop guidelines for human research subject protection, identify ethical principles to guide the conduct of research. To conduct /organize training workshops and seminars i.e. build capacity for researchers in research ethics and methodologies, and also build capacity of IRB members.
DATE OF ESTABLISHMENT
NIMR HREC was established in 2004
APPOINTMENT AND COMPOSITION
The present NIMR-IRB was constituted on the 23rd of October, 2024 by the Director-General of NIMR, Prof John Obafunwa. The board consists of twenty (20) members with Dr Babatunde Adewale as the Chairman and Dr Qosim Osuolale as the Administrative Secretary
NIMR-Institutional Review Board Members
S/N | Names | Gender | Profession | Organization | Position on Board |
1. | Dr. B. Adewale | M | Bioethicist | NIMR | Chairman |
2 | Dr. T.Y. Raheem | M | Med. Laboratory Scientist | NIMR | Vice Chairman |
3 | Dr. K. Osuolale | M | Biostatistician | NIMR | Admin Secretary |
4 | Mrs N.I Akintan | F | Administrator | NIMR | Asst. Admin Secretary |
5 | Dr C. K. Onwuamah | M | Virologist | NIMR | Member |
6 | Rev. Ariire Bankole | M | Cleric | Anglican Church, Lagos | Member |
7 | Dr. E. Chukwu | F | Medical Microbiologist | NIMR | Member |
8 | Barr. N. Udu | M | Lawyer | NIMR | Member |
9 | Dr. F. Akinsolu | M | Public Health | NIMR | Member |
10 | Prof O.M Ajala | M | Pathologist | Eko Med | Member |
11 | Dr. N. Kalu | F | Pediatrician | FMC | Member |
12 | Alh. B. A.T. Lawal | M | Imam | Muslim Society | Member |
13 | Dr. P. Ezeobi | M | Medical Doctor | NIMR | Member |
14 | Dr. S. Ekama | F | Pharmacist | NIMR | Member |
15 | Dr. O. M. Olayemi | M | Librarian | NIMR | Member |
16 | Dr. O. Ajibaye | M | Biochemistry | NIMR | Member |
17 | Prof. O. Oladokun | F | Biochemistry | Lead City University | Member |
18 | Mr. A.K. Adeneye | M | Medical Sociologist | NIMR | Member |
19 | Dr. D. A Oladele | M | Medical Doctor | NIMR | Member |
20 | Dr. A. Ajayi | M | NIMR | Member |
REGISTRATIONS WITH NATIONAL AND INTERNATIONAL BODIES
The NIMR Institutional Review Board registrations with national and international bodies:
- National Health Research Ethics Committee(NHREC)
- Office of Human Research Protection (OHRP)
- Federal Wide Assurance number (FWA)
COLLABORATION
NIMR HREC has collaborated with a lot bodies & Organizations such as,
- National Health Research Ethics Committee (NHREC)
- Office of Human Research Protection (OHRP)
- Federal Wide Assurance number (FWA)
- Bill and Melinda Gates
- The African Malaria Network Trust (AMANET)
Nigerian Institute of Medical Research (NIMR)New HIV and Microbicides Advocacy Society (NHVMAS) - South African Research Ethics Training Initiatives (SARETI)
- West African Bioethics Training Programme (WABTP)
- National Health Research Ethics Committee (NHREC)
- African Malaria Network Trust (AMANET)
- Bioethics Society of Nigeria (BESON)
MEETINGS
- Statutory meetings are bimonthly held to discuss issues on health research, research protocols, review process, approved protocol and ratifications of protocols
ETHICS REVIEW PROCESS
First Stage
The Review Process is divided into three stages as stated below:
- The NIMR-IRB assesses the social need, value, scientific merit and validity of the proposed research. If human participants are to be recruited, the inclusion and exclusion criteria would be assessed for ethical and scientific appropriateness while assessment is also being given to the informed consent process to ensure that all pertinent aspects are covered.
- Submission of both electronic and paper copy of full version of Proposal to be reviewed
- Submission of electronic copy of abridged version of proposal to be reviewed
- Payment of processing fees
Second Stage
- Full version of submitted proposal is assigned to four designated Reviewers for comprehensive review. (Designated reviewers are assigned protocol according to the area of study in relation to the reviewer’s discipline/role on the Board.)
- The abridged version of the protocol will be forwarded to all members of the Board for further review at meeting.
The four reviewers present brief oral summary of their comments.
- The Chairperson or designee entertains discussion on each document under consideration (e.g., protocol, informed consent, investigator’s and site qualifications, and advertisements).
iii. Recommendations for modifications to the protocol, consent form, and/or advertisements as requested by the Committee are noted in the meeting minutes as “with modifications made by IRB” and will be communicated to the investigator.
- The Chairperson or designee calls for a separate vote on each element in review
- The Committee votes to either:
- Approve the study to start as presented with no modifications
- Approve the study to start with Committee approved modifications to the consent. (Approved with recommendation)
- Require modifications to items noted at the convened meeting and follow-up by the Chairperson, after receipt of the requested modifications. (Approved with recommendation)
- Require modifications to the items and full Committee review of the materials. (Approved with stipulation or Re-submission)
- Request further information regarding the item and full Committee re-review of the material. (Approved with stipulation or Re-submission for re-review)
- Not approve the study, stating the reason for disapproval (Disapproved)
- If the study is approved, the Committee determines the frequency of Continuing Review from each investigator.
- The letter contains, at a minimum, a listing of each document approved, the date set by the Committee for frequency of continuing review, and a review of other obligations and expectations from the investigator throughout the course of the study.
- vi. If the Committee votes not to approve the study, the Secretariat immediately notifies the investigator in writing about the decision and the reason for not approving the study.
- – A computer generated approval and expiration date is placed on every page of each consent form approved by the IRB Institute
- – The Secretariat sends an action letter along with the approved documents to the investigator.
- If the investigator wishes to appeal to the decision, he/she may do so by contacting the IRB Secretariat. The appeal process is stated in the action letter to the investigator.
- vii. If the Committee requires modifications to any of the documents, the Secretariat either generates the revisions to the documents, or sends a written request of the specific changes to the investigator asking him or her to make the necessary changes and resubmit the documents to the IRB.