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NIMR IRB

 

 

 

 

 

 

 

6, Edmond Crescent Off Murtala Muhammed Way, P.M.B. 2013 Yaba, Lagos.
Tel: 08023513399; 09090166992
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 inaugurated into office on the 26th of September, 2016 by the Director-General of NIMR, Prof. Babatunde Lawal Salako.  The Board consists of fifteen (15) members with Dr. O.C Ezechi the Chairman and Mrs. O.A Nwogbe as the Administrative Secretary.

NIMR-Institutional Review Board Members

NAMEQUALIFICATIONSEXROLEPOSITION
Dr. O.C EzechiMD, PhDMClinicianChairman
Dr. A.N. DavidMDFClinicianVice Chairman
Mrs. A . O NwogbeM.I.SFAdministrative SecretaryMember / Secretary
Dr. Tajudeen BamidelePhDMScientistMember / Asst. Secretary
Dr. B. AdewalePhDMBioethicsMember
Ms. Olayide AkanniM.ScFCivil Society RepresentativeMember
Barr. Olatunde DauduL.L.BMCommunity RepresentativeMember
Dr. R. A. AuduPhDFScientistMember
Alh. A. S YunusazazzauMPAMSocial ScientistMember
Dr. A. Z. MusaM.ScFStatiscianMember
Dr. O.O. AinaPhDMScientistMember
Msgr. P. NwaezeapuMPriestMember
Dr. G. OhihoinPhDMClinicianMember
Ms. Ifeoma IdigbeM. Sc.MSocial ScientistMember
Alh. T.Y RaheemFMLSMLaboratory ScientistMember
Alh. Bashiru AT LawalMReligious PersonMember

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.
  1. Submission of both electronic and paper copy of full version of Proposal to be reviewed
  2. Submission of electronic copy of abridged version of proposal to be reviewed
  3. Payment of processing fees

Second Stage

  1. 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.)
  2. 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.

  1. 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.

  1. The Chairperson or designee calls for a separate vote on each element in review
  2. 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) v.     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.

The list of NIMR-IRB useful materials

IRB Submission Requirements


NIMR-IRB Annual Reports