USE OF HUMAN SUBJECTS FOR RESEARCH











  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
  • USE OF HUMAN SUBJECTS FOR RESEARCH
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Standard Operating Procedure

1. All members of staff, students, visiting academics and researchers and any other person using human subjects for research, teaching or demonstrations as an activity in the University must submit an application for ethical approval to the ABUHSR before the activity may commence.
2. Applications for approval must be submitted in the prescribed format that is obtainable from the ABUCUHSR.
3. Applications must be submitted at the latest two weeks before the next scheduled meeting of the ABUCUHSR to be circulated to reviewers for comment. If any clarification is needed the applicant will be notified in writing and given the opportunity to reply a week before the meeting in order to avoid unnecessary delays in obtaining approval.
4. Applications are approved by consensus or, if necessary, by a majority vote. The committee may require minor amendments, in which case the Chairman can be authorized to sign the approval as soon as the requirements are met, or major amendments, in which case the application must be resubmitted. In the case of urgent or non-contentious applications the Chairman can be authorized to sign the approval after consultation with one or more members of the committee. Such approvals should be ratified at the next committee meeting.
5. Researchers have the right to appeal the decision of the Committee. The request to appeal must be submitted through the office of the chair of the Research Subcommittee to the Vice Chancellor. The appeal must contain a clear motivation as to the reasons for the appeal. The documents must include an executive summary and motivation from a subject specialist other than the author of the protocol, stating clearly the reasons for appeal and why this protocol should be reconsidered. The Vice Chancellor may then approach outside consultants to evaluate the protocol and to furnish him/her with a report and a recommendation. The ABUHSRwill then reconsider the entire protocol with new motivations at the meeting following the one on which the appeal was tabled.
6. Approved submissions will be kept on record. Any deviations from the approved procedures with any ethical implications must be submitted for approval.
The ABUCUHSR reserves the right to interview the researcher and/or the study director; to inspect the facilities where animals are housed and experimental procedures performed, prior to or during the experiment, to request that records are made available; and to seize any animal and stop an experiment if deemed necessary.
The application process For new projects based in, supervised/guaranteed by or in liaison with the University, applicants must complete the prescribed application form for consideration at a meeting of the ABUCUHSR.
Staff members applying for research grants from funding bodies such as the University Board of Research should make sure that their applications are submitted to the ABUHSRin time to obtain approval by the required date. A reference number will be issued and the application will be considered at the next scheduled ABUCUHSRmeeting. If the Principal Investigator has not received an acknowledgement within one week of lodging the application, please contact the Secretary to ensure that the application was received.
Initial Application
1. Application should be submitted to the Secretary of ABUCUHSR.
2. The responsible investigator (RI) will receive an acknowledgement from the Secretary to confirm receipt of the application.
3. The application will then be placed on the agenda for the next meeting, this willeither be an Executive meeting or a full ABUCUHSR meeting dependingonthe application is received.
4. ABUCUHSR meetings are monthly. Dates for meetings and submission of applications can be obtained from the Committee Secretary. Submissions must be received 7 days prior to the meeting.
5. Executive meetings are held approximately a week before Committee meetings. The Executive screens applications to identify ethical concerns and deficiencies before the applications are presented to the Committee. It cannot approve initial or renewal applications but can approve straightforward applications for minor modifications and associate investigator applications at its discretion. The Committee at its following meeting reviews all decisions of the Executive.
6. If the application has been presented at a full ABUSRHSP meeting, the RI will be informed by the Secretary within 2 working days after the meeting to advice of the outcome.
7. If the application has been presented at an Executive meeting, the RI's attention maybe sought by the Secretary if the Executive has identified any areas of concern that should be addressed prior to the full meeting. Applications will automatically be forwarded to the full ABUHSR for consideration after presentation at an Executive meeting.
Official notification of the decision will be forwarded to the Principal Investigator as soon as possible following a meeting, or after any required clarifications, amendments, additional information or signatures are received and approved.
Fees No fee will be charged by the ABUCUHSR for the approval of projects for researchers or instructors except where such project involves travelling for inspection where the staff or researcher concerned shall be required to offset the logistics.