Human Subjects approval must precede submission of all research applications to any sponsor. This applies to funding requests for internal or external resources, domestic and international applications. This policy applies to all applications including those to for-profit, not-for-profit, governmental or charitable organisations.
Review & Response Time
The committee will respond to each proposal within four weeks following its review. If the Committee determines that a submission involves vulnerable populations or greater than minimal risk, the applicant will have an opportunity to modify the research design, sampling strategies, process or format of data collection, or any other concern that is raised by the Committee. Appeals can be formally addressed by the Provost with the Chair of the Human Subjects Review Committee. If an appeal is approved, the full committee will revisit the proposal and will entertain all concerns of the Principal Investigator. In the event that an appeal is also denied, the proposal must be closed for further consideration unless methodological and ethical issues are adequately addressed in the form of a new submission.
Incomplete Application
Applications that are incomplete will not be forwarded to the Committee for review. Incomplete applications will be returned to the applicant. Applicants are advised to be mindful of schedules and time requirements for the review process and urged to submit proposals as early as possible.
Committee Dispositions
A letter will be sent to applicants as quickly as possible about Committee decisions regarding the status of an IRB Application. Status can be:
a. Approval without conditions
b. Conditional approval: pending completion of specific items in the application, clarification of confusing text, or other details as noted by reviewer(s).
c. Disapproval: indicating that the submission was so deficient that the applicant must try again from the beginning.
Faculty or Staff Submissions and External Organisational or Individual Submissions
Faculty (or staff) of Ashesi University, and all externally-sourced applications, must submit completed application forms and appendices to the Chair of the IRB in soft copy form. Faculty and staff applications are accepted throughout the academic year (full semesters). Applications can be submitted during the summer period with prior approval from the Chair. The implication of this approval is that the Chair will be responsible for orchestrating an ‘off season’ review by either members of the Ashesi IRB or competently trained faculty as ad hoc members for a single review.
Archiving and Security
Human Subjects Review documentation is to be secured and preserved for a minimum of seven (7) years after original data collection or subsequent to the first publication based on the collected data, whichever is the longer time period.
Validity Period
All approved / conditionally approved Human Subject Review Applications are valid for two (2) years from the date of validation.
Modifications After Review
Any substantive changes made to the project after approval by the Institutional Review Board should be immediately brought to the attention of the committee by the principal investigator or supervisor and this may necessitate another review.