2.4 Policies and Procedures
As far as academic research conducted at the Academy is concerned, whether by faculty or by students,
the IRB will be involved in the entire process, from the writing of the proposal to the dissemination of the
results of the research. The following sections describe the involvement of the IRB in this entire process.
2.4.1 Procedure for Submitting an Application
An application along with the research proposal, supporting documents and annexes will be submitted to
the Chairperson of the IRB for review. All applications will be reviewed in a uniform fashion and according
to the established review procedure outlined below.
2.4.2 Elements of the Review
1.
Scientific Design and Conduct of the study
Predictable risks and inconveniences weighted against the anticipated benefits for the research
participants and the concerned communities.
Criteria set by the researcher for prematurely withdrawing research participants.
Criteria set by the researcher for suspending or terminating the research as a whole.
The adequacy of the site, including support staff, available facilities and emergency procedures.
The manner in which the results of the research will be reported and published.
2.
Recruitment of Research Participants
The characteristics of the population from which the participants will be drawn.
The means by which the initial contact and recruitment is to be conducted.
The means by which full information is to be conveyed to potential research participants or their
representatives.
Inclusion criteria for research participants.
Exclusion criteria for research participants.
3.
Care and Protection of Research Participants
The suitability of the investigator’s qualifications and experience for the proposed study.
Any plans to withdraw or withhold standard therapies for the purpose of the research, and the
justification for such action.
A description of any plans to make the study product available to research participants following
the research.
A description of any financial costs to research participants.
The rewards and compensations for the research participants.
4.
Protection of Research Participants Confidentiality
A description of the persons who will have access to personal data of the research participants,
including medical records and biological samples.
