Why submit research through an Institutional Review Board?

An IRB needs to review studies to make sure that the benefits of the proposed research study outweigh the risks, and that the research will be conducted ethically. Studies vary with the level of examination that the IRB needs to analyze the studies with. For example, some studies require only an expedited review, while others require a fuller review.

What does an Institutional Review Board look for when evaluating a study?

Risks should be minimized, equitable, and reasonable when compared to the benefits of the study, both in general considering the knowledge gained, as well as to participants.
Selection of participants should be equitable, and no group of participants should bear more risk than others or have a smaller proportion of benefits.
Each participant should give informed consent to participate, and this should be appropriately documented.
The study should be monitored to ensure participants’ safety.
Privacy of participants and the confidentiality of data should be maintained.
Safeguards against coercion or influence should be in place to protect participants’ rights and welfare.

What is the general process of IRB review and approval?

The following are the steps taken at Divine Mercy University:

First, the researcher completes a web-based training program on ethical issues in research on human subjects.  Then, the level of risk is determined and based on this, the researcher fills out the appropriate IRB form (i.e. exempt, expedited, or full).

After the application is filled out, it is reviewed by the faculty supervisor, who checks it for completeness and accuracy. Then documents are attached, including the certificates of completion of the training program. Then the faculty supervisor signs off on the project, indicating that the project has merit, meets IRB certification, and that the application has been prepared according to the guidelines.

Then, the application is logged and forwarded to an IRB member for review. The member reviews the application if it is exempt or expedited or sends it to the IRB board for review if full. Review may take up to 30 days and sent back for revisions.

The cover page contains certification conditions. When the study is certified and signed, a copy of the cover page is returned to the researcher and faculty supervisor. The original is securely stored.

At the end, a project completion report is completed, and filed with the original report.

What are the general components of an IRB application/protocol?

1.    The reasons for conducting the research
2.    Reasons for choosing the participant population and any recruitment methods
3.    The research apparatus, its purpose, and effects on participants
4.    Copies of any questionnaires
5.    Description of the potential experiences of participants
6.    Summary of any instructions to be given
7.    A description of alleviation or elimination of any adverse effects
8.    If deception is used, any methods to debrief the participants and relieve any uneasiness.
9.    A description of the benefits
10.    A description of risks, how they will be minimized, and measures to be followed if participants suffer harm
11.    A risk-benefit analysis
12.    A description of procedures for obtaining informed consent including a copy of the form if needed.