What is the institutional review board (IRB)?

VandenBos (2007) defines the IRB as “a committee named by an agency or institution to review research proposals originating within that agency for ethical acceptability.” (p. 486)

You will notice in this definition that the IRB is a committee, a group of people. And the goal of this committee is to review and approve the ethical procedures and safety precautions for participants included in research studies.

The IRB As A Screening Tool

New developments are occurring at some universities when it comes to the IRB application of the dissertation proposal.

These schools are going beyond the primary intent of the IRB and using it for a complete review of all aspects of the proposed research – not just “ethical acceptability.” The IRB is becoming a sort of screening device so that universities can increase the standards of excellence earlier in the dissertation process.

Some schools are breaking up the board into separate faculty members who have different specialty areas, such as style/readability, methodological procedures, and protection details for human subjects. In these cases, the IRB application is reviewed by one of the faculty members who offer recommendations and/or requirements for change. It is then returned to the student who must implement the feedback.

Assuming the changes the student makes are acceptable, it is then forwarded to a second faculty evaluator who makes additional suggestions and/or requirements. When these changes have been implemented, the application is again forwarded to a third faculty member for review.

The IRB application process was originally designed to focus exclusively on protection of human subjects. Now it appears that all aspects or sections of the proposal are evaluated microscopically and the time frame for approval has been extended from a few weeks to a few months. With this new extremely high priority placed on the IRB application, I don’t believe most students understand now just how closely it will be scrutinized.

You will want to consult The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research for details on what you should do to protect participants in your study from possible harm.  

The IRB Application

The IRB application needs to be written as a separate document because it will be evaluated independently from the dissertation, even if you attached a copy of the proposal. Each school will have their own topics and/or questions, but here are some of the most common ones:

  • Nature of the Study;
  • Statement of the Problem;
  • Purpose of the Study (should be stated exactly the same as in Chapter One);
  • Description of Participants/Subjects (inclusion criteria);
  • Procedures for Recruitment of Participants/Subjects;
  • Acknowledgement of Possible Risks to Participants/Subjects;
  • Specific Safety Actions to Protect Participants/Subjects;
  • Procedures for Data Collection;
  • Procedures for Data Analysis;
  • Social Benefits of the Study;
  • Expected Findings/Results; and
  • Time for Data Collection (predicted beginning and ending dates).

In the application these topics may be presented separately or grouped together depending on the unique wording of questions at your school.

Possible Negative Impacts

The IRB at your university will evaluate your study the way studies in psychology, education, and other disciplines seek to protect human subjects. Because of the nature of most studies, it is unlikely that your participants are at high risk. But it is “possible” for some unknown reason that one or more of your participants, during or after participating in your study, could have a negative reaction. If that happens not only are they at risk, but you and the university could have a potential liability.

The IRB application and the Informed Consent should be written and submitted simultaneously since parts of the two are similar. After you have described your study and the expectations you have for the participants in the Informed Consent, you will want to make a statement something like this:

The nature of this study is positive by design and you will be asked to share your perceptions, thoughts, and feelings about …(enter the topic of the interview). It is possible that after your participation in the interview (or completion of the instrument) you could have some concerns, thoughts, or feelings that trouble you. Below is a list of individuals you can contact should you need or want to talk to someone.”

Include a pre-approved list of licensed mental health professionals and their contact information.

It would be a good idea to look in the appendix of recent dissertations at your school that dealt with anything psychological or a design that dealt with personal negative events in people’s lives. Either in the Informed Consent or in a special form you will see some of the common statements your university has previously approved regarding the protection of human subjects. By using the phraseology and sentences that have already been previously approved, your statements will be more easily accepted.

To show that you have done everything possible to protect human subjects, you can do three additional things for your participants:

  1. Give them your telephone number;
  2. Give them the phone numbers of two mental health professionals who have already agreed to allow you to give their office numbers in case of any of the participants need to talk to someone or has an emergency; and
  3. Give the local mental health emergency hotline phone number.

This information could also be presented on the last part of the Informed Consent that both you and they sign. You would want to make sure that you have a signed copy and that the participants also have a copy.

Important:  The IRB application is probably the most critical assignment you will have during the entire dissertation research and writing process. The IRB will expect the application to be excellent, comprehensive, and detailed.

I have met students who kind of throw their responses together with little serious thought. This is a mistake because it leads to an application that is poorly done.  Without an approved IRB application, no data can be legally and ethically collected and there can be no study.

Although the experiences of others are not indicative of how your IRB application will be addressed, I know of two cases where the application approval was delayed many months.

In one instance the participants were located on a military installation and in the other they would be interviewed in a hospital. The students were not told why the delay lasted so long. My guess is that the perceived risk to the participants from the perspective of the IRB was greater than the estimated risk the dissertation students claimed on the application.

With approximately 40,000 accredited academic doctoral degrees awarded annually in the United States, based on data included in the annual Doctorate Recipients from U.S. Universities Summary Report, the number of dissertation research proposals is extremely high. Therefore, universities are projecting that their potential liability is great. This means that all IRB applications will be scrutinized much more closely than they were in recent years.    

Make the IRB application your highest priority and take all questions and topics seriously. This will win you respect from your committee and the university administration. When you take this approach, you will see it as a shorter and painless process.

References

National Science Foundation, Division of Science Resources Statistics. (December 2012). Doctoral Recipients from U.S. Universities: Summary Report 2010-11.Arlington, VA: National Science Foundation.

United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1978). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. DHEW Publication Number (OS) 78-0012.

VandenBos, G.R. (2007). (Ed.) APA Dictionary of Psychology. Washington, DC: American Psychological Association.

Recommended citation for this report:

Wargo, W.G. (2014). A.I.C. Report #8, Institutional Review Board (IRB) Application: Human Subjects Protection Guidelines. Menifee, CA: Academic Information Center.

If you have questions or need assistance in completing your IRB application, you can call me at (951) 301-5557 or “toll-free” (888) 463-6999 or send an e-mail to wgwargo@academicinfocenter.com.

 

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