Mind-Body Medicine

07/12/2012

The Saybrook Institutional Review Board and your Research

Dr. M. Willson Williams
Dr. M. Willson Williams

The SIRB and your Research

One aspect of being an ethical professional is that all research should be proposed and approved by an institutional review board, which assures the well-being of any human participants involved in the research. For Saybrook students and faculty, the Saybrook Institutional Review Board (or SIRB) must approve any research project before it is implemented.

The Director of the Saybrook IRB, Dr. M. Willson Williams (see photo), is extremely knowledgeable about federal research guidelines, University policies, and other relevant regulations governing the conduct of research. Dr. Williams provides a thorough and expert review, in a timely fashion, for all proposed research projects. Most IRB applications will qualify for an Expedited review, meaning that the full 10-person committee does not need to review the IRB materials. However, if a research protocol proposes the inclusion of vulnerable populations (such as prisoners, children, or persons under legal guardianship) or involves intrusive or invasive procedures, then a full IRB review will be warranted; this extends the review process as the full IRB only meets once per month. Applications that do not need a full Board review are processed throughout the year; however, the full Institutional Review Board does not meet during June, July, or August.

Each PhD student in the College of MBM will submit an application to the SIRB during the Quantitative or Qualitative Research Design courses (MBM 5538/39 and MBM 5548/49). Each master’s student pursuing a Thesis will also complete a SIRB application in preparation for the thesis research. All SIRB policies and forms are available on the Saybrook University website at:  https://www.saybrook.edu/mysaybrook/sirb   Always be sure to use the most current forms posted on the website; that is, do not just use a form submitted for a prior course, as the process and forms are continually being updated.

It is important to remember that the SIRB must review every aspect and detail of your proposed research, even the initial announcements and flyers that you intend to use to solicit participants. This means that even the recruitment process cannot begin until your proposal has been approved by your course instructor or thesis/dissertation chair, and the SIRB has approved the details of your research design. You thus cannot ask anyone to be a participant in your research until the SIRB approves your recruitment process. Any violation of this policy could result in having to start over, as any data gathered prior to IRB approval of a protocol are considered void. That is, you’d have to start over as you could not use any data you might have collected prior to IRB approval. That would be a very serious ethical violation.

Due to a recently revised policy, MS Projects are now defined as not involving any contact with human participants, and do not require SIRB oversight. But if you are including human participants, even other professionals (key informants), who will be interviewed for their expert perspective on a topic, then this will now be a Thesis and will require that you go through the SIRB review and approval process.

Every student and every faculty member serving as an instructor for a course involving research or who serves on thesis or dissertation committees must take a brief research ethics tutorial offered by the National Institutes of Health, and complete a short multiple choice test about the protection of human participants. The tutorial and test are available free online at:  http://phrp.nihtraining.com/users/login.php

MBM students take this online tutorial routinely in the research design courses and/or in their Professional Development Seminar. Be sure that you have completed that tutorial, earning the NIH Protecting Human Research Participants certificate. Be sure that your thesis or dissertation committee members have as well. Faculty members lacking the NIH certificate have delayed some of our current students. The SIRB cannot review your IRB application materials until both the student and faculty involved have submitted their certificates. Such certification must be updated every three years.

Finally, we are including here a recent communication from the Director of the Saybrook IRB:

We want to remind you that you may not solicit Saybrook students as research participants unless you have the explicit permission of the IRB to do so. If we allow our students to send out solicitation requests to their peers simply because it is an easy population to tap, students will be inundated with such requests. In addition, if a student has a legitimate research-based rationale for needing to solicit Saybrook students, the IRB can give such permission if requested. But that rationale must be based on and reflected in the research question(s) and explained in the IRB application. For instance, this could be a question that asks “What is the experience of X in graduate students enrolled in a distance-learning program?” or something similarly germane. But researchers may not just solicit from a convenient population without some rationale for their inclusion. The IRB has already set up a MyLearning link for such solicitations to be posted if approved. But researchers may not solicit any constituents of any university without prior IRB approval.

 If you have any procedural questions about the IRB process, you may contact Dr. Williams by email at WWilliams@Saybrook.edu or by phone at 505-629-1492. However, you must work with your research supervisor to complete the application materials, as that is the person who is taking ultimate responsibility for the ethical treatment of human subjects. All the IRB can do is review materials as proposed by you and approved by your course instructor or thesis/dissertation chair.

-- Donald Moss, PhD

Posted at 01:48 PM

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Comments

Thank you for posting this information, it's very helpful for students planning on conducting research to understand the importance of the IRB process thanks!

Posted by Anonymous (not verified) | 08/24/2013 @ 06:50 PM