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How To Get Through Institutional Review Smoothly

Delays in the Institutional Review Board (IRB) approval process can greatly inconvenience investigators and set back research projects. The following suggestions can help researchers minimize the time for IRB approval.

Explain what will happen to patients if they enroll in the study

The IRB is charged with protecting human subjects. What will it be like to participate in the study from the participant's perspective, in terms they can understand? If they will be admitted to the General Clincal Research Center, will they be able to leave the hospital, have visitors, walk around, etc.?

Give the IRB reviewers the information they will need to review your study

IRB reviewers will not necessarily be in your clinical field. You need to explain such basic information as the clinical condition of the participants, the usual standard of clinical care for the condition, etc.

Explain recruitment and consent procedures fully

A number of patients complain about how they were identified as eligible for studies and contacted by researchers. Thus, the IRB is required to examine these procedures carefully for concerns about invasions of privacy and breaches of confidentiality. Because of such patient concerns researchers who have no prior relationship to a patient (for example as a physician in the clinic where the patient receives care) may not contact a patient directly, but must either work through a treating physician or recruit only patients who have agreed to be contacted for research. To be sure, these requirements slow down recruitment for studies. However, the IRB is required to ensure that patients' reasonable expectations regarding privacy and confidentiality are respected.

Recruitment and consent procedures need to be explained in sufficient detail that the IRB knows that the experience will be like for prospective participants. For example, it is not sufficient to say, "will be recruited in the clinic waiting room." Who will do the recruiting? Where will discussions take place? Will other people in the waiting room be able to overhear the conversations?

Anticipate concerns that members of the Committe on Human Research are likely to raise

For complicated or controversial studies, it is best to explain the options you considered and the reasons for choosing the approach you did. The goal is to show the Commitee on Human Research (CHR) that you have thought seriously about the ethical issues and have good reasons for the approach you chose. The CHR staff can help you anticipate CHR concerns and understand the kinds of approaches that have been accepted in similar studies.

Obtain the suggestions of CHR staff

CHR staff have a good idea of what concerns and questions the CHR is likely to raise and what approaches the Committee has found acceptable in the past. CHR staff are available by phone to answer questions. Remember that it is in interest of the CHR and the staff to have investigators submit applications that are approved on the first review.

Make sure your application is well organized and clear

For each meeting, a committee member needs to review a number of protocols. If your CHR application is poorly organized or not clear, and reviewers have to read it several times to understand what you are doing, you are putting yourself at a disadvantage.

Carefully address CHR questions or concerns

The situation is similar to responding the reviews of a grant application or manuscript submission. A thoughtful response to each point is needed. If you disagree, you have the burden of providing a convincing argument to the CHR. Again, CHR staff can be helpful in helping you understand what kinds of information or justification the CHR is seeking. Getting the resubmission right on the first submission will save you a lot of time.

Bernard Lo, M.D.

Topic revision: r13 - 05 Mar 2012 - 13:06:53 - MaryBanach
BERDpedia.GetThroughIRB moved from Main.GetThroughIRB on 08 Feb 2008 - 05:42 by MichaelGold?
 
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