More Tips: What If a Cooperative Extension Professional Must Work With Two or More Institutional Review Boards?

Introduction

This is the first follow-up to a series of four recent articles designed to help Extension Professionals navigate the university Institutional Review Board (IRB) process (Brown, Martin, & Weigel, 2004; Martin, Weigel, & Brown, 2005; Weigel, Brown, & Martin, 2004; Weigel, Martin, & Brown, 2005). In this article the focus is on working with more than one IRB at a time regarding one project. The authors of this article have had many years of experience with multiple IRBs in and outside of the university.

There are several situations that may necessitate application to, approval from, and compliance with IRBs in addition to the Extension Professional's own university IRB such as when:

• Receiving funds or a grant from a government or private agency
• Collaborating with colleagues at one or more other universities
• Working internationally
• Working with Tribal Nations
• Working with school districts
• Using existing data sets from outside sources
• Sharing your data with colleagues from outside your university

When a second or third IRB enters the picture, the situation becomes more complex due to different forms and protocols, sometimes contradictory expectations and rulings, and timelines that may not coincide. The authors use their experience with a project funded by a federal government agency to illustrate some of the issues and tips for success.

All IRBs have instructions for developing a protocol for review. While the content of university protocols and third-party IRB protocols will be similar, there will be differences in specific details requested. This means you will have to prepare multiple documents. Below are some general issues that may arise when working with third-party IRBs and tips that may ease the process.

Issues and Tips

Differing Protocol Requirements

When you understand what your university IRB requires and have successfully navigated a review, the requirements from a third-party IRB may seem daunting. It can be helpful to talk to someone who has gone through the process with the particular agency or organization. They may have suggestions for helping you navigate that system.

Instructions may be written to apply to a variety of disciplines, from laboratory and basic science studies, to epidemiologic studies, to behavioral and social science studies. Because some pieces may not apply to your project, you will not have to address every topic.

Differing Policies Among IRBs

Clarify each IRB's position on the relationship between IRB approval and program implementation. Some IRBs are concerned only with data collection, while others govern all contact with participants. On our project, we planned to do focus groups with potential participants prior to implementing the project to assess what types of information would be most useful. Our university IRB would have permitted this without IRB approval because the data was for programming purposes only; it would not have been shared publicly. However, our funder's IRB would not allow any contact prior to approval, even for planning purposes. Therefore, our planning process was significantly delayed.

Consent Forms

Multiple IRBs may differ in requirements for consent forms. Work with IRB staff to develop something that is acceptable to all. Our university IRB required a standard authorization paragraph. However, our funding agency's IRB required the consent form to be written at a 5th-grade reading level. The language in the authorization paragraph is at a 12th-grade reading level. It took a great deal of discussion to find language our university would accept and yet was at a reading level our funder would approve.

The language requirements in consent forms may also differ. Our university IRB requires the consent form to be written in first-person, while our funding agency's IRB mandates the use of third-person. We initiated discussion with the two IRBs again to agree.

Timing of Submissions

It may be most efficient to submit protocols to both IRBs simultaneously. Although both will likely require revisions, you will be able to address everyone's concerns at the same time and will have documentation from each to help with justifying your revisions.

Simultaneous approval becomes a problem when one IRB takes significantly longer to review a protocol. For example, for the first round of reviews, our university took 4 weeks, while our funding agency took 3 months.

Approval Process

Feedback from your IRB reviews will require changes to your protocols followed by resubmission for another review. The comments from each review panel may ask you to change different pieces and may even contradict one another. For example, our university IRB requires the standard introductory and authorization paragraphs on the consent form to be entirely in bold, but our funder's IRB does not allow emphasis anywhere. We resolved this by explaining to each IRB the policies of the other and attaching written documentation to justify the final format. Approval from both your university and third-party IRBs will be needed before your project can begin.

Be prepared for a lengthy process until approval is finally received. It may take several protocol revisions before the multiple IRBs clear your project. On our project, we received final university IRB approval in 10 weeks. However, final approval from our funding agency took one and a half years.

Human Subjects Training and Certification

Training for staff involved in data collection with human subjects is required by most IRBs. If you received certification from one IRB, check with the other IRB(s) to see if your certification is acceptable before completing the protocols or additional training. In our project, both our university and funder accepted the other's certification.

Communication

Let each IRB know that you are also submitting a protocol to another IRB for review.

Contact IRB panel members or other IRB staff. They often have suggestions for preparing the initial protocol, how to best address issues raised during the reviews, and how to come to a reasonable resolution when comments from multiple IRBs are conflicting.

Conclusion

Although this process can be confusing and somewhat intimidating, the goal of protection of human subjects is shared by all agencies involved. Close attention to detail and communication are the keys to successful reviews. A future article will share tips for working specifically with Tribal Nations.

Here are some good resources for preparing IRB protocols for third-party organizations:

U.S. Department of Agriculture--Research, Education, and Economics--ARS, CSREES, ERS, and NASS Policies and Procedures
http://www.afm.ars.usda.gov/ppweb/605-01.HTM

The U.S. Department of Health and Human Services' Office for Human Research Protection is the largest federal government office dealing with human subjects issues and thus guides most policies.
http://www.hhs.gov/ohrp/

National Institutes of Health--Office of Behavioral and Social Sciences Research--Funding and Training
http://obssr.od.nih.gov/funding.html

Centers for Disease Control and Prevention--Office of the Chief Science Officer--Human Research Protection Program
http://www.cdc.gov/od/ads/hsr2.htm

References

Brown, R., Martin, S., & Weigel, D. (2004). What Cooperative Extension professionals need to know about institutional review boards: Recruiting participants. Journal of Extension [On-line], 42(6). Available at: http://www.joe.org/joe/2004december/tt1.shtml

Martin, S., Weigel, D., & Brown, R. (2005). What Cooperative Extension professionals need to know about institutional review boards: Obtaining consent. Journal of Extension [On-line], 43(2) Article 2TOT1. Available at: http://www.joe.org/joe/2005april/tt1.shtml

Weigel, D., Brown, R., & Martin, S. (2004). What Cooperative Extension professionals need to know about institutional review boards. Journal of Extension [On-line], 42(5). Available at: http://www.joe.org/joe/2004october/tt1.shtml

Weigel, D., Martin, S., & Brown, R. (2005). What Cooperative Extension professionals need to know about institutional review boards: Risks and benefits. Journal of Extension [On-line], 43(1) Article 1TOT1. Available at: http://www.joe.org/joe/2005february/tt1.shtml