IRB Part III: Jim Hammerman on Developing In-house Capacity

I’m Jim Hammerman, and I Co-Direct the Evaluation Group at TERC, a non-profit, primarily grant-funded math, science and technology, education research, development, and evaluation company in Cambridge, MA. I’m also a current member and former Chair of TERC’s Institutional Review Board (IRB).

Several of us recently noted on AEA’s LinkedIn group that there are at least three ways to address the issue of Institutional Review for nonprofit organizations:

  1. Partner with a university and use their IRB process;
  2. Contract with a commercial IRB;
  3. Develop the capacity in-house, establishing your own IRB.

Over the course of three days on the aea365 blog, we’ve been sharing a few lessons learned about pursuing these approaches. I’m going to talk about option 3.

Lessons Learned: As a mid-sized non-profit of about 120 employees, several years ago we found it both necessary and advantageous to establish our own IRB. It took a bit of effort to complete the paperwork and establish the policies to obtain and maintain a Federal Wide Assurance (FWA) number through the NIH Office of Human Resource Protection (OHRP).

We started with documents borrowed from collaborators and with advice from some of our own staff who had served on university IRBs. Initially we had paper-based record-keeping, but setting up electronic systems for archiving and tracking IRB review status has been very helpful.

Having our own IRB allows us to review and oversee projects for which we’re prime, or for which our evaluation subcontract is the only real research (e.g., the prime is doing development). But arrangements can be flexible. Sometimes we obtain review for our portion of a project through a university or other institution with their own IRB when they’re the prime; sometimes our IRB oversees research of our partners if they don’t have their own IRB. For liability reasons, we don’t conduct reviews for folks with no affiliation with TERC.

Having our own IRB allows staff to work with peers who know and understand the nature of the work when developing procedures and informed consent documents. Rapid modification of procedures or consents is also easier with an in-house IRB – e.g., when we encounter unanticipated issues in some of our cutting edge work in online learning environments or with out-of-school library or community action groups. Experience as a member of the IRB can also help junior researchers become familiar with a range of study types and issues, building internal capacity. Having your own IRB can provide a number of benefits for your organization.

Resources: IRB guidelines and requirements regarding membership, meetings, initial and continuing review procedures, record-keeping, and the like can be found in the Code of Federal Regulations 45CFR690.101-124 available through the NSF (http://www.nsf.gov/bfa/dias/policy/human.jsp) or NIH (http://www.hhs.gov/ohrp/).

This contribution is from the aea365 Daily Tips blog, by and for evaluators, from the American Evaluation Association. Please consider contributing – send a note of interest to aea365@eval.org.

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