Answering Questions

Before I get into the topic of this blog, I want to apologize, once again, for my sporadic posting. Our consulting firm (HRP Consulting Group) has been undergoing considerable growth and change over the past year and I have not had the time to devote to keeping up with blogging. I want to assure any readers that I have left that I am now committed to maintaining this blog. In fact, I have asked my colleagues in the firm to nag me on a regular basis about this! In this blog I will continue to share my thoughts and comments on the HRPP field, but, from time to time, I may turn this space over to my colleagues (Cheryl Savini and Nick Slack) when they have interesting thoughts they would like to share.

And now for my topic of the day – answering questions. I just got back from a very exciting PRIM&R meeting. While at the meeting, I conducted a few workshops where there were lots of questions asked and I was asked lots of questions in the hallways and at our booth. This caused me to think about what it means to answer questions in our field, and I thought I’d share my thoughts about this.

First of all, I do not believe that there are any “right” answers to questions in our field. Nothing in human research protections is black or white; it is all gray. Everything is open to interpretation, even the regulations. And the only wrong answers are those that are clearly in violation of the regulations. So, when I answer a question, my answer is my opinion, based my years of experience and my interpretation of the regulations and best practice. For example, I was asked several questions about “quorum” at IRB meetings. The regulations at 45 CFR 46.108(b)/21CFR 56.108(c) say: “Except when an expedited review procedure is used, [each IRB shall] review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.” This may seem straight forward, but there is plenty that is open to interpretation. What is a majority? What is a nonscientist?

My answer will reflect my opinion on how best to meet the spirit of the regulations and implement practical procedures for ensuring the maintenance of a quorum. So, I would suggest a “simple majority” which is more than half of the members (for example, if there are 9 members 5 would be a majority). A nonscientist should be someone who clearly has no scientific training or experience; if there is any doubt, then that person is not a nonscientist. And, institutions should not rely solely on the unaffiliated member to be the nonscientist since it is sometimes hard to get the unaffiliated member to a meeting. Could someone else come up with a different answer? Certainly! Is my answer the “right” one? There is no one “right” answer but my answer will not be a “wrong” answer. If I give you an answer to a question, you should see it as my expert opinion and weigh how well it works for you and your circumstances.

Second, there is almost always more than one way to accomplish regulatory and ethical goals in our field. What works at one institution may not work at another. People should get as many opinions as possible on a given issue and choose the one that works best for them. For example, in a study on heroin use, subjects may reveal information about other people (dealers, fellow users, etc.). Under the regulations these people may be considered subjects because identifiable, private information is being obtained. How is the IRB to deal with these “secondary” subjects? One institution may require informed consent from these people. Another may require that they be de-identified and another might have the IRB waive the requirement for informed consent if the confidentiality procedures are sufficient to say that is a minimal risk study. When I am answering a question I will always try to give options and, even if I don’t, there are always other options available.

Finally, the federal regulations are the “floor,” not the “ceiling.” They set minimum standards and specify the least that you can do, not what you should do. A good human research protections program should not be based only on compliance with regulations, but also based on best practice. Institutions have been working with these regulations for almost 40 years and have figured out good ways to implement them in ways that protect subjects while continuing to facilitate research. For someone to say, “This is what it says in the regulations and that’s what you should do,” ignores best practice and the need for higher standards. And, once you get into the area of best practice, you leave the realm of right and wrong.

So, am I saying that my answers are not useful because they are not definitive or “right”? No, I think my knowledge of the regulations and my over 30 years of experience in the field give some weight to my answers. However, don’t expect me to tell you what is “right”.