October 17, 2017 | Norman Goldfarb is Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI. His passion is advancing the practice of clinical research by standardizing best practices in incremental steps, so every day is better than the last. He joins Clinical Informatics News with a monthly column highlighting new ideas for advancing clinical research. This month he speaks with Erica Heath, IRB Historian and Guru.

Erica, what do you think it's about time for the clinical research enterprise to start doing?

We need to think long and hard about whether we should be doing things the right way — the culture of compliance — or going to the next step to doing the right things — the culture of conscience. Unfortunately, the culture of compliance usually trumps the culture of conscience Ideally, we should do both, but there are often tradeoffs that force us to choose one or the other.

There are often business considerations. When I was the president of an independent IRB, I was frequently asked how a for-profit IRB could maintain high ethical standards in the face of pressure from our customers to deliver fast, inexpensive and favorable approvals. (Local IRBs can face the same pressures, but they are called “politics.”) No question, we ran into challenging situations where we could satisfy our customers and comply with the regulations, but that meant not going beyond to do the right thing.

Can you give me an example?

Sure, most of the consent forms that arrive at any IRB cover all the essential elements and meet all the other regulatory and institutional requirements within the customer’s preferred style. However, many of them are also excessively long, repetitive, written at college level, and larded with legal protections for the investigator and study sponsor. So, should the IRB quickly and efficiently approve the consent form or should it run up its costs and displease the sponsor by insisting on a rewrite?

IRBs can often identify protocols that, while approvable, are probably going need major revisions to enroll study participants. It’s not the IRB’s job to advise on study feasibility, so should it offer its advice or just approve the study?

An IRB  can approve a study or ask a question and condition approval on receiving a satisfactory answer. How the question is worded makes a big difference. If the IRB dictates the desired response and the investigator study sponsor agrees, the response does not need to go to the convened board. However, that might not be the most accurate answer.  If the IRB instead asks an open-ended question, it might get a better answer but the response must go to a convened meeting. In other words, dictating an acceptable answer meets the regulatory requirements, and is faster and cheaper for the IRB and study sponsor, but it might not generate the right answer.

Is the problem just limited to IRBs?

Not at all. Here’s another example: Imagine you are a principal investigator. You’ve started talking to patients about the study but they are not willing to give consent until they talk to their families and give it more thought. The study budget does not include a second consent visit and the study sponsor is not willing to pay for one, so should you press for a signature or do the right thing and absorb the cost of a second visit?

Is there an answer?

Well, an IRB — or any institution — has to decide how it wants to balance compliance with conscience. Some customers will disagree and take their business elsewhere. That is not to say, necessarily, that they are unethical, just that their point of balance is different. Other customers will see the advantages of the IRB’s position, for example, in improving some aspect of the study or avoiding possible litigation or scandals down the road.

The FDA takes the position that protecting the study participant is the top priority, regardless of the rules, but, with the advantage of hindsight, it might not agree with how this principle was applied in a specific circumstance. IRBs have to remember that their paramount mission, indeed, their sole mission, is to protect human research participants — and keep reminding everyone of that.

A lot of the problem is that most clinical research training focuses on the rules and mechanics of compliance. An exception is in the arena of informed consent where there is excellent training available. Performance assessment must be flexible enough to reward quality of thought and assessment, as well as compliance. Employees must feel empowered to ask questions.

Ethics is hard to teach and is not even necessary for someone who is just tasked with following the rules. Metrics are easy but they reward efficiency and compliance but rarely measure quality. We need to expand our thinking if we are ever going to have a culture of conscience.

That makes sense, but it sounds like a huge challenge. Are there any shortcuts?

Not really, there seldom are. However, it would be a good start to give people permission to just say “stop, let’s think about this” when they see an ethical problem. A bit of consideration is not too much to ask.

Well, Erica, you've really given us food for thought.

That’s what we need, more thinking and less mechanically following the rules.

Norman M. Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical research best practices information services. Contact him at 1.650.465.0119 or ngoldfarb@firstclinical.com.