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Kyruus Blog

Will Industry Disclosures Follow the IRB Path?

This is guest blog post by Ben Resner, Product Manager at Kyruus.

Much has been written here about the Physician Payment Sunshine Act (PPSA) currently making its way through congress. It is important to see this legislation as part of a larger trend of transparency and regulation in the healthcare industry. In the same way the PPSA mandates the creation of entities to gather and report financial conflict of interest, The National Research Act of 1974 initiated the creation of Institutional Review Boards (IRB) that now oversee research on human subjects and provide the public with protections in that arena . This legislation was in response to the outrage associated with the Tuskegee syphilis experiment, Milgram electrical shocks, Stanford prisoner experiment, and of course the unimaginable medical atrocities seen during WW2. Prior to this law, oversight of research on human subjects was dependent on the values of the principle investigators (P.I.’s). Researchers interested in controversial topics relied on informal peer networks to review research protocols and raise ethical questions regarding decisions to proceed. This, as became apparent, left subjects vulnerable to abuse and left well-intentioned investigators exposed if an otherwise properly-designed experiment caused harm.

IRBs have become a cornerstone of life-sciences research in part because they include a systematic process to provide review of a proposed protocol through lenses other than that of the P.I . This helps protect the subjects, the researcher, and institution against poor judgment and enables science to progress. It also ensures participants fully understand the risks and have the option to decline participation at any point in the research. Despite the significant time required to create, review and implement an IRB policy, there is no mainstream or even fringe movement to abolish them.

In the same way IRBs open the process by which researchers and human subjects interact to greater public scrutiny, the PPSA is an opportunity to open to public scrutiny the financial interactions between industry and physicians. This would allow physicians who genuinely believe in the therapeutic effect of a drug to both prescribe it to his or her patients as well as be compensated for time spent researching on behalf of the developer. The hope is a standardized disclosure policy means legitimate prescription patterns can be cleared and questionable prescription patterns detected. We hear anecdotes of physicians who are reluctant to attend industry-sponsored events now that cash and non-cash transfers of value are reported in states like Massachusetts and soon at the federal level. This is unfortunate because the physician is denying his or her curiosity about a therapy that might help patients. We hope the PPSA helps remove this stigma and engenders a dialogue about relationships just as the National Research Act has helped promote health-sciences research on human subjects.

Implementation of IRBs is an evolving process and not without controversy. The first IRBs were staffed by researchers at local institutions with domain knowledge of the experiment under review. More recently, private for-profit IRBs have appeared. These entities have the value-proposition that today’s research is too complex for volunteers to fully review and a professional class of dedicated IRB reviewers is necessary. While this premise merits further debate, IRBs have firmly established a meaningful role in protecting subjects while advancing medical science.

We should expect similar debates in how the PPSA is implemented. But we need to understand the era of hidden interactions between physicians and industry is and should be over.