Authored by Alexander Bagley

Dr. Berg’s lecture ‘PI Role and Conflict of Interest’ discussed two important topics that are directly relevant to clinical investigators: the institutional review board (IRB) and conflicts of interest (COI). As Dr. Berg explained, the IRB is responsible for reviewing proposed research protocols and informed consent documents before ultimately deciding whether to approve, require modifications, or disapprove of the research proposal. She explained that for proposals involving multiple sites, a single IRB of record is now required. After defining research and human subjects, she reviewed the criteria for IRB approval, which mandate that “risks to subjects are minimized, risks to subjects are reasonable relative to benefits, selection of subjects is equitable, informed consent will be sought [and] documented, provisions [are] made for data and safety monitoring, provisions [are] made to protect confidentiality, [and] safeguards [are] in place for vulnerable subjects.” She reviewed the essential elements of an informed consent document (ICD), which must also be reviewed and approved by the IRB; particularly helpful here was the discussion of broad consent, which allows for the “storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens” and how this relates to secondary research for which more limited IRB review is required. Dr. Berg advised that by developing protocols that have a sound scientific foundation and statistical design, most of the IRB concerns can be anticipated and addressed in advance.

Dr. Berg then transitioned to a discussion of investigator conflicts of interest, a relevant topic for oncology investigators given the significant and growing role of industry-academic collaborations in the development of new therapies. She reviewed the NIH definition of a significant financial interest as “anything of monetary value, except […] salary, royalties, etc. received from the institution; income from lectures, advisory panels, etc. for government or academic entities; equity in publicly traded entity ≤ $5,000; or other payments ≤ $5,000” and explained that these would represent conflicts if these could directly and significantly affect the research. These definitions were contrasted with the FDA’s definition of financial interests. She highlighted that other sources including foreign financial or research support, positions or scientific appointments, or any significant research activities performed outside the United States must be reported. She then reviewed online resources including the CMS Open Payments database to identify financial COI. Dr. Berg concluded her lecture with a helpful discussion of the research COI committees, which are tasked with ensuring that bias in the design, conduct, and reporting of research is minimized; she reviewed typical management strategies including “public disclosures; monitoring by independent reviewers; modification of the research plan; disqualification from participation; and divestiture/severance of relationships” that apply for the life of the award and any time the grant is cited.

This lecture addressed two important concepts for clinical investigators in oncology. Having a clearer understanding of the role and concerns of the IRB ultimately helps investigators design better protocols that maximize clinical knowledge gained and minimize potential patient harm. Similarly, having an awareness for COI definitions and procedures will help investigators design and report research that minimizes biases while continuing to foster collaborations between academia and industry. Given the intricacies and complexities of each of these topics, Dr. Berg’s final advice (“When in doubt, ask for help”) rings especially true for younger investigators in the process of launching their careers.