School of Medicine COI Policy
The goal of industry interactions is to enhance the transfer of knowledge and expertise from the faculty to the community to promote the public good. The purpose of Stanford Industry Interactions Policy (SIIP) is to identify areas of industry interaction where personal or institutional financial interests could create real and/or perceived conflicts. Specifically, the focus of SIIP is on preventing conflicts with our clinical care activities and protecting the integrity of our education and training programs. Guidance involving research activity is provided under our policies on conflicts of interest.
SOM Policy on COI in Human Subjects Research
Conflicts of interest are common and practically unavoidable in a modern research university. Conflicts of interest can call into question the professional objectivity and ethics of the individual, and reflect negatively on the University. Opportunities to profit from research may influence or appear to influence the choice of the direction of the research, the design and conduct of the research, objectivity of the data, or interpretation of research results. Moreover, in human research, these opportunities to profit may influence or appear to influence a researcher's judgments about which human subjects to enroll, the clinical care provided to subjects, and the proper use of subjects' confidential health information, and such influences may create biases in study design, data collection and analysis, adverse event reporting, or the presentation and publication of research findings. On the other hand, there may be special circumstances that create compelling reasons for an individual to engage in research involving human subjects despite having a financial conflict of interest.
It is our practice for managing conflicts of interest related to human subjects research (HSR) to utilize "the rebuttable prohibition" approach (also referred to as ‘the rebuttable presumption” in the Association of American Medical Colleges (AAMC) Guidelines when an investigator has a financial interest or relationship related to the HSR valued at over $10,000, or has any stock/stock options in a privately-held company. Investigators meeting this threshold are presumed to be too conflicted to participate in the study unless they can provide a compelling justification for an exception to the prohibition.
Compelling justification requires (1) a singular expertise, e.g. you are an inventor of a device that requires your participation for subject safety, or a technology only you have access to, as well as (2) a plan to protect the subjects, data, you, and the university. If the study can be conducted by someone else, either at Stanford, or elsewhere, or it is part of a multi-center trial, it generally will not meet the criteria for an exception to the rebuttable prohibition. The fact that you are a leading expert in the field, is not sufficient justification per se in this situation.
SOM COI FAQs
Q. How will I know if an industry sponsored talk I have been asked to give is promotional? Does SIIP apply to me?
There is no way to answer this question perfectly, and in the end, you must rely on your own good sense and judgment. Here are a series of questions to help you try to determine if the company is compensating you for a talk in a promotional capacity.
- Is compensation coming from the marketing division rather than the research division of the company?
- Is your compensation for giving the talk reasonable and customary?
- Is the company providing some/all of the content for the talk (slides, talking points, teaching aides, etc)?
- Is the company dictating the topic of the talk with any level of specificity?
- Does the company have any control over the topic/content talk? Do they review the talk contents prior to presentation?
- Is the company offering inducements to learners to attend the talk (e.g. meals, travel, gifts, lodging, honoraria, other)?
- Has the company asked you to attend a speakers training session?
- Is the venue for the talk more appropriate for a holiday or vacation than for a learning experience?
- The SIIP prohibition on engaging in educational activities that are promotional applies to all full time and part time faculty, including active emeriti, UTL, MCL, Clinician Educators, Adjunct faculty, staff, students and trainees
- When in doubt ask Barbara Flynn, Harry Greenberg, or your Department Chair.
Q. If I give a talk sponsored by industry that is allowable under SIIP what guidelines I should follow?
- Ensure that your financial support by industry is fully disclosed by the meeting sponsor
- Prominently disclose to the attendees that you are being paid by the company to give the talk
- Do not use the Stanford name in a non-Stanford event except to identify your title and affiliation
- Make sure you communicate to the audience that the content reflects your views and not the views of Stanford School of Medicine, Stanford Hospitals and Clinics or Lucile Packard Children's Hospital
- Provide a fair and balanced assessment of therapeutic, diagnostic or preventative options and promote educational material that is scientifically accurate
Q. How can some industry relationships derail education?
- Faculty who accept gifts from industry model this behavior for their students and trainees
- Pharmaceutical and device companies have a history of using educational talks by academic leaders to promote their products
- Industry support of many continuing medical education (CME) activities has been associated with programs that were geared toward promoting their products in order to encourage sales rather than advancing knowledge
- In order to counter-act the effect of industry support on CME the Stanford School of Medicine does not accept direct support for its CME programs. Greater emphasis will be on education that targets outcomes and quality improvement:
- takes advantage of emerging technologies
- focuses more on the professional and technical development and education of the learner
- based upon the best scientific evidence available
- designed to change physician competence, performance-in-practice and/or patient outcomes
Q. Do free meals really influence us?
- Food is the most commonly used technique to derail the judgment aspect of decision-making. [Katz]
- Gifts of food influence attitudes, a fact that has been documented by Social Science research for decades
- Experimental subjects were more likely to accept persuasive messages when accompanied by food [Janis]
Q. When is a gift not a gift?
- Gifts become a social contract that creates a sense of obligation called reciprocity [ Cialdini]
- Even di minimus gifts, such as pens, engender a sense of obligation and reciprocity on the part of the recipient [Wazana]
- Feelings of obligation to reciprocate are unrelated to the value of the gift
- Reciprocal giving is often unequal—the return gift may have a higher value (e.g. a pen vs. writing a prescription with that pen) [Cialdini]
- Gifts that are unwanted or unsolicited still create the sense of obligation to reciprocate. [Cialdini]
- Gifts produce a feeling of obligation even when the giver is disliked; [Regan]
Q. Why would I believe that a gift could influence me?
- 61% of physicians reported that gifts don’t influence them, but only 16% thought they don’t influence others [Dana]
- The size or value of the gift does not directly correlate with its influence
- Medical students were significantly more likely to think that gifts were more problematic for public officials than physicians [McKinney]
- Physicians that attended an industry-sponsored seminar including travel to a resort location, increased their usage of the sponsor's drug but deny the seminar had an influence [Orlowski]
Q. Is it allowable for our department to receive grants from industry for scholarships or other educational funds for students and trainees?
Yes, as long as receipt is compliant with SIIP. Support must be specifically for the purpose of education and meet the following conditions:
- The School of Medicine (SoM – department, institute, program or division) selects the student or trainee
- The recipient is not subject to any implicit or explicit expectation of providing something in return for the support, i.e., a "quid pro quo"
- The funds are provided to SoM and not directly to student or trainee
- SoM has determined that the funded conference or program has educational merit
Bibliography
1. Cialdini RB. Influence: Science and Practice. New York: Harper Collins College Publishers, 1993.
2. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA. 2003;290(2):252-5.
3. Janis IL, Kaye D, Kirschner P. Facilitating Effects of "Eating-While-Reading" on Responsiveness to Persuasive Communications. J Pers Soc Psychol. 1965;95:181-6.
4. Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioeth. 2003;3(3):39-46.
5. McKinney WP, Schiedermayer DL, Lurie N, Simpson DE, Goodman JL, Rich EC. Attitudes of internal medicine faculty and residents toward professional interaction with pharmaceutical sales representatives. JAMA. 1990;264(13):1693-7.
6. Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns. There's no such thing as a free lunch. Chest. 1992;102(1):270-3.
7. Palmisano P, Edelstein J. Teaching drug promotion abuses to health profession students. J Med Educ. 1980;55(5):453-5.
8. Regan DT. Effects of a favor and liking on compliance. J Exp Soc Psychol. 1971;7:627-39.
9. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283(3):373-80.
