CIA RESEARCH-RELATED OBLIGATIONS
Research & Publication Practices
1. All sponsored research must address a legitimate scientific question or need and must be approved by
the relevant research governance organization.
2. Establish requirements and procedures for sponsorship or support of post-market research involving
consented subjects and government-reimbursed products.
(a) Conducted by physicians licensed to practice in the US.
3. Sponsored research and investigator-sponsored studies of these government-reimbursable products
must be approved by the medical or research organizations.
(a) Sales, marketing or other commercial teams may not participate in study design, conduct or
(b) Exception for non-interventional health outcome studies (overseen by medical).
(c) Human subject research and resulting publications are for the purpose of fostering increased
understanding of scientific, clinical or medical issues.
(d) Researchers must disclose, as a condition of funding, that the company’s support, and any financial
interest the researcher may have in the company, are disclosed in the publication of the research.
4. Company to disclose sponsorship of post-marketing clinical trials, post-marketing studies and
investigator sponsored studies of government-reimbursable products.
5. Company to disclose financial support for post-marketing study investigators and medical writers.
6. Establish policies for notification of institutional review board or ethics committees about premature
discontinuation of sponsored research, including reasons for termination.
7. Establish policies and procedures for reporting of adverse events to FDA.
(a) Require reporting of adverse events by investigators and other study-related data to the company
before final payment is made by the company.
(b) Assess sponsors of investigator sponsored studies for compliance with safety reporting
requirements per contractual agreements.
8. Appropriate conduct of Product Related Functions (which include preparing and disseminating non-
promotional materials, and hiring healthcare professionals for post-marketing studies or authorship and
publication of study results).
9. Procedures for response to requests for information about off-label uses for government-reimbursable
drugs by medical information or medical affairs.
(a) Obtaining the requestor’s signature and written affirmation that the request was unsolicited.
10. An inquiries database to be maintained by medical affairs or medical information staff.
11. Develop materials, information and procedures for distribution medical information to healthcare
12. Consulting arrangements with healthcare professionals and institutions for activities such as advisory
13. Establish procedures for the way in which medical affairs or field-based medicine staff (often part of
the research organization) may interact with healthcare professionals and representatives of
healthcare institutions at meetings.
14. Required publication of sponsored research and its results.
15. Publication of study results in peer-reviewed, searchable journals, where possible.
(a) Company must make a “good faith effort” to seek publication.
(b) Establish written requirements for Investigator Sponsored Studies which require the investigator
to use best efforts to publish study results.
16. Listing of clinical trials, including any updates or status changes, for access by the public.
17. Develop a (company) clinical study register for posting results of interventional research studies of
government reimbursable products, sponsored observational studies, study analyses and summaries of
study protocols; as well as publishing about discontinuation of studies.
18. Establish requirements for use of information resulting from research (e.g. for journal articles or
19. Review of submissions to Compendia or other resource databases that provide information about
government reimbursable products.