Table 2 Curricular priorities for business ethics in medical research
Topic | Consensus for MS Curriculum | Mean for MS Curriculum | Consensus for PG Curriculum | Mean for PG Curriculum |
|---|---|---|---|---|
The ideals of the medical research profession | YES (8/10) | 4.3 | YES (8/10) | 4.2 |
- Pursuing new knowledge | ||||
- Developing new drugs and devices to serve patients | ||||
- Protecting the welfare of human and animal subjects | ||||
Potential problems that conflicts of interest cause | YES (8/10) | 4.2 | YES (10/10) | 4.5 |
- Inappropriate participant recruitment | ||||
- Biased data publication and ghost authorship | ||||
- Shifting research priorities | ||||
Strategies for managing conflicts of interest in research | YES (8/10) | 4.2 | YES (9/10) | 4.4 |
- Disclosure | ||||
- Increased oversight | ||||
- Divestment or recusal from specific roles | ||||
Challenges of playing the roles of both physician and researcher | YES (7/10) | 4.0 | YES (10/10) | 4.5 |
- Possibility of ‘therapeutic misconception’—when patients mistake research participation for individualized therapy | ||||
- Conflicting roles could contribute to tacit pressure on patients to enroll or to biased presentation of consent information | ||||
Legal and policy issues surrounding conflicts of interest in research | YES (6/10) | 3.8 | YES (8/10) | 4.4 |
- NIH conflict of interest policies | ||||
- Institutional policies | ||||
- Bayh-Dole act | ||||
Valid clinical research study design | NO (5/10) | 3.7 | YES (6/10) | 4.0 |
- Good research practices | ||||
- Common deviations from good research practices | ||||
Issues in academic medical research centers | NO (2/10) | 3.0 | NO (4/10) | 3.3 |
- Pressures to obtain grant and contract funding | ||||
- Pressures to publish | ||||
- Balancing roles as investigator and mentor/educator | ||||
Physician as entrepreneur, patent holder, and owner of data and materials | NO (2/10) | 2.7 | NO (4/10) | 3.3 |
- Federal and institutional rules on patents and data ownership | ||||
- Managing conflicts of interest in ‘start up’ company research | ||||
- Managing institutional conflicts of interest | ||||
Institutional offices that provide information and oversight on fiscal matters in research | NO (3/10) | 2.7 | NO (5/10) | 3.3 |
- Office of research services (or pre-award program) | ||||
- Office of sponsored programs (or post-award program) | ||||
- Conflict of interest committee | ||||
- Research integrity office | ||||
Research budgeting, costs, and billing | NO (2/10) | 2.5 | NO (3/10) | 3.0 |
- OMB circular A-21 rules on allowable costs | ||||
- Effort reporting and conflicts of commitment | ||||
- Accurate budget development |