A: We asked researchers about restrictions relating to data ownership, study design, and dissemination of findings. While there was great variation in responses, we found that many researchers did accept a fair amount of industry control over their studies. While most (92%) believed that the industry sponsor did not have the right to prevent publication (as in the case of negative findings), we did find that about 40% would accept clauses in clinical trials that:

• allowed the sponsor to use its own statistical analyses in the publication
• allowed the sponsor to significantly revise the manuscript
• prevented researchers from discussing the findings post-trial

A: We looked at the characteristics of those who were more willing to accept industry control, and found that in general they were:

• involved in clinical trials at a high level
• junior faculty
• worked at a medical school which had a relatively low level of NIH funding

The reasons behind willingness to accept more industry control are hypothetical at this point. There are at least four possibilities:

• the experienced clinical trialist may have knowledge that, in practice, the provisions are not as restrictive as they sound
• we may have encountered a measurement error, if researchers responded with what they thought was acceptable, rather than what they actually did,
• researchers who are more comfortable sharing control over their work with industry may be particularly attracted to clinical trial work, or
• doing clinical trial work, especially work with industry sponsors, may change researchers' ethical views ("familiarity breeds tolerance")

A: Most academic medical centers have developed policies or guidelines setting forth what they consider acceptable and unacceptable provisions for clinical trial agreements with industry sponsors. Faculty investigators should work closely with administrators in their institution's office of sponsored research when negotiating agreements with sponsors, even at the early stages. Most faculty who work closely with their research administrators report high levels of satisfaction with the interaction. No faculty member, especially a junior investigator, should have to face these ethical and legal challenges alone.