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2009 HHMI EARLY CAREER SCIENTIST COMPETITION
Q&A: Clinical Research
Can I perform clinical trials or studies as an HHMI early career scientist?
Yes, HHMI early career scientists can serve as principal investigators and co-investigators on trials and studies. HHMI's policies relating to clinical studies or trials apply equally, whether the early career scientist is involved as a principal investigator or as a co-investigator.
Will HHMI pay for the costs of a clinical study or trial on which an early career scientist is a PI or co-investigator?
In general, HHMI does not sponsor interventional clinical trials or pay for patient care costs. Early career scientists may, however, allocate part of their budget to research activities that are a part of clinical trials and studies.
Does HHMI have an Institutional Review Board (IRB) that will review my human subject protocols?
No, HHMI does not have an IRB. As an early career scientist, you would continue to submit your human subject protocols to your host institution's IRB.
Does HHMI provide professional liability (medical malpractice) insurance for the early career scientist who has patient-care responsibilities?
No. We require that the host institution provide the early career scientist with professional liability (medical malpractice) coverage.
I have been asked to be a PI on a clinical trial that would be funded by a company. Is this a problem for HHMI?
HHMI has a number of requirements relating to company-sponsored trials. These include the following:
- The company funding may be used only for patient care costs, not to support research in the laboratory of the early career scientist;
- There can be no salary support for the early career scientist or any staff in the laboratory, whether or not employed by HHMI;
- Publication must be allowed on terms HHMI considers acceptable; and
- The agreement with the corporate sponsor cannot interfere with the early career scientist's ability to pursue his or her own research program effectively.
I am already a PI on a company-funded clinical trial that is expected to run for the next couple of years. If I become an early career scientist, will HHMI still apply its requirements to this trial or could it just go on until it is completed as scheduled?
If the arrangements for the trial are not consistent with our requirements, the arrangements would need to be modified or your involvement with it would need to end before we could proceed with your appointment.
Can I own stock in a company that I am collaborating with?
This depends upon the nature of the collaboration. Consistent with HHMI's approach to conflict of interest issues, we do not permit an early career scientist to collaborate with a company on a clinical trial or study of a pharmaceutical product or medical device that is proposed or under development by the company, if the early career scientist or a member of his or her immediate family owns stock or other equity in a company. A similar approach applies to those under the early career scientist's supervision: if they or members of their immediate family own stock or other equity in a company, they should not be involved in this type of collaboration with the company.
If you are collaborating or propose to collaborate with a company on a project other than one described above, we will ask you whether you or your immediate family have an equity interest in the company, and will consider whether it is appropriate for you to proceed with the collaboration while holding the equity.
Can I receive royalties from a company with which I am collaborating?
This depends on the nature of the collaboration and the royalty interest. Consistent with HHMI's approach to conflict of interest issues, we do not permit an early career scientist to collaborate with a company on a clinical trial or study of a pharmaceutical product or medical device proposed or under development by the company, if the early career scientist or a member of his or her immediate family is entitled to receive royalties from the company with respect to any technology relating to the trial or study. Receipt of royalties in cash form from the company under a prior license of technology that does not relate to the trial or study would not be precluded. A similar approach applies to those under the early career scientist's supervision: if they or members of their immediate family are entitled to receive royalties from a company with respect to technology relating to a company-sponsored trial or study, they should not be involved in work on the trial or study.
So, for example, as an HHMI early career scientist you could not be a PI on a company-sponsored clinical study or trial of a compound or device that you developed and that is licensed to the sponsoring company, if you receive or will receive a share of royalties under the license (whether in the form of equity or cash). You could receive royalties, in cash form only, under a prior license to the company of technology that is unrelated to the compound or device.
If you are collaborating or propose to collaborate with a company on a project other than one described above, we will ask you if any technology you developed has been licensed to the company, and discuss with you any issues that this may present.
I do a lot of very short-term consulting for pharmaceutical companies; for example, I might meet with company representatives for just part of a day. Could I still do this if I am a PI on a trial that the company is sponsoring?
You could still meet with the company, and you could accept reimbursement of reasonable out-of-pocket travel expenses, but you could not accept an honorarium or other fee. Any agreement covering your meeting with the company must be reviewed and approved by HHMI in advance.
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