Industry-Sponsored Protocols: General

An institution conducting research that is sponsored by a pharmaceutical company is usually paid in accordance with the reasonable costs of conducting the study. This may include being paid on a 'per enrolled subject' basis. These funds may be used to support research work in the investigator's laboratory. This, in and of itself does not constitute a conflict of interest, but the subject has the right to disclosure of this relationship. A section should be added to the informed consent document as follows:

Payment to Institution:

This project is funded, in part, by a grant or contract from {the Acme Pharmaceutical Company} to the Research Foundation of Stony Brook University, in support of the Investigators' work on this study.

A. Enrollment Incentives

Rarely, there are provisions in some contracts that allow for 'enrollment incentives', also referred to in other terms, such as 'competitive enrollment'. This refers to the situation where the institution will be paid more (via the applicable RF account) by the sponsor if a certain quota is met (based on subject #'s, or time it takes to enroll the subjects).

This method of compensation raises ethical concerns, and constitutes an area of debate within the field of Human Subjects research. For example, the December 2001 report of the Association of American Medical College's (AAMC) Task Force on Financial Conflicts on Interest in Clinical Research states:

Payments for subject enrollment…should be permitted only to the extent that such payments:

1. are reasonably related to costs incurred, as specified in the research agreement between the sponsor and the institution
   
2. reflect the fair market value of services performed, and
   
3. are commensurate with the efforts of the individuals performing the research.'

As such, protocols involving enrollment incentives will be assessed by the ORC and CORIHS on a case by case basis. Allowance of such incentives will be based on several criteria including:

a) amount and scheduling of the incentive
b) the aims of the research
c) prior compliance history of the PI

The IRB retains the right to refuse to allow enrollment incentives for a particular protocol.

Further, enrollment incentives (monetary or otherwise) meant to provide personal benefit to any investigator (Principal investigator or otherwise) are prohibited.

The main concern when enrollment incentives are in place is that the recruitment and consent processes may be compromised. Therefore, the IRB may require, as a condition of approval, any or all of the following:

1. The PI may not be involved in the recruitment or consenting of subjects.
2. The PI may not place undue pressure on, or offer incentives to subinvestigators to enroll subjects as quickly as possible.
3. The consent processes for any or all subjects may be witnessed by an IRB or ORC representative.
4. A section of the consent form that reads:

Payment to the Institution:

This project is funded, in part, by a grant or contract from {the Acme Pharmaceutical Company} to the Research Foundation of Stony Brook University, in support of the Investigators' work on this study. Amount of payment from this sponsor is dependent upon…. (Detail is provided depending on the nature of the agreement).

The Principal Investigator will not participate in the recruitment or consent phase of this study. (added if required by CORIHS)

The CORIHS accepts SBU's definition of Significant Financial Interest in Research per Section III.D of University Policy P-209 http://naples.cc.stonybrook.edu/Admin/policy.nsf/pages/p209

If any of the investigators on the protocol have a significant financial interest as defined above, the IRB requires, as a condition of approval, that:

• the SBU COI committee provides written confirmation that the conflict of interest can be managed.
• the investigator cannot be involved in the recruitment or consenting of subjects. If you are named in the consent form as not involved in recruitment or consenting of subjects, it means that the discussion of any details concerning the research protocol in question must be conducted by an IRB-approved co-investigator. In the case where you may be a patient's treating physician, you may state that there are standard therapies available, as well as research studies that the patient may be interested in hearing about. If the patient is interested in hearing more about his/her research options, referral to the IRB-approved co-investigator must occur. 
• the investigator cannot place undue pressure on, or offer incentives to, other investigators to enroll subjects.
• a section of the consent form must be added that reads:

Payment to the Investigator:

Dr. ______________, who is one of the investigators conducting this study, has a significant financial interest in the company supporting this study, which means he/she may receive personal financial benefit from the results obtained. Dr. _____________will not be involved in the recruitment or consenting of subjects.

In addition, as with any study, the consent processes for any or all subjects may be witnessed by an IRB or ORC representative.

The policy and procedures described in this document will be followed, where applicable, in cooperation with the SUNY Policy on Financial Disclosure (current, and as amended).

The IRB requirement described in the section is in addition to the University requirements regarding financial disclosure, as addressed in detail in University Policy P209 (link above). The CORIHS accepts SBU's definition of Significant Financial Interest in Research per Section III.D of University Policy P-209 http://naples.cc.stonybrook.edu/Admin/policy.nsf/pages/p209

C. Investigator Conflict of Interest Unrelated to Current Financial Interest (New Policy)

There are instances where a member of the study team has a vested personal interest in the future commercial success of the drug, device, etc under study (e.g., was involved in discovery, patent, licensing, IND/IDE filings etc.), but does not, at this time, have a financial interest that reaches the level of significant, as defined and discussed in the next section. In this situation, the IRB has determined that, although recruiting or consenting of potential subjects by the affected investigator is acceptable, a section should be added to the consent form that reads:

"Investigator’s Personal Commercial Interest in the Study Drug"

Dr. ______________, who is one of the investigators conducting this study has a personal commercial interest in or may financially benefit in the future from the development of the [drug, device, etc] being tested in this study.

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Last Updated: 2007-03-02