Pharmacists and Industry: Guidelines for Ethical Interactions

American College of Clinical Pharmacy

Disclosures

Pharmacotherapy. 2008;28(3):410-420. 

In This Article

Guideline 6

Pharmacists who participate in industry associated research should only do so if that research meets accepted ethical, regulatory, and scientific standards.

The ACCP white paper, Ethical Issues Related to Clinical Pharmacy Research, originally published in 1993,[54] has recently been revised.[55] The discussion below highlights some of the issues addressed in the paper that relate to pharmacist-industry interactions.

Pharmacists participate in research on many levels beginning with hypothesis generation through publication of study results. Pharmacists must conduct high-quality clinical, translational, or health-system research according to established ethical, regulatory, and scientific standards to maintain credibility as competent scientific investigators. Pharmacists should not be involved in research in which the sponsor imposes any obstacle to publication of the study results. Research whose primary purpose is promotion of a drug product or device is not legitimate and does not hold patient welfare in the highest regard. As an example, pharmacists should not participate in studies for which the primary purpose is to familiarize prescribers with specific drug products (i.e., marketing or "seeding" studies).

Disproportionate fees for collection of patient data in a research study should lead one to evaluate closely the purpose of the study, as excessive compensation for conducting a study constitutes a gift. Payments to patients, subjects, or health professionals participating in studies should be reasonable and represent appropriate reimbursement for time and expenses (e.g., parking, travel). If allowed by the granting agency, money that remains after all study expenses (such as investigator and coordinator salaries and overhead) have been paid should be restricted to support research training programs (e.g., residencies, fellowships, graduate programs), enhance the educational or research mission of the institution, or improve patient care directly. Reimbursement of expenses for pharmacists attending clinical investigators' meetings is appropriate; however, study sponsors should avoid extravagance when choosing the setting for a meeting, and expenses should cover the period of the meeting and the investigators only.

Pharmacists involved in clinical research should also follow all pertinent federal and state disclosure guidelines. The 1995 federal guidelines for disclosure state that "all investigators must disclose significant financial interests that would 'reasonably' appear related to the sponsored research...significant is defined as $10,000 per year in income or 5% equity in a company...This applies to the investigator, spouse, and dependent children."[56] Full disclosure of financial support for a research project should be made at the time of publication or presentation of study results.[57]

Most hospitals and other health care institutions have ongoing clinical trials, and the pharmacy staff may be involved in providing services related to the studies. The pharmacist providing these types of services should ensure that informed consent has been obtained from all study patients and that the study is being conducted in an ethical manner.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....