Pharmacists and Industry: Guidelines for Ethical Interactions

American College of Clinical Pharmacy

Disclosures

Pharmacotherapy. 2008;28(3):410-420. 

In This Article

Guideline 5

Pharmacists who are members of an institutional review board (IRB) should avoid any real, potential, or perceived conflicts of interest that could occur in connection with industry-related matters before the IRB.

Federal regulations have empowered IRBs to review and then approve, require modifications, or disapprove any human-subject research.[51] There are specific federal regulations governing membership of IRBs.[52] The IRB is also required to ensure its members do not have conflicts of interests that would impair their ability to make a fair and reasonable judgment concerning a protocol under review.

Pharmacists participating as a member of an IRB should assess research protocols, drug therapy, and patient risk in a fair and unbiased manner. Pharmacists, as a result of their clinical expertise in pharmacotherapy and involvement in research, often participate in the IRB as chairs, members, or presenters. Conflicts of interest can occur when an IRB member has a financial interest or any other professional or personal relationship with industry that may compromise his/her independent judgment in safeguarding the rights and welfare of the research subjects. Conflicts of interest have the potential to directly affect the design, execution, interpretation, and/or approval of a study. Conflict of interest by an investigator of a clinical study or member of an oversight committee can result in regulatory action, negative publicity, and lawsuits.[53] For the pharmacist member of an IRB, full disclosure to the chair and/or IRB committee prior to any action on a research project is vital. As a result of the disclosure, the pharmacist may be required to abstain from voting if he/she or his/her immediate family members have a financial relationship with any company sponsoring a proposed study. In addition, if the pharmacist has access to confidential information, he/she must adhere to IRB policies and the U.S. Food and Drug Administration regulations.

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