Drugs

Guidance on Payment/Reimbursement to Trial Participants Updated

FDA has updated a guidance for Institutional Review Boards and Clinical Investigators to revise its “Payment for Research Subjects: Information Sheet” to clarify that reimbursement for travel expenses to clinical trial sites and associated costs (airfare, parking, and lodging) are acceptable under current practices. The updates were made based on inquiries from stakeholders about appropriate reimbursement practices. The information sheet has been revised and renamed to reflect these changes — “Payment and Reimbursement to Research Subjects.”

“Paying research subjects in exchange for their participation is a common and, in general, acceptable practice,” the guidance says. “Payment to research subjects for participation in studies is not considered a benefit that would be part of the weighing of benefits or risks; it is a recruitment incentive. FDA recognizes that payment for participation may raise difficult questions that should be addressed by the IRB. For example, how much money should research subjects receive, and for what should subjects receive payment, such as their time, inconvenience, discomfort, or some other consideration. In contrast to payment for participation, FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence. Other than reimbursement for reasonable travel and lodging expenses, IRBs should be sensitive to whether other aspects of proposed payment for participation could present an undue influence, thus interfering with the potential subjects’ ability to give voluntary informed consent.”

The guidance also says it is permissible to hold a small proportion of payment/reimbursement as an incentive for completing the study, “providing that such incentive is not coercive.” IRBs have discretion to determine an acceptable amount paid as a bonus for completing studies, it says, adding that all information concerning payment should be outlined in informed consent documents.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome