Tag:informed consent
Updates to Autorenewal Regulations and Enforcement
In the age of online consumerism, many companies utilize automatic renewal programs to deliver their products and services to customers on a recurring basis for a monthly or annual charge. Recently, autorenewal programs have seen an increase in consumer protection through legislation at both the state and federal level along with enforcement actions brought by private plaintiffs, state attorney generals, and the Federal Trade Commission (“FTC”). Organizations that utilize automatic renewal should be aware of the uptick in autorenewal program enforcement and look to strengthen and update their policies where appropriate.
Impact of Provisions of Revised Rules of FDA-Regulated Clinical Investigations
The FDA regulationson human subject protection and Institutional Review Boards(IRBs) provide guidance to protect the rights, safety, and welfare of subjects who participate in FDA-regulated clinical investigations. The regulations conform with the requirements set forth by the Department of Health and Human Services (HHS) Federal Policy of Human Research Subjects(45 CFR 46, part A). In order to reduce confusion and burdens associated with complying with both the FDA regulations and the HHS policies regarding human subject protections, the FDA is revising the current “common rule”.