Being Held to Standards Beyond the Legal Minimum

By Ryan Meade

One of many interesting themes discussed during sessions at the HCCA Research Compliance Conference is what are the implications of an organization’s research commitment that go beyond the legal minimum. In most instances, a regulated actor is only held accountable by federal agencies to the standards of the law and not to commitments beyond the law. In many regulatory areas, the agencies stop at “the law” in imposing penalties and corrective actions for non-compliance. Whether federal agencies can penalize organizations when they do not violate the law but do violate their policies is a question of unsettled law – except in clinical research. Under clinical research regulations, the federal government can hold an organization accountable to its commitments that go above and beyond the legal minimum.

Two examples of this involve (a) non-federally sponsored studies that an organization has voluntarily given jurisdiction to HHS; and, (b) commitments in the informed consent form related to payment of costs associated with subject-injury.

Under current law there is no authority for HHS-Office for Human Research Protections (OHRP) to regulate non-federally sponsored or subsidized clinical research studies. However, when a research institution files its federalwide assurance (FWA) with HHS, the organization must decide whether to “check the box” and give OHRP jurisdiction over all of its studies, including the ones that are not federally sponsored. Organizations should know whether they have gone above and beyond the legal minimum and “checked the box.” If they have, then they must comply with OHRP regulations (including obligations to self-report certain incidents).

With respect to costs to treat subject-injury during a research study, the current version of the Common Rule requires the research institution to provide information in the informed consent form: “For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.” 42 CFR 46.116(a)(6). This regulation does not say what the institution must do with respect to costs associated with treating injury, but whatever the institution decides to do it will be held to that standard by government agencies.

The take-away from the conference on this theme is to make sure the institution understands that in some instances the organization can be held to standards above and beyond the legal minimum standard.