HHS To Boost Protections In Clinical Trials

HHS To Boost Protections In Clinical Trials

July 26th, 2011 // 1:12 pm @

After two decades during which complaints have mounted over various aspects of clinical trials, the US Department of Health & Human Services has issued a proposal that would, presumably, better protect clinical trial subjects. There are various suggestions, but include improving consent forms for participants and mandating the use of a single institutional review board for multi-study sites.

“The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site,” the HHS states in its proposal, which indicates comments can be submitted for 60 days as of July 25 – which is today – according to an HHS spokeswoman.

“Although the regulations have been amended over the years, they have not kept pace with…the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics.”

A portion of the proposal is also devoted to suggested changes that would involve boosting data protections to lessen the risk that patient info is used improperly or goes unprotected; revising or eliminating certain criteria used to determine when trials should be expedited; boosting consent protections for reusing or running additional analyses of existing data and biospecimens, and shifting away from studies that are exempt from IRB review to a new category called excused.

The sections that may generate some of the most significant discussion, though, involve strengthening consent forms and requiring a single IRB review. As the HHS notes, consent forms frequently fail to include “some of the most important pieces of information that a person would need in order to make an ‘enlightened decision’ (to quote the Nuremberg Code) to enroll in a research study…but instead of presenting the information in a way that is most helpful to prospective subjects – such as explaining why someone might want to choose not to enroll – the forms often function as sales documents, instead of as genuine aids to good decision-making.”

The agency acknowledges that regs have changed little since 1974, but the average length of consent forms has increased and become “excessively long and legalistic,” even for routine and low-risk research. “It is not uncommon for documents to stretch to 15 or even 30 pages…Moreover, studies have shown that the reading level of many of these documents is above the desired 8th grade level.” That means many participants may avoid reading forms or are unable to understand them.

And so the HHS proposes requiring “appropriate content” with “greater specificity” than is currently mandated; restricting content that would be inappropriate to include in consent forms; limiting the acceptable length of various sections of the forms; mandating how info should be presented, such as infor that should be included in the beginning of a form or types of info that should be included in appendices and not in the main body of a form; reducing institutional “boilerplate” language, and making available standardized consent form templates.

As for multiple IRBs, the HHS notes that the Common Rule requires each institution engaged in a multi-site research study obtain IRB approval for the study, but does not require a separate local IRB at each institution conduct a review. Just the same, this does happen, resulting in hundreds of reviews for one study. And so when any of these IRBs requires changes to a research protocol that are adopted for the entire study, study investigators must re-submit the revised protocol to all reviewing IRBs, which can significantly delay research. Another problem – the HHS cites reports that there can be “widely differing outcomes” among reviews from IRB to IRB, “even for identical studies.”

So the HHS suggests mandating that all domestic sites in a multi-site study rely upon a single IRB as their IRB of record for that study. And this would apply regardless of whether the study underwent convened review or expedited review. The proposal would only affect the IRB designated as the IRB of record for institutional compliance with review requirements, and would not relieve any site of its other obligations under regulations to protect human subjects.

As for data security, the HHS suggests calibrating protection standards to match what is required by the HIPAA Privacy Rule. As a result, an IRB would no longer be responsible for assessing the adequacy of a study’s procedures for protecting against informational risks.

And three changes are being considered for research that will receive expedited review – revising criteria that make research studies eligible for expedited review, eliminating the requirement of routine annual continuing review of expedited studies and streamlining submission requirements. To sort this out, the HHS may change the list of research activities that qualify a study for expedited review, and also determine that a study involves no more than minimal risk and meets requirements of a section of federal law known as 45 CFR 46.111.

This states that before an IRB may approve a research study, including research that is
being reviewed under an expedited procedure, the IRB must find that risks to subjects are minimized and are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. Selection of subjects must also be equitable and informed consent will be sought from each prospective subject or a legally authorized representative. And finally, informed consent will be appropriately documented.

Source: Pharmalot


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