Informed Consent

21st Century Cures Act and Informed Consent in Trials

When then-President Barack Obama signed the 21st Century Cures Act into law in December 2016, he said the legislation would deliver breakthroughs to some of the greatest health challenges of our time. Over ten years, the legislation is set to provide the NIH with $4.8 billion and the FDA with $500 million, along with $1 billion in state grants to tackle the opioid crisis.

Yet despite the bipartisan $6.3 billion medical package aimed at modernizing the healthcare system, Joel C. White, executive director of Health IT Now, says the law is lagging. Much remains to be done to see the law implemented through regulations, he writes.

Regardless of some of the perceived inadequacies of the legislation, an important component of the Act is how it sets out to harmonize the consent waiver and alteration requirements between  FDA regulations and HHS Common Rule.

In this post, we explore how the Act will impact consent requirements and address the issue of interoperability of data sources and systems.

Syncing FDA and Common Rule Requirements

Before the 21st Century Cures Act came into being, patient consent in clinical trials was waived only in life-threatening cases or for emergency research, Michael Mezher at Regulatory Affairs Professional Society writes.

However, Section 3024 of the Act expanded the conditions to waive or change patient consent requirements when there is minimal risk to participants to FDA-regulated studies to bring them in line with the Common Rule. Healthcare attorney Carrie A. Hanger notes that in drug studies, waiver or alteration is permitted when consent is not feasible, not in the patients’ best interests, or the clinical testing presents minimal risks to patients and safeguards their rights and wellbeing.

For device studies, Hanger explains, consent waivers and alterations are permitted if the clinical testing presents minimal risk to patients and safeguards their rights safety, and welfare of the human subject. The Act, however, does not specify what those safeguards are.

The Act Will Likely Be a Boost to Minimal Risk Trials

The Cures Act will help FDA-funded research catch up to Common Rule, which has allowed consent requirements to be waived or changed in instances of minimal-risk research since 1991, explains healthcare attorney Bonnie Scott.

Should the Proposed Rule be finalized (set for sometime in 2019), benefits will include improved harmonization of FDA regulations with the Common Rule, which governs matters of research on human patients conducted or supported by HHS and other federal agencies. The FDA is not likely at this time to adopt the recent (January 2017) addition to the four criteria that allows for waiving or altering consent, she adds.

The fifth criterion allows for consent waiving or alteration in research, which uses identifiable private data or biospecimens that could not be carried out without using the data in an identifiable format.

Besides better harmonization, Scott suggests that the Proposed Rule would enable a great number of minimal risk clinical studies to be carried out that otherwise would not have, given the existing consent requirements. The knock-on effect is increased opportunities for sponsors and investigators and better treatment options for patients.

21st Century Cures Act


Delving Deeper into the Act’s Wording Around Consent Requirements

The Cures Act should be applauded for harmonizing consent, writes Jim Gearhart, who sits on the Board of Directors at Quorum Review. He praises the Act’s ambition, noting that the criteria stipulated within will be familiar to all researchers, sponsors or IRBs that have been involved in minimal risk research under the common rule.

The Act, as we saw above, states that an IRB can permit the exclusion of or change to informed consent in four instances.

Minimal risk demands that the “probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

Also important, Gearhart notes, is that the waiver or change will not negatively impact patients’ rights or wellbeing, is necessary for the study to be conducted and, wherever possible, patients will be given important information after study participation. Examples of FDA-regulated research that meets those conditions include post-approval observational studies using EMRs for data on safety or efficacy, and studies that test remaining clinical specimens in an assay considered an in vitro diagnostic device.

Enhanced Interoperability

The Act also aims to improve the interoperability of patient data from multiple and digital sources.

Interoperability of various data sources and systems is essential for an effective and efficient healthcare system, Dr. Donald Rucker, national coordinator for Health IT, explains. But this means more than just transferring medical records between providers, he adds, and should empower patients.

Because of increased digital information of patients, there needs to be better interoperability between the various sources, particularly EHRs and EDC, internist Nita K. Thingalaya agrees. While data sources include standardized and unstandardized data from patients such as demographics and medical reports, the EHR is regarded as the most important overarching system holding them together.

“The EHR maintains an auditable time trail that is compliant with the updated certification requirements,” Thingalaya says. Used in conjunction with EHRs, EDC systems can create patients’ source documents faster, more efficiently and with fewer errors. Greater interoperability will mean that when patients in trials give informed consent to sponsors, they will also have a unified data identity that is consistent across EHRs and EDC systems.

21st Century Cures Act


Removing Administrative Burdens on Sponsors and IRBs

The proposed consent waiver rule, according to information from the law firm Ropes & Gray, would result in less time and cost expended on IRB review requirements. IRBs would not be required to review informed consent forms under the new proposal.

The major saving here is sponsors’ time and money as the new rule will no longer require IRBs and researchers to determine differing compliance requirements as stipulated by FDA regulations and the Common Rule.

The Act Requires Only One IRB Even in Multi-Site Studies

Multi-site trials place greater administrative burdens on sponsors compared with single-site studies because of review requirements when researching medical devices, lawyer Michele Russell-Einhorn, VP of Human Research Protection Services and Institutional Official at Schulman IRB, explains.

As it stands now, a study with 10 or 12 sites, for example, would require the same number of local IRBs, each with their own specifications concerning protocol and consent forms. This would inevitably result in delays. Section 3056 of the Cures Act states that a single IRB of record will be required in NIH-funded multi-site studies for medical devices, so sponsors need react only to a single IRB’s feedback.

With the savings in time and administrative resources, the IRB and sponsor could devote more attention to developing a system of unified informed consent across all of its sites, Russell-Einhorn says.

Certificates of Confidentiality

The issue of certificates of confidentiality is important in the debate surrounding consent. And the Cures Act adds fresh governance to these matters, explain Leslie E. Wolf, J.D., and Laura M. Beskow, Ph.D. in a study published by the American Journal of Law & Medicine.

These certificates are set out in federal law to safeguard sensitive patient data that can lead to that patient’s identification from being disclosed. Certificates are often used in cases of essential research on contentious and emotive topics, such as the opioid epidemic or HIV in minority youth, write the researchers.

Critics of the certificates say IRBs and researchers don’t have enough knowledge about them and end up not using them when they could be valuable to the research. Another criticism is that certificates are not equipped to deal with keeping data safe in the digital age.

Wolf and Beskow say that the Cures Act works well to address confidentiality concerns by, for example, requiring certificate protection in federally funded research involving identifiable and sensitive research data. It also ensures that the NIH automatically includes protections to research that it funds.

Cures Act Leads to Patient-Centred Care

With patient data coming from multiple sources, regulating how it is exchanged is vital for a more patient-centred approach to treatment, according to William A. Yasnoff, M.D., Ph.D., and Richard D. Marks CEO and VP, respectively, of The Health Record Banking Alliance. Issues of patients’ identities, consent and privacy of data would all become better managed under the Act’s requirements.

That, coupled with greater and easier access to RWD, would lead to more efficient gathering of data of higher quality. The pair says that the result would be better treatments for patients.

The goal of medical tech innovations and better data processing, as well as the legislation underpinning healthcare, is to ensure patients receive the best possible care. While the industry is yet to enjoy the Act’s new regulations, the matter of harmonizing consent between FDA regulations and  the Common Rule will be a valuable addition to the clinical trials industry.

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