May 1, 2018: Proposal for 6-month Delay for Implementation of Revised Common Rule

On April 20, 2018, the Department of Health and Human Services and 15 other federal departments and agencies proposed a rule to delay both the effective and compliance dates for the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule). The Interim Final Rule initially announced a delay until July 19, 2018, and the new, proposed rule would delay by a further 6 months to January 21, 2019. This is intended to give institutions additional time to prepare to implement the revisions. Before January 21, 2019, institutions must comply with the pre-2018 Common Rule, except for these three proposed allowances, which are intended to reduce burden on regulated entities:

  1. Entities may use the 2018 definition of “research,” which deems certain activities not to be research,
  2. No annual continuing review is needed for certain categories of research, and
  3. Institutional review boards (IRBs) are not required to review grant applications related to research.

Comments on the proposal will be accepted until midnight EST on May 21, 2018, on the Federal eRulemaking Portal or through regular mail. To use the portal, search for “83 FR 17595” and click the box “Comment Now!”

Modernizing the Common Rule for the 21st Century


The New England Journal of Medicine today published a perspective by NIH Deputy Directory Kathy L. Hudson, PhD, and NIH Director Francis S. Collins, MD, PhD, in which they outline the major reforms proposed for regulations governing the ethical conduct of research involving humans, known as the Common Rule (45 CFR 46, Subpart A).

The proposed changes are meant to enhance respect for research participants, calibrate oversight to level of risk, simplify consent documents, streamline IRB review, increase privacy and security safeguards, and facilitate broad participation in research.

“These long-overdue reforms will bring the Common Rule into the 21st century. They should help the scientific community take a giant leap forward in showing respect for research participants, without whom the biomedical research enterprise would cease to exist.”

The NIH is encouraging all stakeholders—the public, researchers, and patients—to closely review the proposed changes and participate in the comment process by the December 7, 2015, deadline.

For more information on the proposed revisions:

Grand Rounds Presentation, Kathy Hudson (video)

Department of Health and Human Services' website on the NPRM 

OHRP Webinars on the NPRM

Living Textbook Chapter: Informed Consent: Emerging Issues and Controversies

OHRP Town Hall Meeting to Discuss NPRM


The Office for Human Research Protections (OHRP) has announced a public Town Hall Meeting to be held October 20, 2015, to respond to questions related to the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking (NPRM) published on September 8, 2015.

The goal of the NPRM is to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The NPRM seeks comments on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

The purpose of the Town Hall Meeting (agenda) is for OHRP, HHS agencies, and other Common Rule departments and agencies to provide responses to questions from the public about the NPRM in order to clarify the NPRM proposals and better inform public comment on the NPRM. The public will be able to ask questions during the Town Hall Meeting, and to submit questions before the meeting. Watch via webinar.

Public Town Hall Meeting 
October 20, 2015, 9 am to 5 pm
Hubert H. Humphrey Building, Great Hall
200 Independence Ave SW
Washington, DC 20201

This PDF document (#2015-25564) contains details about the format of the public Town Hall Meeting and how to register or submit questions prior to the meeting.

Important deadlines:

  • While there is no registration fee, individuals planning to attend the Town Hall in person must register by 5:00 pm October 13, 2015. Registration will be accepted on a first-come, first-served basis and may be completed by sending an email to OHRP@hhs.gov, with the subject line “Registration for OHRP Town Hall Meeting.”
  • The deadline for submission of questions about the NPRM prior to the Town Hall Meeting must be received no later than 5:00 pm October 13, 2015.
  • Details on the NPRM are at the OHRP website. To be assured consideration, comments on the NPRM must be received no later than the extended deadline of January 6, 2016.

 

OHRP Offers Webinars on Proposed Revisions to the Common Rule


The Office for Human Research Protections (OHRP) has posted a series of six webinars explaining the recent Notice of Proposed Rulemaking (NPRM) regarding revisions to the Common Rule (the federal policy for human subjects protection). The presentations by policy experts can be viewed anytime; they cover the following topics:

  • Overview of the NPRM
  • Exclusions and exemptions
  • Informed consent
  • IRB review and operations
  • Research with biospecimens
  • Secondary research use of data

For more information on the NPRM, visit the OHRP website. The deadline for comments on the proposed revision has been extended to January 6, 2016.


Notice of Proposed Rulemaking (NPRM): Protection of Human Subjects


The U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule (45 CFR 46, Subpart A)  in 1991. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015 (see the press release).

The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. Comments must be received no later than the extended deadline of 5 pm on January 6, 2016. Visit the HHS page for a summary of the proposed changes and instructions on submitting or browsing comments.

Webinars are available explaining the changes proposed in the NPRM, and a town hall meeting is planned to be held in Washington, DC, in October.

Among the major changes being proposed in order to better protect research subjects and help build public trust are modifications to rules affecting patient informed consent. With regard to informed consent in general (such as consent to participate in a clinical trial), the rules would be significantly tightened to ensure that the process becomes more meaningful. Consent forms in particular would be affected. A common complaint about informed consent forms is that they are often unduly lengthy and cumbersome, with important information often buried and hard to find. Under the proposed changes, such documents would need to be streamlined in ways that provide appropriate details about the research that is most relevant to a person’s decision to participate in the study, such as information a reasonable person would want to know, and present that information in a way that highlights the key information.

The proposed modifications are designed to continue to uphold the ethical principles upon which the Common Rule is based, as applied to the current social, cultural, and technological environment. In brief, the most significant changes proposed in the NPRM include:

  1. Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that must be given to prospective subjects.
  2. Generally require informed consent for the use of stored biospecimens in secondary research.
  3. Exclude from coverage under the Common Rule certain categories of activities that should be deemed not to be research, are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated.
  4. Add additional categories of exempt research to accommodate changes in the scientific landscape and to better calibrate the level of review to the level of risk involved in the research.
  5. Change the conditions and requirements for waiver or alteration of consent such that waiver of consent for research involving biospecimens (regardless of identifiability) will occur only in very rare circumstances.
  6. Mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions.
  7. Eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing data or involve only observational follow-up in conjunction with standard clinical care.
  8. Extend the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt human subjects research.

 

SACHRP Meeting to Discuss Research Consent Issues


The Department of Health & Human Services’ Secretary’s Advisory Committee on Human Research Protections (SACHRP) has announced that it will be holding a 2-day public meeting centering on consent issues in clinical research.

Part of the meeting will be devoted to discussion of consent issues in the context of cluster randomized trials. Unlike “typical” clinical trials that randomly assign an individual research volunteer to receive one of two treatment options, or a treatment vs. a placebo, a cluster randomized trial (or CRT) randomly assigns groups of people to an intervention. These groups can include clinics, hospitals, city blocks, or whole healthcare systems. Because CRTs randomize groups rather than individuals, obtaining consent from the people involved in such research can present a number of challenging issues.

Meeting participants will also discuss a variety of other topics related to the application of regulations governing research conduct in the current era, as well as potential changes to such regulations.

The meeting, which will include programmed presentations as well as a period for public comment, will be held in Washington, DC, on March 12-13, 2014, at the U.S. Department of Health and Human Services, 200 Independence Avenue SW., Hubert H. Humphrey Building, Room 800. A full program of the meeting’s events is available here, and additional description and context are available from the Federal Register.


Changes to Informed Consent in the Era of Learning Healthcare Systems


In 2007, a seminal report from the Institute of Medicine (IOM) threw a sharp spotlight on a series of problems facing the broader U.S. healthcare system:

Evidence on what is effective, and under what Cover page of IOM report - The Learning Healthcare Systemcircumstances, is often lacking, poorly communicated to decision makers, or inadequately applied, and despite significant expenditures on health care for Americans, these investments have not translated to better health.

—The Learning Healthcare System (IOM Workshop Summary), 2007

The IOM report called for a new approach to closing the existing gaps in patient care, one that would create a system in which patient care, quality improvement efforts, and clinical research would exist as integrated components within a virtuous cycle of feedback—the “learning healthcare system.” (The original report, plus a series of related reports [PDF], can be read for free online at the National Academies Press website.)

In the years since The Learning Healthcare System was first published, researchers, healthcare providers, health systems, and governmental and regulatory agencies have all struggled with the monumental task of building such a system. One aspect that has presented a particularly complex set of challenges centers on the issue of informed consent. The principle of informed consent—the idea that all patients have the right to make a fully informed decision, free from coercion or other undue pressure, about whether or not to participate in research—is a foundational tenet of clinical research ethics. However, some of the tools that are widely considered to be critical to the success of achieving a workable learning healthcare system, such comparative effectiveness studies and cluster-randomized trials, are difficult or even impossible to conduct under existing models of individual informed consent.

Recent efforts from the Ottawa Consensus Statement Group and a series of articles published in an issue of the Hastings Center Report have explored explored informed consent in such circumstances. These are now joined by a pair of articles published in the February 20, 2014 issue of the New England Journal of Medicine. In the first, Faden and colleagues outline a case for streamlining or even dispensing with individual informed consent in certain kinds of randomized comparative-effectiveness or quality improvement studies that present a minimal risk of harm to patients [1]. The authors also describe the larger framework that would provide transparent and accountable oversight of such studies, as well as overseeing the integration of findings from such research into the patient-care process.

The second article, by Kim and Miller, presents a different vision for informed consent,  the “Integrated Consent Model” [2]. Unlike Faden and colleagues, the authors argue for preserving the element of informed consent for all randomized pragmatic research, even in circumstances considered to pose minimal risk to patients. Kim and Miller suggest that such a model, in which the prospect of participating in research is offered as part of the general clinical discussion about treatment options and documented by the physician, will satisfy ethical imperatives for informing patients while remaining sufficiently streamlined to meet the demands of pragmatic clinical research. They also argue that an “integrated consent” approach could be accommodated under existing regulations.

Regardless of whether either or both of these perspectives can be incorporated into the emerging learning healthcare system, the larger questions surrounding informed consent are  garnering significant interest, as evidenced by the response to the Department of Health and Human Service’s 2011 call for public comment on a proposal to modify rules governing clinical research. And with the proliferation of new technologies and trial designs that use data extracted directly from patient’s electronic health records (such as the demonstration projects coordinated through the NIH Collaboratory) and the emergence of innovative networks devoted to pragmatic patient-centered research, the need for a solution both protects patients and enables vitally needed research will only continue to grow.

For additional perspective on the recent publications in the New England Journal of Medicine, see "Research Permissions–Angels on the Head of a Pin, or the Key Issue to Decipher?" by NIH Collaboratory PI Dr. Rob Califf.

References


1. Faden RR, Beauchamp TL, Kass NE. Informed consent, comparative effectiveness, and learning health care. N Engl J Med 2014;340:766-768. 10.1056/NEJMhle1313674.

2. Kim SYH, Miller FG. Informed consent for pragmatic trials — The integrated consent model. N Engl J Med 2014; 370:769-772. doi: 10.1056/NEJMhle1312508.