Clinical Research To Implement Long Overdue Changes to the “Common Rule” for the Protection of Human Subjects

December 28, 2015

health-care-lawClinical research trials involving human subjects have changed considerably over the last two to three decades.  However, the “Common Rule” for the Protection of Human Subjects (or Subpart A, Part 46, 45 Code of Federal Regulations), has remained largely unchanged since 1991.

The Department of Health, Education and Welfare (HEW) first published the regulations for the protection of human subjects in 1974.  Since that time, the Department of Health and Human Services (HHS) has revised them twice (once in the early 1980s and again in 1991).  The process for the adoption of the 1991 revisions began in the late 1980s.  Eventually the proposal was accepted by 15 federal agencies leading to heightened uniformity, understanding and compliance with human subject protections.  This effort also helped to create a uniform body of regulations across federal departments and agencies, promulgating what we now refer to as the “Common Rule.”

Our federal laws and regulations come from international treaties such as the Geneva Conventions and other long-standing agreements on human rights.  The necessity for national laws and regulations was really brought home and received emphasis during the Nuremberg Trials which disclosed human experimentation by the Nazis.

HHS (along with other federal agencies) issued its notice of proposed rule making (NPRM) addressing the long overdue changes proposed to the existing “Common Rule” on September 8, 2015.  Typically, the NPRM allows for public comment for up to 60 days.  However, it was recently announced that the comment period for this particular NPRM has been extended an additional 30 days to January 6, 2016.

To read the full applicable law providing protections for human research subjects at Part 46, 45 Code of Federal Regulations, click here.

Clinical Research Involving Human Subjects is Expanding.

Lawmakers acknowledge that since the implementation of the “Common Rule” in 1991, the volume and landscape of research involving human subjects have changed quite considerably.  Clinical research has been expanding and becoming more diverse overall.  As technology evolves it is only rational that laws must evolve as well to remain modernized and consistent alongside the advances in research and medicine.

Some examples of developments in research involving human subjects include:

(a)        An expansion in the number and type of clinical trials, as well as observational studies and cohort studies;

(b)        a diversification of the types of social and behavioral research being used in human subjects research;

(c)        increased use of sophisticated analytic techniques for use with human biospecimens; and

(d)       the growing use of electronic health data and other digital records to enable very large data sets to be analyzed and combined in novel ways.

Similar State Laws.

Most states have also enacted state laws and rules patterned after the federal ones.  More specifically, Florida tends to model its laws regarding clinical research on human subjects after The Belmont Report, issued on April 18, 1979, by the Office of the Secretary for the Department of Health, Education and Welfare.  The report, denoting Ethical Principles and Guidelines for the Protection of Human Subjects of Research, sets the stage for necessary considerations, respect, applications and boundaries for human subjects.

To read the full report, click here.

Florida law intersects with federal law governing the protections of human subjects in several areas including legal age of consent, genetic testing, HIV testing, treatment of persons who are developmentally disabled, treatment of persons determined to be incapacitated, researchers working with confidential governmental records and fetal research restrictions.  To see a full listing of Florida laws on human subjects research, click here.

Florida law regarding experimental research can be found at Section 381.026(4)(e), Florida Statutes. This section provides guidance to Florida researchers on patients’ rights and their knowledge of the same.

HHS Invites the Public to Weigh In.

HHS, in coordination with the President’s Office of Science and Technology Policy (OSTP), published an advance notice of public rule making (ANPRM) on July 26, 2011.  The purpose of the ANPRM was to request comment on how current regulations for the protection of human subjects who participate in research might be modernized and revised for heightened effectiveness.  The aim is to better protect human subjects while also maintaining the facilitation of valuable research efforts.

HHS invited public comments, expert advice and stakeholder opinions.  The most significant elements of the dialogue put forth regarding the changing nature of research has centered on the appropriate level of transparency in the government and medicine and how patient and participant expectations should be incorporated into corresponding government policies.  This was the crux that assisted HHS in its development of the regulatory actions contained in the current pending NPRM.

Key Components of the NPRM Proposal.

The primary goals of the NPRM include:

(a)        increasing human subjects’ ability and opportunity to make informed decisions;

(b)        reducing potential for harm and increasing justice with the heightened uniformity of human subject protections in areas such as:

(i)         information disclosure risk;

(ii)        coverage of clinical trials; and

(iii)       coverage of Institutional Review Boards (IRBs); and

(c)        facilitating current and evolving types of research that offer promising approaches to treating and preventing medical and societal problems by way of:

(i)         reduced ambiguity in the interpretation of the regulations;

(ii)        increased efficiencies in the performance of the review system; and

(iii)       reduced burdens on researchers that do not appear to provide commensurate protections to human subjects.

It is the final intention of HHS to further promote public trust in the research system by the implementation of such changes.

HHS proposed the following (most significant) changes to the “Common Rule” to effectuate its goals per the NPRM:

(1)        Improve informed consent;

(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 are inherently low risk (and should not be considered “research”) and are similarly protected by separate mandate;

(4)        Add additional categories of exempt research to accommodate changes in the scientific landscape (the NPRM lists the various categories to be added);

(5)        Change the conditions and requirements for waiver or alteration of consent (waiver 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 few exceptions);

(7)        Eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions (for studies merely analyzing data); and

(8)        Extend the scope of the policy to cover all clinical trials conducted at a U.S. institution that receives federal funding (regardless of the funding source).

To read the NPRM in its entirety, click here.