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Regulations governing research in human subjects are changing. The New York Medical College IRB, and all others are awaiting further guidance from the federal Office for Human Research Protections (OHRP) on the regulatory changes scheduled for implementation on January 19, 2018

The U.S. Department of Health and Human Services and 15 other federal agencies issued a final rule to update regulations that safeguard individuals who participate in research.

At this time, the federal government remains on track to implement the regulatory changes in January, however, HHS proposed a one year delay of the general implementation date. The proposed delay is currently under review by the federal Office of Management and Budget.

The current regulations, which have been in place since 1991, are often referred to as the “Common Rule.” In September 2015, HHS and the other Common Rule agencies published a Notice of Proposed Rulemaking (NPRM), which drew more than 2,100 comments.  In response to concerns raised during the extensive review process, the final rule contains a number of significant changes from the proposed rule.

Important elements in the final rule include:

  • The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
  • Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
  • For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
  • The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules. 
  • Removal of the requirement to conduct continuing review of ongoing research of studies in certain instances where such review does little to protect subjects.
  • Requirement that consent forms for certain federally funded clinical trials be posted on a public website.

Medical advances would not be possible without individuals who volunteer to participate in research. Oversight and protection of research participants is an important safeguard and essential to advancing the research enterprise. Today’s action reaffirms the federal government’s commitment to all those who participate in research studies.

New York Medical College’s Office of Research Administration and the staff of the IRB have begun updating institutional policies and templates in preparation for the revised Common Rule. For further information, please contact Carla Charles, BS, CCRC, Director  Human Subjects Administration in the IRB Office: 914-594-2590


Educational Program for Those Involved with Human Subjects Research

The College has implemented a new human subjects research educational program. Effective immediately, all persons participating in any research activity involving human subjects will be required to complete the appropriate (Biomedical Research Personnel or Social & Behavioral Research Personnel)Collaborative Institutional Training Initiative (CITI) course, which is available on-line at: www.CITIprogram.org

  • Research personnel who have fulfilled New York Medical College’s previous education requirements must complete the CITI course by January 1, 2010.
  • Research personnel who have not fulfilled NYMC’s previous requirements must complete the CITI course before research can begin.

Failure to comply with this requirement will result in delayed permission to initiate or continue conducting human subject research.

As in most professions, continuing education is a means to update members on new information as well as to reinforce the basic foundation. NYMC now offers the CITI course, an on-line, self-paced, modular program, to replace the previous study manual. All research personnel, defined as anyone who has contact with human participants and/or access to research data, must complete this course. As an added benefit and incentive, the sponsor of the program, the University of Miami, affords the opportunity, for a fee, to obtain CME credits. If you do not choose to obtain CME credits, the course is free.

Visit the CITI website and follow the registration instructions. For additional assistance, print the instructions before going to the CITI website. Once you have completed the required modules you will be able to print a course complete report for your records and to submit to the Office of Research Administration.

Collaborative Institutional Training Initiative (CITI): www.CITIprogram.org