NEW YORK MEDICAL COLLEGE INSTITUTIONAL REVIEW BOARD for the PROTECTION of HUMAN SUBJECTS (IRB) ANNOUNCEMENT
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:
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
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