NIH Mandate for Training in Human Subject Protection

All NIH grant and contract awards that involve human subjects issued after October 1, 2000, require signed institutional documentation that all key personnel on a given award have received education/training in the protection of human subjects.  This new rule was issued by NIH on June 5, 2000 to view click here.


This requirement falls under the NIH “just in time” procedures, meaning that the required training does not have to be completed by the time of proposal submission; rather, the training must be completed and certified by the institution BEFORE an award can be made.  For further, clarification, see “Frequently Asked Questions for the Requirement for Education on the Protection of Human Subjects”, to view click here.


Collaborative Institutional Training Initiative (CITI)
MSM has chosen to meet the NIH training policy by requiring the completion of the Collaborative Institutional Training Initiative (CITI) Core training.  The CITI course provides instruction in human subject’s protection.  The course is designed to help users understand human subject’s protection issues through a web based program.  Researchers and key personnel are responsible for ensuring that they complete the required training before commencing any human subjects research.  This training is required regardless of the source of funding.


Human Subject Projection Training for all personnel involved with a study must be completed and its completion registered with the IRB office before receiving IRB approval.  This training requirement is designed to provide information and guidance to faculty, professionals, and administrators to promote the institution’s ideals for scientific and scholarly integrity, and to minimize institutional risks.


The CITI Program is a subscription service providing research ethics education to all members of the research community.  MSM subscribes to this program so that all MSM faculty, staff and students may utilize these training modules.  A completion report will be issued after successful completion of the CITI training program.  The initial training certificate is valid for two years.  A CITI refresher course in human subjects research must be completed every 2 years to renew certification.


The type of training module that should be completed depends on the type of research to be conducted.  In general, human subjects research can be classified as Biomedical or Social/Behavioral.


Social/Humanist/Behavioral research involves observational and survey research, work with population and /or epidemiological studies.  This type of research does not involve any drugs or devices.


Biomedical research involves any type of clinical research studies, including those that involve investigational drugs and/or devices.


The CITI program offers several training programs, including:


  • Basic Courses in the Protection of Human Research Subjects:
    1. Biomedical Focus
    2. Social and Behavioral Focus
    3. Refresher Courses
  • Good Clinical Practice Course
  • Health Information Privacy and Security Course (HIPS)
  • Laboratory Animal Welfare Courses for investigators and IACUC Members
  • Responsible Conduct of Research (RCR)


MSM researchers will first need to create a user name and ID at the CITI website.  After logging in to the CITI site, researchers will choose an appropriate training program (Social/Humanist/Behavioral or Biomedical).  There are several modules that are required for each training program and several others that are optional.


  • You may change your training program as your research training needs change
  • A refresher course for each program will need to be completed every 2 years
  • IRB members are required to complete both training programs
  • Depending on the nature of your research and the population in your protocol, you may also need to take one or more “optional modules.”  The IRB can assist you in determining whether these additional modules are necessary
  • A copy of your completion report will automatically be sent to the MSM IRB.


Additional Training and Education Resources


Ethics Training
NIH Human Research Protections Course
NIH provides a free training course for protecting human research participants.  The course contains 7 modules that address the principles used to define ethical research and the regulations, policies and guidance that describe the implementation of those principals.


Education Resources
IRB members participate in continuing education activities about human subjects research, on a monthly basis.  Some of the training sessions include educational handouts.  The educational handouts can be accessed here.


IRB Education Day-Protecting Human Subjects in Research. Whose Responsibility is it?
Join us on October 19, 2012 for a 1/2-day Comprehensive Morehouse School of Medicine Human Research Subjects Protections Conference. To register or for more information click here.