IRB Manual
8.1 Training in the Protection of Human Research Participants
     
    Research Conducted under FWA 00006105 (RFMH and DMH)
     
   

The Research Foundation for Mental Hygiene, Inc. and Department of Mental Hygiene are committed to maintaining the highest ethical standards in research.  The purpose of this policy is to ensure that all persons who participate in the conduct and review of research involving human subjects are appropriately trained in issues relating to the protection of human subjects.

     
  8.2 Regulatory Basis for Training
     
   

NIH requires education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects.   Investigators must provide a description of education completed in the protection of human subjects for each individual identified as “key personnel” in the proposed research.  Key personnel include all individuals responsible for the design and conduct of the study. This term is broadly interpreted and includes, but is not limited to, the principal investigator, co-investigators and all other individuals who participate in study design, subject recruitment, screening, consent, assessment of capacity to consent, or research interventions.
The Common Rule and FDA regulations (107(a)) require that an IRB:

  • must be sufficiently qualified through the experience and expertise of its members … to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects
  • in addition to possessing the professional competence necessary to review specific research activities the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
  • if it regularly reviews research involving a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects
It is the responsibility of the institution/organization operating the IRB to ensure that IRB members receive both initial and ongoing training to fulfill these requirements and to bring in consultants to assist the IRB when additional expertise is needed to review a particular study.
     
  8.3 Training Requirements
     
   

RFMH has obtained three licenses for the use of the web-based Collaborative IRB Training Initiative (CITI). These licenses cover 1) Nathan S. Kline Institute for Psychiatric Research;  2) New York State Psychiatric Institute;  3)  Institute for Basic Research in Developmental Disabilities and all other RFMH/DMH research other than NYSPI and NKI.

The CITI program was founded in March 2000 as a collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop a web-based training program in human research subjects protections.   The CITI Program includes the "Basic" courses in the Protection of Human Research Subjects for Biomedical as well as for Social / Behavioral Research, a “Good Clinical Practices” course, and "Refresher” courses for re-certification purposes.  (Note: CITI IACUC training is also available under our licenses.)
     
  8.3.1   A. Requirement for CITI Training Program
     
   

As initial training, all researchers, staff and others involved in the design and conduct of research involving human subjects, regardless of the source of funding, if any, (collectively “Key Personnel”), IRB administrative staff and IRB members must complete the modules of the applicable “Basic” course unless equivalent training, approved under section C below, has been successfully completed.
Each module takes approximately 15-20 minutes to complete. Therefore the training requirement will take up to 3 1/2 to 4 1/2 hours to complete.
A passing score of 90% or better is required to complete the course. Participants are expected to go back and repeat the quizzes if a low score is received on any particular module. If an answer is wrong, the correct answer is provided and participants can go back and re-take the quiz.

Institutional Officials (DMH Facility Directors at facilities where human subjects research is conducted and persons approving studies in this capacity for Central Office, Commissioner's Designee, RFMH Managing Director and Deputy Managing Director, and, if applicable, their designees) are required to complete the Institution Officials course. Note: An Institutional Official who is also a Key Personnel must complete the training requirements for Key Personnel.

Training is valid for three years. Prior to the expiration of the three year period Key Personnel must complete the continuing education requirements in D below.

       
  8.3.2   B. Applicability of Requirement
     
   

All persons involved in research involving human subjects must have completed acceptable training prior to participating in the design or conduct of the research. 

  • Acceptable alternate training completed within the past 12 months –  CITI training, as described in A above, not required;
  • No training within the past two years – CITI training, as described in A above, required before any involvement in human subjects research.
     
  8.3.3   C. Equivalent Training
     
   

Some facilities have arrangements with human subject training programs conducted by academic  affiliates and other external organizations.  If a facility believes that an external training program is sufficiently comprehensive to provide training equivalent to the CITI Program, it should prepare a description of the program and submit it to RFMH.
Completion of the NIH course entitled “Protecting Human Research Participants” (http://phrp.nihtraining.com) or other sufficiently comprehensive training may also be considered acceptable alternative training for certain individuals collaborating with OMH/OPWDD/RFMH investigators who are not affiliated with an institution having an IRB and who are involved in the design and conduct of no more than minimal risk components of human subject research.   Investigators should identify any such individuals in their IRB applications and explain the role of such individuals in the research study.   This exception is intended to apply to individuals with limited literacy, individuals not fluent in a language in which CITI training is available, or any other individuals for whom completion of the CITI program may be difficult.   Based on the justification submitted by the investigator in the IRB application, the applicable IRB shall determine whether the alternate training should be approved for specified individuals and record this decision on the PDF or other similar document. 
RFMH will consult with the DMH representative and appropriate requests to permit use of the external program or alternative training for certain individuals to replace the CITI Program will be approved. 

     
  8.3.4   D. Continuing Education and Additional Training
     
   

Continuing education is required for all Key Personnel, IRB administrative staff and IRB members, and Institutional Officials.  A  CITI “Refresher” course (3 Year Refresher or 6 Year Refresher)  must be completed  every three years.  A passing score of 90% or better is required to complete the course.  Participants are expected to go back and repeat the quizzes if a low score is received on any particular module.  

Depending on the nature of research conducted and the level of involvement of the individual, specialized training may also be appropriate. The CITI “Good Clinical Practices” course offers additional instruction. It is recommended that all persons who conduct or review clinical research also complete the GCP modules. Facilities and individuals are also encouraged to supplement the CITI training with participation in local and external training programs.
     
  8.4 Access to the CITI Program
    8.4.1     Frequently Asked Questions
    8.4.2     Procedures for Accessing CITI Training-Refresher Course
    8.4.3     Procedures for Accessing CITI Training-New Users
       
     


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