UTHSCH policy (HOOP 23.11 Research Training) requires that all investigators participating in research involving human research subjects, human derived materials, or human derived data complete approved training on the protection of human research subjects regardless of the funding source for the research. For the purposes of this policy, investigators include: principal investigators; laboratory personnel working with human-derived data or samples and/or contributing to study design; study coordinators; study nurses; subcontractors/consortium arrangement recipients; and consultants. It does not apply to research involving de-identified human materials or de-identified human derived data.

Certificates must be submitted for all personnel involved in the research protocol and covered by the policy. The educational requirement may be met by completing one of several courses identified below, and certificates of completion must be on record PRIOR to protocol submission for review by the Committee for Protection of Human Subjects (CPHS). Certificates should be sent to the CPHS office (fax # 713-500-7951) so that the human subjects training database may remain accurate and current. OSP has access to this database but certificates should be sent to the CPHS office.

NIH Required Education

Approved courses to satisfy the UTHSCH requirement for education on the protection of human subjects include the following options:

• Attending a course given by CPHS staff**; OR
• Attending an IRB 101** course given at Baylor College of Medicine, UT MD Anderson Cancer Center, or UTHSCH; OR
• Completing an online course offered by:
  • University of California (www.training.arc.ucla.edu)
  • National Institutes of Health (NIH)
  • Office for Human Research Protections (OHRP) (http://www.research.umn.edu/irb/training/)
  • CITI - (Course in The Protection of Human Research Subjects)
    ( https://www.citiprogram.org/default.asp )

**Please note that IRB 101 courses and courses taught by CPHS staff are not currently provided on a routine basis. If you are not currently certified, we recommend taking one of the above mentioned on-line courses. These on-line courses are provided to you free of charge and require approximately two hours to complete.

Re-certification is also required every two to three years (certificates from an IRB 101 class expire after 3 years while all other courses expire after two years). This may be through one of the above listed courses or through another continuing education class, although any course not listed above MUST be approved by the CPHS office.

Once the certificate is submitted, you will receive a reminder via e-mail approximately one month prior to its expiration date. For questions regarding the educational requirement, please call the CPHS office at 713-500-7942.

NIH non-competing applications must include a letter that verifies the training has been completed. The letter should be prepared/signed by the principal investigator and forwarded to OSP for signature. The letter should include: the names of the key individuals responsible for the design and conduct of the research; the title of the educational program completed by each individual identified in the letter; and a one sentence description of the educational program(s). Key personnel from other institutions are required to submit a letter to OSP that has been co-signed by one of their institutional officials and includes the required elements.