CSULB Reporting Format -- Instructions (Rev. 1/10/01)
For proposals from CSU Long Beach to any agency of the U.S. Department of Health and Human Services (DHHS), including all agencies of the U.S. Public Health Service, i.e., NIH, CDC, HRSA, etc., the one page document, below, will be sent to the funding agency upon notification that a grant application will be funded.
- First, open a email document to to research@csulb.edu.
- Second, highlight the text of the Documentation of Certified Education in the Protection of Human Subjects (on white background), C opy it, and then P aste it into the email.
- Third, replace the italicized parts, i.e., the title of the research project and the names of the key researchers on this project who have completed the Orientation to Human Subjects Training Module. (See Roster for names of those who have completed the Human Subjects Module.)
- Send the email.
The Director of Research will print out the text onto Office of Research letterhead, sign it, and return the original to the requesting faculty for their signature and delivery to the funding agency.
Documentation of Certified Education in the Protection of Human Subjects
The key personnel in the design and conduct of the proposed research entitled: Full Title of Project
are: Name of PI and names of other key research personnel whose activities contribute to the design and conduct of the research, all of whom have completed the Human Subjects Module and submitted their final examination.
Each of the above named persons has completed the Human Subjects Module of the CSU Long Beach Responsible Conduct of Research Education Program.
The CSU Long Beach Human Subjects module is available for review at: http://www.ur.csulb.edu/rcr.htm. Click on "Human Subjects."
The module contains sections on (1) the Ethics of Using Human Subjects, (2) Informed Consent, (3) Risk-Benefit Analysis, and (4) the Functioning of the IRB. Certification is established by graded final examination on the subject matter.
Signatures and Date Signed:
_____________________________________
Principle Investigator
_____________________________________
Director, Office of University Research:
James R. Brett, Ph.D.
562-985-5314 research@csulb.edu
REFERENCE:
NIH Clarification on Required Education in the Protection of Human Research Participants
September 14, 2000: (http://grants.nih.gov/grants/news.htm)
This is to clarify the June 5, 2000 NIH Guide announcement on Required Education in the Protection of Human Research
Participants. The NIH has received a large number of inquires regarding the recent announcement requiring investigators to document their education in the protection of human subjects. This notice is intended to clarify two issues: (1) what constitutes documentation and (2) when documentation should be submitted to the NIH.
With respect to the type of documentation, the NIH requires a letter that includes the names of the key personnel who are responsible for the design and conduct of the study; the title of the education program completed by each named personnel plus a one sentence description of the program. This letter must be signed by the principal investigator and co-signed by an institution official.
The timing of submission of documentation is in keeping with just-in-time procedures. Thus, the NIH will request this letter documenting education before an award is issued. |
