Good Afternoon!

This query is directed primarily to RESADM-L'ers involved in the IRB.

Our institutional policy on research using human subjects is being
revised.  We are struggling to fine tune our requirements for initial
training and continuing training in the protection of human subjects.
I would appreciate your feedback on your policies for the education
requirements.  Specifically:

1.  The NIH notice defined Key Personnel as "all individuals responsible
for the design and conduct of the study."  How to you define individuals
who "conduct" the study?  Are "key personnel" any individuals who
interact with human subjects in any way?

2.  What are your requirements for continuing education in the
protection of human subjects?  The FAQ with the NIH notice states: "The
NIH policy is silent on the frequency of education. The intent of the
education requirement is for investigators to keep abreast of
development in human subject protection. We believe that investigators
are in the best position to make the determination of when they need
additional education."  Did your institution implement a policy on
continuing education?  If so, (1) how often do investigators need to
show they have completed additional education and (2) who is required to
complete continuing education (investigators, students, data
collectors)?

3.  What is your policy on the education and continuing education of
students conducting research using human subjects?  Specifically,
master's and Ph.D. candidates conducting thesis research.

4.  What is your policy on the education and continuing education of
staff assisting with the conduct of research using human subjects?

Your feedback will be greatly appreciated!

Ruth Tallman
Office of Research and Sponsored Programs
Lehigh University
526 Brodhead Avenue
Bethlehem, PA  18015
Phone:   (610)758-3024
FAX:    (610)758-5994
E-mail:   xxxxxx@lehigh.edu

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