Participant Outreach

VI.03

 

 

Participant Outreach

 

 

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Objective

It is the policy of The University of Texas Health Science Center at Houston (UTHSC-H) Committee for the Protection of Human Subjects (CPHS) to provide information to the community regarding the rights of a research participant as a volunteer as outlined in this Policy/Procedure.

 

Policy/Procedure

I.        The CPHS contact information will be included in each informed consent form following a statement about whom the participant may contact regarding questions or for additional information concerning his/her rights as a research participant.

 

II.     The CPHS will receive all concerns and complaints from participants or others confidentially.

 

III.   A research intermediary, who is unaffiliated with the specific research protocol, shall be available to provide a safe, confidential, and reliable channel for current, prospective, or past research participants or their designated representatives that permits them to discuss problems, concerns, and questions; and obtain information.

 

 

Applicable Regulations and Guidelines

21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html )

21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html )

38CFR 16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html )

45CFR 46 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html )

ICH E6 ( http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB )

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Updated 5/2007, Report broken links