PMID- 16619861
OWN - NLM
STAT- MEDLINE
DCOM- 20060516
LR  - 20211020
IS  - 0017-8594 (Print)
IS  - 0017-8594 (Linking)
VI  - 65
IP  - 2
DP  - 2006 Feb
TI  - The research subject advocate at the University of Hawai'i Clinical Research 
      Center: an added resource for protection of human subjects.
PG  - 50-2
AB  - In early 2001 the National Institutes of Health (NIH) created the Research 
      Subject Advocate (RSA) position as an additional resource for human subjects 
      protection at NIH-funded Clinical Research Centers (CRCs) to enhance the 
      protection of human subjects participating in clinical research studies. The 
      purpose of this article is to describe the RSA position in the context of 
      clinical research, with a particular emphasis upon the role of the RSA in one of 
      the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) 
      program. Through participation in protocol development, informed consent 
      procedures, study implementation and follow-up with adverse events, the RSA works 
      closely with research investigators and their staff to protect study 
      participants. The RSA also conducts workshops, training and education sessions, 
      and consultation with investigators to foster enhanced communication and 
      adherence to ethical standards and safety regulations. Although it is too early 
      to provide substantive evidence of positive outcomes, this article seeks to 
      illuminate the value of the RSA position in ensuring that safety of research 
      participants is accorded the highest priority at CRCs. Based upon initial 
      results, we conclude that the RSA is an effective mechanism for achieving the 
      NIH's goal of maintaining the utmost scrutiny of protocols involving human 
      subjects.
FAU - Easa, David
AU  - Easa D
AD  - University of Hawaii, John A. Burns School of Medicine, Honolulu, HI 96821, USA. 
      david@kapiolani.org
FAU - Kim, Kari
AU  - Kim K
FAU - Kato, Kambrie
AU  - Kato K
FAU - Ho, Tammy
AU  - Ho T
FAU - Balaraman, Venkataraman
AU  - Balaraman V
FAU - Medina, Louise
AU  - Medina L
FAU - Hammatt, Zoe
AU  - Hammatt Z
FAU - Shomaker, T Samuel
AU  - Shomaker TS
LA  - eng
GR  - P20 RR011091/RR/NCRR NIH HHS/United States
GR  - P20RR11091/RR/NCRR NIH HHS/United States
GR  - U54 RR014607-078071/RR/NCRR NIH HHS/United States
GR  - P20 RR011091-09/RR/NCRR NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Hawaii Med J
JT  - Hawaii medical journal
JID - 2984209R
SB  - IM
MH  - *Academic Medical Centers
MH  - Hawaii
MH  - *Human Experimentation
MH  - Humans
MH  - *Patient Advocacy
MH  - Safety Management
PMC - PMC1470972
MID - NIHMS10011
EDAT- 2006/04/20 09:00
MHDA- 2006/05/17 09:00
PMCR- 2008/01/27
CRDT- 2006/04/20 09:00
PHST- 2006/04/20 09:00 [pubmed]
PHST- 2006/05/17 09:00 [medline]
PHST- 2006/04/20 09:00 [entrez]
PHST- 2008/01/27 00:00 [pmc-release]
PST - ppublish
SO  - Hawaii Med J. 2006 Feb;65(2):50-2.