PMID- 16315389
OWN - NLM
STAT- MEDLINE
DCOM- 20060126
LR  - 20181113
IS  - 1049-510X (Print)
IS  - 1049-510X (Linking)
VI  - 15
IP  - 4 Suppl 5
DP  - 2005 Autumn
TI  - The research subject advocate at minority Clinical Research Centers: an added 
      resource for protection of human subjects.
PG  - S5-107-10
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 participants in clinical research studies. We describe the 
      RSA position in the context of clinical research, with a particular emphasis on 
      the role of the RSA in two 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 
      we cannot yet provide substantive evidence of positive outcomes, this article 
      illuminates the value of the RSA position in ensuring that safety of research 
      participants is accorded the highest priority at CRCs. On the basis of initial 
      results, we conclude that the RSA is an effective mechanism for achieving the NIH 
      goal of maintaining the utmost scrutiny of protocols involving human subjects.
FAU - Easa, David
AU  - Easa D
AD  - John A Burns School of Medicine, University of Hawai'i at Manoa, USA. 
      davide@kapiolani.org
FAU - Norris, Keith
AU  - Norris K
FAU - Hammatt, Zoe
AU  - Hammatt Z
FAU - Kim, Kari
AU  - Kim K
FAU - Hernandez, Esther
AU  - Hernandez E
FAU - Kato, Kambrie
AU  - Kato K
FAU - Balaraman, Venkataraman
AU  - Balaraman V
FAU - Ho, Tammy
AU  - Ho T
FAU - Shomaker, Samuel
AU  - Shomaker S
LA  - eng
GR  - P20 RR11145/RR/NCRR NIH HHS/United States
GR  - P20 RR011091/RR/NCRR NIH HHS/United States
GR  - P20 RR011091-11/RR/NCRR NIH HHS/United States
GR  - P20 RR011145/RR/NCRR NIH HHS/United States
GR  - P20 RR011145-09/RR/NCRR NIH HHS/United States
GR  - P20 RR11091/RR/NCRR NIH HHS/United States
GR  - U54 RR014607-05/RR/NCRR NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - Ethn Dis
JT  - Ethnicity & disease
JID - 9109034
SB  - IM
MH  - *Biomedical Research
MH  - *Human Experimentation
MH  - Humans
MH  - Minority Groups
MH  - National Institutes of Health (U.S.)
MH  - *Patient Advocacy
MH  - United States
PMC - PMC1364475
MID - NIHMS7771
EDAT- 2005/12/01 09:00
MHDA- 2006/01/27 09:00
PMCR- 2008/01/25
CRDT- 2005/12/01 09:00
PHST- 2005/12/01 09:00 [pubmed]
PHST- 2006/01/27 09:00 [medline]
PHST- 2005/12/01 09:00 [entrez]
PHST- 2008/01/25 00:00 [pmc-release]
PST - ppublish
SO  - Ethn Dis. 2005 Autumn;15(4 Suppl 5):S5-107-10.