This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Topic Collections  • Medical Practice  • Medical Ethics  • Statistics and Research Methods  • Genetics  • Genetics, Other  • Alert me on articles by topic  Social Bookmarking   What's this?

Rita McWilliams, MPH; Julie Hoover-Fong, MD; Ada Hamosh, MD, MPH; Suzanne Beck, MD; Terri Beaty, PhD; Garry Cutting, MD

JAMA. 2003;290:360-366.

Context  Sequencing of the human genome provides an immense resource for studies correlating DNA variation and epidemiology. However, appropriately powered genetic epidemiology studies often require recruitment from multiple sites.

Objectives  To document the burden imposed by review of multicenter studies and to determine the variability among local institutional review boards (IRBs) in the approval of a multicenter genetic epidemiology study.

Design  A PubMed search was performed to determine the frequency of citations of multicenter studies by 5-year intervals from 1974 through 2002. A 7-question survey was sent to all participating study centers to obtain information on frequency of IRB meetings, dates for submission and approval, use/nonuse of a specific consent form, type of review performed, types of consent forms required, preparation time, and number of changes requested by the IRB at each center. Centers also provided a copy of all consent forms they generated and IRB correspondence regarding the study.

Setting and Participants  Thirty-one of 42 cystic fibrosis care centers in this single US multicenter genetic epidemiology study of cystic fibrosis replied, yielding a 74% response rate.

Main Outcome Measures  Frequency of published research studies and consistency among IRBs.

Results  The number of all published single-center studies has increased 1.3-fold since 1985, while the number of published epidemiology and genetic epidemiology multicenter studies increased by 8- and 9-fold, respectively, during this same period. Evaluation of the risk of the same genetic epidemiology study by 31 IRBs ranged from minimal to high, resulting in 7 expedited reviews (23%) and 24 full reviews (77%). The number of consents required by the IRBs ranged from 1 to 4; 15 IRBs (48%) required 2 or more consents, while 10 (32%) did not require assent for children. The most common concern (52%) of IRBs pertained to the genetic aspects of the study.

Conclusions  Review of a protocol for a multicenter genetic epidemiology study by local IRBs was highly variable. Lack of uniformity in the review process creates uneven human subjects protection and incurs considerable inefficiency. The need for reform, such as the proposed centralized review, is underscored by the ever increasing rate of genetic discoveries facilitated by the Human Genome Project and the unprecedented opportunity to assess the relevance of genetic variation to public health.

Author Affiliations: Bloomberg School of Public Health (Ms McWilliams and Dr Beaty) and McKusick-Nathans Institute of Genetic Medicine (Drs Hoover-Fong, Hamosh, and Cutting), Johns Hopkins Medical Institutions, Baltimore, Md; Department of Pediatrics, Drexel University College of Medicine, and St Christopher's Hospital for Children, Philadelphia, Pa (Dr Beck).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Considerations for ethics in multisite research in paediatric palliative care
Cadell et al.
Palliat Med 2009;23:274-275.
 

Researchers' preferences and attitudes on ethical aspects of genomics research: a comparative study between the USA and Spain
Ruiz-Canela et al.
J. Med. Ethics 2009;35:251-257.
ABSTRACT | FULL TEXT  

Research Risk for Persons With Psychiatric Disorders: A Decisional Framework to Meet the Ethical Challenge
Yanos et al.
Psychiatr. Serv. 2009;60:374-383.
ABSTRACT | FULL TEXT  

Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges?
Nyika et al.
J. Med. Ethics 2009;35:189-193.
ABSTRACT | FULL TEXT  

Access to medical records for research purposes: varying perceptions across research ethics boards
Willison et al.
J. Med. Ethics 2008;34:308-314.
ABSTRACT | FULL TEXT  

Ontario Cancer Research Ethics Board: Lessons Learned From Developing a Multicenter Regional Institutional Review Board
Saginur et al.
JCO 2008;26:1479-1482.
ABSTRACT | FULL TEXT  

A Self-scaling, Distributed Information Architecture for Public Health, Research, and Clinical Care
McMurry et al.
J. Am. Med. Inform. Assoc. 2007;14:527-533.
ABSTRACT | FULL TEXT  

Institutional Review Board Review of Multicenter Studies
Sobolski et al.
ANN INTERN MED 2007;146:759-759.
FULL TEXT  

The IRB Challenge for Practice-based Research: Strategies of the American Academy of Family Physicians National Research Network (AAFP NRN)
Graham et al.
J Am Board Fam Med 2007;20:181-187.
ABSTRACT | FULL TEXT  

Institutional Review Board Approval: Why It Matters
Parvizi et al.
JBJS 2007;89:418-426.
ABSTRACT | FULL TEXT  

Payments to Children and Adolescents Enrolled in Research: A Pilot Study
Iltis et al.
Pediatrics 2006;118:1546-1552.
ABSTRACT | FULL TEXT  

Variation in Standards of Research Compensation and Child Assent Practices: A Comparison of 69 Institutional Review Board-Approved Informed Permission and Assent Forms for 3 Multicenter Pediatric Clinical Trials
Kimberly et al.
Pediatrics 2006;117:1706-1711.
ABSTRACT | FULL TEXT  

Vulnerable Research Participants: Anyone May Qualify
Jacobson
Nurs Sci Q 2005;18:359-363.
ABSTRACT  

Human Subjects Issues and IRB Review in Practice-Based Research
Wolf et al.
Ann Fam Med 2005;3:S30-S37.
ABSTRACT | FULL TEXT  

Practice-Based Research Network Studies in the Age of HIPAA
Pace et al.
Ann Fam Med 2005;3:S38-S45.
ABSTRACT | FULL TEXT  

Informed Consent and Biobanks
Clayton
J Law Med Ethics 2005;33:15-21.
 

Ethics, audit, and research: all shades of grey
Wade
BMJ 2005;330:468-471.
FULL TEXT  

Registries and Informed Consent
Clark et al.
NEJM 2004;351:612-614.
FULL TEXT  

Ethics review procedures for research in developing countries: a basic presumption of guilt
Gilman and Garcia
CMAJ 2004;171:248-249.
FULL TEXT  

Improving the Decision Processes of Institutional Review Boards
Wagner
JAMA 2004;291:1698-1698.
FULL TEXT  

Ethical aspects of molecular epidemiology of cancer
Vahakangas
Carcinogenesis 2004;25:465-471.
ABSTRACT | FULL TEXT  

Applying the Common Rule to Public Health Agencies: Questions and Tentative Answers About a Separate Regulatory Regime
Burris et al.
J Law Med Ethics 2003;31:638-653.
 

The Role of State Law in Protecting Human Subjects of Public Health Research and Practice
Burris et al.
J Law Med Ethics 2003;31:654-662.
 

Local vs Central Institutional Review Boards for Multicenter Studies
Rose
JAMA 2003;290:2126-2126.
FULL TEXT