The Role of Community Advisory Boards: Involving Communities in the Informed Consent Process

Overview

Journal Am J Public Health

Specialty Public Health

Date 2001 Dec 1

PMID 11726369

Citations 89

Authors

R P Strauss

S Sengupta

S C Quinn

J Goeppinger

C Spaulding

S M Kegeles

G MILLETT

Affiliations

Soon will be listed here.

Abstract

Ethical research involving human subjects mandates that individual informed consent be obtained from research participants or from surrogates when participants are not able to consent for themselves. The existing requirements for informed consent assume that all study participants have personal autonomy; fully comprehend the purpose, risks, and benefits of the research; and volunteer for projects that disclose all relevant information. Yet contemporary examples of lapses in the individual informed consent process have been reported. The authors propose the use of community advisory boards, which can facilitate research by providing advice about the informed consent process and the design and implementation of research protocols. These activities could help reduce the number of individual informed consent lapses, benefiting study participants and the scientific integrity of the research in question.

Citing Articles

Considerations for using participatory systems modeling as a tool for implementation mapping in chronic disease prevention.

Moore T, Hennessy E, Chusan Y, Ashcraft L, Economos C Ann Epidemiol. 2024; 101():42-51.

PMID: 39681242 PMC: 11728936. DOI: 10.1016/j.annepidem.2024.12.002.

CASCADE: A Community-Engaged Action Model for Generating Rapid, Patient-Engaged Decisions in Clinical Research.

Kelleher B Res Sq. 2024; .

PMID: 39257986 PMC: 11384825. DOI: 10.21203/rs.3.rs-4790564/v1.

Building the African American/Black Community's Capacity to Elucidate Factors for High Smoking Rates in Jackson, MS: Results from Implementing a Community-Led Needs Assessment.

Leung E, Yazdi H, Drayton M, Davis D, Middleton D, Senter L J Racial Ethn Health Disparities. 2024; .

PMID: 38969927 DOI: 10.1007/s40615-024-02066-1.

REPRESENTATION AND EXTRAPOLATION: EVIDENCE FROM CLINICAL TRIALS.

Alsan M, Durvasula M, Gupta H, Schwartzstein J, Williams H Q J Econ. 2024; 139(1):575-635.

PMID: 38859982 PMC: 11164133. DOI: 10.1093/qje/qjad036.

A rapid qualitative methods assessment and reporting tool for epidemic response as the outcome of a rapid review and expert consultation.

Dong D, Abramowitz S, Matta G, Moreno A, Nouvet E, Stolow J PLOS Glob Public Health. 2023; 3(10):e0002320.

PMID: 37889886 PMC: 10610454. DOI: 10.1371/journal.pgph.0002320.

References

Connor E, Sperling R, Gelber R, Kiselev P, Scott G, OSullivan M . Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994; 331(18):1173-80. DOI: 10.1056/NEJM199411033311801. View

Lurie P, Wolfe S . Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med. 1997; 337(12):853-6. DOI: 10.1056/NEJM199709183371212. View

Thompson D . Real knife, fake surgery. Time. 2001; 153(7):66. View

Barry M . Ethical considerations of human investigation in developing countries: the AIDS dilemma. N Engl J Med. 1988; 319(16):1083-6. DOI: 10.1056/NEJM198810203191609. View

Thomas J . Placebo surgery. Mo Med. 1999; 96(2):41. View

Macklin R . The ethical problems with sham surgery in clinical research. N Engl J Med. 1999; 341(13):992-6. DOI: 10.1056/NEJM199909233411312. View

McKeon V . The Breast Cancer Prevention Trial: evaluating tamoxifen's efficacy in preventing breast cancer. J Obstet Gynecol Neonatal Nurs. 1997; 26(1):79-90. DOI: 10.1111/j.1552-6909.1997.tb01510.x. View

French H . AIDS research in Africa: juggling risks and hopes. N Y Times Web. 2001; :A1, A14. View

Msellati P, Ramon R, Viho I, Noba V, Mandelbrot L, Dabis F . Prevention of mother-to-child transmission of HIV in Africa: uptake of pregnant women in a clinical trial in Abidjan, Côte d'Ivoire. AIDS. 1998; 12(10):1257-8. DOI: 10.1097/00002030-199810000-00026. View

10.

Israel B, Checkoway B, Schulz A, Zimmerman M . Health education and community empowerment: conceptualizing and measuring perceptions of individual, organizational, and community control. Health Educ Q. 1994; 21(2):149-70. DOI: 10.1177/109019819402100203. View

11.

Cox L, Rouff J, Svendsen K, Markowitz M, Abrams D . Community advisory boards: their role in AIDS clinical trials. Terry Beirn Community Programs for Clinical Research on AIDS. Health Soc Work. 1998; 23(4):290-7. DOI: 10.1093/hsw/23.4.290. View

12.

Melton G, LEVINE R, Koocher G, Rosenthal R, Thompson W . Community consultation in socially sensitive research. Lessons from clinical trials of treatments for AIDS. Am Psychol. 1988; 43(7):573-81. DOI: 10.1037//0003-066x.43.7.573. View

13.

Markowitz L, Bernier R . Immunization of young infants with Edmonston-Zagreb measles vaccine. Pediatr Infect Dis J. 1987; 6(9):809-12. DOI: 10.1097/00006454-198709000-00001. View

14.

Deschamps M, Johnson Jr W, Pape J . Feasibility and cohort development for HIV vaccine trials in Haiti. AIDS Res Hum Retroviruses. 1994; 10 Suppl 2:S231-3. View

15.

Whalen C, Johnson J, Okwera A, Hom D, HUEBNER R, Mugyenyi P . A trial of three regimens to prevent tuberculosis in Ugandan adults infected with the human immunodeficiency virus. Uganda-Case Western Reserve University Research Collaboration. N Engl J Med. 1997; 337(12):801-8. DOI: 10.1056/NEJM199709183371201. View

16.

Snowdon C, Garcia J, Elbourne D . Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med. 1997; 45(9):1337-55. DOI: 10.1016/s0277-9536(97)00063-4. View

17.

Leach A, Hilton S, Greenwood B, Manneh E, Dibba B, Wilkins A . An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in The Gambia, West Africa. Soc Sci Med. 1999; 48(2):139-48. DOI: 10.1016/s0277-9536(98)00317-7. View

18.

Edgar H, Rothman D . The institutional review board and beyond: future challenges to the ethics of human experimentation. Milbank Q. 1995; 73(4):489-506. View

19.

Abdool Karim Q, Abdool Karim S, Coovadia H, Susser M . Informed consent for HIV testing in a South African hospital: is it truly informed and truly voluntary?. Am J Public Health. 1998; 88(4):637-40. PMC: 1508450. DOI: 10.2105/ajph.88.4.637. View

20.

Preziosi M, Yam A, Ndiaye M, Simaga A, Simondon F, Wassilak S . Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. N Engl J Med. 1997; 336(5):370-3. DOI: 10.1056/NEJM199701303360511. View