Most human subjects research studies require informed consent. Frequently consent is documented using an informed consent form. It is important for the researchers to understand that informed consent is the process that is documented on the form and simply signing a form does not constitute informed consent. The consent process begins in the first interaction with participants and does not end until an individual’s participation in a study concludes.
Participants have a right to know the purpose of the research, the activities involved, duration, incentives (if any), risks and benefits. While the informed consent form provides some of this information, it is not the only source of information for participants. This information should be found within the following study documents: protocol or description of the study, informed consent, and recruitment materials. The following questions should be considered in the design of your study.
- How will you explain the purpose of the study to participants? The information should be presented in a clear and accurate manner at a level appropriate for the participants.
- Why should they participate in your project? How will participation benefit them directly? Will participation benefit others?
- Will the proposed research place anyone at risk? (psychological, legal, political, becoming ostracized by others)?
- Under what conditions can confidentiality be fully honored? (In some cases it may be necessary to violate the confidentiality of participants. For example, if they report harm to themselves or others, you maybe mandated to report this).
- What kind of informed consent, if any, is necessary? (While most research will require an informed consent, there are a few exceptions)
- What is the informed consent process you will use?
- Who will have access to the data?
- For what purposes will they have access to the data?
- How long will you keep the data and how will it be destroyed?
- Are there any special considerations regarding interaction with the participants? (For some populations that are vulnerable, have cultural differences or traditions, specific environmental conditions, additional consideration may be needed to ensure respect.) .
- Are the participants fluent in English (or the language of the study materials)? If not, how will the material be translated into the language of the participants?
For principal investigators and researchers conducting ethical research is a complex endeavor beginning with the design of a study through data collection and finally data analysis. Informed consent is a process and the steps involved differ based on the individual population. Below you will find information on articles and other resources related to recruitment, informed consent and data collection with a variety of populations.
Diverse Perceptions of the Informed Consent Process: Implications for the Recruitment and Participation of Diverse Communities in the National Children’s Study
Kimberley D. Lakes, Elaine Vaughan, Marissa Jones, Wylie Burke, Dean Baker, James M. Swanson
Am J Community Psychol (2012) 49:215–232
Informed Consent Issues in Traumatic Brain Injury Research: Current Status of Capacity Assessment and Recommendations for Safeguards
Doug Johnson-Greene, PhD, MPH, ABPP
Journal of Head Trauma Rehabilitation:
March/April 2010 – Volume 25 – Issue 2 – p 145–150
Ethics of Research without Informed Consent
John Jesus, Shamai A. Grossman, Arthur R. Derse, James G. Adams, Richard Wolfe, Peter Rosen, Dave W. Lu, Jonathan Burstein, John Jesus
Ethical Problems in Emergency Medicine: A Discussion-Based Review
Published Online: 20 JUN 2012
The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries
Amulya Mandava, Christine Pace, Benjamin Campbell, Ezekiel Emanuel, Christine Grady
J Med Ethics
EMS Providers and Exception from Informed Consent Research: Benefits, Ethics, and Community Consultation
Elizabeth Ripley, Cornelia Ramsey, Amy Prorock-Ernest, Rebecca Foco, Solomon Luckett, Jr., Joseph P. Ornato
Prehospital Emergency Care
Informed Consent and Placebo Effects: A Content Analysis of Information Leaflets to Identify What Clinical Trial Participants are Told about Placebos
Felicity L. Bishop, Alison E.M. Adams, Ted J. Kaptchuk, George T. Lewith
Recruitment and consent of women with intellectual disabilities in a randomised control trial of a health promotion intervention.
Swaine, J.; Parish, S. L.; Luken, K.; Atkins, L.;
Journal of Intellectual Disability Research, 2011 May; 55 (5): 474-83
ISSN: 0964-2633 PMID: 21385259
The capacity to give informed consent in a homeless population with developmental disabilities.
Morton LG II; Cunningham-Williams RM;
Community Mental Health Journal, 2009 Oct; 45 (5): 341-8
ISSN: 0010-3853 PMID: 19263221
Informed consent in Mexican American family cancer caregivers: strategies to promote diverse community research.
Wells HN, Cagle CS;
Southern Online Journal of Nursing Research, January 1, 2010, Vol. 10, Issue 1
Use of a Modified Informed Consent Process among Vulnerable Patients: A Descriptive Study
Sudeore, R; Landefeld, C; Williams, B; Barnes, D; Lindquist, K; Schillinger, D;
Journal of General Internal Medicine, 2006 Aug; 21(8): 867-873