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Tag Archive: Informed Consent
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Improve informed consent. Today more than ever, those three words resonate as both mantra and mandate for institutions, sponsors, research ethics boards, and regulatory agencies alike.
Echoing closely behind those three words are three more: increase participant comprehension. Ensuring participants have appropriate knowledge of a study (as well as their rights and responsibilities within it) is a crucial goal of the informed consent process—and a too-often elusive one: Researchers say that participants do not consistently understand or sometimes even read information in the consent forms for the studies they are joining., 
[ad name=”cf-wp-6-approaches” align=”right”]Studies of the informed consent process have documented the challenge of assuring participant comprehension—and offered possible solutions. The following is an overview of six research-based approaches that can improve informed consent and support participants’ understanding of the studies they are asked to join.
1. Apply health literacy best practices to consent forms.
Many studies indicate that consent forms with simpler diction and better design meaningfully enhance participant comprehension, as compared with their more complex and less visually accessible counterparts.
Research indicates that discussions between prospective participants and research staff (or independent educators) are more effective than any other intervention in improving participant comprehension during the informed consent process.
Teach-back—asking prospective participants to discuss the study in their own words—may allow for gauging comprehension and identifying gaps in participants’ understanding.
Research suggests that low literacy can hamper understanding of a study—even when efforts are made to improve the consent document or process.
Studies on the use of these methods in non-research settings show that they can meaningfully enhance patients’ knowledge of standard-of-care procedures—and experts suggest that they may offer similar value in research contexts. Note also that at least one study has verified the ability of decision aids to improve prospective participants’ knowledge during informed consent for clinical research.
6. Trust and support research staff.
Ensure that research team members have the time, support, resources, and training they need to understand a given protocol as well as prepare for and conduct informed consent discussions.
Looking for more?
For more on this topic, including analysis and examples, download: Informed Consent: 6 Approaches to Increase Participant Comprehension
Quorum also offers custom consent form services to address the challenges of developing a compliant, accurate consent form before Board review, as well maintaining it as your study changes.
 Montalvo, W. & Larson, E. (2014). Participant Comprehension of Research for Which They Volunteer: A Systematic Review. Journal of Nursing Scholarship, 46(6), 423–431. doi: 10.1111/jnu.12097
 Larson, E., Foe, G., & Lally, R. (2015). Reading Level and Length of Written Research Consent Forms. Clinical and Translational Science, 8(4), 355–356. doi: 10.1111/cts.12253
 Nishimura, A., Carey, J., Erwin J., Tilburt, J., Murad, M., & McCormick, J. (2013). Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Medical Ethics, 14(28). doi:10.1186/1472-6939-14-28
 Flory, J., & Emanuel, E. (2004). Interventions to Improve Research Participants’ Understanding in Informed Consent for Research: A Systematic Review. JAMA: Journal of the American Medical Association, 292(13), 1593–1601.
 Nishimura, A. et al. (2013).
 Montalvo, W. et al. (2014).
 Cordasco, K. (2013). Chapter 39, Obtaining Informed Consent From Patients: Brief Update Review. Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices. Evidence Reports/Technology Assessments, No. 211. Agency for Healthcare Research and Quality. Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK133402/
 Aldoory, L., Emperatriz, K., & Rouhani, A.M. (2014). Best Practices and New Models of Health Literacy for Informed Consent: Review of the Impact of Informed Consent Regulations on Health Literate Communication: Commissioned Paper for the Institute of Medicine. Retrieved from http://iom.nationalacademies.org/Activities/PublicHealth/HealthLiteracy/~/media/Files/Activity%20Files/PublicHealth/HealthLiteracy/Commissioned-Papers/Informed_Consent_HealthLit.pdf
 Kripalani, S., Bengtzen, R., Henderson, L.E. & Jacobson, T.A. (2008). Clinical research in low-literacy populations: Using teach-back to assess comprehension of informed consent and privacy information. IRB: Ethics and Human Research (30)2, 13–19.
 Montalvo, W. et al. (2014).
 Flory, J. et al. (2004).
 Nishimura, A. et al. (2013).
 Stacey, D., Légaré, F., Col, N.F., Bennett, C.L., Barry, M.J., Eden, K.B., Holmes-Rovner M., Llewellyn-Thomas, H., Lyddiatt, A., Thomson, R., Trevena, L., Wu, J.H. (2014). Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 28:1:CD001431. doi: 10.1002/14651858.CD001431.pub4
 Cordasco, K. (2013).
 Juraskova I., Butow, P., Bonner, C., Bell, M.L., Smith, A.B., Seccombe, M., Boyle, F., Reaby L., Cuzick J., & Forbes J.F. (2014). Improving decision making about clinical trial participation – a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial. British Journal of Cancer, 111(1), 1–7. doi: 10.1038/bjc.2014.144
 The conclusions in this section are influenced by the following report: Center for Information and Study on Clinical Research Participation (CISCRP). (2014). Research Participant Concerns — Factors That Most Inform and Educate Clinical Research Participants: Findings from CISCRP Focus Groups with study volunteers. Retrieved from https://www.ciscrp.org/wp-content/uploads/2014/03/ciscrp_research_participant_concerns.pdf
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