Concise Consent Forms Appreciated—Still Not Comprehended: Applying Revised Common Rule Guidelines in Online Studies

2019 ◽  
Vol 14 (4) ◽  
pp. 299-306 ◽  
Author(s):  
Evan K. Perrault ◽  
Seth P. McCullock
Keyword(s):  
Informed Consent ◽  
Institutional Review Board ◽  
Consent Process ◽  
Future Research ◽  
Approval Process ◽  
Common Rule ◽  
Consent Forms ◽  
Online Study ◽  
Additional Information ◽  
Institutional Review

As informed consent documents have historically gotten lengthier, recent revisions to federal Common Rule guidelines now require consent forms that are “concise” and presented in ways that “facilitate comprehension.” The current research sought to apply these guidelines by developing a consent process for an online study that was only 71 words and also allowed participants a choice to either continue directly to the study or learn more about the study to which they were consenting. All participants (100%, N = 429) decided to continue directly to the study, choosing to forgo additional information about the study and the institutional review board (IRB) approval process. Participants indicated they liked this streamlined consent process, even though on average they only comprehended about half of the information this streamlined process contained. A plurality of participants indicated they would like to see this style of streamlined consent continued in future online studies. However, if we want to continue referring to informed consent as informed, future research should be welcomed and supported by IRBs to seek ways to apply the newest Common Rule guidelines while increasing comprehension; otherwise, informed consent will likely always remain an oxymoron.

scholarly journals Improving readability of informed consents for research at an academic medical institution

2017 ◽  
Vol 1 (6) ◽  
pp. 361-365 ◽  
Author(s):  
Kristie B. Hadden ◽  
Latrina Y. Prince ◽  
Tina D. Moore ◽  
Laura P. James ◽  
Jennifer R. Holland ◽  
...  
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Plain Language ◽  
Post Intervention ◽  
Consent Forms ◽  
Institutional Review ◽  
Final Rule ◽  
The Mean ◽  
Protection Of Human Subjects

IntroductionThe final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.MethodsReadability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.ResultsThe mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.ConclusionsProviding investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

Ethics and Regulation in Organ Procurement Research

2002 ◽  
Vol 12 (4) ◽  
pp. 257-265 ◽  
Author(s):  
Terrence F. Ackerman ◽  
Rebecca P. Winsett
Keyword(s):  
Informed Consent ◽  
Organ Procurement ◽  
Institutional Review Board ◽  
Future Research ◽  
Ethical Practice ◽  
Human Research ◽  
Research Activities ◽  
Institutional Review ◽  
Waiver Of Consent

This article explores the role of ethics and regulation in human research conducted by organ procurement agencies; basic ethical principles for human research are outlined. Organ procurement agencies are not required to observe federal regulations; however, voluntary adherence will ensure that procurement research is conducted according to current standards of ethical practice. Although most organ procurement research will qualify for exempt status, this determination should be made by an institutional review board. Even if studies qualify for exempt status, there is a moral presumption that informed consent should be sought, unless certain narrow conditions for waiver of consent are satisfied. Finally, when future research utilizing organ procurement records is anticipated, procurement coordinators should provide sufficiently detailed information to families about such plans to permit their advance informed consent to research activities.

CONSENT: IN RESEARCH AND IN DAILY PRACTICE

PEDIATRICS ◽  
1989 ◽  
Vol 84 (5) ◽  
pp. A68-A68
Author(s):  
Student
Keyword(s):  
Informed Consent ◽  
Clinical Medicine ◽  
Daily Practice ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Utilization Review ◽  
Human Research ◽  
Consent Forms ◽  
Institutional Review ◽  
Board System

It is arguably the case that informed consent requirements have affected human research more deeply than they have the practice of clinical medicine, and that this is so at least in part because informed consent in research has been mandated and monitored by federal controls and regulations that link funding for research to consent procedures. However, it is doubtful that. . . adding review of consent forms to the tasks of utilization review committees would have the same level of impact on clinical medicine as the institutional review board system has had on human research. Institutional review boards are a system of prior, rather than after-the-fact, review they are concerned solely with questions of research ethics; and they are in a position to address questions of voluntariness and competency in a way utilization committees could not.

Readability of Informed Consent Forms: Analysis and Recommendations for Development of Consent Forms for Use with Communities with Limited or Low Literacy

2016 ◽  
Author(s):  
Miraida Morales ◽  
Sarah Barriage
Keyword(s):  
Informed Consent ◽  
Pilot Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Measurement Tool ◽  
Low Literacy ◽  
Consent Forms ◽  
Early Readers ◽  
Research With Children ◽  
Consentement Éclairé

This poster presents a pilot study that analyzed a small corpus of informed consent forms used in research with children, adolescents, and adult early readers using Coh-Metrix, a readability measurement tool. Recommendations for increasing readability of consent forms in order to improve the informed consent process are also provided. Cette affiche présente une étude pilote qui a analysé un corpus restreint de formulaires de consentement éclairé utilisés dans la recherche avec les enfants, les adolescents et les lecteurs précoces adultes,  utilisant Coh-Metrix, un outil de mesure de la lisibilité. Nous fournissons également des recommandations pour augmenter la lisibilité des formulaires de consentement afin d'améliorer le processus de consentement éclairé.

scholarly journals Suitability of Placental Blood Samples of Newborns for Pre-Transfusion Testing

2021 ◽  
Vol 9 ◽  
Author(s):  
Rana Alissa ◽  
Patty D. Williams ◽  
Erika L. Baker ◽  
Jennifer A. Hipp ◽  
Jinous Saremian ◽  
...  
Keyword(s):  
Informed Consent ◽  
Categorical Data ◽  
Institutional Review Board ◽  
Abo Blood Group ◽  
Blood Samples ◽  
Rhesus Factor ◽  
Institutional Review ◽  
Antiglobulin Test ◽  
Placental Blood ◽  
Antibody Screen

Objective: To show concordance between heel stick and placental blood sample pairs for newborns' pre-transfusion testing and to validate placental blood's tube and gel methodology.Methods: Placental samples were collected for pre-transfusion testing at birth from 78 singleton and twin newborns admitted to our Mother–Baby Unit to compare with the results of heel stick samples taken from same newborns. Gestational age ≥35 weeks, weight ≥2,000 g. The study was approved by the Institutional Review Board (IRB). Informed consent was obtained from newborn parents. ABO blood group, Rhesus factor (Rh), direct antiglobulin test (DAT), and antibody screen were performed. Ortho ProVue Analyzer was used for tube and gel methods. McNemar's test for paired categorical data was performed.Results: One hundred percent concordance in 78 pairs for ABO and Rh. Seventy-four pairs were tested for antibodies, 72 were both negative, 1 was both positive, and 1 gave discordant result. Ninety-nine percent concordance, p = 0.999. Sixty-five pairs were both DAT negative, seven were both DAT positive, and six gave discordant results. Ninety-two percent concordance, p = 0.68. Placental blood gave identical results comparing tube with gel methods.Conclusions: Placental blood is suitable for pre-transfusion testing and can replace heel sticks. Placental blood tube and gel methods are validated.

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