Food and Drug Administration and Institutional Review Board Approval of a Novel Prehospital Informed Consent Process for Emergency Research

2020 ◽  
pp. 1-7 ◽  
Author(s):  
Jason McMullan ◽  
Christopher Droege ◽  
Col. Richard Strilka ◽  
Christopher Lindsell ◽  
Michael J. Linke
Keyword(s):  
Informed Consent ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Informed Consent Process ◽  
Institutional Review Board ◽  
Consent Process ◽  
Emergency Research ◽  
Institutional Review Board Approval ◽  
Institutional Review

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

2019 ◽  
Vol 16 (3) ◽  
pp. 283-289 ◽  
Author(s):  
Rami Tadros ◽  
Gillian E Caughey ◽  
Sally Johns ◽  
Sepehr Shakib
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Healthy Volunteers ◽  
Drug Administration ◽  
Study Drug ◽  
Informed Consent Process ◽  
Consent Process ◽  
Phase I Clinical Trials ◽  
Study Drug Administration

Aims/Background A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer’s autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. Methods The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer. Results A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8–6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly. Conclusion The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer’s safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

scholarly journals Analysis of consultations by the Committee for Publication Ethics of the Korean Association of Medical Journal Editors

2020 ◽  
Vol 7 (2) ◽  
pp. 184-188
Author(s):  
You Sun Kim ◽  
Dong Soo Han
Keyword(s):  
Medical Journal ◽  
Informed Consent ◽  
Institutional Review Board ◽  
Publication Ethics ◽  
Ethical Considerations ◽  
Journal Editors ◽  
The United Kingdom ◽  
Institutional Review Board Approval ◽  
Institutional Review ◽  
Duplicate Publication

This study aimed to analyze the inquiries on research and publication ethics submitted to the Committee for Publication Ethics of the Korean Association of Medical Journal Editors. A total of 80 inquiries were initiated over the course of 3 years, from April 2017 to March 2020. Based on a categorization of these inquiries, four common topics are discussed in detail. We present specific cases derived from actual situations, and the steps taken in processing these inquiries. The number of inquiries by topic was as follows: duplicate publications (12), secondary publications (11), authorship disputes (11), informed consent (6), proceedings (5), copyright (5), institutional review board approval (5), plagiarism (4), corrections (4), and others (17). Cases of duplicate publication and authorship disputes can be treated according to the flow chart of the Committee on Publication Ethics of the United Kingdom. Secondary publications may be permitted if the readers or audiences are different and both journals’ editors grant permission. Editors should be cautious about publishing cases without informed consent, even in the absence of identifiable photos, because patients or their families may be able to identify the cases. An adequate awareness of ethical considerations relevant to publication can help reduce the number of instances of research and publication ethics misconduct.

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.

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