Some researchers wear yellow pants, but even fewer participants read consent forms: Exploring and improving consent form reading in human subjects research.

2020 ◽  
Author(s):  
Benjamin D. Douglas ◽  
Emma L. McGorray ◽  
Patrick J. Ewell
Keyword(s):  
Human Subjects ◽  
Consent Form ◽  
Human Subjects Research ◽  
Consent Forms

Some Researchers Wear Yellow Pants, but Even Fewer Participants Read Consent Forms: Exploring and Improving Consent Form Reading in Human Subjects Research

2020 ◽  
Author(s):  
Benjamin Douglas ◽  
Emma McGorray ◽  
Patrick Ewell
Keyword(s):  
Human Subjects ◽  
Behavioral Research ◽  
Consent Form ◽  
Human Subjects Research ◽  
Consent Forms ◽  
Research Domains

Though consent forms include important information, those experienced with behavioral research often observe that participants do not carefully read consent forms. Three studies examined participants’ reading of consent forms for in-person experiments. In each study, we inserted the phrase “some researchers wear yellow pants” into sections of the consent form and measured participants’ reading of the form by testing their recall of the color yellow. In Study 1, we found that the majority of participants did not read consent forms thoroughly. This suggests that overall, participants sign consent forms that they have not read, confirming what has been observed anecdotally and documented in other research domains. Study 2 examined which sections of consent forms participants read and found that participants were more likely to read the first two sections of a consent form (procedure and risks) than later sections (benefits and anonymity and confidentiality). Given that rates of recall of the target phrase were under 70% even when the sentence was inserted into earlier sections of the form, we explored ways to improve participant reading in Study 3. Theorizing that the presence of a researcher may influence participants’ retention of the form, we assigned participants to read the form with or without a researcher present. Results indicated that removing the researcher from the room while participants read the consent form decreased recall of the target phrase. Implications of these results and suggestions for future researchers are discussed.

scholarly journals Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations

2008 ◽  
Vol 36 (2) ◽  
pp. 219-248 ◽  
Author(s):  
Susan M. Wolf ◽  
Frances P. Lawrenz ◽  
Charles A. Nelson ◽  
Jeffrey P. Kahn ◽  
Mildred K. Cho ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Human Subjects ◽  
Research Participant ◽  
Institutional Review Boards ◽  
Expert Evaluation ◽  
Human Subjects Research ◽  
Potential Health ◽  
Consent Forms ◽  
Institutional Review ◽  
Research Analysis

Researchers, institutional review boards (IRBs), participants in human subjects research, and their families face an important but largely neglected problem — how should incidental findings (IFs) be managed in human subjects research. If researchers unexpectedly stumble upon information of potential health or reproductive significance, should they seek expert evaluation, contact the participant’s physician, tell the research participant, or respond with some combination? What should consent forms and the entire consent process say about how IFs will be handled in research? What should IRBs require?

Informed Consent for Online Research—Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms

2021 ◽  
pp. 155626462110201
Author(s):  
Caitlin Geier ◽  
Robyn B. Adams ◽  
Katharine M. Mitchell ◽  
Bree E. Holtz
Keyword(s):  
Individual Differences ◽  
Informed Consent ◽  
Research Process ◽  
The Other ◽  
Consent Form ◽  
Online Research ◽  
Consent Forms ◽  
Potential Benefits

Informed consent is an important part of the research process; however, some participants either do not read or skim the consent form. When participants do not read or comprehend informed consent, then they may not understand the potential benefits, risks, or details of the study before participating. This study used previous research to develop experimentally manipulated online consent forms utilizing various presentations of the consent form and interactive elements. Participants ( n = 576) were randomly exposed to one of six form variations. Results found that the highly interactive condition was significantly better for comprehension than any of the other conditions. The highly interactive condition also performed better for readability, though not significantly. Further research should explore the effects of interactive elements to combat habituation and to engage participants with the parts of the consent form unique to the study.

The Patient in Patient Safety: Contemporary Issues, From COVID-19 to Citizen Science

2021 ◽  
Vol 10 (1) ◽  
pp. 301-303
Author(s):  
Elizabeth Lerner Papautsky ◽  
Richard J. Holden ◽  
Rupa S. Valdez ◽  
Jordan Hill ◽  
Janetta Brown
Keyword(s):  
Social Media ◽  
Patient Safety ◽  
Citizen Science ◽  
Human Subjects ◽  
Lessons Learned ◽  
Human Subjects Research ◽  
Research Strategies ◽  
Face To Face

In the 4th panel on the topic of The Patient in Patient Safety, we highlighted topics of current relevance and facilitated a reflection session. The objective was to highlight the ways in which the COVID-19 pandemic has impacted patient ergonomics research and work, with particular focus on safety. After a topic overview, panelists presented their work on overcoming challenges to human subjects research created by the suspension of face-to-face activities during the COVID-19 pandemic. A facilitated reflection and brainstorming session using Miro followed. We used questions to elicit examples of patient and caregiver roles in safety during the pandemic and research strategies and challenges. These questions were also distributed on social media prior to the event. The panel served as an opportunity to share lessons learned.

scholarly journals 515 How Has ‘Montgomery’ Changed the Way We Document Risks on Consent Forms for Deceased Donor Kidney Transplantation? A Single-Centre Audit and Re-Audit

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
A M Hussein ◽  
C J Callaghan
Keyword(s):  
Gold Standard ◽  
Deceased Donor ◽  
Consent Form ◽  
Donor Kidney ◽  
Consent Forms ◽  
Legal Case ◽  
Deceased Donor Kidney ◽  
Single Kidney ◽  
Donor Kidney Transplantation ◽  
Deceased Donor Kidney Transplantation

Abstract Introduction The 2015 Montgomery case changed the remit of risk discussions required during the consent process. This audit reviewed single kidney transplant (SKT) consent forms to establish which risks are documented, and whether this legal case affected discussions. Following the audit, we introduced a pre-printed consent form and closed the audit loop by assessing its uptake. Method Trust paper consent forms for all patients aged 50+ who received a deceased donor SKT in our centre in 2014 (n = 58; pre-Montgomery) and 2017 (n = 70; post-Montgomery) were reviewed to see if 20 perceived ‘gold standard’ risks were documented. A pre-printed procedure-specific consent form including all gold standard risks was then introduced in July 2019. A re-audit reviewed the case-notes of every alternate recipient aged 50+ of a deceased donor SKT from 01/08/19 to 29/02/20 to check if the pre-printed form was used. Results Overall, 53% of the 20 ‘gold standard’ risks were documented in 2014 versus 59% in 2017 (p = 0.55). There was a 91% uptake of the pre-printed consent form. Discussion This audit established the importance of using a pre-printed consent form to standardise risk discussions We propose that pre-printed procedure-specific forms should be encouraged throughout the NHS to support ‘Montgomery-appropriate’ consent discussions.

scholarly journals Human Subjects Requirements and Economic Education Researchers

2007 ◽  
Vol 51 (2) ◽  
pp. 49-60 ◽  
Author(s):  
Jane S. Lopus ◽  
Paul W. Grimes ◽  
William E. Becker ◽  
Rodney A. Pearson
Keyword(s):  
Human Subjects ◽  
Economic Education ◽  
Opportunity Costs ◽  
Federal Regulations ◽  
Research Projects ◽  
Human Subjects Research ◽  
Web Based ◽  
American Universities ◽  
Net Benefits ◽  
Low Levels

This paper presents the results of a web-based survey of economic educators who were asked about their knowledge and experience with human subjects research and the mandated federal protocols that govern such research at most American universities. The results indicate that while economic education researchers are experienced in conducting human subjects research and are aware of the federal regulations, they are not well informed about key details of the regulations. They are skeptical of the net benefits of the mandated protocols because of the perceived discouraging burdens of the paperwork that rarely result in significant modifications of their research projects. The authors conclude that recent calls for modifications to the federal regulations for classroom-based research projects may be justified given the opportunity costs of adhering to the regulations compared to the relatively low levels of perceived benefits.

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