Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research

التفاصيل البيبلوغرافية
العنوان: Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research
المؤلفون: Amy Corneli, Steve Sortijas, Thomas Grey, Jeremy Sugarman, Jenae Tharaldson, Monique P. Mueller, Emily Namey
المصدر: Journal of Empirical Research on Human Research Ethics. 12:14-25
بيانات النشر: SAGE Publications, 2017.
سنة النشر: 2017
مصطلحات موضوعية: medicine.medical_specialty, Biomedical Research, Evidence-based practice, Social Psychology, Human immunodeficiency virus (HIV), Alternative medicine, HIV Infections, 0603 philosophy, ethics and religion, Affect (psychology), medicine.disease_cause, Article, Education, Consent Forms, 03 medical and health sciences, 0302 clinical medicine, Informed consent, Surveys and Questionnaires, Humans, Medicine, 030212 general & internal medicine, Medical education, Research ethics, Informed Consent, business.industry, Communication, 06 humanities and the arts, humanities, Clinical research, Attitude, 060301 applied ethics, Prevention trials, Comprehension, business, human activities, Social psychology
الوصف: Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants’ understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.
تدمد: 1556-2654
1556-2646
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::aa9990f3cdfc98005b6c20757f20578cTest
https://doi.org/10.1177/1556264616682550Test
حقوق: OPEN
رقم الانضمام: edsair.doi.dedup.....aa9990f3cdfc98005b6c20757f20578c
قاعدة البيانات: OpenAIRE