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.

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.

Making Research Consent Forms Informative and Understandable: The Experience of the Indian Health Service

1994 ◽  
Vol 3 (4) ◽  
pp. 510-521 ◽  
Author(s):  
William L. Freeman
Keyword(s):  
Informed Consent ◽  
Health Service ◽  
American Indian ◽  
Alaska Native ◽  
Institutional Review Boards ◽  
Indian Health Service ◽  
Research Model ◽  
Consent Forms ◽  
Indian Health ◽  
Institutional Review

The mission of the Indian Health Service (IHS) affects what research is done and how It is reviewed and managed and in turn affects the forms and process used to obtain informed consent. Consent forms must be Informative and understandable to American Indian and Alaska Native (AI/AN) potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards (IRBs) developed seven research Model Volunteer Consent Forms (available from the author).

Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest

2019 ◽  
pp. 545-548
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Ethical Conduct ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Essential Components ◽  
Financial Conflicts Of Interest

Describe the essential components of the ethical conduct of research, the role of the institutional review board, the process of informed consent, the potential areas of conflict of interest for clinicians participating in research, and other ethical issues related to research in HIV medicine.

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.

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.

The Institutional Review Board and Protecting Human Subjects: 10 Frequently Asked Questions

2005 ◽  
Vol 15 (3) ◽  
pp. 291-295
Author(s):  
Sheldon Zink ◽  
Laura Kimberly ◽  
Stacey Wertlieb
Keyword(s):  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Human Research ◽  
Institutional Review Board Approval ◽  
Institutional Review ◽  
Human Research Subjects ◽  
Review Boards

It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.

Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB

2012 ◽  
Vol 40 (4) ◽  
pp. 997-1007 ◽  
Author(s):  
David Perlman
Keyword(s):  
Public Health ◽  
Human Subjects ◽  
Public Health Practice ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Human Research ◽  
Institutional Review ◽  
Or Practice ◽  
Human Research Protection Program ◽  
Human Research Protection

A number of unique problems plague human research protection efforts at United States (US) State and Territorial Departments of Health (DOHs). The first problem is related to the number of Institutional Review Boards (IRBs) operated by and Federalwide Assurances (FWAs) held by DOHs. The lack of these two essential regulatory human research protection program mechanisms points to a possible inadequacy of infrastructure at DOHs for protecting human subjects. The second and third problems are related to the use and interpretation of research protection laws and regulations at DOHs. Parsing public health activities into research or practice (1) can be vexing and (2) likely produces variability in (a) how individual DOHs make the determination between research and practice and (b) the outcomes of such decisions for the same or similar projects. A related problem is that DOH or Institutional Review Board (IRB) officials might misclassify public health practice activities as research (and vice versa), which can have costly, adverse consequences.

scholarly journals Bridging the gap between researchers and patients

JAHR ◽  
2017 ◽  
Vol 8 (2) ◽  
pp. 191-208
Author(s):  
Elena Villamanan ◽  
Marta Ruiz
Keyword(s):  
Informed Consent ◽  
Personal Data ◽  
Institutional Review Boards ◽  
Materials Management ◽  
Misleading Information ◽  
Consent Forms ◽  
Institutional Review ◽  
Inadequate Information ◽  
Ethical Approval ◽  
Expected Benefits

Background: The Institutional-Review-Boards (IRB) frequently give unfavorable opinions to evaluated studies due to deficiencies in informed consent forms (ICFs), which delays the ethical approval of the study and increases waste in research. Objective: To analyze the extent to which IRB in our center gives unfavorable opinions due to documents deficiencies and to evaluate types of objection. Material and methods: Retrospective observational study of decisions during the first review by the IRB in our center (2012-2015). We carried out a systematic review of minutes when decisions on approval of studies are collected. If not approval, we analyzed appealed objections. Results: 1858 clinical studies were evaluated by the IRB. 1558 required informed consent for participating (83.9%, CI95%:82.1-85.5), 987 were not approved during the first review due to deficiencies in ICFs (63.3%, CI95%:60.9-65.7). The main causes of objections for non-approval were unreadability (11.7%, CI95%:10.6-12.9), inadequate information given about access to personal data rights (9.2%, CI95%:8.1-10.2), biological samples management (7.8%, IC95%:6.9-8.8), and expected benefits (7.6%, IC95%:6.7-8.6). Conclusions: Deficiencies in ICFs are an important reason for non-approval of protocols evaluated by an IRB. There are three fundamental weaknesses on which the IRB plays a key role: 1) improving readability; 2) adapting them to regulations concerning data protection and biological materials management; 3) avoiding misleading information towards enrollment.

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