scholarly journals Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration

2020 ◽  
Vol 20 (1) ◽  
pp. 76-80
Author(s):  
Grace Gartel ◽  
Heather Scuderi ◽  
Christine Servay
Keyword(s):  
Informed Consent ◽  
Institutional Review Board ◽  
Consent Form ◽  
Research Staff ◽  
Common Rule ◽  
Institutional Review ◽  
Informed Consent Form ◽  
Rule Changes

scholarly journals Research Ethics Step by Step

2020 ◽  
pp. 227-273
Author(s):  
Jaap Bos
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Institutional Review Board ◽  
Consent Form ◽  
List Type ◽  
General Knowledge ◽  
Know How ◽  
Institutional Review ◽  
Informed Consent Form ◽  
Research Designs

After Reading This Chapter, You Will: Have a general knowledge of Institutional Review Board (IRB) procedures Have the capacity to anticipate the basic ethical pitfalls in research designs Know how to counter common ethical objections Be able to design an informed consent form

scholarly journals Applying a Digital Health Checklist and Readability Tools to Improve Informed Consent for Digital Health Research

2021 ◽  
Vol 3 ◽  
Author(s):  
Camille Nebeker ◽  
Maryam Gholami ◽  
Daniah Kareem ◽  
Emily Kim
Keyword(s):  
Informed Consent ◽  
Health Research ◽  
Grade Level ◽  
Digital Health ◽  
Institutional Review Board ◽  
Consent Form ◽  
Word Count ◽  
Readability Score ◽  
Institutional Review ◽  
Consent Document

Background: As research involving human participants increasingly occurs with the aid of digital tools (e.g., mobile apps, wearable and remote pervasive sensors), the consent content and delivery process is changing. Informed consent documents to participate in research are lengthy and difficult for prospective participants to read and understand. As the consent communication will need to include concepts and procedures unique to digital health research, making that information accessible and meaningful to the prospective participant is critical for consent to be informed. This paper describes a methodology that researchers can apply when developing a consent communication for digital health research.Methods: A consent document approved by a US institutional review board was deconstructed into segments that aligned with federal requirements for informed consent. Three researchers independently revised each segment of text with a goal of achieving a readability score between a 6–8th grade level. The team then consulted with an external readability expert well-versed in revising informed consent documents into “plain language.” The resulting text was evaluated using Microsoft Word and Online-Utility accessibility software. The final step involved adding visual images and graphics to complement the text. The Digital Health Checklist consent prototype builder was then used to identify areas where the consent content could be expanded to address four key domains of Access and Usability, Privacy, Risks and Benefits, and Data Management.Results: The approved consent was evaluated at a 12.6 grade reading level, whereas the revised language by our study team received 12.4, 12, and 12.58, respectively. The final consent document synthesized the most readable of the three revised versions and was further revised to include language recommended by the software tool for improving readability, which resulted in a final revised consent readability score of a 9.2 grade level. Moreover, word count was reduced from 6,424 in the original consent to 679 in the rewritten consent form.Conclusion: Utilizing an iterative process to design an accessible informed consent document is a first step in achieving meaningful consent to participate in digital health research. This paper describes how a consent form approved by an institutional review board can be made more accessible to a prospective research participant by improving the document readability score, reducing the word count and assessing alignment with the Digital Health Checklist.

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 Pelaksanaan Informed Consent pada Pemeriksaan Intra Vena Pyelografi di Instalasi Radiologi Rumah Sakit Umum Sukoharjo

2017 ◽  
Vol 3 (1) ◽  
pp. 199-203
Author(s):  
Rini Indrati ◽  
Meita Shinta Fatikhatul Laila ◽  
Andrey Nino Kurniawan
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Consent Form ◽  
Radiology Department ◽  
Medical Council ◽  
Patient Understanding ◽  
Informed Consent Form ◽  
Descriptive Qualitative

Background: The implementation of informed consent at Radiology department of Sukoharjo Hospital was conducted by administrative officer and radiographer. The officer explained the preparation of pyelographic intra-venous examination to the patient then the patient was asked to fill out and sign the informed consent form. According to the Indonesian Medical Council and Regulation of the Minister of Health of Indonesia, the delivery of informed consent is carried out by doctors. The doctor explains all the information contained in the contents of informed consent before taking any medical action. The purpose of this research is to know the implementation of informed consent done in the radiology department and patient understanding of the contents of the informed consent form.Methods: The type of this research is descriptive qualitative research with the observational approach. Data were collected in March-June 2017 by observational of informed consent and interviews of 30 patients who will conduct intra vena pyelographic examination. Data analyzed by descriptively.Results: The results showed that the provision of informed consent to intravenous pyelographic examination patient at Sukoharjo Hospital was performed by administration officer and radiographer before conducting the examination. The patient's understanding of the contents of informed consent has not been in accordance with the content of the informed consent form because the information submitted by the radiologist only concerning the preparation of intravenous examination of pyelography does not include examination procedures, objectives, risks, complications, diagnoses, prognoses, alternative other measures and risks, and costs.Conclusions: In radiology department of Sukoharjo hospital at Intravenapyelography patient informed consent delivered by administrative officers and radiographer. Patients understanding the content of informed consent

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.

Usability Testing

2001 ◽  
Vol 9 (2) ◽  
pp. 15-20
Author(s):  
Susan Waters ◽  
Melody Carswell ◽  
Eric Stephens ◽  
Ada Sue Selwit
Keyword(s):  
Informed Consent ◽  
Usability Testing ◽  
Consent Form ◽  
Research Project ◽  
Informed Consent Form ◽  
The Difference

How information is presented in an informed consent form can mean the difference between success and failure in a research project.

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