Dataset Information

Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives.

ABSTRACT: One of the significant modifications to the Common Rule is the requirement that prospective participants be given information sufficient for a "reasonable person." However, research is limited on what types of information patients, caregivers, and providers consider "key information." Although certain aspects of informed consent (IC) may be considered standard, considering the individualized needs and preferences of patients is necessary for patient-centered consent. In this study, we qualitatively examined the specific types of information that patients and caregivers involved in hematopoietic cell transplantation (HCT), as well as their providers, believe to be important and necessary as part of the IC process to make a decision about participating in clinical research; and further, how these perspectives are aligned. Our findings suggest opportunities for improving the IC document and process by emphasizing information of importance to patients, such as the benefits to others and contributions to science that are associated with participation in clinical research. Furthermore, increasing patient engagement during the IC process may allow providers to streamline information that is aligned with patient information needs and preferences.

SUBMITTER: Raj M

PROVIDER: S-EPMC5743761 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Publications

Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives.

Raj Minakshi M Choi Sung Won SW Gurtekin Tuba Suzer TS Platt Jodyn J

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation 20170904 1

One of the significant modifications to the Common Rule is the requirement that prospective participants be given information sufficient for a "reasonable person." However, research is limited on what types of information patients, caregivers, and providers consider "key information." Although certain aspects of informed consent (IC) may be considered standard, considering the individualized needs and preferences of patients is necessary for patient-centered consent. In this study, we qualitativ ...[more]

PMID: 28882447

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Project description:BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.MethodsAn adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.ResultsFifty-three recommendations were evaluated. After the first round, 34 recommendations were judged "appropriate"; 19 were judged "uncertain"; and none was judged "inappropriate". After the second round, 9 "uncertains" changed to "appropriate". All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = "extremely inappropriate", 5 = "uncertain", 9 = "extremely appropriate"). The sections "General recommendations" and "Gender perspective during the consent process for clinical studies" showed the highest "uncertainty" rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators' communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant's possible lack of health literacy and a glossary of terms.ConclusionsThe RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged "appropriate" by all stakeholders involved in the informed consent process.

Dataset Information

Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives.

Publications

Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives.

Similar Datasets

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