Towards guidelines for informed consent for prospective stem cell research

Greenberg, Jacquie; Smith, Danielle C.; Burman, Richard J; Ballo, Robea; Kidson, Susan H.

doi:10.7196/sajbl.8408

Cited by 3 publications

(10 citation statements)

References 15 publications

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“…Future medical and societal benefits, both for the participants and for other groups, can be outlined as well as potential uses of iPSCs [14]. The extent of personal and medical data that will be collected for the research, e.g., age, sex, and family history of the disease, ought to be specifically provided [15]. Donors should be aware of their rights and circumstances for the withdrawal from the study [13].…”

Section: General Information For the Donormentioning

confidence: 99%

“…Donors should be aware of their rights and circumstances for the withdrawal from the study [13]. Information on the kind of donation required, e.g., skin cells or hair sample, the methods applied to derive the body cells, and the number and frequency of visits during the course of research should be included [15,16]. Moreover, information about whether the procurement of biomaterial involves harm, pain, or social risks for the donors and about treatment provided in case of damage should be incorporated [17].…”

Section: General Information For the Donormentioning

confidence: 99%

“…Such redress could involve financial compensation provided by the research's insurance or the possibility of medical treatment financed by the researchers' insurance coverage. Contact possibilities for donors' inquiries should be included [15]. Moreover, some information on the unique nature of the human genome should be a part of the general information for the donor [14].…”

Section: General Information For the Donormentioning

confidence: 99%

“…The central question here is to whom the property of body tissues or genetic matter belongs after the moment of donation [20]. Patient information should include whether there will be direct financial compensation to the donor for participation in the research and a clause about payment in case of future products derived from the donation [15,19]. Donors should be informed about the commercial interests of the researchers conducting the study, institutions, sponsoring companies, and referring physicians [14].…”

Section: General Information For the Donormentioning

confidence: 99%

“…Therefore, authors plead for alternative approaches including multimedia. Other possible recommendations include the use of videotapes, photographs, or diagrams of research procedures, pre-visits to the research site, group discussions, Web sites, and comics that explain the nature of the research [15]. Yet, such visits may involve health and safety concerns or involve additional costs and complex organization, especially in cases when the research site is geographically distant from the specimen collection points.…”

Section: Process Of Donor Informationmentioning

confidence: 99%

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Donor information in research and drug evaluation with induced pluripotent stem cells (iPSCs)

Orzechowski¹,

Schochow²,

Kühl

et al. 2020

Stem Cell Res Ther

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Background: The discovery of induced pluripotent stem cells (iPSCs) opened the possibilities for reprogramming cells back to a pluripotent state. Because of no apparent ethical issues connected with donation and derivation of biomaterial, iPSCs are considered as a research alternative to ethically highly disputed human embryonic stem cells (hESCs). However, the unique character of iPSCs leads to numerous ethical considerations, which mainly concern the issue of donor information and consent for the use of biospecimen in research and drug evaluation. Methods: For the purpose of this analysis, we conducted a review of the literature in the PubMed/MEDLINE and Web of Science databases. The search algorithm led to the identification of 1461 results. After removing duplicates and screening of title and abstract, 90 articles were found to be relevant to the study's objective. Full texts of these articles were apprised and 62 articles were excluded at this step for not properly addressing the study's objective. In the final step, 28 articles were included in the analysis. Analyzed were both research and non-research manuscripts published in peer-reviewed journals. Results: In the case of iPSC research, the information process should be guided by general frameworks established for research on human subjects but also by specific characteristics of iPSCs. We determined four main domains and 12 thematic subdomains that should be included in donor information. Our results show that majority of authors agree to the content of information with regard to the areas of general information, storage of cells, and protection of privacy. Two main issues that are discussed in the literature are donor's consent for use in future studies and the process of donor information. Conclusions: Given the unique character of iPSCs and the possibility of their various uses in the future, the content of donor information should contain specific information central to iPSC research. Effective methods of communicating information to donors should combine written and oral information with the possible use of multimedia.

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Section: General Information For the Donormentioning

confidence: 99%

Section: General Information For the Donormentioning

confidence: 99%

Section: General Information For the Donormentioning

confidence: 99%

Section: General Information For the Donormentioning

confidence: 99%

Section: Process Of Donor Informationmentioning

confidence: 99%

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Donor information in research and drug evaluation with induced pluripotent stem cells (iPSCs)

Orzechowski¹,

Schochow²,

Kühl

et al. 2020

Stem Cell Res Ther

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Application of protection motivation theory to clinical trial enrolment for pediatric chronic conditions

Brooks

Bubela

2020

BMC Pediatr

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Background: Parents of children living with chronic but manageable conditions hope for improved therapies or cures, including Advanced Therapy Medicinal Products (ATMPs). Multiple pediatric clinical trials for ATMPs are underway, but the risk profile of ATMPs for chronic conditions is largely unknown and likely different than for terminal pediatric illnesses. Applying Protection Motivation Theory modified to the context of pediatric ATMP clinical trial enrollment, our study analyses information needs of parents of children living with chronic manageable conditions: Type 1 Diabetes (T1D) or Inherited Retinal Diseases (IRD). Methods: We conducted semi-structured interviews with 15 parents of children living with T1D and 14 parents of children living with an IRD about: a) family background and the diagnostic experience; b) awareness of gene and stem cell therapy research and clinical trials for T1D and IRD; c) information sources on trials and responses to that information; d) attitudes to trial participation, including internationally; e) understanding of trial purpose and process; and f) any experiences with trial participation. We then discussed a pediatric ATMP clinical trial information sheet, which we developed with experts. We applied directed qualitative content analysis, based on PMT, to examine the information preferences of parents in deciding whether to enrol their children in stem cell or gene therapy clinical trials. Results: Parents balanced trial risks against their child's ability to cope with the chronic condition. The better the child's ability to cope with vision impairment or insulin management, the less likely parents were to assume trial risks. Conversely, if the child struggled with his/her vision loss, parents were more likely to be interested in trial participation, but only if the risks were low and likelihood for potential benefit was high. Conclusions: Fear of adverse events as part of threat appraisal was the predominant consideration for parents in considering whether to enroll their child living with a manageable, chronic condition in a pediatric clinical trial of an ATMP. This consideration outweighed potential benefits and severity of their child's condition. Parents called for available safety data and fulsome communication processes that would enable them to make informed decisions about clinical trial enrolment on behalf of their children.

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Content and Method of Information for Participants in Clinical Studies With Induced Pluripotent Stem Cells (iPSCs)

Orzechowski

Schochow

Kühl

et al. 2021

Front. Cell Dev. Biol.

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Research with induced pluripotent stem cells (iPSCs) involves specific ethical challenges, which should be addressed in the informed consent process. Up to now, little concern has been paid to the practice of information in iPSC-clinical studies. In order to fill this research gap, we have searched the documentation of the Research Ethics Committee at Ulm University from the years 2007 to 2019. In our previous research, we have identified 11 items for evaluation of the process of information in iPSC research. We used these items to analyze content and form of information provided for participants in the iPSC studies conducted at Ulm University and Ulm University Hospital in Germany. All analyzed studies provide general information regarding the study’s aim, method, and collection of donor’s personal data and specimen. The information for participants in these studies adheres to general guidelines for research involving human subjects; however, in several areas fails to take into account the specific nature of research with iPSCs. The majority of analyzed studies fail to provide information about possible individual consequences connected with genetic research, such as the possibility of re-identification of the donor or incidental findings acquired during research. Missing is also information about the possibility of future studies involving reproductive research or transplantation of cells and organs. The donor information process in all analyzed studies is conducted in form of the information sheet and oral information. The results of our research show that the process of informed consent in iPSC research should be updated as new developments emerge in this area. However, comprehension of information should not be jeopardized through information overload. Effective communication of essential information requires improved information methods tailored to the needs of participants, such as video animations, interactive consent modules or social media instruments.

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Towards guidelines for informed consent for prospective stem cell research

Cited by 3 publications

References 15 publications

Donor information in research and drug evaluation with induced pluripotent stem cells (iPSCs)

Donor information in research and drug evaluation with induced pluripotent stem cells (iPSCs)

Application of protection motivation theory to clinical trial enrolment for pediatric chronic conditions

Content and Method of Information for Participants in Clinical Studies With Induced Pluripotent Stem Cells (iPSCs)

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