Electronic informed consent information for residual newborn specimen research: findings from focus groups with diverse populations

Frost, Caren J.; Johnson, Erin; Witte, Brieanne; Stark, Louisa A.; Botkin, Jeff; Rothwell, Erin

doi:10.1007/s12687-020-00496-y

Cited by 2 publications

(2 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…When it comes to language, most original items were in accord with each other on how the language should be presented in electronic informed consent [ 49 – 51 ]. Appropriateness, simplicity and concise are the adjectives used to simplify the language.…”

Section: Discussionmentioning

confidence: 99%

Electronic informed consent criteria for research ethics review: a scoping review

Yusof

Teo

2022

BMC Med Ethics

View full text Add to dashboard Cite

Background The research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes. Methods The search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work. Results Of 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent. Conclusion The current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.

show abstract

Section: Discussionmentioning

confidence: 99%

Electronic informed consent criteria for research ethics review: a scoping review

Yusof

Teo

2022

BMC Med Ethics

View full text Add to dashboard Cite

show abstract

“…Currently, paper-based IC is still widely used in neonatal research. Less attention has been given to the implementation or use of eIC in clinical research involving neonates ( 28 , 29 ). For this reason, this study aims to investigate health care professionals' (HCPs) perspectives, as one of the relevant group of stakeholders, on the current paper-based IC process and how this process could be improved by using eIC.…”

Section: Introductionmentioning

confidence: 99%

Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era

et al. 2021

View full text Add to dashboard Cite

Background: Currently, many initiatives are devoted to optimizing informed consent for participation in clinical research. Due to the digital transformation in health care, a shift toward electronic informed consent (eIC) has been fostered. However, empirical evidence on how to implement eIC in clinical research involving neonates is lacking.Methods: Semi-structured interviews were conducted with 31 health care professionals active in Belgium or the Netherlands. All health care professionals had experience in conducting clinical research involving neonates. Interviews were audio-recorded, transcribed and analyzed using the framework method.Results: Interviewees generally supported the use of eIC in clinical research involving neonates. For example, eIC could enable parents to receive study feedback via the eIC system. Requirements were expressed for parental involvement to decide on which feedback would be appropriate to return. Moreover, experts specialized in presenting information and designing electronic systems should be involved. Broad consensus among health care professionals indicates that the face-to-face-interaction between parents and the research team is vital to establish a relationship of trust. Therefore, it is necessary that the use of eIC runs alongside personal interactions with the parents. Concerns were raised about the accessibility of eIC to parents. For this reason, it was suggested that parents should always be given the possibility to read and sign a paper-based informed consent form or to use eIC.Conclusions: Health care professionals' views indicate that the use of eIC in clinical research with neonates may offer various opportunities. Further development and implementation will require a multi-stakeholder approach.

show abstract

Electronic informed consent information for residual newborn specimen research: findings from focus groups with diverse populations

Cited by 2 publications

References 5 publications

Electronic informed consent criteria for research ethics review: a scoping review

Electronic informed consent criteria for research ethics review: a scoping review

Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era

Contact Info

Product

Resources

About