The Impact of a Digital Vaccine Consent Form in a Large Community Pharmacy Chain
Aylin Unal, Amy Sparkman, Pramit Nadpara, Jean-Venable R. Goode
Innovations in Pharmacy, 26 July 2021; 12(3)
Abstract
Background
A large community pharmacy chain implemented a new digital platform to eliminate the need for patients to fill out a traditional vaccine consent form in the pharmacy. The new digital vaccine consent form allowed patients to complete the form online, where it was transmitted directly to the pharmacy’s network.
Objectives
To identify the characteristics of patients who used an online digital vaccine consent form to receive vaccinations and to evaluate patient satisfaction and confidence in utilizing the digital vaccine consent form to receive pharmacy services.
Methods
This three-month prospective study was conducted in the Mid-Atlantic division of a large community pharmacy chain. A 16-question survey was developed using information from the literature to collect demographic information and patient confidence and satisfaction with the digital vaccine consent form. An email was sent to pharmacy staff containing instructions on the procedure for posting a recruitment flyer, distributing the survey post-vaccination, and how to return completed surveys. Univariate and bi-variate analysis were conducted.
Results
Thirty-six participants responded to the survey, majority of participants were female (56%). Two patients used the digital vaccine consent form; both used because it was more convenient and were likely to use the form again. For those who did not use the digital vaccine consent form, 32% feel somewhat unconfident in using digital technologies for pharmacy services. A majority of patients prefer to be notified about new online services by email (39%) or advertisements in the pharmacy (31%). When asked the likelihood of using the digital vaccine consent form in the future, majority stated unlikely (34%) or neutral (25%).
Conclusions
Most participants did not utilize the new digital vaccine form. This provides an opportunity to further engage patients on the availability and use of the digital vaccine consent form in order to advance digital technologies for pharmacy services.

The CORBEL matrix on informed consent in clinical studies: a multidisciplinary approach of Research Infrastructures Building Enduring Life-science Services
Research Article
Cinzia Colombo, Michaela Th. Mayrhofer, Christine Kubiak, Serena Battaglia, Mihaela Matei, Marialuisa Lavitrano, Sara Casati, Victoria Chico, Irene Schluender, Tamara Carapina, Paola Mosconi
BMC Medical Ethics, 17 July 2021; 22(95)
Open Access
Abstract
Background
Informed consent forms for clinical research are several and variable at international, national and local levels. According to the literature, they are often unclear and poorly understood by participants. Within the H2020 project CORBEL—Coordinated Research Infrastructures Building Enduring Life-science Services—clinical researchers, researchers in ethical, social, and legal issues, experts in planning and management of clinical studies, clinicians, researchers in citizen involvement and public engagement worked together to provide a minimum set of requirements for informed consent in clinical studies.
Methods
The template was based on a literature review including systematic reviews and guidelines searched on PubMed, Embase, Cochrane Library, NICE, SIGN, GIN, and Clearinghouse databases, and on comparison of templates gathered through an extensive search on the websites of research institutes, national and international agencies, and international initiatives. We discussed the draft versions step-by-step and then we referred to it as the “matrix” to underline its modular character and indicate that it allows adaptation to the context in which it will be used. The matrix was revised by representatives of two international patient groups.
Results
The matrix covers the process of ensuring that the appropriate information, context and setting are provided so that the participant can give truly informed consent. It addresses the key topics and proposes wording on how to clarify the meaning of placebo and of non-inferiority studies, the importance of individual participants’ data sharing, and the impossibility of knowing in advance how the data might be used in future studies. Finally, it presents general suggestions on wording, format, and length of the information sheet.
Conclusions
The matrix underlines the importance of improving the process of communication, its proper conditions (space, time, setting), and addresses the participants’ lack of knowledge on how clinical research is conducted. It can be easily applied to a specific setting and could be a useful tool to identify the appropriate informed consent format for any study. The matrix is mainly intended to support multicentre interventional randomized clinical studies, but several suggestions also apply to non-interventional research.

Informed consent in biomedical research: Scopes and challenges
Reflections on Research
Kingshuk Chatterjee, Nilay K Das
Inidian Dermatology Online Journal, 14 July 2021; 12(4) 529-535
Abstract
Medical science is evolving constantly and this evolution cannot happen without biomedical research involving human participant. Owing to a tumultuous history, importance of ethical research cannot be over emphasized in today’s world and the concept of informed consent becomes the guardian of ethics, not only to improve the bonding between the participant and researcher aiding a wholehearted involvement but also ensuring safety for the participants from research related injury/loss. Subject information sheet (SIF) and Informed consent form (ICF) are the fundamental elements of informed consent document. Process of obtaining them from illiterate and vulnerable populations involves the legally authorized representative (LAR) and impartial witness. Audiovisual recording becomes important in case of clinical trials. Process of obtaining informed consent becomes challenging for vulnerable populations as well as during pandemic situations. A comprehensive informed consent is essential for a credible and ethical research.

Enrollment with and without Exception from Informed Consent in a Pilot Trial of Tranexamic Acid in Children with Hemorrhagic Injuries
Original Contribution
Seth W. Linakis, Nathan Kuppermann, Rachel M. Stanley, Hilary Hewes, Sage Myers, John M. VanBuren, T. Charles Casper, Matthew Bobinski, Simona Ghetti, Walton O. Schalick III, Daniel K. Nishijima
Academic Emergency Medicine, 12 July 2021
Abstract
Background
Federal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries.
Methods
We conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3 months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC.
Results
We enrolled 1 of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, 7 (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12 months.
Conclusions
In a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.

Ethical Issues in Intraoperative Neuroscience Research: Assessing Subjects’ Recall of Informed Consent and Motivations for Participation
Research Article
Anna Wexler, Rebekah J. Choi, Ashwin G. Ramayya, Nikhil Sharma, Brendan J. McShane, Love Y. Buch, Melanie P. Donley-Fletcher, Joshua I. Gold, Gordon H. Baltuch, Sara Goering, Eran Klein
AJOB Empirical Bioethics, 6 July 2021
Abstract
Background
An increasing number of studies utilize intracranial electrophysiology in human subjects to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects’ motivations for participation. Yet a thorough empirical examination of these issues in a participant population has been lacking. The present study therefore aimed to empirically investigate ethical concerns regarding informed consent and voluntariness in Parkinson’s disease patients undergoing deep brain stimulator (DBS) placement who participated in an intraoperative neuroscience study.
Methods
Two semi-structured 30-minute interviews were conducted preoperatively and postoperatively via telephone. Interviews assessed participants’ motivations for participation in the parent intraoperative study, recall of information presented during the informed consent process, and participants’ postoperative reflections on the research study.
Results
Twenty-two participants (mean age = 60.9) completed preoperative interviews at a mean of 7.8 days following informed consent and a mean of 5.2 days prior to DBS surgery. Twenty participants completed postoperative interviews at a mean of 5 weeks following surgery. All participants cited altruism or advancing medical science as “very important” or “important” in their decision to participate in the study. Only 22.7% (n = 5) correctly recalled one of the two risks of the study. Correct recall of other aspects of the informed consent was poor (36.4% for study purpose; 50.0% for study protocol; 36.4% for study benefits). All correctly understood that the study would not confer a direct therapeutic benefit to them.
Conclusion
Even though research coordinators were properly trained and the informed consent was administered according to protocol, participants demonstrated poor retention of study information. While intraoperative studies that aim to advance neuroscience knowledge represent a unique opportunity to gain fundamental scientific knowledge, improved standards for the informed consent process can help facilitate their ethical implementation.