Piloting electronic informed consenting in a pneumococcal human infection study in Blantyre, Malawi
Research Article
Clara Ngoliwa, Chikondi Chakwiya, Joel Gondwe, Edna Nsomba, Vitumbiko Nkhoma, Modesta Reuben, Linda Chantunga, Pemphero Liwonde, Edward Mangani, Evaristar Kudowa, Lumbani Makhaza, Neema Toto, Tiferanji Sochera, Tarsizio Chikaonda, Ben Morton, Marc Y.R. Henrion, Dingase Dula, Stephen B. Gordon, Anthony E. Chirwa
Wellcome Open Research, 29 April 2024
Open Access
Abstract
Background
Electronic consent can potentially improve accuracy, workflow, and overall patient experience in clinical research but
has not been used in Malawi, owing to uncertainty about data security and technical support.
Objectives
We explored the feasibility of using electronic consent (e-consent) in an ongoing human infection study in Blantyre Malawi. We dual-consented participants by both electronic and paper methods to assess the feasibility of electronic consent, and then compared benefits and challenges of the two methods.
Methods
The approved paper consent forms were digitized using Open Data Kit (ODK). Following participant information giving by the research staff, healthy literate adult participants with no audio-visual impairments completed a self-administered e-consent and provided an electronic signature. Signed e-consent forms were uploaded to a secure study server. While the participants were in clinic, the signed electronic consent form was printed as a copy for the participant. The feasibility, advantages and disadvantages including data safety consideration for e-consenting were evaluated by exploring issues surrounding use of e-consenting versus paper-based consenting. Consent forms were analysed by research staff for errors such as overwriting and legibility.
Results
We piloted 109 participants to e-consenting. It was found to be user friendly, had 0% (n 0/109) errors compared to 43.1% (n 47/109) in paper based methods along with enhanced data safety. The challenges included difficult digitization of ethics stamped documents, volunteer unfamiliarity with tablet user interface and its requirement for a working internet and printer.
Conclusion
E-consenting was feasible but required additional resource investment. Benefits included error minimization and data security.
Month: May 2024
Upcoming Calls For Public Consultation
UPCOMING CALLS FOR PUBLIC CONSULTATION
We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].
Request for Information: Soliciting Input on Opportunities, Gaps, and Challenges in Global Health Research in Neurological Diseases and Stroke
Notice Number: NOT-NS-24-018 Response date: July 1, 2024
The National Institute Neurological Diseases and Stroke (NINDS) has released a Request for Information from all stakeholders to identify global health research priorities, capacity building and training needs, and best practices or strategies that could facilitate equitable global health research in neurological disorders. Information requested
This RFI is intended to help NINDS identify global health research priorities, capacity building and training needs, and best practices or strategies that could facilitate equitable global health research in neurological disorders. The NINDS invites input from all stakeholders, including researchers, health care providers, people with lived experience (e.g., patients with neurological conditions, family members, caregivers), patient advocates, health advocacy organizations, scientific or professional organizations, federal agencies, non-profit and private sector organizations, as well as other interested members of the public. Organizations may consider submitting a response on behalf of the organization or share this RFI link with its members.
Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity in Access Planning
Posted on May 21, 2024 Comments must be received by July 22, 2024
NIH is proposing to develop and implement a new policy within the NIH’s Intramural Research Program, the internal research arm of the agency. The policy would require organizations partnering with NIH through a patent licensing agreement that succeed in bringing certain products to market to submit a plan outlining steps they intend to take to promote patient access to any resulting drug, biologic, vaccine, or device. NIH seeks input on this draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions.
NIH will use the responses to this request for information to develop a final policy. Comments on the proposed policy must be submitted at: https://osp.od.nih.gov/comment-form-draft-nih-intramuralresearch-program-policy-promoting-equity-through-access-planning.
In addition, NIH will be hosting an informational webinar on the proposed policy on June 11, 2024. More information on the agenda and how to register will be provided shortly.
For additional context on the benefits of access planning, please see NIH’s 2023 Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer. Questions may be sent to SciencePolicy@od.nih.gov.
Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language
Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language
National Institute of Health, May 2024
Key Points
- This resource provides points to consider and sample language for informed consent of research studies which plan to use digital health technologies. The use of this resource is completely voluntary.
- The considerations and sample language provided in this resource may not apply to all studies or cover all potential contexts of use. Users of this resource should apply relevant considerations/sample language as applicable to their study. Points to consider and sample language below are included in the most relevant sections, although they may be relevant to multiple sections.
- This resource does not take the place of an informed consent document. The considerations and sample language included in this resource are specific to the inclusion of digital health technologies in a study; other general and population-specific informed consent considerations and language still apply. The sample language provided in this resource should be tailored for individual studies and may need further revision or clarification when used in an informed consent.
- The sample language provided in this resource does not alone satisfy the regulatory requirements for informed consent as described in the 2018 revised Common Rule at 45 CFR46.116 or the FDA’s regulations governing the protection of human participants (i.e., 21 CFR parts 50 and 56).
- Within this resource, the term digital health technology refers to wearable devices, sensor technologies, and mobile software applications (“apps”) most often used with tablets, watches, or phones. The resource does not address considerations for implantable devices, artificial intelligence, or other types of digital health technologies.
- This consent resource does not address future use of data collected from digital health technologies, which may have additional considerations when developing or reviewing informed consent.
Center for Informed Consent Integrity 