Introduction
The primary purpose of consent is to enhance patient protection as it fosters trust between researchers and participants by ensuring good understanding. Participants can choose what is best for them if there is excellent communication regarding the value that can be derived from the research.
Challenges with informed consent
It is a difficult task to create a consent form that not only complies with legal standards but also provides complicated scientific information in a way that is understandable to the average individual. In addition to providing the patient with medical facts, the consent form must also convey complexities regarding the research such as risks, benefits, conflicts of interests, data dissemination practices, right to withdraw, and so forth.
A signed informed consent may provide a documentary proof that the participant has given informed consent to participate in a clinical study and that they have been given the requisite information, but researchers are obligated to ensure that the participants achieve complete comprehension by providing participants with all the necessary information, but in a way that can be completely understood by the participants.
eConsent and Regulations
With the advent of electronic consent(eConsent), researchers have the opportunity to acquire consent from the participants electronically which opens up the possibilities to work on innovative ways to achieve higher degree of comprehension with the help of multi-media and presentations. eConsent also improves clinical study process and its efficiency by providing insight into the patient experience with increased data quality, and a completely computerized system.
Although, acquiring participants information via electronic means is not a complicated affair but gathering participants’ signatures can be challenging, as eSignature requirements and regulation vary by country. In the US, Researchers need to consider the FDA’s requirements set forth in Code of Federal Regulations (CFR) Part 11 before even rolling out an eConsent Form. eConsent systems must follow following requirements documented in Part 11:
Validation: As eConsent requires eSignatures, it is essential that eSignature must be valid, and researchers must be able to confirm the identity of the participant who is signing the form and the person signing the form must also be legally eligible to provide consent. Cases where legally authorized representative may provide consent on behalf of a participant shall also be accounted for and validated.
Audit Trail: All systems that store health data must have audit trails. The local time and date of the activity that changed the record should be included in audit trails, and these audit trails should be produced independently of the system operator. They must be kept on file log for as long as the record is kept on file, and they cannot replace the old data.
Accurate and portable Records: All systems must be able to create or export precise, comprehensive copies of the data they store. Computer systems must be able to produce both paper copies or printouts and electronic copies. 
Overall, the eSignature implementation regulations provide an outline structure for consideration while planning to implement eConsent software solutions.
Data Safety requirements
eConsents solutions streamline the consent acquiring process but while operating, an array of participant’s Personal Identifiable Data gets generated which makes the eConsent software solutions highly susceptible to cyber-attacks and data thefts. This means it is essential for researchers to invest in a secure eConsent software solution which ensures Data integrity, safety, and privacy for the participants.
Key Considerations while choosing an eConsent Solution
While striving to achieve positive outcomes and results from the study, Researchers must adopt eConsent solutions which follow all data safety and regulatory compliances. Today, various eConsent solutions are available in the market but researchers must examine and validate the following checklist before choosing a solution:
Similarity with traditional Consent: The eConsent solution should empower participants to achieve higher understanding with its easy to comprehend information disclosure practices. Researchers should be able to easily determine whether participants are competent or eligible to make their own voluntary decisions.
Re-consent support: The eConsent form contains the necessary information and may need to be updated during a study for a variety of reasons. In such situations the eConsent solution should provide provisions to acquire re-consent from the participants.
Global adoption: Researchers need to stay adept with regulatory trends of the world as eSignature regulations differ by country, which highly influences its adoption. Hence, Researchers must fully understand the eConsent solution’s regulatory compliance readiness for each country in which they intend to operate the study.
Significance to participants: The eConsent solution should be highly adaptable to be integrated into cross-platform environments as it provides ease of use and aids participants to provide consent from any part of the world thereby enhancing participant experience.
Hybrid solution: Apart from acquiring consent electronically, the eConsent solution should provide the flexibility to acquire Consent using other methods such as Mail and in person visits as well.
Future of eConsent
In both ethics and law, Consent is essential when administering medical treatment or enrolling participants in registries. Traditionally, Pen and Paper method has long been used by researchers in dealing with patients but the benefits of using eConsent in clinical studies and research greatly outweighs the brief disruption in the study/research routine. eConsent establishes consistent mechanisms for developing and managing informed consent and its communication while ensuring that the study/research is compliant with all rules and regulations from day one. This implies that eConsent tools are on their way to becoming an irreplaceable feature of the clinical research experience. Thus, in order to equip participants with the express ability to make informed decisions regarding their care, course of treatment and clinical research it becomes essential to put significance on eConsent.
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