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Obtaining Medical Informed Consent

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How does Contract Cloud help the patient informed consent process?

Institutional Review Boards (IRBs) and Research Sponsors are required to obtain and document patient informed consent in accordance with the FDA’s Health and Human Services Code of Federal Regulations, Title 21, Chapter 1, Part 50. Contract Cloud helps IRB and Research Sponsor compliance by implementing a digital video witness during the informed consent process. The patent-pending system demonstrates patient identity, timing, understanding and intent, while maintaining patient privacy and platform security.

For information on how IRBs and Research Sponsors can use Contract Cloud to regulate internal operations please see “Contract Cloud & Documenting Medical Informed Consent.”

What is Contract Cloud?

Contract Cloud is a patent-pending video recording system through which patients read customized digital scripts and/or answer customized questions based on their treatment. The platform is flexible to allow providers to customize scripts and/or questions based upon patient specific treatments. Please visit our website for our HIPAA compliance overview and a demonstration of the technology.

In what scenarios should I use Contract Cloud for obtaining informed consent?

Procedures to obtain informed consent must adequately promote the patient’s comprehension to all information provided. Without comprehension, the patient cannot achieve true autonomy in making decisions. Contract Cloud improves and ensures the patient’s understanding and autonomy. A simple method of determining whether a patient understands information regarding a procedure is to ask the patient to recount what he or she has been told during a video recorded attestation. This demonstrates that the information given to the patient is also in a language understandable to the patient.

Informed consent is an invitation for patients to participate in health care decisions and share responsibility with the IRBs and Research Sponsors. Patients have the chance to review disclosed information and ask questions so they can make a voluntary choice to accept, refuse or discontinue treatment without penalty. If the patients don’t ask questions, then the doctors and researchers won’t know what the patient doesn’t understand. Video attestation through Contract Cloud can be used to record the patient attesting to having all of their questions answered by the institution. This proof further demonstrates the patient comprehends the answers they received and the terms of the engagement.

Regulation requires circumstances that minimize the possibility of coercion or undue influence while providing patients with a sufficient opportunity to consider whether or not to participate in their operation. Valid informed consent assumes that patients are not pressured when they make their decision. Using Contract Cloud to record voluntary consent demonstrates the patient is competent to make the decision at hand. Video attestation further demonstrates they had an adequate opportunity to study the disclosed information before signing their paperwork and freely made a decision based on what they felt is best for them.

All of the recorded video attestations listed above are readily accessible to the IRBs and Research Sponsors for review and monitoring online. Documentation on how to incorporate Contract Cloud into this process is listed below.

How does it integrate with my current informed consent process?

Contract Cloud’s application program interface (“API”) plugs into the IRB’s or Research Sponsor’s informed consent process at the point where patients electronically sign documents. The scripts displayed to the patient through the API are pre-curated by the IRB to ensure credibility and to communicate all adequate information to the patient.

Contract Cloud can be used as a stand-alone app in circumstances where the patients’ consents or attestations are done in traditional paper processes. The institution simply needs to download Contract Cloud’s app to their iPads. In this case, the institution manages scripts for the patient through a secure web-portal.

In both API and App products, the recordings are securely uploaded and stored by Contract Cloud’s patent-pending system. The recordings are managed, sorted and retrievable at any time by designated administrators. Contract Cloud has provisions in place to protect the privacy of patients and the confidentiality of data. For additional security information please review our HIPAA Compliance documentation.

Start demanding a better method of informed consent, prevent unnecessary patient disputes, and increase trust with your patients. Contract Cloud is beyond consent; it is your video witness.

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