Electronic Informed Consent Capabilities/ e-consent platform

Notice of Intent to Sole Source for Electronic Informed Consent Capabilities/ e-consent platform

NIH-SS- 7003851

The National Institutes of Health intends to award a Firm-Fixed-Price purchase order to Medrio Inc. 345 California ST. STE 325, San Francisco, California 94104-2658, for electronic informed consent capabilities e-consent platform. In accordance with FAR Part 6.302-1, the Contractor is the only known responsible source who can provide the instrument as no other source has been identified who can provide the requirement listed below.

Justification:

Medrio's e-consent platform, allows for collection of multiple participant signatories at multiple sites, optimized workflows, user acceptance testing, and build specifications, and only the manufacturer can provide the follow on service or maintenance because of proprietary data. To fulfill its clinical research mission, eyeGENE requires electronic informed consent capabilities to allow for re-consent of over 6,400 existing eyeGENE participants (eyeGENE Stage 1 reconsent). This is necessary for changes in response to technology advances (e.g. whole genome/exome sequencing and the possibility of secondary findings, etc.) and in staying compliant with NIH's evolving stance on genetics and clinical consents.

Additional Supporting Facts:

The National Ophthalmic Disease Genotyping and Phenotyping Network (eyeGENE ) is a research venture created by the National Eye Institute (NEI), part of the National Institutes of Health (NIH). eyeGENE aims to advance studies of eye diseases and their genetic causes by giving researchers access to DNA samples, clinical information, and patients looking to participate in research studies and clinical trials.

As of the December 31, 2015, eyeGENE had accrued 6,400 participants' clinical data and corresponding bio-samples. The original scope of consent that participants agreed to was to engage in studies of eye disease'. This is generally assumed to limit the types of genetic testing and other potential cross-cutting research that may be proposed over time. As research methods have changed significantly since the beginning of the Program, eyeGENE would like to consent participants to allow their information to be used in research that may not be strictly vision-related. For instance, recent advances towards gene discovery allows screening of an individual's whole genome or whole exome. Many research requests have been made for eyeGENE to allow this type of screening to further understand the genetic mechanism of disease. Yet, the American College of Medical Genetics and Genomics (ACMG) recommends reporting select secondary findings when whole genome or whole exome testing is performed. These secondary findings are not likely related to vision; therefore eyeGENE samples cannot not to be used for this purpose. It is extremely desirable to allow this sort of expanded screening as thousands of eyeGENE participants have not had the genetic cause of their disease identified.

For the limited eyeGENE staff to individually consent 6,400 participants would be extremely burdensome, inefficient and costly, so the Program is planning to add an electronic consent and comprehension web-based option for consent. The application will not only allow for the participant to provide consent for expanded research use and allow the program to reconsent participants who were enrolled as minors when they reach the age of majority.

This notice is not a request for competitive quotes. However, any party that believes it can provide the requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. A determination by the Government to compete this proposed award based upon responses to this notice is solely within the discretion of the Government.

In order to be considered for an award, an offeror must have completed the online electronic Representations and Certifications located at https://www.sam.gov in accordance with FAR 4.1201(a). By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in SAM at https://www.sam.gov/ prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (Lack of registration in the System for Award Management will make an offeror ineligible for award). All responsible sources may submit an offer that may be considered by the Agency.

It is anticipated that an award will be issued approximately five (5) days after the date of this notice unless the Government determines that another organization has the capability to meet this requirement. Please email responses to ryan.alexander@nih.gov no later than 9:00 a.m. EST on Tuesday September 3rd, 2024.