HRPG RFI 70RSAT25RFI000003.pdf

Notice ID: 70RSAT25RFI000003

REQUEST FOR INFORMATION

70RSAT25RFI000003

Department of Homeland Security (DHS) Science and Technology (S&T) Directorate

Compliance Assurance Program Office (CAPO) Human Research Protections Group (HRPG) Support Services

NOTE: THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and market research planning purposes. This RFI shall not be construed as an obligation on the part of the Government. This is NOT a Request for Quotations or Proposals.

No solicitation document exists, and the Government may or may not issue a formal solicitation as a result of the responses received to this RFI.

The Government will not pay for any response or demonstration expenses. All costs incurred responding to this RFI will be solely at the interested party's expense. Failure to respond to this RFI will not preclude participation in any future solicitation. Any information received will become the property of the Government and will not be returned to the submitter. Interested parties are responsible for adequately marking proprietary or sensitive information.

The Government’s explicit intent, in this request for information, is to not receive from respondents any proprietary data, trade secrets, business sensitive information, or information considered CONFIDENTIAL under 18 U.S.C. §1905. The Government’s constraint does not in any way relieve contractors from their responsibility to properly mark proprietary data when it is provided, nor does it alleviate any requirement for the Government to protect marked data. The Government is not obligated to protect unmarked data.

The information provided in this RFI is subject to change and is not binding on the Government.

All submissions become the property of the Government and will not be returned.

I. PURPOSE OF THIS RFI

The purposes of this RFI are:

a) To gain an understanding of Industry’s view of optimum approaches for providing human research protections (HRP) oversight and compliance reviews, pre- and post-approval compliance, and monitoring activities for all human subjects’ research (HSR) conducted, funded, supported, and assisted by DHS.

b) Obtain Industry feedback on recruiting resources with expertise in human research protections

(HRP).

c) Obtain feedback on the proposed Compliance Assurance Program Office (CAPO) Human Research Protections Group (HRPG) organizational approach described in this RFI.

d) Obtain feedback on proposed costing structure as described in the RFI.

II. BACKGROUND/DESCRIPTION

The Department of Homeland Security (DHS) is committed to using cutting edge technologies and scientific talent in our quest to make America safer. DHS Science & Technology (S&T) Directorate is tasked with researching and organizing the scientific, engineering, and technological resources of the United States and leveraging these existing resources into technological tools to help protect the homeland. Central to the integrity and advancement of these endeavors is the need to ensure departmental compliance with applicable federal laws, regulations, and guidelines. Support services are required to provide the requisite technical expertise and programmatic assistance to meet this need, with a focus on regulatory compliance monitoring federal regulation, standards, and guidelines for the protection of HSR, and other applicable legal and/or policy initiatives or developments.

The DHS is made up of Headquarters (HQ) and various Components and Directorates. Each Component has unique and separate requirements and operates in its specific mission space.

With a department-wide purview and in support of each components’ unique and various missions, Research, Development, Testing and Evaluation (RDT&E) needs, the CAPO HRPG requires support that combines expertise in, federal, state, tribal and international HRP regulations, laws and policies, clinical, Social Behavioral Educational Research (SBER), best practice and up-to-date industry-wide sentiments regarding HSR and social media, Artificial Intelligence, privacy and complex data management, biometrics, synthetic data and other emerging concerns and technologies.

The required support will operate within several geographical locations namely, the National Capital Region (NCR) and long-distance remote.

III. QUESTIONS FOR INDUSTRY

Based on your understanding of the CAPO, approach for Developing a HRPG in the attached Statement of Work (SOW), please answer the following questions:

Interest in Project *The Government would appreciate receiving negative responses to assist with planning future requirements.

1. Contract Type: DHS is contemplating a single award ordering type vehicle (e.g. OASIS+ IDIQ) for providing CAPO HRPG support services.

a. Please describe your capacity to deliver the required HRP oversight and compliance reviews, pre- and post-approval compliance, and monitoring activities for all HSR conducted, funded, supported, and assisted by DHS within the NCR and remote / virtual locations.

b. Please describe the recommended contract type (e.g., Labor Hour (LH), Time and Material (T&M), Firm Fixed Price (FFP), or Hybrid) that would be most effective for acquiring the required services and briefly explain why.

2. Required Technical Expertise: The CAPO HRPG requires a strong mix of Subject Matter Expert (SME), technical and administrative skills to accomplish its mission.

a. Describe your capability to provide personnel with the technical skills, knowledge, and experience in all the following technical disciplines:

i. Expertise in, interpretation and application of the “Federal Policy for the Protection of Human Subjects" (the Common Rule) and other applicable federal, state, regional, tribal, and international laws, and regulations.

ii. Expertise in creating and maintaining electronic research management tools and best practices.

iii. Expertise in developing and presenting HSR educational tools and materials.

iv. Expertise in creating, writing, and maintaining HRP policies and standard of operation procedures (SOPs).

v. Staying abreast of federal and state requirements, emerging topics and other matters in the domestic and global scientific community that impact HSR; and

vi. Sufficient expert level experience in performing HSR administrative, Institutional

Review Board and other ethics reviews, organization, and oversight.

b. Describe your capability and process for building and maintaining sufficient resources for the CAPO HRPG.

c. Do you consider the Government’s preference for staff expertise to be financially feasible? Why or why not? Please provide a detailed explanation.

3. Staffing Requirements: DHS envisions the CAPO HRPG support would consist of SME and journey-man level personnel providing the necessary technical expertise described.

DHS is explicitly not seeking personnel with zero HRPs experience. Acceptable expertise required includes two (2) years or more of direct HRPs , ethical and direct HRP program administrative experiences, or be eligible to sit for the Certified Institutional Review Board (IRB) Professional (CIP) certification despite degree level obtained. SMEs with Masters, PhDs, JDs, and IT expertise in addition to HRP experience will be considered highly preferred. SMEs with bachelor’s degrees and extensive HRP experience will be considered highly preferred. Knowledge and experience with federal HRP programs will be considered highly desirable.

LCAT Full Time Equivalent (FTE)

Lead Analyst/Senior Associate (HRPG Team Lead) 1 FTE Scientist/Engineer I 2 FTE Senior Project Manager (Program Manager) 0.25 FTE

a. Provide feedback on the staffing approach envisioned by the Government.

b. Are the mix of skills the Government describes above technically feasible?

If not, provide brief explanation.

c. What is your capability to provide personnel in response to the stated requirements?

4. Personnel Security Requirements: The minimum level of clearance required for contractors is Public Trust, while the highest possible level of clearance for contractors is Top Secret and Sensitive Compartmentalized Information (TS-SCI) clearance is a preferred aspect, it shouldn’t take precedence over a highly qualified staff to conduct the work activities related to human subject’s research protections oversight and compliance.

The decision regarding necessity of security clearance for HRP contractors should be coordinated with the Federal HRPG manager prior to onboarding. The contractor with a TS-SCI clearance will be required to be onsite as needed and reside within the NCR commuting area to work on assignments that require that clearance level for access.

Normal work may be performed onsite, remote and via telework. Describe the capability to provide personnel with TS-SCI clearance.

5. Other Capabilities: Describe any additional capabilities that should be considered by the Government in its planning for a contract for providing CAPO HRPG support services.

IV. SUBMISSION INSTRUCTIONS

Interested parties are invited to address the questions pertaining to CAPO HRPG services identified in this RFI. The total submission page count shall not exceed 15 pages, Times New Roman, Font Size 11, excluding the cover page. Only one submission will be reviewed per vendor for this RFI.

Only electronic submissions will be accepted. Emails with attachments larger than 5 MB shall be broken down into multiple emails with no one attachment exceeding 5 MB. Each electronic submission shall include:

1) Response to RFI Notice 70RSAT25RFI000003

2) Company legal business name and physical address.

3) Identify business socio-economic status.

4) Recommend the NAICS Code most aligned with the requirement.

5) Company points of contact including phone numbers and email addresses.

6) A comprehensive response that addresses the above delineated questions.

7) Identify if you firm currently hold any Best-in-Class (BIC) vehicles (e.g., OASIS+, GSA GWAC, GSA MAS contracts, etc.), to include the applicable contract number(s).

8) Identify if your company would be interested in competing for this requirement as prime contractor or subcontractor, if solicited. If subcontracting, identify any joint ventures or teaming arrangements that would be pursued.

Responses to this RFI may be reviewed by Government technical experts drawn from staff within DHS and other Federal agencies. The Government may also use selected support contractor personnel to assist in the review of the responses. These support contractors will be bound by appropriate non-disclosure agreements to protect proprietary and source selection information.

All responses shall be submitted to the Office of Procurement Operations (OPO) at the following email address: Contracting Officer (CO) Danette Williams; Danette.Williams@hq.dhs.gov, and Contract Specialist: Debra.Bryce@hq.dhs.gov no later than NOON, Eastern Time, Tuesday, January 7, 2024.

Note: The Government reserves the right to hold one-on-one meetings as a result of responses received from this RFI as part of its market research. Meetings may be held with companies who provide comprehensive and relevant responses to the topic and questions in this notice.

mailto:Danette.Williams@hq.dhs.gov mailto:Debra.Bryce@hq.dhs.gov