ORP Form_V_1_0_02162021.pdf

USAMRDC Regulatory Review Submission Template for Funded Projects Version 19 December 2020 1

Award Number:

US Army Medical Research and Development Command Regulatory Review Requirements

Regulatory Review Submission Template for Funded Projects

Purpose: The information below is required for requesting regulatory review by the United States Army Medical Research and Development Command Office of Research Protections (USAMRDC ORP). All Department of Defense (DoD)/USAMRDC supported research involving animals, humans, cadavers, human data, or human specimens must be reviewed for compliance with Federal and DoD regulatory requirements and approved by the ORP. Additional information will be required for individual protocol submissions.

Instructions: Please complete the template and submit with proposal documents to ORP electronic mailboxes. Animal research should be submitted to the ACURO mailbox usarmy.detrick.medcom-usamrmc.other.acuro@mail.mil, human or cadaver research submitted to the HRPO mailbox usarmy.detrick.medcom-usamrmc.other.hrpo@mail.mil, and both types of research to both ACURO and HRPO boxes.

(Examples: MRDC Contract Number; MIPR/FAD # (e.g., HDTRA 1828370 funded through W15QKN-16-9-1002, OTA Agreement #)

(Examples: COR/STM/PM/SO)

System Log Number: (if applicable)

(Examples: DTRA ROB Number (e.g., CB-2019-##); OTA Base Agreement Number (e.g., 2018-833); MCS Proposal Log Number; etc…)

PMO First Name PMO Last Name

PMO Email Address PMO Telephone

PMO Prefix

Award Administration Contact:

(Examples: Contract/Grant Specialist)

Award Admin First Name Award Admin Last Name

Award Admin Email Address Award Admin Telephone

Award Admin Prefix

Program Management Office:

Other PMO:

Fiscal Year:

Program Management Office Contact:

SECTION I: PROGRAM AND AWARD INFORMATION

USAMRDC Regulatory Review Submission Template for Funded Projects Version 19 December 2020 2

SECTION II: PROPOSAL INFORMATION

Proposal Title:

Period of Performance (if known): to

Proposal Investigator Information:

Proposal Investigator Prefix Proposal Investigator Last Name

Proposal Investigator Degree(s) if known or Suffix

Proposal Investigator Email Address

Proposal Investigator institution:

PI street address line 1:

PI street address line 2:

Proposal Investigator city:

Proposal Investigator state:

Proposal Investigator zip code:

Proposal Investigator country:

POP End Date POP Start Date

Proposal Investigator First Name

Proposal Investigator Telephone

USAMRDC Regulatory Review Submission Template for Funded Projects Version 19 December 2020 3

Is this project linked to a prior or on-going DOD/USAMRDC Award(s), if known?

No

Yes (If yes, please describe below)

Award Number Active (Y/N) Funding Activity/Program

Office

Proposal

Statement of Work (SOW)

Award/funding documentation

Statement of scientific merit

HRPO/ACURO

Log Number (if known)

System Proposal/ Log Number (if known)

SECTION III: DoD/USAMRDC Proposal Documentation for Submission (please check all documents submitted)

Documents required at the time of submission:

Documentation of scientific merit when available:

Estimated ACURO Start (if known):

(Example: Animal research will start right away)

Estimated HRPO Start (if known):

(Example: Human Subject research projected in year 2)

USAMRDC Regulatory Review Submission Template for Funded Projects Version 19 December 2020 4

ACURO Yes No

Animals used?

ACURO appendix provided?

IACUC approval?

Animal protocol provided?

Notes to ACURO

Human Cell Line Use Yes No Notes to HRPO (cell line use)

Research involves cell lines?

Commercially available (for purchase) cell lines used?

Non commercially available (not for purchase) cell lines used?

Commercially available human embryonic cell lines used?

Cell lines of unknown source used?

Optional verification documentation (e.g. Claim of

Exemption or letter)?

SECTION IV: ORP CHECKLIST

Please indicate Yes or No, and provide additional notes to ORP (Indicate Animal &/or Human Use, as applicable)

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Notes to HRPO (cadaver use)

Notes to HRPO (human subject use)

1) Human subjects used?

a) Human use exempt study?

b) Local IRB approval provided?

c) Detailed human subject protocol provided?

d) Informed consent documents provided?

2) Proposal includes clinical trial(s)?

a) FDA regulated?

b) Planned emergency research with trauma patients?

Human Subjects Yes No

Human Anatomical Substance Use Yes No Notes to HRPO (anatom. substance use)

Human anatomical substances or data used?

HRPO submission form on use of data/specimen form provided?

IRB letter or institutional letter provided?

Cadaver Use Yes No

Cadaver use?

ORP cadaver checklist provided?

USAMRDC Regulatory Review Submission Template for Funded Projects Version 19 December 2020 6

SECTION V: SAFETY AND ENVIRONMENT (for MRDC Extramural research ONLY) Please indicate Yes or No, and provide additional notes where applicable

Environment Yes No Notes to Safety and Environment

Involves army provided infectious agents?

Involves use of biological select agents or toxins (BSAT)?

Involves use of specific chemical agents?

Involves pesticides outside of established lab?

Potential likelihood of significant negative effects on public health, safety or environment?

Biological select agents and toxins (BSAT) Chemical Agents List (See page 7) https://www.selectagents.gov/SelectAgentsandToxinsList.html

Chemical Agents

Schedule 1 Chemical Agents Sarin Soman Tabun

VX

Ricin Sulfur mustards Lewisites Nitrogen mustards Saxitoxin

Schedule 2 Chemical Agents Amiton

PFIB

3-Quinuclidinyl benzilate

Schedule 3 Chemical Agents Phosgene Cyanogen chloride Hydrogen cyanide Chloropicrin

Return to Safety/Environment

USAMRDC Regulatory Review Submission Template for Funded Projects Version 19 December 2020 7