B08-Attachment 4 - Section H Addendum (Final).docx

Attachment 4 [Version 021523]

Section H Addendum - Special Contract Requirements

Human Research: There |_| is not |X| is human research involved with the client’s command mission. If there is human research involved with the client’s command mission, is there a copy of the IRB protocol in the contract file? |_| Yes |X| No. This contract |_| does not or |X| does require human-subjects research assurance certification (Federalwide Assurance) by the contractor performer. If this contract is for research and involves human subjects, then the Human Research Protection Official (HRPO) |_| has |X| has not reviewed this document to ensure that appropriate information is included in the solicitation and subsequent award. The RFI, RFP, or award, if applicable, and approved IRB documents were sent to HRPO/DoD responsible office for review on _______________. This contract is for |X| intramural (DoD) |_| extramural (non-DoD) research. Research herein involving human subjects |_| has |X| has not been separated into an option that would not be exercised until all documentation is provided.

This contract |_| does not |X| does require a BAA and if so then the BAA is attached. This contract |X| does not |_| does require a Data Use Agreement or Data Sharing Agreement.

Research with human subjects may not begin until the contractor obtains either a DoD granted Institutional Assurance or a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). Additionally, all research must be approved by an Institutional Review Board (IRB) named in the Assurance application before the research commences. A copy of the approved DoD Assurance, along with all IRB approval documentation, shall be provided to the technical point of contact assigned to the specific contract, and to the IRB of the (Service) institution being supported, before any human subject research begins. All DoD supported research must also comply with the Health Information Portability and Accountability Act (HIPAA) Privacy Rule, and related DoD instructions. Any contract that does require research on human subjects requires that the DoD component be responsible for contractor oversight of compliance with 32 CFR Part 219, Protection of Human Subjects; and that the Government personnel responsible for such oversight is the client’s Human Research Protection Official as defined by DFAR 252.235-7004, Protection of Human Subjects. All research needs to be determined to be compliant with Federal and Department of Defense regulations for protecting human subjects. All studies similarly need to be compliant with the requirements of the Health Information Portability and Accountability Act (HIPAA) Privacy Rule. Further, evolving human subject protection regulations need to be investigated and training plans developed to educate researchers as to their human subject responsibilities. Contractor shall support Institutional Review Board (IRB) functions and HIPAA Privacy Office functions by reviewing all command studies, including those in the areas of medical resource planning, enhancing performance during shipboard and ground operations, investigating and monitoring disease incidence among military personnel, development of computer systems for monitoring the physiologic status of individual patients, clinical research studies, survey administration efforts, and evaluating physiological effects of various agents found in military operational environments. Such support shall include analyzing research protocols to determine compliance with relevant human subject protection regulations and drafting administrative correspondence detailing review proceedings and findings. Support shall also include development of educational materials, monitoring of research, and database development for tracking of research protocols. If human-subjects research assurance certification is required, then the offeror shall provide a copy of the FWA in their proposal. See Section H-1 below.

Animal Research: There |_| is not |X| is animal use involved with the client’s effort. If there is animal use involved with the client’s effort, is there a copy of the IACUC protocol in the contract file? |_| Yes |X| No. This contract |_| does not or |X| does require animal use assurance and accreditation by the contractor performer.

Any contract that does require the use of animals in research shall be compliant with all applicable federal and DoD regulations, specifically including 7 U.S.C. 2131 et. Seq. and 9 CFR 1-4, “Animal Welfare Act”; DoDI 3216.01, “Use of Animals in DoD Programs”; and specific DoD component management plans. Evolving animal use and care regulations need to be investigated and training plans developed to educate researchers regarding their animal use and care responsibilities. Contractor shall support Institutional Animal Care and Use Committee (IACUC) functions and comply with any procedures required for IACUC approval, including research protocol submission, Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation, Department of Health and Human Services (DHHS) Office of Laboratory Animal Welfare (OLAW) assurance, and USDA site inspections. See Section H-11 below.

Indemnification of the Government by the Contractor and Requirement for Medical Liability Insurance: This contract |_| does not or |X| does require indemnification and medical liability insurance. If indemnification and medical liability insurance is required, then the offeror shall provide documentation in their proposal supporting the amounts recommended as acceptable coverage, including individual occurrence and aggregate limits. The aggregate limit may be at the discretion of the Contracting Officer. See Section H-8 below.

H-1 RESEARCH INVOLVING HUMAN SUBJECTS

DoD Instruction 3216.02 Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and –Supported Research, 15-April-2020, applies.

All research involving human subjects shall be conducted in accordance with 32 CFR 219 “The Common Rule”, 10 USC 980 “Limitation on Use of Humans as Experimental Subjects”, and DoDD 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research”, as well as other applicable federal and state law and regulations, and DoD component guidance. Offerors must be cognizant of and abide by the additional restrictions and limitations imposed on the DoD regarding research involving human subjects, specifically as they regard vulnerable populations, recruitment of military research subjects, and informed consent and surrogate consent and chemical and biological agent research. Food and Drug Administration regulation and policies may also apply.

“Human use” protocols apply to all research that meets any of the following criteria:

a. Any research involving intervention or an interaction with a living person that would not be occurring or would be occurring in some other fashion but for this research.

b. Any research involving identifiable private information. This may include data/information/specimens collected originally from living individuals (broadcast video, web-use logs, tissue, blood, medical or personnel records, health data repositories etc) in which the identity of the subject is known, or the identity may be readily ascertained by the investigator or associated with the data/information/specimens.

CONDUCT OF REGULATED RESEARCH: Services provided under this contract must be conducted in accordance with all state, federal, DOD, and command laws, regulations, policies, and procedures that govern the conduct of regulated research. Federal regulations governing GCP are found in 21CFR Parts 11, 50, 54, 56, 312, and 314 and important guidelines are in the FDA Information Sheets. Additional regulations for human subjects protection are found in 45CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is also standards governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at http://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.hrpo_policies.

252.235-70XX Protection of Human Subjects.

As prescribed in 235.072(e), use the following clause:

PROTECTION OF HUMAN SUBJECTS (XXX 2008)

(a) Definitions. As used in this clause--

(1) Assurance of compliance means a written assurance that an institution will comply with requirements of 32 CFR Part 219, as well as the terms of the assurance, which the Human Research Protection Official determines to be appropriate for the research supported by the Department of Defense (DoD) component (32 CFR 219.103).

(2) Human Research Protection Official (HRPO) means the individual designated by the head of the applicable DoD component and identified in the component's Human Research Protection Management Plan as the official who is responsible for the oversight and execution of the requirements of this clause, although some DoD components may use a different title for this position.

(3) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information (32 CFR 219.102(f)).

For example, this could include the use of human organs, tissue, and body fluids from individually identifiable living human subjects as well as graphic, written, or recorded information derived from individually identifiable living human subjects.

(4) Institution means any public or private entity or agency (32 CFR 219.102(b)).

(5) Institutional Review Board (IRB) means a board established for the purposes expressed in 32 CFR Part 219 (32 CFR 219.102(g)).

(6) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements (32 CFR 219.102(h)).

(7) Research means a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of 32 CFR Part 219, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities (32 CFR 219.102(d)).

(b) The Contractor shall oversee the execution of the research to ensure compliance with this clause. The Contractor shall comply fully with 32 CFR Part 219 and DoD Directive 3216.02, applicable DoD component policies, 10 U.S.C. 980 and, when applicable, Food and Drug Administration policies and regulations.

(c) The Contractor shall not commence performance of research involving human subjects that is covered under 32 CFR Part 219 or that meets exemption criteria under 32 CFR 219.101(b), or expend funding on such effort, until and unless the conditions of either the following paragraph (c)(1) or (c)(2) have been met:

(1) The Contractor furnishes to the HRPO, with a copy to the Contracting Officer, an assurance of compliance and IRB approval and receives notification from the Contracting Officer that the HRPO has approved the assurance as appropriate for the research under the Statement of Work and also that the HRPO has reviewed the protocol and accepted the IRB approval for compliance with the DoD component policies. The Contractor may furnish evidence of an existing assurance of compliance for acceptance by the HRPO, if an appropriate assurance has been approved in connection with previous research. The Contractor shall notify the Contracting Officer immediately of any suspensions or terminations of the assurance.

(2) The Contractor furnishes to the HRPO, with a copy to the Contracting Officer, a determination that the human research proposed meets exemption criteria in 32 CFR 219.101(b) and receives written notification from the Contracting Officer that the exemption is determined acceptable. The determination shall include citation of the exemption category under 32 CFR 219.101(b) and a rationale statement. In the event of a disagreement regarding the Contractor's furnished exemption determination, the HRPO retains final judgment on what research activities or classes of research are covered or are exempt under the contract.(d) DoD staff, consultants, and advisory groups may independently review and inspect the Contractor's research and research procedures involving human subjects and, based on such findings, DoD may prohibit research that presents unacceptable hazards or otherwise fails to comply with DoD procedures.

(e) Failure of the Contractor to comply with the requirements of this clause will result in the issuance of a stop-work order under Federal Acquisition Regulation clause 52.242-15 to immediately suspend, in whole or in part, work and further payment under this contract, or will result in other issuance of suspension of work and further payment for as long as determined necessary at the discretion of the Contracting Officer.

(f) The Contractor shall include the substance of this clause, including this paragraph (f), in all subcontracts that may include research involving human subjects in accordance with 32 CFR Part 219, DoD Directive 3216.02, and 10 U.S.C. 980, including research that meets exemption criteria under 32 CFR 219.101(b). This clause does not apply to subcontracts that involve only the use of cadaver materials.

(End of clause.)

H-2 HUMAN RESEARCH PROTECTION OFFICIAL (HRPO)

The Government’s HRPO for this contract is:

Name:

Phone:

E-mail address:

Address:

When applicable, the Government shall identify who their designated HRPO is and the contact information for the HRPO. The Contractor shall disclose in their proposal who their counterpart is, along with contact information. The HRPO does need to review the contract Statement of Objectives, Statement of Work, or Performance Work Statement to ensure that appropriate information is included in the contract solicitation and award document.

H-3 INSTITUTIONAL REVIEW BOARD (IRB) CHAIR AND PROTOCOLS

The Government’s IRB Chair for this contract is:

Name:

Phone:

E-mail address:

Address:

Additional Government IRB Members may be assigned.

When applicable, the Government shall identify who their designated IRB Member is and the contact information for the Member. The Contractor shall disclose in their proposal who their counterpart is, along with their contact information. The Government shall identify any and all applicable protocols to the contract and make available those protocols to the contract awardee/incumbent. The approved IRB documents shall be sent to the contract HRPO for review and the date of review shall be recorded.

At the discretion of the Contracting Officer and Government Principal Investigator, a contract may be segregated into two parts: (1) research that does not need approval documentation; and (2) research that does need approval documentation. The purpose of segregation is to allow the contract to proceed with the first part, until such time the second part has been approved. The second part cannot be performed until such time approval documentation has been provided.

H-4 FEDERAL ASSURANCE OR FEDERALWIDE ASSURANCE (FWA)

Contractors performing or supporting human research are required to have an FWA before performing on a contract. Contractors must maintain an active FWA during the contract period of performance. Contractors may perform to a Government client’s assurance but the requirement for the Contractor to have its own FWA still stands. The FWA is an assurance of compliance with the U.S. federal regulations for the protection of human subjects. Agencies, such as the Department of Defense, have adopted the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule). Refer to the U.S. Department of Health and Human Services (HHS) website www.hhs.gov/ohrp for step-by-step instructions for filing an FWA.

H-5 BUSINESS ASSOCIATE AGREEMENT (BAA)

Contractors performing or supporting human research are required to have a company-authorized signed BAA before being awarded such a contract. Each contract shall have its own BAA. The BAA complies with the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Breach and Enforcement Rules (HIPAA Rules). The version of the BAA shall include language that has been updated to reflect the 2013 Health Information Technology for Economic and Clinical Health (HITECH) Act modifications to the HIPAA Rules issued by HHS. Provisions on breach response are included. Note that the BAA language only covers HIPAA requirements and not language on other Federal privacy and information laws.

DoD commands are a Covered Entity. However, in performance of its mission, the DoD command may and does contract out to non-DoD entities (e.g., Contractors) such that these non-DoD entities may have access to information covered under the HIPAA of 1996. When doing so, the DoD command must execute documentation in accordance with this Act as it pertains to non-DoD entities by executing with the non-DoD entity a BAA (not to be confused with a Broad Agency Announcement).

Government-approved BAA templates shall be obtained from the Contracting Officer.

H-6 FEDERAL PRIVACY LAWS: PERSONALLY IDENTIFIABLE INFORMATION (PII) AND PROTECTED HEALTH INFORMATION (PHI) The following documents apply:

· DHA PGI 224 Attachment 2 Personally Identifiable, Protected Health Information and Federal Information Requirements, 23-May-2017

· DoD Manual 6025.18 Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs, 13-March-2019

· Defense Health Agency (DHA) Procedures, Guidance, and Information (PGI) 224 Protection of Privacy and Freedom of Information, 23-May-2017 [Note to the Contracting Officer: If the Contractor’s performance involves access to PII/PHI for any purpose, the Contracting Officer shall review the “Decision Tree Matrix” to determine whether the solicitation/contract action must incorporate the appropriate language. This information is available at the link “standard contract language” on the page http://www.health.mil/Military-Health Topics/Privacy-and-Civil-Liberties/Privacy-Contract-Language/DHA-Standard-Contract-Language. If it is determined that the appropriate language is required, the incorporation by reference to the appropriate language is accomplished by including the following provision in the applicable section of the solicitation/contract:] “The Contractor shall comply with the document entitled ‘Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements,’ which is incorporated by reference in its entirety.” However, the “in its entirety” language may be replaced with “except for paragraph __,” if it is determined that a paragraph is not applicable to the contract. For example, if the Contractor is determined not to be a HIPAA business associate, then the “in its entirety” language may be replaced with “except for paragraph 8, HIPAA Business Associate Provisions.”

H-7 DATA SHARING AGREEMENT (DSA)

DSAs are administrative controls used by the Defense Health Agency (DHA) to document that the requested use of data managed by DHA is in compliance with Federal law and implementing Department of Defense (DoD) policies. Note that the DHA Privacy Office does not provide data extractions or grant system access. The System Managers who grant access to data require a DSA. The DHA Privacy and Civil Liberties Office (Privacy Office) reviews and approves DSAs based upon compliance with these policies. Contractors or non-government researchers seeking to obtain Military Health System (MHS) data managed by DHA to perform a government-sponsored initiative, or government personnel conducting research, are required to submit a Data Sharing Agreement Application (DSAA), which must be approved before a DSA will be executed. See www.health.mil for further information.

H-8 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (FAR 52.237-7)

This applies when FAR subpart 37.4l.

As prescribed in 37.403 , insert the following clause:

Indemnification and Medical Liability Insurance (Jan 1997) (a)It is expressly agreed and understood that this is a nonpersonal services contract, as defined in Federal Acquisition Regulation (FAR) 37.101, under which the professional services rendered by the Contractor are rendered in its capacity as an independent contractor. The Government may evaluate the quality of professional and administrative services provided, but retains no control over professional aspects of the services rendered, including by example, the Contractor’s professional medical judgment, diagnosis, or specific medical treatments. The Contractor shall be solely liable for and expressly agrees to indemnify the Government with respect to any liability producing acts or omissions by it or by its employees or agents. The Contractor shall maintain during the term of this contract liability insurance issued by a responsible insurance carrier of not less than the following amount(s) per specialty per occurrence: *_______________.

(b)An apparently successful offeror, upon request by the Contracting Officer, shall furnish prior to contract award evidence of its insurability concerning the medical liability insurance required by paragraph (a) of this clause.

(c)Liability insurance may be on either an occurrences basis or on a claims-made basis. If the policy is on a claims-made basis, an extended reporting endorsement (tail) for a period of not less than 3 years after the end of the contract term must also be provided.

(d)Evidence of insurance documenting the required coverage for each health care provider who will perform under this contract shall be provided to the Contracting Officer prior to the commencement of services under this contract. If the insurance is on a claims-made basis and evidence of an extended reporting endorsement is not provided prior to the commencement of services, evidence of such endorsement shall be provided to the Contracting Officer prior to the expiration of this contract. Final payment under this contract shall be withheld until evidence of the extended reporting endorsement is provided to the Contracting Officer.

(e)The policies evidencing required insurance shall also contain an endorsement to the effect that any cancellation or material change adversely affecting the Government’s interest shall not be effective until 30 days after the insurer or the Contractor gives written notice to the Contracting Officer. If, during the performance period of the contract the Contractor changes insurance providers, the Contractor must provide evidence that the Government will be indemnified to the limits specified in paragraph (a) of this clause, for the entire period of the contract, either under the new policy, or a combination of old and new policies.

(f)The Contractor shall insert the substance of this clause, including this paragraph (f), in all subcontracts under this contract for health care services and shall require such subcontractors to provide evidence of and maintain insurance in accordance with paragraph (a) of this clause. At least 5 days before the commencement of work by any subcontractor, the Contractor shall furnish to the Contracting Officer evidence of such insurance.

* Contracting Officer insert the dollar value(s) of standard coverage(s) prevailing within the local community as to the specific medical specialty, or specialties, concerned, or such higher amount as the Contracting Officer deems necessary to protect the Government's interests.

(End of clause) An example of when the aforementioned is required is when a Contractor phlebotomist, under Government contract, is drawing blood from a human subject in support of infectious disease research.

If aforementioned insurance is required, then the Offeror shall provide documentation in their proposal, supporting the amounts recommended as acceptable coverage, including individual occurrence and aggregate limits.

H-9 CONTRACTOR’S RELEASE, PUBLICATION, AND USE OF DATA (38 CFR 27.404-4) AND DATA RESTRICTIONS Restrictions concerning contractor’s publishing and contractor’s own use of data shall be specified.

(Excerpt)

(a) In contracts for basic or applied research with universities or colleges, agencies shall not place any restrictions on the conduct of or reporting on the results of unclassified basic or applied research, except as provided in applicable U.S. statutes. However, agencies may restrict the release or disclosure of computer software that is or is intended to be developed to the point of practical application (including for agency distribution under established programs). This is not considered a restriction on the reporting of the results of basic or applied research. Agencies may also preclude a contractor from asserting copyright in any computer software for purposes of established agency distribution programs, or where required to accomplish the purpose for which the software is acquired.

(b) Except for the results of basic or applied research under contracts with universities or colleges, agencies may, to the extent provided in their FAR supplements, place limitations or restrictions on the contractor's exercise of its rights in data first produced in the performance of the contract, including a requirement to assign copyright to the Government or another party. Any of these restrictions shall be expressly included in the contract.

(End of excerpt)

H-10 NOTICE REGARDING THE DISSEMINATION OF EXPORT-CONTROLLED TECHNICAL DATA

Export of information, which includes release to foreign nationals within the United States, without first obtaining approval or license from the Department of State for items controlled by the International Traffic in Arms Regulations (ITARS), or the Department of Commerce for items controlled by the Export Administration Regulations (EAR), may constitute a violation of law.

For violation of export laws, the contractor, its employees, officials or agents are subject to:

(1) Imprisonment and/or imposition of criminal fines

(2) Suspension or debarment from future Government contracting actions

The Government shall not be liable for any unauthorized use or release of export-controlled information, technical data or specifications in this contract.

H-11 RESEARCH INVOLVING ANIMAL SUBJECTS

DoD Instruction 3216.01 Use of Animals in DoD Conducted and Supported Research and Training, 20-March 2019, applies.

All activities involving animal subjects shall be conducted in accordance with DoDD 3216.01 “Use of Laboratory Animals in DoD Programs”, 9 CFR (parts 1- 4) “Animal Welfare Regulations”, National Academy of Sciences Publication “Guide for the Care & Use of Laboratory Animals”, as amended, and the Department of Agriculture rules implementing the Animal Welfare Act as amended (7 U.S.C. 2131-2159), as amended, as well as other applicable federal and state law and regulation and DoD instructions.

“Animal use” protocols apply to all activities that meet any of the following criteria:

a. Any research, training, testing or experimentation involving a living animal or animals.

b. An animal is defined as any live, vertebrate organism (non-human) that is being used or is intended for use in research, education, training or testing.

c. A vertebrate is a member of the subphylum Vertebrata (within the phylum Chordata), specifically, those chordates with backbones or spinal columns.

When applicable, a copy of the Institutional Animal Care and Use Committee (IACUC) protocol for each contract shall be in the contract file. Contractor shall support IACUC functions and comply with any procedures required for IACUC approval, including research protocol submission, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International accreditation, HHS Office of Laboratory Animal Welfare (OLAW) assurance, and USDA site inspections.

1552.223-72 Use and care of laboratory animals.

As prescribed in 1523.303-72, insert the following clause in all contracts involving the use of animals in testing, research or training:

USE AND CARE OF LABORATORY ANIMALS MARCH 2015

(a) Use of laboratory animals. (1) Before undertaking performance of any contract involving the use of laboratory animals, the contractor shall register with the Secretary of Agriculture of the United States in accordance with the Secretary of Agriculture of the United States in accordance with the Animal Welfare Act of 1966, as amended (AWA), codified at 7 U.S.C. 2131 et seq. and promulgated at 9 CFR parts 1-4. The contractor shall furnish evidence of such registration to the contracting officer.

(2) The contractor shall acquire animals used in research and development programs from a dealer licensed by the Secretary of Agriculture, or from exempted sources in accordance with 9 CFR 2.25-2.28. Animals shall not be acquired from any random source Class B dealer.

(3) The contractor may request registration of his/her facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which his/her research facility is located. The location of the appropriate APHIS Regional Office as well as information concerning this program may be obtained at http://www.aphis.usda.gov/contact__us/.

(b) Care of laboratory animals. (1) In the care of any live animals used or intended for use in the performance of this contract, the contractor shall adhere to:

(i) The standards and practices incorporated in the Guide for Care and Use of Laboratory Animals, prepared by the Institute of Laboratory Animal Research of the National Research Council of the National Academies (ILAR/NRC),

(ii) The Animal Welfare Regulations found in 9 CFR parts 1-4, and

(iii) The National Institutes of Health (NIH) Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals.

(2) In case of conflict between standards, the higher standard shall be used.

(3) The contractor's reports on portions of the contract in which animals were used shall contain a certificate stating that the animals were cared for in accordance with the principles enunciated in the Guide for Care and Use of Laboratory Animals, prepared by the ILAR/NRC, and/or in the Animal Welfare Regulations found in 9 CFR parts 1-4.

(End of clause)