U.S. Army Combat Capabilities Development Command (DEVCOM) Armaments Center
HUMAN RESEARCH PROTECTION PROGRAM (HRPP)
Overview
The primary mission of the Armaments Center HRPP is to ensure that research conducted under its assurance is ethical, responsible and scientifically sound. The HRPP protects the rights and welfare of research volunteers by providing policies, procedures, support, guidance, and education to facilitate conscientious mission orientated research.
The Armaments Center HRPP is a collaborative effort between organizational representatives who develop, conduct, review, approve and facilitate human subject research. Our community includes institutional officials, Institutional Review Board (IRB) members, researchers, and staff.
Research conducted by Armaments Center investigators must be reviewed by the Armaments Center HRPP. Only an Exempt Determination Official from the Armaments Center HRPP can determine if research is considered exempt. All non-exempt research is reviewed by the Armaments Center Institutional Review Board (IRB) or a designated IRB member.
Regulatory Background
The Armaments Center HRPP has a Department of Defense Assurance and an Assurance issued by the Department of Health and Human Services (HHS). The Army Human Research Protection Office provides oversight for the DoD Assurance and the Office of Human Research Protection provides oversight for the HHS Assurance.
The Armaments Center HRPP Plan provides an overview of the HRPP. The document defines roles, our mission, and includes the regulatory requirements that must be adhered to. Federal regulations (45 CFR 46, 32 CFR 219, and DoDI 3216.02) require each institution that conducts or supports research involving human subjects must have a HRPP. Internal and external research involving human subjects must receive review and approval prior to initiating the project. Review by the Armaments Center HRPP is required for all Human Subjects Research conducted by Armaments Center investigators and when Armaments Center provides support for research (funding, facilities, equipment, CRADA, etc.).
References
Guiding Principles
Department of Defense Resources
- Protection of Human Subjects (DOD 32 CFR 219)–)
- Protection of Human Subjects and Adherence to Ethical Standards in DOD-Supported Research Regulation: DoD Instruction (DODI) 3216.02
- Research Integrity and Misconduct Regulation: DODI 3210.7
- Protection of Human Subjects “The Common Rule” Regulation: 45 CFR 46 (HHS Regulation)
HRPP REVIEW PROCESS
Submit the following information to: usarmy.pica.devcom-ac.mbx.hrpo@army.mil
If your review is undergoing:
Initial Review (Exempt):
- Scope of work (sometimes called the task order)
- Current CV for principal investigator (PI) and all members of the study team
- Determination Form
- Consent form, if applicable
- Copies of data collection tools/surveys, if applicable
- Determination letter from the external IRB, if applicable
Initial Review (Non-exempt):
- Scope of Work (task order/contract information)
- Assurance and reliance agreement information
- Protocol
- Consent form
- Documentation of Scientific Review
- Current CV for principal investigator (PI) and all members of the study team
- Documentation of current human subjects training for PI (CITI Training)
- Copies of data collection tools/surveys, if applicable
- Recruitment materials, if applicable
- Equipment information, if applicable
- Command Letter of Support/Approval, if applicable
- External IRB approval, if applicable
Amendments
- Amendment Form
- Final version of all documents, including new consent forms and study instruments
- External IRB approval of amendment, if applicable
Reportable Events
- Contact the Armaments Center HRPP Office about the incident within 24 hours.
- Report sent by the investigator to the IRB.
- Determination from the external IRB, if applicable.
Continuing Review
- Current CV for principal investigator (PI) and all members of the study team
- Documentation of current human subjects training for PI (CITI Training)
- Copies of data collection tools/surveys, if applicable
- Recruitment materials, if applicable
- Equipment information, if applicable
- Command Letter of Support/Approval, if applicable
- External IRB approval, if applicable
Closure
- Report sent by the investigator to the IRB
- IRB acknowledgement of closure letter
HRPP FREQUENTLY ASKED QUESTIONS
Q: What is the Human Research Protection Program at the Armaments Center?
A: The Human Research Protection Program (HRPP) provides oversight for all research activities involving human subjects at the Armaments Center. Before a research study can start, scientists and engineers develop a plan for their research. The plan (protocol and test plan) is first reviewed by the Human Research Protection Program to determine if the research involves human participants, directly or indirectly. If there is human participation, a review is then conducted by the DEVCOM AC Institutional Review Board (IRB).
Q: What is the Definition of Human Subject Research?
A: Human subject research are activities that include both a systematic investigation designed to develop or contribute to generalizable knowledge and involve a living individual about whom an investigator conducting research obtains information or biospecimens through intervention or interaction with the individual, or identifiable private information, or biospecimens.
In accordance with DoDI 3216.02, in order for an activity to be considered human subject research it must meet two criteria: 1) The investigator obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes, or generates identifiable private information, personally identifiable information, or identifiable biospecimens.
Q: What are Excluded Activities?
A: The following activities conducted or supported by the DoD are not considered human subject research IAW DoDI 3216.02:
a. Activities carried out solely for purposes of diagnosis, treatment, or prevention of injury and disease under force health protection programs of DoD, including health surveillance pursuant to 10 USC 1074f, and the use of medical products consistent with DoDI 6200.02.
b. Health and medical activities as part of the reasonable practice of medicine or other health professions undertaken for the sole purpose of diagnosis, cure, mitigation, treatment, or prevention of disease in a patient.
c. Activities performed for the sole purpose of medical quality assurance (see 10 USC 1102, and DoDI 6025.13).
d. Activities that meet the definition of operational test and evaluation as defined in 10 USC 139 (a)(2)(A).
e. Activities performed solely for assessing compliance, including occupational drug testing, occupational health and safety reviews, network monitoring, and monitoring for compliance with requirements for protection of classified information.
f. Activities, including program evaluation and surveys, user surveys, outcome reviews, and other methods, designed solely to assess the performance of DoD programs where the results are only for the use of government officials responsible for the operation or oversight of the program being evaluated.
Q: What is Exempt Research?
A: Human subjects research that is classified as “exempt” means that the research qualifies as no risk or minimal risk subjects and fit into one or more exempt categories. Exempt research applications are reviewed by the Armaments Center HRPP Exempt Determination Officer (EDO) and involve a shorter application form and generally a faster review process than non-exempt studies. Exempt research is human subject research that meets specific federal criteria in 32 CFR Part 219, falling into one of the eight categories of exempt research listed in 32 CFR 219.104. Exempt human subject research must be initially determined as exempt by an IRB, its designee, or designed DoD Human Research Protections Program (HRPP) personnel, and then is exempt from further review.
Q: When does Exempt Research Require Limited IRB Review?
A: Limited IRB review may be required for exempt categories listed in 45 CFR 46.104(d)(2)(iii), (d)(3)(i)(C), (d)(7), or (d)(8) to ensure appropriate protections are in place for identifiable private information and identifiable biospecimens. The limited IRB review examines whether there are adequate provisions to protect the privacy of participants and maintain the privacy of the data. This review should be conducted by an IRB member who is knowledgeable about these facets of research.
Q: What is Expedited Research?
A: In order to qualify for review via expedited procedures, the research must not be greater than minimal risk* and fall into at least one of the expedited categories defined by the federal regulations. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal risk.
*Minimal risk is defined by the federal regulations as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
The expedited review category is used for certain types of research involving no more than minimal risk and minor changes to research previously approved by the full committee, during the period for which approval has been authorized. Research eligible for expedited review is also reviewed by the IRB.
Q: What a Full Board Review?
A: Studies are reviewed by the full board when they involve more than minimal risk to research subjects or do not otherwise fit into a minimal risk category of research.
Q: What is the IRB?
A: The Armaments Center Institutional Review Board (IRB) is a component of the Armaments Center Human Research Protection Program. The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member who is not affiliated with the institution and one member who is not a scientist. The IRB is made up of scientists, engineers, medical professionals and non-scientists. Its duty is to ensure the protection of people enrolled in research studies. If the IRB does not approve a study, a study cannot start. All studies involving human participants conducted at the Armaments Center must be reviewed and approved by the Armaments Center IRB. The Principal Investigator (researcher) may be required to return to the IRB any time there is a change and report the progress of the study at least annually.
Q: What is an IRB Reliance Agreement?
A: It is an agreement between engaged institutions for the single IRB review for a research study. The agreement is made between the institutions for one or more institutions to cede review to another institution that is not organizationally or legally part of the institution. DoD calls these agreements Institutional Agreement for Institutional Review Board Review (IAIR).
Q: Why do I need a Scientific Review in addition to an IRB review?
A: Documentation of Scientific Review means the project must be reviewed for scientific merit by independent subject matter expert(s). Three possible ways this can be done are:
Scientific review is incorporated into the IRB process and documented in the external IRB approval letter (if applicable);
Standard operating procedure from the reviewing institution detailing the scientific review process.
Completion of the Armaments Center scientific review form by an independent subject matter expert.
Q: How Long Are Review Times?
A: Review times are based on several factors:
1.The quality and completeness of the submission.
2.The number of studies in the queue at the time of the submission. Studies are reviewed in the order in which they are received.
3.The length of time it takes researchers to respond to review stipulations and requests for clarification. Submissions are administratively withdrawn from review if the PI does not respond within 60 days.
4.The availability of IRB members to review submissions.
Q: How Often Does the Armaments Center IRB meet?
A: The Armaments Center IRB meets twice a month and reviews research studies as well as conducted educational training sessions for IRB members.
Q: Why do I need a HRPO review if the study has already been approved?
A: The Department of Defense Instruction 3216.02 stipulates that Human Research Protection Official (HRPO) reviews are required to ensure the Armaments Center HRPP concurs with the decision made by an external IRB. The HRPO review ensures that the rights, safety, and welfare of the research volunteers are adequately protected. HRPO reviews may still be required even if Armaments Center serves as the IRB of record because it is possible that the project is both an internal and external project. External research is defined as any time Armaments Center provides support for research (funding, facilities, equipment, CRADA, etc.) to a non-DoD institution. A Human Research Protection Official (HRPO) review is required for all external research. A HRPO review is also required for any external approval of exempt determinations. The HRPO review must concur with all IRB determinations before any research activity can begin. The HRPO review is an administrative/regulatory review only. It is not a secondary IRB review and the HRPO cannot impose any additional stipulations/conditions for the PI.
Q: What if I was asked to participate in a study don’t I want to be part of a study?
A: After you are asked to join and listen to all of the information about the study, you decide
whether or not you wish to participate. You are under no obligation to participate in any study.
Voluntary permission in required order to participate in a research study. You will not be a participant in a study without your knowledge and consent. You are under no obligation to participate in any research study. Your decision will not affect any potential benefits you may receive at the Armaments Center or from the U.S. Army.
Q: What information is provided about a study to a potential volunteer?
A: The consent process will contain the following:
- An invitation to be part of the research and who will sponsor the study.
- An explanation of why the study is being done and a description of the study procedures.
- Information about who may participate in the study.
- Detailed information on any bad effects (risks) as well as any good effects (benefits) that may occur in the study.
- Identify who will have access to your personal information, and who will be able to use information obtained from the study.
- Identify who you may ask for more information about the study or about your rights as a participant in the research study.
The consent form may be long because it is important for you to have all the information needed to make an informed decision. There will be time to answer your questions. You will receive a copy of the consent form after you sign it so that you may refer to it when needed.
If you feel you have been pressured to sign a consent form, please contact the Armaments Center HRPP Office.
Q: I signed up to be part of a study but what if I change my mind?
A: You may change your mind at any time and leave the study. It will have no effect on your work, command or relationship with the Armaments Center.
Q: Who can I contact if I have more questions?
A: There are several people you can reach out to if you have more questions:
- The PI is available to answer questions about the study.
- The Armaments Center Human Protection Director is available to answer questions about your rights as a research subject.
- If you would like more information about how research is conducted, how it is overseen, or if you have questions about your rights as a research subject, please contact our office.