ELEMENT I.1.A.

ELEMENT I.1.A.: The organization has and follows written policies and procedures for determining when activities are overseen by the Human Research Protection Program.

An organization should explain in written materials how to differentiate activities that are research involving human participants from activities that are not research involving human participants. Activities that are determined to meet the definition of research involving human participants subsequently fall under the auspices of the HRPP.

A determination of whether an activity is research involving human participants must consider the regulations, laws, codes, and guidance that the organization follows. Many organizations oversee or conduct activities that are covered by two or more sets of laws, regulations, codes, and guidance. In these cases, the organization must apply all relevant definitions of research and participant or develop a plan that guides the HRPP in determining which definitions apply in specific research instances. Written materials must describe equivalent protections for research not covered by laws, regulations, codes or guidance.

If an organization follows DHHS regulations, written materials should describe requirements in state or local laws, tribal laws, and foreign laws, when they provide additional protections beyond those in DHHS regulations.

If the organization follows neither the DHHS nor the FDA regulations, the organization should define “research” as a systematic investigation designed to produce or contribute to generalizable knowledge and “human participant” as living individuals about whom information is obtained or with whom there is interaction, or develop an equivalent definition.

The person making a decision about whether an activity represents research involving human participants should have the authority to represent the organization and have no direct involvement in the activity he or she is examining. The person making the decision should be familiar with regulations, organizational policies, and the nature of research.

Written materials should describe the communication of such decisions to the person seeking a decision.

Regulatory and guidance references

DHHS: 45 CFR 46.101(a), 45 CFR 46.101(f-h), 45 CFR 46.101(l), 45 CFR 46.102(b), 45 CFR 46.102(e), 45 CFR 46.102(l); OHRP FAQ Newborn Blood Spot
DoD: Instruction 3216.02 6 paragraph 13.a-e., DODI 3216.02
DOE: 10 CFR 745, DOE Order 443.1C (November 2019)
DOJ: 28 CFR 512.10
FDA: 21 CFR 50.1, 21 CFR 50.3(a), 21 CFR 50.3(c), 21 CFR 50.3(g), 21 CFR 50.3(j), 21 CFR 56.101, 21 CFR 56.102(c), 21 CFR 56.102(l)
VA: 38 CFR 16.102; VHA Directive 1200.05(3) section 3; VHA Directive 1200.01(1) section (3)

Required written materials

Essential requirements:
1. Written materials define “research involving human participants” so that all involved in the HRPP understand which activities are overseen by the HRPP.
  1. General definitions:
    1. Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, or an equivalent definition.
      1. Written materials define “a systematic investigation” relevant to the organization’s research portfolio.
      2. Written materials define “generalizable knowledge” relevant to the organization’s research portfolio.
    2. Human participant means a living individual about whom a researcher conducting research obtains data through intervention or interaction with the individual, or obtains identifiable private information, or an equivalent definition.
2. Written materials describe the process to provide determinations about whether an activity is research involving human participants, which includes:
  1. The entity or office that can provide a determination.
  2. Criteria used to make determinations.
  3. Process to inform individuals whether an activity is research involving human participants.
3. Written materials include:
  1. A description of the scope of human participants research that requires review by the organization’s IRB or EC (e.g., all research by employees or all research in facilities).
  2. A description of the criteria by which persons are considered engaged (agents) in the research and come under the requirements of the IRB or EC.
  3. Guidance to researchers and IRBs or ECs concerning activities that sometimes are or are not overseen by the HRPP at the organization, such as classroom research, quality improvement, case reports, program evaluation, and surveillance activities.
  4. A definition of any other activities the organization considers research, when these are outside the scope of activities covered by regulations or laws (e.g., research on non-living individuals).
  5. When activities are covered under other laws, the definition encompasses activities that are “research involving human participants” as defined by those laws. For example, many organizations in the US are also covered by HIPAA, and written materials need to incorporate the definition of research when following HIPAA.
4. Written materials include a description of the process the organization uses to track all open studies, even if ongoing review by an IRB or EC is not required.
5. Written materials describe the process for registering IRBs or ECs, when required by regulatory agencies.
When following DHHS regulations:
1. Written materials specify whether the organization:
  1. Applies the same policies used to comply with DHHS regulations to all research.
  2. Applies different requirements to research that is not covered by DHHS regulations.
2. Written materials describe whether the organization will apply the revised Common Rule only to research approved after January 21, 2019, or whether it will apply the revised Common Rule to research approved prior to this date.
3. The definition of "research involving human participants" encompasses activities that are “research” and involve “human subjects” as those terms are defined by DHHS regulations:
  1. Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
  2. Human participant means a living individual about whom a researcher conducting research:
    1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens.
    2. Obtains uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
  3. Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
4. The following activities are not considered research:
  1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  2. Public health surveillance activities conducted by a public health authority, limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.
    1. Including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.
    2. Including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.
    3. Including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  4. Authorized operational activities (as determined by the relevant federal agency) in support of intelligence, homeland security, defense, or other national security missions.
When following DoD requirements:
1. Human participant research involving the testing of chemical or biological agents is prohibited, pursuant to Section 1520a of Title 50, United States Code (U.S.C.). Some exceptions for research for prophylactic, protective, or other peaceful purposes apply. Before any excepted testing of chemical or biological agents involving human participant research can begin, the DoD component seeking to conduct such research must obtain explicit written approval from the DoD Office for Human Research Protections (DOHRP).
2. Written materials ensure “research involving a human being as an experimental subject” is conducted in accordance with 10 USC 980, as implemented by DoDI 3216.02, section 3.11.
3. Classified research is defined in DoDI 3216.02 section 3.13.
When following DOE requirements:
1. DOE requirements apply to all research conducted with DOE funding, at DOE institutions (regardless of funding source), or by DOE or DOE contractor personnel (regardless of funding source or location conducted), whether done domestically or in an international environment, including classified and proprietary research.
  1. When research involves contractors, DOE “Contractor Requirements Document” describing contractor responsibilities for protecting human research participants must be included in contracts.
  2. Policies and procedures must specify whether the organization conducts classified research.
2. Research that uses social media data must be submitted to the appropriate IRB for human participant research review and determination.
3. Research that involves the study of humans in a systematically modified environment must be submitted to the appropriate IRB for HSR review and determination.
4. Classified and unclassified human participant research that is funded through the Strategic Intelligence Partnership Program (SIPP) must be reviewed and approved by the Central DOE IRB-Classified.
5. Human Terrain Mapping (HTM) is managed as research involving human participants.
  1. Policies and procedures must specify whether the organization engages in DOE human terrain mapping research.
When following DOJ requirements:
1. For research conducted within the Bureau of Prisons: Implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research.
When following FDA regulations:
1. Research is any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505 (i) or 520 (g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations.
2. Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject might be either a healthy individual or a patient. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used.
3. When medical device research involves in vitro diagnostics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects.
When following VA requirements:
1. VA research is research that is conducted by researchers serving on VA compensated, without compensation (WOC), or interagency personnel agreement (IPA) appointments while on VA time or on VA property. The research may be funded by VA, by other sponsors, or be unfunded. VA research must have Research and Development (R&D) Committee approval before it is considered VA Research and before it can be initiated. All research activities approved by the R&D Committee are considered VA Research.
2. VA-affiliated nonprofit research and education corporations (NPC) are authorized by Congress under 38 U.S.C. 7361-7366 to provide flexible funding mechanisms for the conduct of research and education at one or more VA facilities. Research approved by a facility R&D Committee and education approved by the facility Education Committee are considered to be a VA research project or a VA education activity respectively, regardless of the source of funding, the entity administering the funds, or the research or education site.
3. VA research includes VA-approved research conducted at international sites not within the United States, its territories, or Commonwealths; and includes any VA-approved research using either identifiable or de-identified human biological specimens or identifiable or de-identified human data originating from international sites, or any VA-approved research that entails sending such specimens or data outside the United States.
4. The VA does not conduct classified research involving human participants. Classified research is research that is considered restricted or secret by the Federal government, sponsor, or any third party. For example, research for the Federal government that is considered sensitive or would affect national security.

Common types of materials that may be used to meet the element

Application form
Reviewer checklist
Template letters to researchers

Outcomes

The organization is able to determine and recognize when an activity is research involving human participants as defined by its policies and procedures.
Decisions about whether an activity is research involving human participants are made promptly.
Decisions about whether an activity is research involving human participants are made accurately.
Researchers and others receive a decision about whether an activity is research involving human participants.

Proceed To: ELEMENT I.1.B.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.1.A.