IM OSQI 2026-02 USGS Human Research Protections Program
U.S. GEOLOGICAL SURVEY DIRECTIVE
INSTRUCTIONAL MEMORANDUM
Issuance Number: OSQI 2026-02
Subject: USGS Human Research Protections Program
Issuance Date: May 1, 2026
Expiration Date: Retain until superseded or cancelled.
Responsible Office: Office of Science Quality and Integrity
Instruction: This is a new Survey Manual (SM) Instructional Memorandum (IM).
Approving Official: /s/ William (Bill) Cunningham
Acting Director, Office of Science Quality and Integrity
1. Purpose and Scope.
The U.S. Geological Survey (USGS) is committed to the safe and responsible execution of Bureau research activities. The USGS is further committed to ensuring human safety by providing guidelines and procedures that maintain safeguards and protections against public harm while planning and conducting Bureau research activities.
This directive outlines the core principles that guide USGS research involving or affecting human subjects. It defines professional, institutional, and ethical standards and establishes the USGS Human Research Protection Program along with review processes through an Institutional Review Board (IRB). This directive also addresses the process for determining whether Bureau research involves human subjects (as defined in Section 4C and 4I) and if proposed research is exempt from IRB review (as defined in Section 4B). The directive applies to personnel planning and executing USGS research, including employees, volunteers, external partners, emeriti, contractors, and students (further referred to as “USGS personnel”).
2. Authority.
A. Protection of Human Subjects, Common Rule, 45 CFR Part 46, eCFR :: 45 CFR Part 46 -- Protection of Human Subjects
B. The Privacy Act of 1974, Pub Law No. 93-579, 88 Stat 1896 (Dec. 31, 1974), codified at 5 U.S.C. § 552a (2018) STATUTE-88-Pg1896.pdf
C. Freedom of Information Act 2016, Public Law No. 114-185, S.337 - 114th Congress (2015-2016): FOIA Improvement Act of 2016 | Congress.gov | Library of Congress
D. Paperwork Reduction Act of 1995: Text - S.244 - 104th Congress (1995-1996): Paperwork Reduction Act of 1995 | Congress.gov | Library of Congress
E. Foundations for Evidence-Based Policymaking Act of 2018 STATUTE-132-Pg5529.pdf
3. References.
A. SM Part 502 USGS Fundamental Science Practices Policies; Program Series, 500.1-1100.7
B. SM 431.1 - Records Management Roles and Responsibilities
C. 32 CFR 2002 - Controlled Unclassified Information (CUI); 32 CFR 2002 - CONTROLLED UNCLASSIFIED INFORMATION (CUI) - Content Details - CFR-2024-title32-vol6-part2002
4. Definitions. The definitions provided below are specific to their use within this policy document.
A. Common Rule. The federal regulation that establishes ethical standards and procedural requirements for biomedical and behavioral research involving human subjects as codified in Title 45, Code of Federal Regulations (CFR), Part 46.
B. Exempt Research. USGS research that is determined not to require initial or continuing IRB review as per exemption criteria in 45 CFR Part 46.104 may qualify as exempt. This includes, but is not limited to, activities involving human subjects in which the identity of individuals cannot readily be ascertained, and participation does not place the human subject at greater than minimal risk.
C. Human Subject. A living individual about whom a USGS scientist, staff member, or representative is conducting research:
(1) Obtains information or biospecimens through intervention or interaction with the individual, and subsequently uses, studies, or analyzes that information or material; or
(2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
D. Identifiable Biospecimen. A biospecimen for which the identity of the human subject is or may readily be ascertained by the USGS personnel conducting the work or the identity can be associated with the biospecimen in a different way.
E. Identifiable Private Information. Private information for which the identity of the human subject is or may readily be ascertained by the USGS personnel conducting the work or the identity can be associated with the biospecimen in a different way.
F. Institutional Review Board (IRB). A committee responsible for reviewing and overseeing research involving human subjects that ensures compliance with applicable regulations, adherence to institutional policies, and the adequate protection of human subjects. The IRB shall be established in accord with and managed consistently with the purposes expressed in 45 CFR Part 46.
G. Minimal Risk. The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life, work, or during the performance of routine physical or psychological examinations or tests.
H. Private Information. Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
I. Research.1 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 this policy, 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. For purposes of this part, the following activities are deemed not to be 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, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are 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 (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include 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 each agency) in support of intelligence, homeland security, defense, or other national security missions.
1 This definition of research is adopted from the Common Rule (45 CFR Part 46) for the purposes of this policy and in the context of Human Research Protection Program administration. This definition is necessary to maintain consistency with standards of practice set across Federal agencies in the context of human subjects research.
5. Policy.
A. The USGS operates a Human Research Protection Program that establishes and maintains guidelines and procedures to meet professional, institutional, and ethical standards for USGS research involving or affecting human subjects.
B. The USGS maintains an IRB that reviews USGS research involving or affecting human subjects.
C. The USGS OSQI must exempt or the USGS IRB must approve any research involving human subjects that the USGS conducts or supports (e.g., through funding or in-kind intellectual contribution) before work involving human subjects can begin.
D. USGS personnel who have a role in research involving or affecting human subjects must receive training in aspects of human subject research to ensure they understand and can perform their responsibilities in compliance with this directive.
6. Responsibilities. Specific responsibilities for the effective operation of the USGS Human Research Protection Program are as follows:
A. USGS Director and Deputy Director(s). The Director and Deputy Director(s) in coordination with other members of the Executive Leadership Team (ELT), jointly ensure the Human Research Protection Program supports the mission of the Bureau. As part of this coordination, they demonstrate the organization’s commitment to protection of human subjects through provision of resources and support.
B. Associate Directors, and Regional Directors. The Deputy Director for Operations, Associate Directors, and Regional Directors provide management for the processes in their chain of command. They collaborate with one another, Science Center Directors (or equivalent), and the Office of Science Quality and Integrity to ensure USGS research involving or affecting human subjects is conducted according to guidelines as identified by the Human Research Protection Program or IRB review. They ensure adequate resources are available to support compliance with current regulations and directives, and that human research protection issues identified within their areas are addressed appropriately and effectively.
C. Science Center Directors. Science Center Directors (or equivalent), along with designated center management and supervisors ensure research involving human subjects within their organizational unit is conducted and monitored in accordance with the requirements of this directive and applicable regulations. Science Center Directors (or their designee) ensure that unanticipated issues or problems are reported to the Human Research Protection Program and ensure that effective corrective actions are taken in response to the problem.
D. Office of Science Quality and Integrity (OSQI). OSQI serves as the office of primary responsibility for administration and oversight of this directive. OSQI maintains this and related policy documents and procedures pertaining to projects involving human subjects; manages the Human Research Protection Program in association with the Senior Scientist for Human Research Protections; and ensures sufficient staffing to support administration and oversight of the program. OSQI staff will provide decisional authority for carrying out program activities including, but not limited to, determining whether a research project meets the criteria for human subjects research; review of USGS research involving human subjects to apply the appropriate review process; and IRB management.
E. Institutional Review Board (IRB). The IRB reviews human subjects research in compliance with 45 CFR Part 46 to ensure that the rights and welfare of human subjects are protected and that the study complies with applicable laws, regulations, and directives, as well as standards of professional conduct and practice. The IRB conducts reviews of proposed research, continuing reviews of ongoing research, amendments to approved research, closure requests, all adverse events, unanticipated problems involving risks to human subjects or others, deviations and violations. The IRB may approve, require modifications (to secure approval), or disapprove research.
F. USGS Personnel. USGS personnel performing human subject research are responsible for complying with this directive. This includes recognizing when proposed and ongoing research will potentially involve human subjects as defined by established policies and communicates to their supervisor; takes efforts as directed in this policy and by the IRB to minimize harms to human subjects, ensures all research involving human subjects is identified as exempt by the OSQI or approved by the IRB prior to work with human subjects begins.