PURPOSE OF THIS POLICY

The purpose of this policy is to articulate the Colorado State University’s guiding principles and program elements for the ethical conduct of research involving human subjects/participants.

APPLICATION OF THIS POLICY

This policy applies to all CSU employees, including faculty, staff, and student employees, students, and all others engaged in activities that meet the regulatory definition of research involving human subjects or clinical investigation involving human subjects and conducted under the auspices of CSU.

EXEMPTIONS OF THIS POLICY

None.

DEFINITIONS USED IN THIS POLICY

The University defines research involving human subjects/participants using current Department of Health and Human Services and/or Food and Drug Administration definitions. The current definitions are as follows, with citations to the relevant code of federal regulations (CFR).

Human Subject as Defined by DHHS: A living individual about whom an investigator (whether professional or student) conducting research:

1. Obtains information or biospecimens through Intervention or Interaction with the individual, and uses, studies, or analyzes the information or biospecimens(45 CFR 46.102(e)(1)); or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

For the purpose of this definition:

• Human Subject as Defined by FDA: An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used (21 CFR 50.3(g)).
• Identifiable Biospecimen: A biospecimen for which the identity or the subject is or may be readily ascertained by the investigator or associated with the biospecimen.
• Identifiable Private Information: Private Information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
• Interaction: Communication or interpersonal contact between investigator and subject
• Intervention: Physical procedures by which information or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. 

1.1     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 which has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).

1.2     Institutional Official (IO): Term utilized by DHHS. The Institutional Official (IO) is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance. The IO is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. The IO represents the institution named in the Federal wide Assurance (FWA)[i]. The IO for Colorado State University is the Vice President for Research.

Research: Research as Defined by DHHS: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

1.2.1.1     The following activities are not considered Research as Defined by DHHS:

1.2.1.2     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.

1.2.1.3     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.

1.2.1.3.1     Including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.

1.2.1.3.2     Including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.

1.2.1.3.3     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).

1.2.1.4     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.

1.2.1.5     Authorized operational activities (as determined by the relevant federal agency) in support of intelligence, homeland security, defense, or other national security missions.

1.2.1.6     Secondary research involving non-identifiable newborn screening blood spots.

1.3     Research as Defined by FDA: Any experiment that involves a test article and one or more Human Subjects, and that meets any one of the following:

1.3.1     Must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice;

1.3.2     Must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR

1.3.3     Any activity 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.

POLICY STATEMENT

Colorado State University (the University) is committed to ensuring the safety, rights, and welfare of all human subjects/participants in research conducted at or by the University. All research, funded or not funded, involving human subjects/participants conducted by members of the University community (employees, officials, students, and agents) or using University facilities or resources will be governed by the Human Research Protection Program (HRPP). The HRPP is guided by the ethical principles of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the “Belmont Report”), applicable professional and ethical standards and codes, and carried out in compliance with applicable federal laws, state laws and University policies or procedures.

POLICY PROVISIONS

The Office of the Vice President for Research (OVPR) is responsible for the HRPP. The HRPP is the core ethical, regulatory, administrative organizational umbrella under which all aspects of the University’s human subject/participants protection activities are directed and managed. The HRPP implements policies and practices to ensure the adequate protection of human subjects/participants to be compliant with relevant laws, professional and ethical standards, and to support and enhance the researchers’ endeavors.

The HRPP includes the following elements:

• Oversight for all human subjects/participants research conducted by or at the University. No research involving human subjects/participants may be conducted without review and oversight by the Institutional Review Board (IRB) or other entities designated by the HRPP to ensure the protection of human subjects/participants in accordance with the HRPP Plan.
• A University designated Official (IO), who is legally authorized to act for and on behalf of the University in matters related to human subjects/participants research and the protection of human subjects/participants. The IO is responsible for ensuring that the HRPP is adequately resourced to protect the rights and welfare of human subjects/participants and functions in compliance with the requirements applicable to research involving human subjects/participants.
• A written HRPP Plan [https://colostate.sharepoint.com/:b:/s/HRPP/EUxKqK-KU9hDmUZ6Ml4qcxYBZPN5pO8NOEQdhodJeIvNug ]specifying procedures governing the conduct of human research to promote institutional and individual compliance with applicable regulatory, legal, external sponsor, and ethical standards. The HRPP Plan may include definitions, functions of the IRB(s), integration of research integrity standards, steps for quality assurance and compliance monitoring, and processes for reviewing ethics concerns. The HRPP plan will document procedures for determining when activities are overseen by the HRPP. The HRPP is subject to the approval of the IO. Unless necessary to immediately protect the rights and welfare of human research participants, significant changes to the HRPP Plan which divert from regulatory standards will be executed with appropriate consultation from stakeholders.
• Institutional Review Board(s) (IRBs) with independent authority to review, approve, suspend, terminate, and monitor research involving human subjects/participants.
• Maintain any federal, state, and other registrations and/or assurances.
• Mechanisms for education, training and support to investigators.
• The HRPP collaborates with various university-wide compliance groups, including but not limited to the Institutional Biosafety Committee (IBC), Conflict of Interest Committee (COI), Environmental Health Services (EHS) - Radiation Safety Committee (RSC), Office of General Counsel (OGC), Risk Management, IACUC, Office of Sponsored Programs (OSP), Tribal and Indigenous Communities, Institutional Research (IR), and Export Control. This collaboration involves an ancillary review of protocols in the Kuali protocol system.
• Processes to seek input from stakeholders and support continuous improvement in the HRPP.

COMPLIANCE WITH THIS POLICY

Compliance with this policy is required. For assistance with interpretation or application of this policy,  please contact the Human Research Protection Program Office at HRPP_Info@colostate.edu.

REFERENCES

• Protection of Human Participants – Institutional Review Board
• The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
• Revised Common Rule, PROTECTION OF HUMAN SUBJECTS, 45 CFR 46
• Institutional Review Boards, 21 CFR Part 56
• HRPP Resource documents
• Regulations, Policy & Guidance | HHS.gov
• Guidance for Sponsors, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable; Availability

APPROVALS

Effective March 27, 2011

Revision approved by Lynn Johnson, Vice President for University Operations on February 17, 2020

Revision approved by Brendan Hanlon, Vice President for University Operations, on November 1, 2024