Policies and Procedures Involving Human Subjects

Preamble

Research involving human subjects conducted under the aegis of State University of New York Plattsburgh is subject to review and oversight by the Institutional Review Board (IRB), previously referred to as the Committee on the Protection of Human Subjects (IRB), in accordance with applicable federal, state, sponsor, and institutional requirements. Activities that do not constitute research involving human subjects under applicable law may nevertheless be subject to institutional review under this policy.

In reviewing research, IRB shall consider the rights and welfare of participants, the adequacy of the proposed informed-consent process, the risks and potential benefits of the research, equitable selection of subjects, privacy and confidentiality protections, and all other criteria required by applicable law and institutional policy.

This policy is intended to implement the federal protections applicable to human-subjects research, including 45 CFR part 46 when applicable. Where a sponsor, federal agency, state law, FDA requirement, or other applicable authority imposes additional requirements, the stricter applicable requirement shall be followed to the extent legally permissible.

A. When to Submit a Protocol to the Institutional Review Board

The protection of human subjects is paramount. Research involving human subjects must be designed and conducted in accordance with applicable federal requirements, including 45 CFR part 46 when applicable, and with institutional requirements. Investigators remain responsible for conducting research in accordance with the approved protocol and applicable requirements.

Before beginning research involving human subjects, the investigator shall determine through the IRB process whether the activity: (1) is not research involving human subjects; (2) qualifies for an applicable exemption under 45 CFR 46.104, when that regulation applies; (3) is eligible for expedited review; or (4) requires review by the convened IRB. Investigators may not independently make a final institutional exemption determination unless IRB procedures expressly authorize that process.

Research supported or conducted by HHS, or otherwise subject to the Common Rule, shall be reviewed under the applicable version of 45 CFR part 46. Research subject to FDA requirements, Department of Education requirements, Department of Justice requirements, or another agency-specific rule shall also comply with those requirements when applicable.

Category I — Exempt Research and Required Limited IRB Review (45 CFR 46.104)

Research may be exempt when it meets one of the exemption categories in 45 CFR 46.104(d), as applicable. Exemption determinations shall be made through the institutional process designated by IRB; investigators shall not independently declare their own research exempt. Where 45 CFR 46.104 requires limited IRB review, IRB shall conduct and document that review.

The current exemption categories include, as applicable, research involving established educational practices; certain educational tests, surveys, interviews, or observation of public behavior; certain benign behavioral interventions; secondary research involving identifiable private information or identifiable biospecimens under specified conditions; certain federal research; certain consumer food and beverage studies; and specified storage/maintenance or secondary-use activities. The precise conditions of 45 CFR 46.104(d) control.

Exemption Category 1 may apply to research conducted in established or commonly accepted educational settings that specifically meets the requirements of 45 CFR 46.104(d)(1). Classroom activities that are not research involving human subjects are outside the federal Common Rule, although they remain subject to applicable institutional requirements.

Observation of public behavior may qualify for exemption only when the specific requirements of the applicable 45 CFR 46.104(d) exemption are satisfied. Additional limitations apply when identifiable information is recorded, when investigators intervene in or participate in the behavior observed, or when other regulatory provisions apply.

Secondary research involving existing information or biospecimens may qualify for an exemption under 45 CFR 46.104(d) only when the conditions of the applicable exemption are satisfied. Public availability is not the sole test for exemption, and identifiable information or biospecimens may be covered by specific exemption provisions.

When an exemption category requires limited IRB review, IRB shall determine whether the required safeguards for privacy, confidentiality, or other regulatory criteria have been satisfied and shall document that determination.

Category II — Research Eligible for Expedited Review

Research may be reviewed under the expedited-review procedure when it meets the applicable federal criteria, including eligibility under the expedited-review categories and the requirements of 45 CFR 46.110. Expedited review is a review procedure; it is not a separate federal category of research.

IRB may use expedited review for eligible minimal-risk research and for eligible minor changes in previously approved research. Eligibility shall be determined under the federal expedited-review framework and current institutional procedures. The fact that research is minimal risk does not, by itself, establish eligibility for expedited review.

Category III — Research Requiring Convened IRB Review

Research requiring review by the convened IRB shall include research that is not eligible for exempt or expedited review, including research for which convened review is required by applicable federal regulations or institutional policy. Greater-than-minimal-risk research ordinarily requires convened review unless an applicable regulatory provision permits another review procedure.

Research involving children, prisoners, pregnant women, fetuses, or neonates must comply with any applicable additional federal protections in 45 CFR part 46, subparts B, C, and D. The involvement of a particular population does not, by itself, automatically require convened review. Persons with disabilities are not automatically subject to a separate federal full-review category solely because of disability.

B. The IRB Review Process

IRB shall review proposed research in accordance with 45 CFR 46.107–46.115, when applicable, and institutional procedures. Review shall be conducted by the appropriate mechanism — exemption determination, limited IRB review, expedited review, or convened review.

No research requiring IRB review may proceed without the required IRB approval. Activities that are formally determined to be exempt, activities that do not constitute research involving human subjects, and other activities specifically excluded from IRB review may proceed in accordance with the applicable institutional process.

IRB may suspend or terminate approval when research is not being conducted in accordance with IRB requirements or when continuation would not adequately protect participants. Suspension or termination shall be documented, communicated to the investigator, and handled in accordance with applicable federal and institutional requirements.

C. How to Prepare a Protocol

A submission shall provide sufficient information for IRB to make the determinations required by applicable regulations. Depending on the research, the submission shall address:

1. Purpose, significance, and objectives of the research.
2. The population of human subjects; inclusion and exclusion criteria; recruitment procedures; compensation, if any; and procedures for protecting privacy and confidentiality.
3. The research procedures, interventions, data or specimens to be collected, duration of participation, foreseeable risks, potential benefits, and alternatives when applicable.
4. The proposed informed-consent process and documentation, including any request for waiver or alteration of consent and the regulatory basis for the request.
5. Safeguards for vulnerable populations and any applicable requirements under 45 CFR part 46, subparts B, C, or D, or other agency-specific requirements.
6. Data-security, confidentiality, and record-retention procedures.
7. Plans for reporting unanticipated problems, noncompliance, protocol deviations, adverse events when applicable, and other reportable information.

8. Any reliance on another IRB, single-IRB arrangement, or cooperative-research agreement.

D. Student and Classroom Research

Faculty and students may not independently declare research exempt unless the institutional process expressly authorizes such a determination. IRB may establish an instructor-supervised process for class research that qualifies for exemption or does not constitute human-subjects research, provided the process documents the applicable determination and required safeguards.

Student research that constitutes research involving human subjects must be supervised in accordance with IRB requirements. The instructor or faculty supervisor is responsible for ensuring that students conduct only activities that have been appropriately determined or approved.

Instructional demonstrations that do not constitute research involving human subjects generally do not require IRB review. Instructors remain responsible for protecting the rights and welfare of students or other individuals who participate in instructional activities.

Human-subjects training requirements shall be established by IRB and shall apply to students, instructors, investigators, and other personnel as appropriate.

E. Additional Institutional Requirements

1. Communications with IRB shall be submitted through the institutional office designated by SUNY Plattsburgh.

Continuing review shall be conducted when required by applicable federal regulations or when IRB determines that continuing review is warranted as an institutional requirement. Under the 2018 Common Rule, continuing review is not universally required for all approved research; investigators must nevertheless comply with IRB requirements for amendments, reporting, closure, and any continuing-review determination applicable to the study.

Investigators shall retain informed-consent documentation and other required research records for the period required by applicable federal, state, sponsor, and institutional requirements. Where 45 CFR 46 applies, IRB records shall be maintained in accordance with 45 CFR 46.115 and investigator records shall be maintained as required by applicable requirements.

1. Informed-consent records and research data shall be stored securely and separately when necessary to protect confidentiality, unless the approved protocol provides another compliant arrangement.
2. Unanticipated problems involving risks to subjects or others, serious or continuing noncompliance, suspensions or terminations, and other reportable events shall be reported to IRB within the time and manner established by IRB procedures and applicable regulations.
3. Amendments to approved research must receive the required IRB approval before implementation, except where an immediate change is necessary to eliminate an apparent immediate hazard to a subject. Such emergency changes must be reported promptly as required by IRB procedures.

F. Informed Consent

“Informed consent” means legally effective consent obtained in accordance with applicable requirements, including 45 CFR 46.116 and 46.117 when applicable. Consent must be sought only under circumstances that provide sufficient opportunity to consider participation and minimize coercion or undue influence.

When informed consent is required, the process and documentation shall satisfy the applicable federal requirements. The information provided must be in language understandable to the prospective subject or legally authorized representative.

The consent process must begin with a concise and focused presentation of the key information that would assist a reasonable person in deciding whether to participate. The consent process must provide sufficient additional information to permit an informed decision.

The consent process and document shall contain the elements required by 45 CFR 46.116, as applicable, including the purpose and procedures of the research; duration; reasonably foreseeable risks or discomforts; benefits when appropriate; alternatives when applicable; confidentiality; compensation and medical treatment for injury when applicable; contacts for questions about the research, research subjects’ rights, and research-related injury; voluntariness; and the subject’s right to discontinue participation without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements shall be included when applicable under 45 CFR 46.116(c) and (d), including statements concerning unforeseeable risks, circumstances for termination, additional costs, consequences of withdrawal, significant new findings, commercial profit and biospecimen use, and whether clinically relevant research results will be returned.

Consent may be obtained from a legally authorized representative when permitted by applicable law and regulation. For research involving children, parental permission and child assent shall be obtained when required by 45 CFR part 46, subpart D and the approved protocol.

IRB may approve a waiver or alteration of informed consent only when the specific regulatory criteria are satisfied and documented, including the applicable requirements of 45 CFR 46.116(e) or (f).

Documentation of informed consent shall comply with 45 CFR 46.117 when applicable. IRB may approve an alternative method of documenting consent when the regulatory requirements for that alternative are satisfied.

G. Student Research

All student investigators conducting research involving human subjects must have the faculty supervision required by IRB. The faculty supervisor is responsible for ensuring that students conduct only research activities that have been appropriately determined or approved.

Class projects may be reviewed as one proposal when the project design and procedures permit such treatment and IRB procedures authorize it. If students use materially different procedures, each procedure or group of procedures must receive the required determination or review.

Students are not prohibited from conducting research requiring convened IRB review. The applicable level of review shall be determined by the federal regulations and institutional procedures, not by the anticipated speed of approval.

H. Cooperative Research, Reliance, and Single-IRB Arrangements

When research is conducted in cooperation with another institution, IRB shall determine whether a reliance agreement, single-IRB arrangement, or other formal authorization is required. For federally funded cooperative research subject to 45 CFR 46.114, the institution shall follow the applicable single-IRB and reliance requirements, subject to the regulatory exceptions and agency-specific requirements.

A reliance arrangement does not eliminate the investigator’s responsibility to comply with the reviewing IRB’s approved protocol and all applicable institutional requirements.

I. Records, IRB Operations, and Reporting

IRB shall maintain the records required by applicable regulations, including approved protocols, consent documents as required for IRB records, continuing-review or other review determinations when applicable, correspondence, minutes, and records of actions taken by the IRB. Records shall be accessible for inspection and copying by authorized representatives as required by law.

IRB shall maintain written procedures addressing membership and conflicts of interest, review procedures, expedited review, exemptions and limited IRB review, continuing review when applicable, amendments, reporting requirements, suspension or termination, records, complaints, and other matters required by 45 CFR part 46 and applicable agency requirements.

J. Conflicts of Interest

No IRB member may participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information at IRB’s request. Investigators and other research personnel shall disclose financial or other conflicts as required by applicable institutional, sponsor, and federal requirements.

K. Federal and Agency-Specific Requirements

This policy establishes the institutional framework for human-subjects protection. When research is supported or conducted by a federal department or agency with requirements in addition to or different from the HHS Common Rule, investigators shall comply with those requirements. Examples include agency-specific regulations, FDA human-subject requirements, Department of Education requirements, Department of Justice requirements, and applicable sponsor terms and conditions.

Where a federal requirement applies only to HHS-supported or conducted research, the institutional determination of whether to apply that requirement more broadly shall be documented in institutional procedures or the applicable approval.

L. Definitions and Regulatory References

Terms such as “research,” “human subject,” “legally authorized representative,” “minimal risk,” “identifiable private information,” and “identifiable biospecimen” shall be interpreted consistently with the definitions in the version of 45 CFR part 46 applicable to the research.

Primary federal references: 45 CFR part 46, including Subpart A (2018 Requirements/Common Rule), Subpart B (pregnant women, fetuses, and neonates), Subpart C (prisoners), Subpart D (children), and Subpart E (IRB registration), as applicable. Investigators should also consult applicable agency-specific regulations and current OHRP guidance.