Research Protections Policies

RP03 The Use of Human Participants in Research

Policy Status: 

Active

Policy Steward: 

Associate Vice President for Research, Director of the Office for Research Protections

Contents:

PURPOSE:

The Pennsylvania State University (University) is positively and unequivocally committed to the promotion, encouragement, and facilitation of academic and clinical research in the broad area of general or specific measurements of human development, health, and performance. The University is dedicated to the ethical treatment of human participants in all research activities conducted under the auspices of this institution and assumes responsibility for safeguarding their rights and welfare. The purpose of this policy is to outline the University's standards for the protection of human participants of research.

POLICY:

The University's policy for the protection of human participants is guided by ethical principles, Federal law, and institutional standards. The guiding ethical principles are embodied in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.Compliance with this policy provides protections for human participants as mandated by applicable laws, regulations, and standards of local, state and Federal government agencies concerning the protection of human participants, including the U.S. Code of Federal Regulations (CFR):

  • Title 45 CFR 46, Protection of Human Subjects, U.S. Department of Health and Human Services (DHSS), Office for Human Research Protections (OHRP)  and
  • Title 21 CFR 50, 56, 312, 600 and 812 of the Food and Drug Administration (FDA) 

The University's policy for the protection of human participants also meets high institutional standards in its ethical principles and regulations. Institutional requirements are mandated for all research, not just federally-funded research.

The Institutional Review Board (IRB) is a specifically constituted administrative review board established for the purpose of protecting the rights and welfare of human participants who are recruited to participate in research. The jurisdiction of the IRB relates to the institution with which it is affiliated.

An Assurance is kept on file with the Department of Health and Human Services' (DHHS) Office for Human Research Protections (OHRP) covering all University colleges and campus locations, with the exception of the College of Medicine (COM), which maintains a separate Assurance with OHRP. The Pennsylvania College of Technology is excepted from both of these assurances. These Assurances set forth the policies for the protection of human participants, and include the duties and procedures of the IRBs.

University-related research, as defined by 45 CFR 46 and 21 CFR, 50, 56, 312, 600, and 812, involving human participants directly or through the use of records, tissues, or other indirect means must receive prior review and approval before any project can begin. Research involving human participants may not be conducted within or on behalf of the University without prior review and approval of the project prior to involving human participants.

Thus, the IRB is the final authority for safeguarding, as defined by 45 CFR 46 and 21 CFR, 50, 56, 312, 600, and 812, research involving human participants. Failure to have research involving human participants reviewed and approved by the IRB is a violation of University policy, Federal regulations, and the Assurance. In addition to review by the IRB, research may be subject to further appropriate review and approval or disapproval by the officials of the institution; however, those officials may not override a decision by the IRB to disapprove research.

DEFINITIONS:

This policy defines “human research” or “research involving human participants” as any activity that meets the DHHS definition of “research” which involves persons who meet the DHHS definition of “human participant,” OR any activity that meets the FDA definition of “research” which involves persons who meet the FDA definition of “human participant.”

“Research” under the DHHS regulations means a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR §46.102[d]).

Human participant” or "Human subject" under the DHHS regulations means a “living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information” (45 CFR §46.102[f])) . Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the participant or the participant’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and participant. Private information includes information about behavior that occurs in a context in which an individual can reasonable expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonable expect will not be made public (for example, a medical record). Private information must be individual identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants.

“Research” under the FDA regulations means any experiment that involves a test article and one or more human participants and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by the FDA as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study and clinical investigation are deemed synonymous for purposes of the FDA regulations (21 CFR §56.102[c]). In practice, all uses of drugs or medical devices constitute “research” under this definition unless the drug or device is both approved and being used in the course of medical practices. In addition, all uses of FDA-regulated test articles in which the results will be submitted to the FDA or held for inspection by the FDA constitute “research” under this definition.

Human participant” or "Human subject" under the FDA regulations means an individual who is or becomes a participant in research, either as a recipient of a test article or as a control. For medical device studies in which data will be submitted to the FDA or held for inspection by the FDA, a human participant includes a human on whose specimen an investigational device is used.

“Minimal risk” means that 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 or during the performance of routine physical or psychological examinations or tests (45 CFR §46.102[i]).

“Research Agreement” is defined as the mutually binding legal document between the funding entity and the University specifying the terms and obligations under which the externally-funded project services will be conducted.

APPLICABILITY:

Research conducted at the University includes both biomedical research and social science research. Due to the large volume and diverse nature of research conducted at the University, multiple IRBs have been established in order to provide the review and oversight for all research involving human participants. The committee members are appointed by the Associate Vice President for Research (located at University Park campus) or the Vice Dean for Research and Graduate Studies, Penn State COM (located at COM) to recommend and implement policies and regulations for the protection of human participants in research.

  1. The University has established two IRBs located at the University Park Campus. These IRBs review all of the research conducted by investigators from all University colleges and campus locations except the COM and the Pennsylvania College of Technology.
  2. Penn State's College of Medicine located at the Penn State Milton S. Hershey Medical Center (PSHMC) has established four IRBs to review and provide oversight for biomedical and social science research projects conducted at the COM and PSHMC, the University Park Regional Campus, and the Penn State Hershey Medical Group locations. PSHMC has a separate Assurance with OHRP and has designated the COM IRBs for the review of research under this Assurance. PSHMC has a written agreement with the COM documenting this reliance on the COM IRBs.

AUTHORITY OF THE IRB:

The IRB has the authority to review all human subject research in which the University is engaged (HRP-311 Engagement Determination), regardless of funding or research site, including the categories exempted or waived by OHRP or FDA regulations.

The IRB has the authority to:

  • Approve, require modification to secure approval, disapprove all research activities overseen and conducted by the organization;
  • Suspend or terminate IRB approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to participants;
  • Observe, or have a third party observe, the consent process; and
  • Observe, or have a third party observe, the conduct of the research.

The IRB will review and approve research conducted outside the United States of America by the University or PSHMC employees or students even if the foreign research receives no U.S. government funding. Such collaborative research activities must meet high ethical standards similar to those required within this policy. The IRB may approve such research, provided it determines that (a) the research conforms to proper codes of ethics (e.g., the Declaration of Helsinki or the Belmont Report), and (b) the research is approved by the foreign research site's ethical review authority. Requirements for the informed consent process will follow the laws and customs of the country in which the research is being conducted. If a U.S. Department or Agency funds the research, then it is probable that the foreign research site will need to file an FWA application. Instructions and templates for foreign research are available from OHRP (Assurances and IRB Registration).

TYPES OF IRB REVIEW:

Three levels of IRB review/approval for research involving human participants have been established: (1) Committee Review, (2) Expedited Review, and (3) Exempt Review. Each type of review is specifically defined in the Federal regulations. The University IRBs must follow these specifications for designating the review type to remain in compliance with the Assurances.

Committee Review - All projects involving human participants exposed to greater than minimal risks (including all research that exposes the participant to x-rays and/or microwaves) must be submitted for review by the IRB at a convened meeting. Such projects require submission of the application, a protocol, informed consent/assent form(s) (if applicable), and supporting documents (e.g., recruitment material, questionnaires, surveys, investigator brochures, and grant proposals [if applicable]).

Following initial review and approval by the IRB at a convened meeting, investigators conducting research designated by the IRB as Committee Review are required to do the following:

  • have all modifications to the research protocol reviewed and approved by the IRB prior to instituting them;
  • report to the IRB problems that require prompt reporting (see HRP-024 – SOP- New Information, , HRP-001 – Standard Operating Procedure:  Definitions, HRP-103 – Investigator Manual, Appendix A-1);
  • maintain IRB approval until data collection and analysis is complete and all research activity has ceased;
  • submit reports/information to the IRB as requested; and
  • submit progress reports at intervals stipulated by the IRB.

Expedited Review - All projects involving human participants exposed to no more than minimal risk, as defined above, or to no risk (e.g., existing record review, use of existing pathology, surveys) and that are included on the list of types of research designated by Federal regulations as qualifying for expedited review may be approved through the expedited review process (45 CFR 46.110). Such projects do not have to wait for a convened meeting of the full IRB, but may be reviewed and approved by the IRB chair or his/her designee, and reported to the IRB at a convened meeting. These projects require submission of the application, a protocol, informed consent/assent form(s) (if applicable), and supporting documents (e.g., recruitment material, questionnaires, surveys, and grant proposals [if applicable]).

Following initial review and approval by the IRB Chair or Chair's designee, investigators conducting research designated by the IRB as qualified for expedited review are required to do the following:

  • have all modifications to the research protocol reviewed and approved by the IRB prior to instituting them;
  • report to the IRB problems that require prompt reporting (see HRP-024- Standard Operating Procedure:  New Information, HRP-001 – Standard Operating Procedure:  Definitions, HRP-103 – Investigator Manual, Appendix A-1);
  • maintain IRB approval until data collection and analysis has been completed, and all research activity has ceased;
  • submit reports/information to the IRB as requested; and
  • submit progress reports at intervals stipulated by the IRB.

Exempt Research - Certain types of research may be found by the IRB to be exempt from IRB oversight (45 CFR 46.101[b]). At the University, investigators may not make an independent determination that research involving human participants is exempt from Federal regulations. Only a designated IRB member or qualified staff from the Office for Research Protections or Human Subjects Protection Office has the authority to make this determination following review of an application, a protocol, informed consent form(s), if applicable, and supporting documents (e.g., recruitment materials, questionnaires/surveys, and grant proposals, [if applicable]). For information on modifications that are required to be submitted at the exempt level, refer to HRP-103 – Investigator Manual.

Activities that do not meet the definition of human subject research do not require review and approval by one of the Organization’s IRBs and do not need to be submitted to one of the Organization’s IRBs unless there is a question regarding whether the activity is human subject research.  Any questions about whether an activity meets the regulatory definitions of human subject research should be referred to the IRB Office who will provide a determination.

OTHER INSTITUTIONS:

The IRB interacts with other institutions to ensure that IRB policies and procedures are followed when the University or PSHMC employees and students perform research at other institutions, or when personnel or students from other institutions perform research at the University or PSHMC facilities.

The IRB may agree to permit another federally sanctioned IRB to serve as the IRB of record for studies to be conducted by, or with the assistance of University personnel, at the facilities of a second institution. The IRB may agree to function as the IRB of record for another investigator and/or institution if the project involves material collaboration from University personnel. Such agreements will require written letters of agreement and may include the completion of additional documentation under the Federal-wide Assurance process. Copies of these agreements will be maintained at the respective administrative area.

REGULATORY AGENCIES:

As required by Federal regulations and by the Assurances, the IRB will contact directly the appropriate governmental authority at OHRP and/or FDA regarding questions or to notify them of reportable events, such as unanticipated problems involving risks to participants or others, serious or continuing investigator non-compliance, or termination or suspension of IRB approval of research rotocols.

RESEARCH AGREEMENT, FINANCIAL INFORMATION AND CONFLICT OF INTEREST:

The research agreement and financial information related to sponsored research, such as project budget, schedule of payments to the University and human participants, arrangements for medical care for research-related injury, and monetary payments, if offered, must be submitted to the Office of Sponsored Programs at the University Park Campus or the Office of Research Affairs at College of Medicine for review (see RA16 - this policy does not exist). If, as the project progresses, there are changes in financial arrangements, these new arrangements must be submitted to the Office of Sponsored Programs or the Office of Research Affairs for review and approval prior to instituting these changes. For federally funded projects, see RA04 - Making Revisions to Budgets and Program Plans on Federally Sponsored Projects. It is the policy of the University that neither it, nor its investigators, or other study personnel, will accept unauthorized incentives or bonuses tied to the rate of recruitment of project participants or to early enrollment of participants in clinical trials, whether such incentives or bonuses are offered as a part of a research agreement or at any other time. For the purposes of this policy, the terms, incentives, or bonuses include anything of value.

In accordance with University Policy RP06 - Disclosure and Management of Significant Financial Interests (formerly Policy RA20), all investigators (as defined in RP06) must apprise the IRB of any significant financial interest. The term "Significant Financial Interest" and financial disclosure thresholds and other policy requirements are detailed and defined in Policy RP06. Additional requirements for researchers at Penn State Hershey campus can be located on the Penn State Hershey Conflict of Interest office website. Final IRB approval for any project will be withheld pending disclosure, management and/or resolution of any conflict-of-interest issues to the satisfaction of the IRB.

PRINCIPAL INVESTIGATOR RESPONSIBILITIES:

The Principal Investigator (PI) is the individual responsible for the implementation of research. The IRB recognizes one PI for each project. All official IRB correspondence is addressed to the PI. Co-investigators communicate with the IRB through the PI. The PI has the ultimate responsibility for his/her research project by:

  • Acknowledging and accepting his/her responsibility for protecting the rights and welfare of human research participants and for complying with all applicable Federal, state, and local regulations, as well as University policies regarding research with human participants;
  • Ensuring that a project is designed to minimize risks to participants while maximizing research benefits;
  • Ensuring that all members of the research team know and understand the research project and they comply with the findings, determinations, and requirements of the IRB;
  • Ensuring the adequacy of both the informed consent form and the informed consent process;
  • Ensuring that all human participant research that he/she conducts receives initial prospective review and approval by the IRB;
  • Ensuring that continuing review and approval of the research has been accomplished within the time frame stipulated by the IRB;
  • Ensuring that no changes in approved research are initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to participants;
  • Ensuring that no research is continued beyond the IRB designated approval period;
  • Notifying the IRB promptly of:
    • Any significant problems that require prompt reporting to the IRB according to HRP-024 – Standard Operating Procedure:  New Information, HRP-001 – Standard Operating Procedure:  Definitions, HRP-103 – Investigator Manual, Appendix A-1)” and;
    • Any suspected non-compliance as described in HRP-024 – Standard Operating Procedure:  New Information, HRP-001 – Standard Operating Procedure:  Definitions, HRP-103 – Investigator Manual, Appendix A-1); with applicable regulatory requirements or determinations of the IRB of which he/she becomes aware.

For additional information, contact:

Office for Research Protections
Penn State University
205 The 330 Building
Innovation Park
University Park, PA 16802
(814) 865-1775

or

Human Subjects Protection Office
Penn State University COM
90 Hope Drive, P.O. Box 855
Mail Code A115, Box 855
Hershey, PA 17033-0850
(717) 531-5687

 

This policy is reviewed and approved by the Associate Vice President for Research, Director of the Office for Research Protections.

FURTHER INFORMATION:

For questions, additional detail, or to request changes to this policy, please contact the Office of the Associate Vice President for Research, Director of the Office for Research Protections.

CROSS REFERENCES:

ADG08 - Collection, Storage and Authorized Use of Social Security Numbers and Penn State Identification Numbers (Replaced Policy AD19)

AD47 - General Standards of Professional Ethics

AD83 - Institutional Financial Conflict of Interest

RA04 - Making Revisions to Budgets and Program Plans on Federally Sponsored Projects

RA16– Administration of Sponsored Project Contract and Subcontracts of the University  [DOES NOT EXIST]

RP02 - Addressing Allegations of Research Misconduct (Formerly RA10, Handling Inquiries/Investigations Into Questions of Ethics in Research and in Other Scholarly Activities)

RP05 - Research Quality in Human Participant Research

RP06 - Disclosure and Management of Significant Financial Interests (formerly RA20, Individual Conflict of Interest)

RPG01 - The Responsible Conduct of Research

Procedure CR2078, Payment to Research Participants

Effective Date: June 8, 2015
Date Approved: June 4, 2015
Date Published: June 8, 2015

Most recent changes:

  • June 8, 2015 - This policy was previously a Research Administration policy, RA14. It has been moved from the Research Administration section to the Research Protections section to reflect the reorganization, and links/cross references have been edited as appropriate.

Revision History (and effective dates):

  • April 17, 2014
    • Editorial change from “PSU” to “University” throughout, revisions made in all sections of the policy to provide clarification and detail about changes in process, definitions, and reference documents. 
    • Associate Vice President for Health Sciences research title changed to Vice Dean for Research and Graduate Studies, Penn State COM. Narrowed Authority of IRB section to only research in which the University is determined by the IRB to be engaged, deleted Cross Reference HRP-091. Added Penn State College of Medicine University Park Regional Campus to Applicability section, “human subject” and “human participant” defined to be used interchangeably in this policy, revised information regarding determination of non-human, non-research in Types of Review section.
  • September 10, 2013 - Editorial change in CROSS REFERENCES section; replaced reference to Policy RA21 - Institutional Financial Conflict of Interest Involving Sponsored Projects, Dedicated Gifts, Research, Scholarship, and Technology Transfer (obsoleted) with Policy AD83- Institutional Financial Conflict of Interest.
  • June 17, 2009 - Revisions made in all sections of the policy to provide clarification and more detail about the process and definitions. Title changed from "The Use of Human Subjects in Research" to "The Use of Human Participants in Research."
  • September 12, 2005 - Major revisions, developed collaboratively with the College of Medicine, and with input from the Office of Sponsored Programs (UP) and the Office of Research Affairs (College of Medicine):

Expanded "Contents," with the following sections added:

  • Authority of the Institutional Review Board (IRB)
  • Types of Review
  • Other Institutions
  • Regulatory Agencies
  • Research Agreement, Financial Information and Conflict of Interest
  • Principal Investigator Responsibilities
  • Cross References
  • February 20, 1998 - Relocated and renumbered Policy RA14 from SY22