Penn State College of Medicine Institutional Review Board (IRB) is responsible for protecting the rights and welfare of subjects of human research conducted at the Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine.
The Human Subjects Protection Office (HSPO) administers the institutional program to protect research subjects, provides administrative support to the IRB, and assists faculty and staff with the requirements to meet ethical and regulatory standards for human research.
IRB review and approval is required for all research involving human subjects conducted at Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine. Both entities have completed assurance agreements with the Office for Human Research Protections in the U.S. Department of Health and Human Services to describe the institution’s human subjects program and assure compliance with federal regulations for human subject protection.
In addition, the institution has successfully met the criteria for full accreditation of its human subjects protection program by the Association for the Accreditation of Human Research Protection Programs. This accreditation is valid from March 2015 to March 2020. See details here.
All submissions to the IRB are handled through the Centralized Application Tracking System (CATS).
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IRB/HSPO news, notices, updates and announcements are sent by email to keep faculty and research staff informed of new information and changes, and are also linked to here.
Workshops and seminars
Workshops and seminars are repeated periodically based on interest. Recurring topics include CATS IRB Training, IRB Process Overview for Researchers, Informed Consent Process for Research, Reportable New Information for Research, Research Document Management and IRB Policy for Security and Integrity of Human Research Data.
IRB Human Research Training
Penn State requires completion of the following two courses:
- Protection of Human Research Subjects course – Required for initial and continuing education (every three years) for investigators and study staff of human research studies.
- Good Clinical Practice (GCP) course – Additional requirement for investigators and staff of Non-Exempt human research studies, along with the above course.
The training is offered through the Collaborative Institutional Training Initiative at the University of Miami (CITI), which may be accessed at citi.psu.edu.
The CITI course instructions provide the steps to enroll or to affiliate from another institution.
For details on training requirements, access the Investigator Manual in CATS IRB and refer to the section “What training is required to conduct Human Research?”
Contact the HSPO to schedule a meeting to discuss a research submission and IRB requirements.
Speakers are available to provide presentations on human subjects protection topics to departments, groups and community organizations, and may be requested by contacting the HSPO.
Incoming submissions to the IRB are addressed in the order received. New submissions for committee review undergo a pre-review process, after which researchers may be required to make changes for completeness. Once a submission is complete it is placed on the next available agenda. Exemptions and expedited submissions are reviewed in the order received.
Submissions for continuing review of ongoing research are due by the date listed on the reminder notice, and are assigned to the next available agenda (or expedited reviewer) to ensure there is no lapse in IRB approval. Other submissions are reviewed in the order received, unless the submission involves an urgent issue that may affect participant safety.
A number of factors affect the timing of communicating review results to investigators, including the type of submission, quality of the submission, and available IRB member expertise and staff, but typically a researcher can expect to receive the results of a submission review within the following timeframes:
- Committee review (full board): Four to six weeks
- Expedited review: two to four weeks
- Exemption review: one to two weeks
Upcoming board review meetings are listed here.
Institutional Review Boards (IRB) are specifically designated boards that conduct ethical and safety review of research involving the participation of human subjects. Four IRBs (Boards A, B, C and D) review proposed and ongoing research at Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine.
In order to conduct thorough reviews of research, IRBs include members with varied experience and expertise, including medical, science and non-scientist perspectives and community representatives serving as non-affiliated members. Each IRB member reviews materials and attends board meetings prepared to discuss proposed research within their realm of expertise or experience. Individuals interested in serving on the IRB need only an appreciation for the importance of clinical research and an interest in protecting research participants. Educational resources are provided to help all members gain the necessary information base regarding research protection.
IRB membership involves attending one regular monthly meeting, generally 1 to 5 p.m. on a Monday afternoon, and also spending time reading materials in advance to prepare for the IRB discussions. A typical IRB member’s overall time commitment is six to eight hours per month. The IRB materials are reviewed electronically and are accessible about 10 days before a meeting. Board members bring a laptop or other device to access and view these materials during the IRB meetings.
Members of the IRB are covered under the institution’s liability insurance for their service on the board. Penn State Health and Penn State College of Medicine employees and students are automatically covered. Community IRB members are required to register with the institutional Volunteer Services office in order to be included in this insurance coverage before beginning IRB service, and instructions will be provided for this process.
Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine hold Federalwide Assurances (FWA) from the Office of Human Research Protection (OHRP), under the U.S. Department of Health and Human Services (DHHS), as follows:
- Penn State College of Medicine (IORG#0000031), Federalwide Assurance (FWA) #4251 (Expires: 06/15/2020), which includes Penn State College of Medicine IRB 1 (IRB # 046); IRB 2 (IRB #047); IRB 3 (IRB #048); and IRB 4 (IRB #2337)
- Penn State Health Milton S. Hershey Medical Center – Federalwide Assurance (FWA) #4252 (Expires: 09/26/2021); relies on the COM IRBs
Information on the IRB registrations is available by searching here for Penn State College of Medicine.
The Institutional Review Boards operate in compliance with DHHS and Food & Drug Administration regulations (45CFR46, 21CFR50, 21CFR56) for protection of human subjects, Commonwealth of Pennsylvania law, and Pennsylvania State University policies for human subjects research. For clinical trials, the organizations commit to apply the Harmonised Tripartite Guideline for Good Clinical Practice E6 (ICH-GCP).
The IRBs follow institutional written policies and procedures for operation, and maintain IRB review documentation in a closed electronic system (CATS IRB) that conforms to 21 CFR Part 11 (Electronic Records: Electronic Signatures) for research subject to FDA regulation, as outlined in the IRB Statement of 21 CFR Part 11 Compliance document.
The IRBs comply with regulatory membership requirements (45CFR46 and 21CF56), register membership rosters with the Department of Health and Human Services, and provide membership rosters to regulatory authorities as required.
Patricia Gordon, MD, Associate Professor of Pediatrics/Human Genetics serves as the IRB executive chair. Penn State College of Medicine maintains three boards with a chair, vice chair and more than 20 members each, and a fourth board that reviews urgent issues. The IRB Roster Representation provides information about the IRB membership categories and expertise represented.
The current composition of the Institutional Review Boards is listed here. See a printable version of the IRB Roster Representation here.
Mailing address: Penn State Health Milton S. Hershey Medical Center
Penn State College of Medicine
Human Subjects Protection Office
Institutional Review Board
Mail Code A115, Academic Support Building, Room 1140
90 Hope Dr., P.O. Box 855
Hershey, PA 17033-0855
Questions, complaints or concerns: Any questions, complaints or concerns related to research involving human participants conducted at or under the auspices of Penn State College of Medicine or Penn State Health Milton S. Hershey Medical Center can be directed to the Director of the Human Subjects Protection Office, Dr. Kathleen Hay, at 717-531-1646 or email@example.com. You may also submit the comment/suggestion form, through which you can choose to receive a response or remain anonymous.
For after-hours urgent concerns regarding human subjects protection, the IRB Executive Chair, Dr. Patricia Gordon, or another IRB Chair may be contacted through the hospital operator at 717-531-8521.
The Institutional Review Board consists of independent committees established to protect the rights and welfare of human subjects involved in research at Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine.
The IRBs evaluate proposed new research and conduct review of ongoing research following guiding ethical principles, applicable regulations and institutional requirements. The fundamental ethical principles are outlined in The Belmont Report, which forms the basis for U.S. federal regulations for the protection of human subjects of research.
The Investigators’ Manual found in the CATS IRB Library under the “General” tab provides an extensive list of answers to questions about the requirements for conducting research at Penn State. The Penn State College of Medicine research guidebook is also a good resource.
Penn State relies on the IRB to make this assessment due to the complexity of the rules. Call the Human Subjects Protection Office (HSPO) at 717-531-5687 to consult with an IRB analyst. The Federal OHRP Human Subject Protections Decision Charts may help you prepare for questions that will need to be addressed to make this determination.
See the IRB SOP HRP-001 Definitions, available in the CATS IRB Library under Standard Operating Procedures, which defines Human Research and provides other definitions followed by the human research protection program.
A regulatory compliance fee is accessed to support the activities of the Human Subjects Protection Office, the Office of Research Affairs, the Clinical Trials Office and other research support functions. The fee is based on the type of IRB review required (e.g., convened committee or noncommittee review, continuing review, amendment, etc.).
For details, call the Clinical Trials Office at 717-531-3779.
All investigator-written human research studies must undergo a scientific review to meet institutional requirements.
- Investigator-written human research studies requiring committee review by the convened IRB must provide documentation of scientific review with the IRB submission.
- Investigator-written human research studies qualifying for expedited review may also require scientific review at the discretion of the IRB. If scientific review has not already occurred for an expedited study, the investigator will be notified of the requirement during the IRB review process if applicable.
The scientific review requirement may be fulfilled by one of the following.
External Peer-Review Process
This method includes research studies funded by an NIH grant, etc.
Department or institute scientific review committees
These departments/institutes have a scientific review process:
- Anesthesiology and Perioperative Medicine
- Cancer Institute
- Family and Community Medicine
- Obstetrics and Gynecology
Scientific review by the Clinical Research Center (CRC) Advisory Committee
This method should be used by investigators from departments without a scientific review process.
- This committee meets the first Wednesday of each month.
- Complete applications must be received by the 25th of the month to be included on the next month’s agenda.
- See the Application for Scientific Review for additional information and instructions.
- When making the IRB submission, under Supporting Documents, upload the Preliminary Scientific Review Checklist signed by the Advisory Committee Chair/Acting Chair as documentation of scientific review.
Penn State College of Medicine investigators are responsible for disclosing the nature of the confidential data they collect for research, and for preparing a data security and integrity plan in accordance with the appropriate security category requirements listed in the SOP Addendum: Security and Integrity of Human Research Data, available in the CATS IRB Library.
Investigators must coordinate with the Office of Research Affairs and Center for Medical Innovation to establish a data transfer agreement or material transfer agreement if data and/or human specimens are to be shared with a third party. For all research involving human research data, a data security and integrity plan must be submitted to the IRB as part of the initial IRB application.
The IRB reviews the data security and integrity plan during initial review. If review by the IT Security Group is required, an ancillary review activity is set in the IRB database system and approval of the study is granted after the IT Security Group has approved the study’s security and integrity plan. The approval memo for the study confers the final approval of the data security and integrity plan by the IRB. For exempt research involving human research data, the exemption determination memo confers acceptance of the data security and integrity plan by the IRB.
- Consultations – Penn State Clinical and Translational Science Institute offers consultations in biostatistics, regulatory and ethics issues and more.
- Research Guidebook – The College of Medicine clinical research guidebook offers a step-by-step walkthrough of the clinical research process.
- Clinical Trials Office – The Clinical Trials Office supports clinical research across the College and Penn State Health Milton S. Hershey Medical Center.
- Cancer Institute Clinical Trials Office – This office provides support for cancer-specific clinical trials.
- Clinical Research Center – Clinical Research Centers in Hershey and University Park provide research infrastructure for investigators who conduct research with human subjects.
- REDCap – REDCap (Research Electronic Data Capture) is a secure, web-based application for databases and online surveys for research purposes.
- Clinical Trial Monitoring – As part of the data management services offered by the Department of Public Health Sciences, clinical trial monitoring can be provided for IND/IDE, multi-site and high-risk clinical trials.
Ethical principles of human subjects protection
- The Belmont Report – ethical foundation for the U.S. system of protection for human subjects of research
- Declaration of Helsinki – World Medical Association ethical principles
- Ethics and Clinical Research – 1966 article by Henry K. Beecher, MD
- Ethics and Clinical Research: The 50th Anniversary of Beecher’s Bombshell – 2016 retrospective article in New England Journal of Medicine
- Office for Human Research Protections (OHRP)
- Office of Civil Rights Health Information Privacy Rules
- Information on Health Information Privacy (HIPAA)
“Common Rule” agencies
- Central Intelligence Agency
- National Science Foundation (NSF)
- National Institutes of Health
- U.S. Agency for International Development
- U.S. Department of Agriculture
- U.S. Department of Commerce
- U.S. Department of Defense
- U.S. Department of Education
- U.S. Department of Energy
- U.S. Department of Homeland Security
- U.S. Department of Housing and Urban Development
- U.S. Department of Justice
- U.S. Department of Transportation
- U.S. Department for Veteran Affairs
- U.S. Environmental Protection Agency
- U.S. Food and Drug Administration
- U.S. Product Safety Commission
National Institutes of Health (NIH) details
- NIH Certificates of Confidentiality
- NIH Genomic Data Sharing Policy
- Human Participant Protections Education for Research Teams – NIH/NCI Tutorial
- Revised NIH Policy for IRB Review of Human Subjects Protocols in Grant Applications
Federal regulations for the protection of human research subjects
- OHRP – (45 CFR 46) Protection of Human Subjects – (the “Common Rule”)
- FDA – (21 CFR 50) Protection of Human Subjects
- FDA – (21 CFR 56) Institutional Review Boards
- FDA – (21 CFR 312) Investigational New Drug Forms and Applications
- FDA – (21 CFR 600) Biological Products
- FDA – (21 CFR 812) Investigational Device Exemptions
- FDA Guidance and Information Sheets
- FDA and other HHS Certificate of Confidentiality contacts
Registration of clinical trials
- ClinicalTrials.Gov – Public registry for trials requiring registration by law or as a condition of publication
- International Committee of Medical Journal Editors (ICMJE) – see registration requirements for publication
- Penn State College of Medicine research guidebook – includes information on registering trials and more