Submission Completion Guidance
Ensuring a complete submission package is crucial to a smooth IRB review process. Below are guidance and tips on how to ensure that your submission package.
IRB Criteria for Approval
Federal regulations outline several criteria that must be satisfied in order for the IRB to approve research. When designing your protocol, ensure all of the following have been considered:
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Risks to subjects are minimized.
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Risks to subjects are reasonable in relation to anticipated benefits.
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Selection of subjects is equitable.
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Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.
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Informed consent will be appropriately documented.
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When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
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When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
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When appropriate, there are additional safeguards are included to protect vulnerable populations being targeted for enrollment.
Criteria for Approval Related Guidance
IRB & Penn Medicine Requirements regarding PHI Security and Storage
Submissions that involve the collection of HIPAA protected health information (PHI) are required to include confidentiality plans that align with the institutional requirements. This guidance details requirements for security during storage and transmission, as well as the use of email and text messaging.
Use of Text Messaging During the Conduct of Research
The Office of Clinical Research (OCR), Penn Privacy, and Penn IRB have developed the attached guidance to provide best practices, considerations, and parameters around when texting may, or may not, be appropriate in the conduct of research.
Penn Medicine /OACP Guidance on Sharing Data and Biological Samples with Third Parties
Investigators are responsible for informing the IRB of any disclosures of participant data or specimens outside the institution. This should be reflected in the HSERA application Procedures Page and/or a standalone protocol. Likewise, best practice calls for informing participants of such disclosures whenever possible, unless the regulatory criteria for a waiver of informed consent / HIPAA authorization are met. Click below for guidance on the stewardship of data and specimens.
Data & Safety Monitoring Plan (DSMP)
Research that is greater than minimal risk should have a Data & Safety Monitoring Plan (DSMP) designed based on complexity and risk of the protocol. For all minimal risk research, there should be clear methods to protect confidentiality and privacy as well as subject safety that are commensurate with the risk. Click below for guidance on data and safety monitoring.
Completeness Considerations
Application Completeness
The attached guidance contains guidance on how questions in HSERA should be answered. The document also contains a checklist to determine which documents should be uploaded for IRB review.
Consent Completeness
The IRB strongly recommends that consent forms be drafted utilizing the most recent version of the Penn informed consent form template. This will ensure that all applicable required elements of consent and institutional language is included.
Guidance for Research Conducted at Penn Medicine Regional Hospitals
Any new research projects involving Penn Medicine Chester County Hospital (CCH) and Penn Medicine Princeton Health (PMPH) should be submitted to the Penn IRB. Key considerations for these sites are detailed below.
Likewise, Penn-employed clinicians leased to Virtua Health are expected to follow Penn policies governing human subjects’ research, including submission to the Penn IRB.
Any new projects to take place at Penn Medicine Chester County Hospital (CCH), enroll CCH patients, or utilize CCH patient data should submit to the Penn IRB.
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For projects led by CCH investigators: within HSERA, Personnel Page, the submitter should ensure that their Responsible Org on the Personnel Page in HSERA is 10600 – Chester County Hospital Consolidated. If this doesn’t auto-populate or key personnel is not selectable, the staff member may need a research affiliation added. Please click below to request a Research Affiliation.
- For projects led by other Penn investigators: Within HSERA, Personnel Page, the submitter should ensure that all Chester County research personnel engaged in the research are listed.
- Research conducted at CCH may require review by the CCH Scientific Review Committee before participant enrollment may begin. Submission to the Penn IRB and the CCH Scientific Review Committee should occur in tandem. Please contact Tony Tabasco with any questions about the CCH Scientific Review Committee process.
Any new projects to take place at Penn Medicine Princeton Health (PMPH) or PMPH affiliated sites, enroll PMPH patients, or utilize PMPH patient data should submit to the Penn IRB.
- For projects led by PMPH investigators: Within HSERA, Personnel Page, the submitter should ensure that their Responsible Org on the Personnel Page in HSERA is 10755 – Princeton HealthCare Holdings Inc. If this doesn’t auto-populate or key personnel is not selectable, the staff member may need a research affiliation added. Please click below to request a Research Affiliation.
- For projects led by other Penn investigators: Within HSERA, Personnel Page, the submitter should ensure that all Princeton Health research personnel engaged in the research are listed.
- Research conducted at Princeton Health may require review by the PMPH Scientific Review Committee before participant enrollment may begin. Submission to the Penn IRB and the PMPH Scientific Review Committee should occur in tandem. Please contact Sheryl Smolensky with any questions about the PMPH Scientific Review Committee process.
Penn-employed clinicians leased to Virtua Health are expected to follow Penn policies governing human subjects’ research, including submission to the Penn IRB, when they are engaged in human research.
A Master Reliance Agreement with Virtua Health has been executed for collaborative research happening at Penn and Virtua. Penn-employed clinicians and Penn Faculty members are encouraged to review the Penn-Virtua IRB Cooperative Master IRB Reliance Agreement to determine if their study is eligible for consideration under the agreement.
Requests to rely on the Virtua IRB for minimal risk research undergoing expedited review must be submitted in HSERA and follow the IRB reliance procedures. Penn will not rely on Virtua for greater than minimal risk research, nor for research that is led by Penn staff.
View Master Agreement Single IRBA Master Reliance Agreement with Penn Medicine Lancaster General Hospital (LGH) has been executed for collaborative research happening at Penn and LGH. Penn-employed clinicians and Penn Faculty members are encouraged to review the Penn-LGH IRB Cooperative Master IRB Reliance Agreement to determine if their study is eligible for consideration under the agreement.
View Master Agreement Single IRBHow to Respond to the IRB