Penn IRB | Human Research Protections Navigation Tool

HRPP Navigation Tool: Create a To-Do List

Below are a list of entities to consider for your protocol approval. Please note that this is intended to be a guide to help you navigate through our internal research administrative processes.

Reviewing Entity	Why?	How?
The Radioactive Research Scientific Committee (RRSC)	You indicated your work involves ionizing radiation. Depending on the type of radioactive materials being used or imaging procedures involving radiation, various approvals from RRSC may be required. Any human research protocol involving the administration of ionizing radiation to subjects solely as a result of their participation in the protocol must be reviewed and approved by the RRSC or in rare circumstances, the Radioactive Drug Research Committee (RDRC). In some cases, it is not definitely known whether subjects will or will not receive the same radiation exposure even if they do not participate in the study. For example, a subject will receive a screening CT scan as part of the research study, if they have not received one clinically within the last 6 months. In this case the subject will have a CT scan, but it may or may not be as part of their clinical care. In these cases, RRSC review and approval is needed. The following is a list of typically used procedures or terms involving ionizing radiation: X-ray Radiograph CT scans DEXA or DXA pQCT Nuclear medicine scan PET scan FDG scan bone scan MUGA Angiogram	In order to initiate the RRSC review process, the protocol and other documents must be submitted to the IRB via the HS ERA system. No other documents need to be submitted to EHRS unless specifically requested. For RDRC review, a separate application must be completed along with the general submission requirements. For questions, contact: Janelle Jesikiewicz, M.S. Medical Health Physicist, EHRS 215-898-2133 jjesik@ehrs.upenn.edu For online info, click HERE.
Institutional Biosafety Committee (IBC)	You indicated your work involves gene transfer. The IBC is responsible for providing review and oversight to all forms of research involving: Recombinant or synthetic DNA or RNA (r∙s∙NA); Genetically modified Biologics (e.g., CAR T Cells) or Biosimilars; Recombinant or genetically modified: o infectious organisms (e.g., Listeria), o established cell lines, o viral vectors, agents/products; Non-biologic vectors/transfer agents delivering any of the above for a clinical trial; Use of novel gene editing approaches (e.g., CRISPR/Cas9, PRIME) The IBC is responsible for ensuring that research using these materials is conducted in a manner that protects the researchers, laboratory workers, human research subjects, the public and the environment. The IBC is authorized to inspect research facilities and clinical research areas, approve research practices and procedures, and to take actions, such as enforcement of cessation of research activities, in the event of an unsafe workplace situation.	Penn’s Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB) must review and approve all Human Gene Transfer (HGT) protocols prior to initiation of enrollment. New and 3-year renewal IBC registrations must be submitted through Penn IBC Electronic Registration System (PIERS). Amendments made to registrations approved in 2021 must also be submitted through PIERS. Amendments made to registrations approved in 2018, 2019, and 2020 must be made by submitting the downloadable form found HERE. For questions or to submit the registration forms, contact: Dr. Andrew B. Maksymowych Associate Director, EHRS 215–898–6236 amaks@ehrs.upenn.edu
Abramson Cancer Center Clinical Trials Scientific Review and Monitoring Committee (CTSRMC)	You indicated your work involves the enrollment of subjects with relevance to cancer. The National Cancer Institute (NCI) requires the CTSRMC to review and track the following categories and protocol types: Clinical Research Category: Involving an agent or device with therapeutic intent Involving other types of interventions (i.e. behavioral modification, nutritional protocols, exercise, counseling, etc.); Involving no intervention Trial or Study Type: Therapeutic: therapeutic intent using drugs, radiation, surgery, other biological agents, or behavioral or other interventions. Prevention: for the modulation of cancer risk and inhibition of cancer progression using chemoprevention drugs, nutritional, dietary, behavioral, or other interventions. Supportive Care: intended to improve the comfort and quality of life for the patient using drugs, nutritional, dietary, behavioral or other interventions. Screening, Early Detection, or Diagnostic: directly testing the efficacy of devices, techniques, procedures; or tests for earlier or more accurate detection or diagnosis of disease. Epidemiologic, Observational, or Outcome: among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants, e.g., surveillance, risk assessment, outcome, environmental, and behavioral studies. Ancillary: studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies included must be linked to an active trial or epidemiologic or other study and should include only patients accrued to that trial or study. Only studies that can be linked to individual patient or participant data should be reported. Correlative: Laboratory based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Only studies that can be linked to individual patient or participant data should be reported.	Detailed information about CTSRMC review is available here: http://www.ctsrmc.org. (requires Pennkey) All cancer-relevant protocols must either be assigned a UPCC# or be acknowledged as a cooperative group protocol by completing registration through the Clinical Research Management System (CRMS), previously CTMS. To gain access to the CRMS you must complete a training. Detailed information, upcoming training dates and registration links can be found here: https://www.med.upenn.edu/clinicalresearch/penncrms.html A UPCC# or Cooperative Group Acknowledgment can be obtained online here if training is pending: http://www.ctsrmc.org./requesting_a_upcc_number.php Information on Protocol Registration for Cooperative Group Protocols can be obtained here: http://www.ctsrmc.org./submitting_a_protocol.php
Center for Human Phenomic Science (CHPS) [formerly the CTRC]	You indicated your work requires the use of the CHPS. The CHPS can adapt to your research needs during study design, set-up, conduct and closeout/publication. The CHPS charges for services and these costs must be included in all budgets. The CHPS Administrative Directors can provide more information. When submitting a new grant application the CHPS leadership can provide a letter of support that can be included in the grant application.	Information about CHPS relevance for every step of your study can be found here in the CHPS Resource Timeline: https://www.med.upenn.edu/chps It is suggested that you contact a CHPS Facilitator while planning your study: https://www.med.upenn.edu/chps/facilitator.html It is suggested that you contact the CHPS Administration when preparing grant budgets and submissions: https://www.itmat.upenn.edu/chps/chps-administration.html For more information about using CHPS during your study, visit its website: http://www.itmat.upenn.edu/chps/
Office of Clinical Research	You indicated your work will involve the use of UPHS services. Please contact the Office of Clinical Research for assistance in developing a prospective reimbursement analysis (PRA) or coverage analysis to distinguish how billing will be routed for your study (e.g. Research bill to research, research bill to insurance, etc.). Additionally studies using hospital services require build in PennChart. The Office of Clinical Research can assist with PennChart training, obtaining an RBN and additional items to support your study start up.	For information on the Prospective Reimbursement Analysis (PRA) process and required templates, go here: https://www.med.upenn.edu/clinicalresearch/budget-development.html. If you need assistance developing your PRA or determining which template to use contact either ocr@upenn.edu or ocrfin@upenn.edu. To obtain a Research Billing Number (RBN) submit a Research Billing Application (RBA) here: https://www.med.upenn.edu/clinicalresearch/research-billing-pennchart.html. If you need assistance with the RBA process contact either ocr@upenn.edu or ocrfin@upenn.edu For PennChart guidance and to download access-request forms, go here: https://www.med.upenn.edu/clinicalresearch/pennchart.html#ResearchBillinginPennChart6. If you would like assistance with PennChart, be it training, PennChart build or billing review, contact either ocr@upenn.edu or pson-ocrops@upenn.edu. Additional forms can be found here: https://www.med.upenn.edu/clinicalresearch/forms-tools-templates.html?link=263
Office of Clinical Research	You indicated that the study involves the administration of a drug product for research purposes AND that the protocol has been written by a Penn Medicine faculty or staff member. This is consider an investigator-initiated trial. Please review IRB guidance on Research with Drug products HERE. Please seek an IND exemption determination from the OCR Regulatory Services. If an IND is required, OCR Regulatory Services can provide guidance on this process. An IND number is required to complete the HSERA application, regardless of who holds the IND.	The OCR offers templates, guides, and forms here: https://www.med.upenn.edu/clinicalresearch/forms-tools-templates.html?link=263. To contact the Office of Clinical Research for assistance, please email psom-ind-ide@pobox.upenn.edu or phone 215-662-4484.
Office of Clinical Research	You indicated that the study involves: Investigating a device product, OR Using an FDA approved device off label, AND The protocol has been written by a Penn Medicine faculty or staff member. This is consider an investigator-initiated trial. Please review IRB guidance on Research with Devices HERE. If you need help with determining if your device meets the definition of a medical device or whether your protocol is exempt from IDE regulations, contact the OCR Regulatory Services. If an abbreviated or full IDE is required, OCR Regulatory Services can provide guidance on this process. An IDE number is required to complete the HSERA application, when an application is required to FDA.	The OCR offers templates, guides, and forms here: https://www.med.upenn.edu/clinicalresearch/forms-tools-templates.html?link=263. To contact the Office of Clinical Research for assistance, please email psom-ind-ide@pobox.upenn.edu or phone 215-662-4484.
Local IT Support Provider/Security Liaison	You indicated your work involves use of PHI/access to medical records. Please contact the IT support provider/security liaison in your school to develop an appropriate plan for data storage, protection and transmission. A description of this plan is required in your HSERA application. Additionally, if your use/access is limited for the purposes of preparation for research or retrospective review of medical records, please contact the Penn Data Analytics Center for help with obtaining de-identified/coded data sets from the various data warehouses at Penn.	Contact your home organization’s IT support provider to initiate the request. You can find which IT group supports your org here: https://www.isc.upenn.edu/get-it-help When reaching out be sure to specify that you are seeking assistance with developing plans to securely protect, store and transmit PHI for research purposes. For complete information about the various services provided by the Data Analytics Center please see: http://www.med.upenn.edu/dac/
Human Stem Cell Research Advisory Committee (HSRAC)	You indicated that this research involves the collection or use of human embryonic stem cells, or human induced pluripotent stem cells. The protocol must be approved by the Human Stem Cell Research Advisory Committee (HSRAC). IRB approval cannot be granted until HSRAC approval is granted. The purpose of this committee is to assist the Penn community with the scientific, legal, ethical and compliance considerations that arise from the use of human stem cells in research — including, but not limited to human embryonic stem cells. hSCRAC will work to ensure that stem cell research activity is in compliance with federal, state and local regulations, and with Penn policies, and that it is conducted in accordance with the highest scientific and ethical standards set by NIH and the National Academy of Sciences. It is the role of hSCRAC to provide procedural guidelines to the community on the derivation, procurement, banking and use for research of human stem cells. The hSCRAC reviews all covered activities and helps maintain a registry of human embryonic stem cell lines used for research at Penn.	Provide your IRB confirmation code or number (once generated by the IRB) to the Research Compliance Officer. Please see: https://research.upenn.edu/committees/#stem.
Center for Magnetic Resonance Imaging and Spectroscopy (CAMRIS)	You indicated that an MRI scan is being performed for research purposes only, and NOT considered standard of care. Research/non-standard use of MRI may include but is not limited to any of the following: Situations in which MRI results may impact subjects current clinical care plan or treatment decisions, such as: The study requires a customized report with specifics regarding the study protocol (i.e., specific measurements or details) Introduction of a device of any kind during the MRI that is not used during a ‘standard of care’ type scan Your MRI is not consistent with standard care time points for MRI imaging. Your MRI is not paid for by insurance.	Consult the CAMRIS website: https://www.med.upenn.edu/camris/application-and-faq.html for application requirements and required institutional consent form language.
Penn Contracting Offices	You indicated that you may be planning to disclosure Penn patient data or specimens outside of the institution. If there is not already an associated agreements or contracts in place due to funding then a data use agreement, business associates agreement, or material transfer agreement may be required to be executed.	Execution of Agreements All agreements are executed through Penn ERA or the Penn Research Inventory System (RIS). All agreements are executed by the contracting offices. Fore more information, please see: https://irb.upenn.edu/homepage/biomedical-homepage/guidance/research-with-penn-patients/sharing-data-specimens. Questions? All questions about contract and agreement execution should be directed to the applicable contracts office. Contract Offices Websites OFFICE OF RESEARCH SERVICES (ORS) OFFICE OF RESEARCH SUPPORT SERVICES (ORSS) OCR LEGAL SERVICES PENN CENTER FOR INNOVATION (PCI)
Research Integrity Office (RIO):	Investigators (any person responsible for the design, conduct or reporting of this research protocol) must disclose (for themselves, spouses and dependent children): Receipt of payments over $5,000 for the past 12 months from any entity that sponsors, provides support, or otherwise has a financial interest in the conduct or outcome of this research protocol (Outside Organization). Investigators must also disclose: equity and any payments from a public company that together exceed $5,000; any equity in a private company; and any management role for any Outside Organization with a financial interest in this protocol. Investigators must also disclose an inventorship or other financial interest in a drug, device or other product or a competing product (IP rights), regardless of whether the IP has been patented, licensed, or assigned to Penn, if such IP is being tested, evaluated, or developed in, or if its commercial value could be affected by, this protocol. Finally, all investigators must complete research-related Conflict of Interest (FCOI) Training prior to participating in research, and again every 4 years.	Investigators are responsible for reviewing Penn’s policy on conflict of interest and for completing FCOI Training. Information on Training and required disclosures is online here: https://research.upenn.edu/compliance-and-training/fcoi. Starting March 18, 2024, researchers and personnel must disclosure in the Research, Interests, and Activities (RIA) system. See: https://portal.research.upenn.edu/conflict-of-interest.
Funding Support Entity	If you anticipate that your research will receive funding during the conduct of the study, or if your research is currently funded (upon submission to the required review entities), the following additional entities may be required for your research to be approved/executed. Grants / Federal funding / Non-Profit Funding Agreements for grants, non-profit, or other federal funding is are executed through the Office of Research Services (ORS) or the Office of Research Support Services (ORSS). Industry / Corporate Sponsored Clinical Trials Industry sponsored clinical trial agreements are executed through the Office of Clinical Research (OCR) Legal Services (previously CTCU) or Abramson Cancer Center Contracts Division for Hematology/Oncology. Industry / Corporate Sponsored Non-Clinical Trial Industry sponsored research agreements (SRAs) for non-clinical trials are executed through Penn Center for Innovation (PCI), Office of Clinical Research (OCR) Legal Services (previously CTCU), or Abramson Cancer Center Contracts Division for Hematology/Oncology. Internal funding (Department/ Division/ Fellowship Awards) Generally, no additional oversight is needed but the type of funding being utilized to conduct the research should be provided for tracking purposes in the HSERA application to the IRB.	For more information on Sponsored Projects, see the manual here: www.upenn.edu/researchservices/Manual.html Questions? All questions about contract and agreement execution should be directed to the applicable contracts office. Contract Offices Websites OFFICE OF RESEARCH SERVICES (ORS) OFFICE OF RESEARCH SUPPORT SERVICES (ORSS) OCR LEGAL SERVICES PENN CENTER FOR INNOVATION (PCI)

Reviewing Entity

Why?

How?

The Radioactive Research Scientific Committee (RRSC)

You indicated your work involves ionizing radiation.

Depending on the type of radioactive materials being used or imaging procedures involving radiation, various approvals from RRSC may be required. Any human research protocol involving the administration of ionizing radiation to subjects solely as a result of their participation in the protocol must be reviewed and approved by the RRSC or in rare circumstances, the Radioactive Drug Research Committee (RDRC).

In some cases, it is not definitely known whether subjects will or will not receive the same radiation exposure even if they do not participate in the study. For example, a subject will receive a screening CT scan as part of the research study, if they have not received one clinically within the last 6 months. In this case the subject will have a CT scan, but it may or may not be as part of their clinical care. In these cases, RRSC review and approval is needed.

The following is a list of typically used procedures or terms involving ionizing radiation:

X-ray
Radiograph
CT scans
DEXA or DXA
pQCT
Nuclear medicine scan
PET scan
FDG scan
bone scan
MUGA
Angiogram

In order to initiate the RRSC review process, the protocol and other documents must be submitted to the IRB via the HS ERA system. No other documents need to be submitted to EHRS unless specifically requested.

For RDRC review, a separate application must be completed along with the general submission requirements.

For questions, contact:

Janelle Jesikiewicz, M.S.

Medical Health Physicist, EHRS

215-898-2133

jjesik@ehrs.upenn.edu

For online info, click HERE.

Institutional Biosafety Committee (IBC)

You indicated your work involves gene transfer. The IBC is responsible for providing review and oversight to all forms of research involving:

Recombinant or synthetic DNA or RNA (r∙s∙NA);
Genetically modified Biologics (e.g., CAR T Cells) or Biosimilars;
Recombinant or genetically modified:
o infectious organisms (e.g., Listeria),
o established cell lines,
o viral vectors, agents/products;
Non-biologic vectors/transfer agents delivering any of the above for a clinical trial;
Use of novel gene editing approaches (e.g., CRISPR/Cas9, PRIME)

The IBC is responsible for ensuring that research using these materials is conducted in a manner that protects the researchers, laboratory workers, human research subjects, the public and the environment.

The IBC is authorized to inspect research facilities and clinical research areas, approve research practices and procedures, and to take actions, such as enforcement of cessation of research activities, in the event of an unsafe workplace situation.

Penn’s Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB) must review and approve all Human Gene Transfer (HGT) protocols prior to initiation of enrollment.

New and 3-year renewal IBC registrations must be submitted through Penn IBC Electronic Registration System (PIERS). Amendments made to registrations approved in 2021 must also be submitted through PIERS.

Amendments made to registrations approved in 2018, 2019, and 2020 must be made by submitting the downloadable form found HERE.

For questions or to submit the registration forms, contact:

Dr. Andrew B. Maksymowych

Associate Director, EHRS

215–898–6236

amaks@ehrs.upenn.edu

Abramson Cancer Center Clinical Trials Scientific Review and Monitoring Committee (CTSRMC)

You indicated your work involves the enrollment of subjects with relevance to cancer.

The National Cancer Institute (NCI) requires the CTSRMC to review and track the following categories and protocol types:

Clinical Research Category:

Involving an agent or device with therapeutic intent
Involving other types of interventions (i.e. behavioral modification, nutritional protocols, exercise, counseling, etc.);
Involving no intervention

Trial or Study Type:

Therapeutic: therapeutic intent using drugs, radiation, surgery, other biological agents, or behavioral or other interventions.
Prevention: for the modulation of cancer risk and inhibition of cancer progression using chemoprevention drugs, nutritional, dietary, behavioral, or other interventions.
Supportive Care: intended to improve the comfort and quality of life for the patient using drugs, nutritional, dietary, behavioral or other interventions.
Screening, Early Detection, or Diagnostic: directly testing the efficacy of devices, techniques, procedures; or tests for earlier or more accurate detection or diagnosis of disease.
Epidemiologic, Observational, or Outcome: among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants, e.g., surveillance, risk assessment, outcome, environmental, and behavioral studies.
Ancillary: studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies included must be linked to an active trial or epidemiologic or other study and should include only patients accrued to that trial or study. Only studies that can be linked to individual patient or participant data should be reported.
Correlative: Laboratory based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Only studies that can be linked to individual patient or participant data should be reported.

Detailed information about CTSRMC review is available here: http://www.ctsrmc.org. (requires Pennkey)

All cancer-relevant protocols must either be assigned a UPCC# or be acknowledged as a cooperative group protocol by completing registration through the Clinical Research Management System (CRMS), previously CTMS.
To gain access to the CRMS you must complete a training. Detailed information, upcoming training dates and registration links can be found here: https://www.med.upenn.edu/clinicalresearch/penncrms.html
A UPCC# or Cooperative Group Acknowledgment can be obtained online here if training is pending:
http://www.ctsrmc.org./requesting_a_upcc_number.php
Information on Protocol Registration for Cooperative Group Protocols can be obtained here: http://www.ctsrmc.org./submitting_a_protocol.php

Center for Human Phenomic Science (CHPS) [formerly the CTRC]

You indicated your work requires the use of the CHPS.

The CHPS can adapt to your research needs during study design, set-up, conduct and closeout/publication.

The CHPS charges for services and these costs must be included in all budgets. The CHPS Administrative Directors can provide more information.

When submitting a new grant application the CHPS leadership can provide a letter of support that can be included in the grant application.

Information about CHPS relevance for every step of your study can be found here in the CHPS Resource Timeline: https://www.med.upenn.edu/chps

It is suggested that you contact a CHPS Facilitator while planning your study: https://www.med.upenn.edu/chps/facilitator.html

It is suggested that you contact the CHPS Administration when preparing grant budgets and submissions: https://www.itmat.upenn.edu/chps/chps-administration.html

For more information about using CHPS during your study, visit its website: http://www.itmat.upenn.edu/chps/

Office of Clinical Research

You indicated your work will involve the use of UPHS services.

Please contact the Office of Clinical Research for assistance in developing a prospective reimbursement analysis (PRA) or coverage analysis to distinguish how billing will be routed for your study (e.g. Research bill to research, research bill to insurance, etc.).

Additionally studies using hospital services require build in PennChart.

The Office of Clinical Research can assist with PennChart training, obtaining an RBN and additional items to support your study start up.

For information on the Prospective Reimbursement Analysis (PRA) process and required templates, go here: https://www.med.upenn.edu/clinicalresearch/budget-development.html. If you need assistance developing your PRA or determining which template to use contact either ocr@upenn.edu or ocrfin@upenn.edu.

To obtain a Research Billing Number (RBN) submit a Research Billing Application (RBA) here: https://www.med.upenn.edu/clinicalresearch/research-billing-pennchart.html. If you need assistance with the RBA process contact either ocr@upenn.edu or ocrfin@upenn.edu

For PennChart guidance and to download access-request forms, go here: https://www.med.upenn.edu/clinicalresearch/pennchart.html#ResearchBillinginPennChart6. If you would like assistance with PennChart, be it training, PennChart build or billing review, contact either ocr@upenn.edu or pson-ocrops@upenn.edu.

Additional forms can be found here: https://www.med.upenn.edu/clinicalresearch/forms-tools-templates.html?link=263

Office of Clinical Research

You indicated that the study involves the administration of a drug product for research purposes AND that the protocol has been written by a Penn Medicine faculty or staff member.

This is consider an investigator-initiated trial.

Please review IRB guidance on Research with Drug products HERE.

Please seek an IND exemption determination from the OCR Regulatory Services.

If an IND is required, OCR Regulatory Services can provide guidance on this process. An IND number is required to complete the HSERA application, regardless of who holds the IND.

The OCR offers templates, guides, and forms here: https://www.med.upenn.edu/clinicalresearch/forms-tools-templates.html?link=263.

To contact the Office of Clinical Research for assistance, please email psom-ind-ide@pobox.upenn.edu or phone 215-662-4484.

Office of Clinical Research

You indicated that the study involves:

Investigating a device product, OR
Using an FDA approved device off label, AND
The protocol has been written by a Penn Medicine faculty or staff member.

This is consider an investigator-initiated trial.

Please review IRB guidance on Research with Devices HERE.

If you need help with determining if your device meets the definition of a medical device or whether your protocol is exempt from IDE regulations, contact the OCR Regulatory Services.

If an abbreviated or full IDE is required, OCR Regulatory Services can provide guidance on this process. An IDE number is required to complete the HSERA application, when an application is required to FDA.

The OCR offers templates, guides, and forms here: https://www.med.upenn.edu/clinicalresearch/forms-tools-templates.html?link=263.

To contact the Office of Clinical Research for assistance, please email psom-ind-ide@pobox.upenn.edu or phone 215-662-4484.

Local IT Support Provider/Security Liaison

You indicated your work involves use of PHI/access to medical records.

Please contact the IT support provider/security liaison in your school to develop an appropriate plan for data storage, protection and transmission. A description of this plan is required in your HSERA application.

Additionally, if your use/access is limited for the purposes of preparation for research or retrospective review of medical records, please contact the Penn Data Analytics Center for help with obtaining de-identified/coded data sets from the various data warehouses at Penn.

Contact your home organization’s IT support provider to initiate the request. You can find which IT group supports your org here: https://www.isc.upenn.edu/get-it-help

When reaching out be sure to specify that you are seeking assistance with developing plans to securely protect, store and transmit PHI for research purposes.

For complete information about the various services provided by the Data Analytics Center please see: http://www.med.upenn.edu/dac/

Human Stem Cell Research Advisory Committee (HSRAC)

You indicated that this research involves the collection or use of

human embryonic stem cells, or
human induced pluripotent stem cells.

The protocol must be approved by the Human Stem Cell Research Advisory Committee (HSRAC). IRB approval cannot be granted until HSRAC approval is granted.

The purpose of this committee is to assist the Penn community with the scientific, legal, ethical and compliance considerations that arise from the use of human stem cells in research — including, but not limited to human embryonic stem cells.

hSCRAC will work to ensure that stem cell research activity is in compliance with federal, state and local regulations, and with Penn policies, and that it is conducted in accordance with the highest scientific and ethical standards set by NIH and the National Academy of Sciences.

It is the role of hSCRAC to provide procedural guidelines to the community on the derivation, procurement, banking and use for research of human stem cells.

The hSCRAC reviews all covered activities and helps maintain a registry of human embryonic stem cell lines used for research at Penn.

Provide your IRB confirmation code or number (once generated by the IRB) to the Research Compliance Officer. Please see: https://research.upenn.edu/committees/#stem.

Center for Magnetic Resonance Imaging and Spectroscopy (CAMRIS)

You indicated that an MRI scan is being performed for research purposes only, and NOT considered standard of care.

Research/non-standard use of MRI may include but is not limited to any of the following:

Situations in which MRI results may impact subjects current clinical care plan or treatment decisions, such as:
- The study requires a customized report with specifics regarding the study protocol (i.e., specific measurements or details)
- Introduction of a device of any kind during the MRI that is not used during a ‘standard of care’ type scan
Your MRI is not consistent with standard care time points for MRI imaging.
Your MRI is not paid for by insurance.

Consult the CAMRIS website: https://www.med.upenn.edu/camris/application-and-faq.html for application requirements and required institutional consent form language.

Penn Contracting Offices

You indicated that you may be planning to disclosure Penn patient data or specimens outside of the institution.

If there is not already an associated agreements or contracts in place due to funding then a data use agreement, business associates agreement, or material transfer agreement may be required to be executed.

Execution of Agreements

All agreements are executed through Penn ERA or the Penn Research Inventory System (RIS). All agreements are executed by the contracting offices. Fore more information, please see: https://irb.upenn.edu/homepage/biomedical-homepage/guidance/research-with-penn-patients/sharing-data-specimens.

Questions?

All questions about contract and agreement execution should be directed to the applicable contracts office.

Contract Offices Websites

Research Integrity Office (RIO):

Investigators (any person responsible for the design, conduct or reporting of this research protocol) must disclose (for themselves, spouses and dependent children):

Receipt of payments over $5,000 for the past 12 months from any entity that sponsors, provides support, or otherwise has a financial interest in the conduct or outcome of this research protocol (Outside Organization).

Investigators must also disclose:

equity and any payments from a public company that together exceed $5,000;
any equity in a private company; and
any management role for any Outside Organization with a financial interest in this protocol.

Investigators must also disclose an inventorship or other financial interest in a drug, device or other product or a competing product (IP rights), regardless of whether the IP has been patented, licensed, or assigned to Penn, if such IP is being tested, evaluated, or developed in, or if its commercial value could be affected by, this protocol.

Finally, all investigators must complete research-related Conflict of Interest (FCOI) Training prior to participating in research, and again every 4 years.

Investigators are responsible for reviewing Penn’s policy on conflict of interest and for completing FCOI Training.

Information on Training and required disclosures is online here: https://research.upenn.edu/compliance-and-training/fcoi.

Starting March 18, 2024, researchers and personnel must disclosure in the Research, Interests, and Activities (RIA) system. See: https://portal.research.upenn.edu/conflict-of-interest.

Funding Support Entity

If you anticipate that your research will receive funding during the conduct of the study, or if your research is currently funded (upon submission to the required review entities), the following additional entities may be required for your research to be approved/executed.

Grants / Federal funding / Non-Profit Funding
Agreements for grants, non-profit, or other federal funding is are executed through the Office of Research Services (ORS) or the Office of Research Support Services (ORSS).

Industry / Corporate Sponsored Clinical Trials
Industry sponsored clinical trial agreements are executed through the Office of Clinical Research (OCR) Legal Services (previously CTCU) or Abramson Cancer Center Contracts Division for Hematology/Oncology.

Industry / Corporate Sponsored Non-Clinical Trial
Industry sponsored research agreements (SRAs) for non-clinical trials are executed through Penn Center for Innovation (PCI), Office of Clinical Research (OCR) Legal Services (previously CTCU), or Abramson Cancer Center Contracts Division for Hematology/Oncology.

Internal funding (Department/ Division/ Fellowship Awards) Generally, no additional oversight is needed but the type of funding being utilized to conduct the research should be provided for tracking purposes in the HSERA application to the IRB.

For more information on Sponsored Projects, see the manual here:
www.upenn.edu/researchservices/Manual.html

Questions?

All questions about contract and agreement execution should be directed to the applicable contracts office.

Contract Offices Websites

Updated: 3/11/2024

The use of this tool is not required. It has been developed to assist the Penn research community in navigating our Human Research Protections Program. The tool should be used as early in the protocol development process as possible to maximize utility.

Please answer the following questions as they pertain to your protocol.

Does the research involve ionizing radiation exposure that is specifically for research purposes?

Yes No

Does this research involve the administration of any of the following to human participants? Recombinant or synthetic DNA or RNA; Genetically modified biologics (e.g., CART) or Biosimilars; Recombinant or genetically modified infectious organisms, established cell lines, or viral vectors/agents/products; Non-biologic vectors/transfer agents; OR novel gene editing approaches?

Yes No

Does the research enroll subjects with relevance to cancer?

Yes No

Does the research require use of the Center for Human Phenomic Science (CHPS)? [formerly known as Clinical Translational Research Center (CTRC)]

Yes No

Does the research involve use of UPHS (Penn Medicine) services?

Yes No

Does the study involve the administration of a drug product for research purposes on a protocol written by a Penn Medicine faculty or staff member?

Yes No

Is the study investigating a device product OR using an FDA approved device off label on a protocol written by a Penn Medicine faculty or staff member?

Yes No

Does the research involve use of protected health information (PHI) or access to medical records?

Yes No

Does this research involve the collection or use of human embryonic stem cells, or human induced pluripotent stem cells?

Yes No

Is an MRI scan being performed for research only and NOT considered standard of care (example: specific scanner, parameters or solely for the purposes of research)?

Yes No

Are you planning to disclosure Penn patient data or specimens outside of the institution?

Yes No