Penn IRB | Screener Pilot

Penn Research Protocols: 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: William Davidson, MS Sr. Medical Health Physicist, EHRS 215-898-2133 wed@ehrs.upenn.edu For online info, visit: https://ehrs.upenn.edu/about-ehrs/contact-ehrs
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: r∙s∙DNA (particularly r∙s∙DNA research involving infectious agents) Human and non-human primate materials (including established cell lines) Select agents Biosafety level 3 (BSL-3) research Human gene transfer studies 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. Forms must be downloaded, completed and emailed to the Institutional Biosafety Officer. PDF’s of the required documents and additional relevant information regarding HGT and IBC submissions can be found here: https://ehrs.upenn.edu/health-safety/biosafety/institutional-biosafety-committee-ibc/ibc-members For questions or to submit the registration forms, contact: Dr. Andrew B. Maksymowych Associate Director, Biological Safety Programs, 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 Trials Management System (CTMS). ◦ To gain access to the CTMS you must complete a training. Detailed information, upcoming training dates and registration links can be found here: http://www.med.upenn.edu/ocr/ctms-training.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: http://www.med.upenn.edu/chps/resources-timeline.html It is suggested that you contact a CHPS Facilitator while planning your study: http://www.itmat.upenn.edu/chps/chps-facilitator.html It is suggested that you contact the CHPS Administration when preparing grant budgets and submissions: http://www.itmat.upenn.edu/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/ocr/secure/pra.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: http://www.med.upenn.edu/ocr/ocr-applications.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: http://www.med.upenn.edu/ocr/about-pennchart.html 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/ocr/secure/forms-tools-templates.htm
Office of Clinical Research	You indicated that a Penn investigator needs assistance with obtaining IND, IDE (including abbreviated IDE), or CTA authorization or approval for investigational use of a Device and/or Drug. An IND/IDE/CTA number is required to complete the HSERA application, regardless of who holds the IND/IDE/CTA. Note that most abbreviated IDEs do not have FDA ID numbers.	The OCR offers an Investigational New Drug (IND) study “start to finish guide” here: http://www.med.upenn.edu/ocrobjects/secure/library/IND_StartToFinish.doc The OCR offers an Investigational Device Exemption (IDE) study “start to finish guide” here: http://www.med.upenn.edu/ocrobjects/secure/library/IDE_StartToFinish.doc To Contact the Office of Clinical Research for assistance with IND/IDE/CTA please email psom-ind-ide@pobox.upenn.edu or phone 215-662-4484. Additional forms can be found here: https://www.med.upenn.edu/ocr/secure/forms-tools-templates.html
Office of Clinical Research	Why You indicated that a Penn investigator needs assistance with obtaining IND/IDE (including abbreviated IDE) or CTA authorization/approval for investigational use of a Device and/or Drug. An IND/IDE/CTA number is required to complete the HSERA application, regardless of who holds the IND/IDE/CTA. Note that most abbreviated IDEs do not have FDA ID numbers.	* The OCR offers an Investigational New Drug (IND) study “start to finish guide” here: med.upenn.edu/ocrobjects/secure/library/IND_StartToFinish.doc * The OCR offers an Investigational Device Exemption (IDE) study “start to finish guide” here: med.upenn.edu/ocrobjects/secure/library/IDE_StartToFinish.doc * To Contact the Office of Clinical Research for assistance with IND/IDE/CTA please email psom-ind-ide@pobox.upenn.edu or phone 215-662-4484. * Additional forms can be found here: med.upenn.edu/ocr/secure/forms-tools-templates.html
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/
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. Disclosures must be submitted in the Financial Interest Disclosure Electronic System (“FIDES”). If research is PHS funded, investigators must also disclose specified financial interests (based on their type and value) related to their Penn responsibilities using the PHS Financial Interests and Travel Statement (PHS-FITS). Finally, all investigators must complete research-related Conflict of Interest (FCOI) Training prior to participating in research, and again every 4 years.	The “Investigator Decision Tree” will help you determine what you must disclose, when it must be disclosed and how to disclose it: http://www.upenn.edu/research/pdf/Investigator_Decision_Tree_for_OVPR_website_5-22-13.pdf Investigators are responsible for reviewing Penn’s policy on conflict of interest http://www.upenn.edu/almanac/volumes/v59/n02/pdf_n02/090412-Supplement-ConflictsInterest.pdf and for completing FCOI Training through Knowledgelink here: https://upenn.plateau.com/learning/user/deeplink.do?linkId=ITEM_DETAILS&componentTypeID=COURSE&revisionDate=1349737260000&OWASP_CSRFTOKEN=97VD-5TUD-RGAF-L64E-OJOF-XFQ5-O3AI-6S7U&componentID=UP.91028.ITEM.FCOI Researchers and personnel must disclosure in FIDES prior to beginning as study, preferably during protocol preparation. Go here to disclose: https://fides.isc-seo.upenn.edu/questions/dashboard/ If research is PHS funded, researchers and personnel must also complete a disclosure in PHS-FITS here; https://phsfits.apps.upenn.edu/phsFits/jsp/fast2.do?fastStart=investigator More information is available at the Office of the Vice Provost for Research website here: http://www.upenn.edu/research/compliance_training/conflicts_of_interest_in_research_program/
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. Federal funding: Office of Research Services (ORS) Industry funding: Clinical Trials Contracting Unit through the Office of Clinical Research (OCR) Industry funding: Penn Center for Innovation (PCI) 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: http://www.upenn.edu/researchservices/Manual.html See a full list of ORS contacts by department: http://www.upenn.edu/researchservices/staffbydept.html Contact the Clinical Trials Contracting Unit regarding a corporate-sponsored clinical trial through the info page here: http://www.med.upenn.edu/ocr/ctcu.html • Learn more about PCI negotiated agreements and contracts, how to submit a request for contract review, and more here: http://www.pci.upenn.edu/contracts-agreements/

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:

William Davidson, MS

Sr. Medical Health Physicist, EHRS

215-898-2133

wed@ehrs.upenn.edu

For online info, visit:

https://ehrs.upenn.edu/about-ehrs/contact-ehrs

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:

r∙s∙DNA (particularly r∙s∙DNA research involving infectious agents)
Human and non-human primate materials (including established cell lines)
Select agents
Biosafety level 3 (BSL-3) research
Human gene transfer studies

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.

Forms must be downloaded, completed and emailed to the Institutional Biosafety Officer. PDF’s of the required documents and additional relevant information regarding HGT and IBC submissions can be found here:

https://ehrs.upenn.edu/health-safety/biosafety/institutional-biosafety-committee-ibc/ibc-members

For questions or to submit the registration forms, contact:

Dr. Andrew B. Maksymowych

Associate Director, Biological Safety Programs, 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 Trials Management System (CTMS).

◦ To gain access to the CTMS you must complete a training. Detailed information, upcoming training dates and registration links can be found here:

http://www.med.upenn.edu/ocr/ctms-training.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:

http://www.med.upenn.edu/chps/resources-timeline.html

It is suggested that you contact a CHPS Facilitator while planning your study:

http://www.itmat.upenn.edu/chps/chps-facilitator.html

It is suggested that you contact the CHPS Administration when preparing grant budgets and submissions:

http://www.itmat.upenn.edu/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/ocr/secure/pra.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:

http://www.med.upenn.edu/ocr/ocr-applications.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: http://www.med.upenn.edu/ocr/about-pennchart.html

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/ocr/secure/forms-tools-templates.htm

Office of Clinical Research

You indicated that a Penn investigator needs assistance with obtaining IND, IDE (including abbreviated IDE), or CTA authorization or approval for investigational use of a Device and/or Drug.

An IND/IDE/CTA number is required to complete the HSERA application, regardless of who holds the IND/IDE/CTA. Note that most abbreviated IDEs do not have FDA ID numbers.

The OCR offers an Investigational New Drug (IND) study “start to finish guide” here:

http://www.med.upenn.edu/ocrobjects/secure/library/IND_StartToFinish.doc

The OCR offers an Investigational Device Exemption (IDE) study “start to finish guide” here:

http://www.med.upenn.edu/ocrobjects/secure/library/IDE_StartToFinish.doc

To Contact the Office of Clinical Research for assistance with IND/IDE/CTA please email psom-ind-ide@pobox.upenn.edu or phone 215-662-4484.

Additional forms can be found here:

https://www.med.upenn.edu/ocr/secure/forms-tools-templates.html

Office of Clinical Research

Why
1. You indicated that a Penn investigator needs assistance with obtaining IND/IDE (including abbreviated IDE) or CTA authorization/approval for investigational use of a Device and/or Drug.
2. An IND/IDE/CTA number is required to complete the HSERA application, regardless of who holds the IND/IDE/CTA. Note that most abbreviated IDEs do not have FDA ID numbers.

* The OCR offers an Investigational New Drug (IND) study “start to finish guide” here: med.upenn.edu/ocrobjects/secure/library/IND_StartToFinish.doc
* The OCR offers an Investigational Device Exemption (IDE) study “start to finish guide” here: med.upenn.edu/ocrobjects/secure/library/IDE_StartToFinish.doc
* To Contact the Office of Clinical Research for assistance with IND/IDE/CTA please email psom-ind-ide@pobox.upenn.edu or phone 215-662-4484.

* Additional forms can be found here: med.upenn.edu/ocr/secure/forms-tools-templates.html

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/

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.

Disclosures must be submitted in the Financial Interest Disclosure Electronic System (“FIDES”). If research is PHS funded, investigators must also disclose specified financial interests (based on their type and value) related to their Penn responsibilities using the PHS Financial Interests and Travel Statement (PHS-FITS). Finally, all investigators must complete research-related Conflict of Interest (FCOI) Training prior to participating in research, and again every 4 years.

The “Investigator Decision Tree” will help you determine what you must disclose, when it must be disclosed and how to disclose it:

http://www.upenn.edu/research/pdf/Investigator_Decision_Tree_for_OVPR_website_5-22-13.pdf

Investigators are responsible for reviewing Penn’s policy on conflict of interest

http://www.upenn.edu/almanac/volumes/v59/n02/pdf_n02/090412-Supplement-ConflictsInterest.pdf

and for completing FCOI Training through Knowledgelink here:

https://upenn.plateau.com/learning/user/deeplink.do?linkId=ITEM_DETAILS&componentTypeID=COURSE&revisionDate=1349737260000&OWASP_CSRFTOKEN=97VD-5TUD-RGAF-L64E-OJOF-XFQ5-O3AI-6S7U&componentID=UP.91028.ITEM.FCOI

Researchers and personnel must disclosure in FIDES prior to beginning as study, preferably during protocol preparation. Go here to disclose:

https://fides.isc-seo.upenn.edu/questions/dashboard/

If research is PHS funded, researchers and personnel must also complete a disclosure in PHS-FITS here;

https://phsfits.apps.upenn.edu/phsFits/jsp/fast2.do?fastStart=investigator

More information is available at the Office of the Vice Provost for Research website here:
http://www.upenn.edu/research/compliance_training/conflicts_of_interest_in_research_program/

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.

Federal funding: Office of Research Services (ORS)

Industry funding: Clinical Trials Contracting Unit through the Office of Clinical Research (OCR)

Industry funding: Penn Center for Innovation (PCI)

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:

http://www.upenn.edu/researchservices/Manual.html

See a full list of ORS contacts by department:

http://www.upenn.edu/researchservices/staffbydept.html

Contact the Clinical Trials Contracting Unit regarding a corporate-sponsored clinical trial through the info page here:

http://www.med.upenn.edu/ocr/ctcu.html

• Learn more about PCI negotiated agreements and contracts, how to submit a request for contract review, and more here: http://www.pci.upenn.edu/contracts-agreements/

Updated: October 30, 2018

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 7 questions as they pertain to your protocol.

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

Yes No

2. Does the research involve gene transfer?

Yes No

3. Does the research enroll subjects with relevance to cancer?

Yes No

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

Yes No

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

Yes No

6. Does the study involve investigational use of a Drug, Device or Biologic?

Yes No

7. Does a Penn investigator require assistance with obtaining IND/IDE approval?

Yes No

8. Does the research involve use of PHI or access to medical records?

Yes No