This page provides a way to quickly link to topics relevant on a less frequent basis:
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Behavioral Research
This page provides guidance for studies where it is possible to discover unexpected suicide risk including assistance for developing a Suicide Risk Management Plan. In addition, there is information covering research that will be conducted in schools, particularly the Philadelphia Public Schools.
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Certificates of Confidentiality
This page information about when to obtain and how to apply for Certificates of Confidentiality (CoC) which are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure.
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Registries & Repositories
Coverage of some of the many issues that need to be kept in mind for developing and operating a registry or a repository.
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Honest Brokers
An honest broker can add a layer of protection by preventing the investigators from having direct contact with subjects' personally identifiable data.
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Sharing Data and Specimens
After a study is over, investigators frequently wish to share their data or specimens with other investigators;
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Incidental Findings
Incidental findings include anticipated and unanticipated findings, unrelated to the research that might impact a subject's current or future health. These can include results such as those from blood tests, radiology imaging studies or genetic findings.
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Investigational Drugs and Devices
These pages provides basic information related to clinical trials that involve the investigational use of FDA-regulated agents including drugs, biologics and devices. In addition, there is information for the IND-IDE holder who is considered a sponsor-investigator by the FDA.
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Emergency Use of Investigational Drugs and Devices
The use of an unapproved drug or device for life-threatening or emergency situations requires that the investigator obtain an emergency IND or IDE from the FDA. When there is insufficient time for IRB approval, investigators may exercise the FDA's emergency exemption from IRB review and approval.
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Recruitment vs Screening
There is considerable confusion about the difference between recruiting a prospective subject and screening a research subject to ensure that they meet the study eligibility criteria. This page explains the differences between the two activities and the impact on the consent requirements.
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Payments to Subjects
This page provides guidance for investigators for compensating and reimbursing research subjects in accordance with the IRB's SOPs.
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Validated Instruments
The CHOP IRB maintains a list of test instruments that it accepts as validated. The instruments on this list do not need to be uploaded into the eIRB system as part of a study submission.