Special Topics

This page provides a way to quickly link to topics relevant on a less frequent basis:

  • 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.

  • 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.

  • 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.

  • Honest Brokers

    An honest broker can add a layer of protection by preventing the investigators from having direct contact with subjects' personally identifiable data.

  • Sharing Data and Specimens

    After a study is over, investigators frequently wish to share their data or specimens with other investigators;

  • 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.

  • 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.

  • 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.

  • 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.

  • Payments to Subjects

    This page provides guidance for investigators for compensating and reimbursing research subjects in accordance with the IRB's SOPs.

  • 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.

Summary:

Social and behavioral research has led to important scientific findings influencing health care today. For this reason, social/behavioral research is highly valued at CHOP. Many features of good clinical research practice apply equally to social/behavioral research. Some of the topics unique to social/behavioral research that deserve particular comment are covered on this page.

Summary:

Certificates of Confidentiality (CoC) are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates of Confidentiality may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by assuring confidentiality and privacy to participants.

Certificates constitute an important tool to protect the privacy of research study participants.

Summary:

Databases, registries (data banks), and repositories (tissue banks) all involve the collection and storage of information and/or biological specimens over time. Some registry/repositories serve diagnostic or clinical purposes, while others are solely for research. Many serve more than one purpose. Rapid advances, particularly in genomics have allowed registry/repositories to serve as tremendous resources for investigators. There are questions to be addressed that extend beyond those envisioned at the time of their creation.

Summary:

An honest broker can provide a firewall between the investigator and subjects' identifiable information. For example, an honest broker could generate or receive a dataset and then strip out subject identifiers so that the data was no longer readily identifiable. They could either create a de-identified data set or a limited data set.

Summary:

Few things are more confusing than the requirements for sharing data with other investigators. This page presents the requirements for sharing deidentified, limited and identifiable data sets and biospecimens (referred to on this page together as "data/specimens").

Summary:

Incidental findings in research are becoming increasingly common due to the advances in imaging and genetics research. Investigators must consider the possibility of IFs as part of their assessment of the risks and benefits of research participation and must have a plan for reporting results.

Summary:

The Section is Under Development

Summary:

Emergency Use is a special case of of the Expanded Access to Investigational Drugs for Treatment Use. Most of the time, the IRB will have sufficient time to review and approve investigator's requests for expanded access to an investigational drug. Even though only a single individual (or a small group) will receive the investigational drug, this is considered research under the FDA regulations.

Summary:

Recruitment includes all activities where information is provided to the prospective participant while screening includes obtaining information from prospective participants. Recruitment does not require the consent of the prospective subject whereas screening does.

Summary:

Inconvenience and costs to subjects related to research impose impediments to enrollment and research participation. When less well off subjects cannot participate and when more well-off subjects refuse to participate, subject selection can become inequitable. Ideally, payments are designed in a way that they "zero out" the subject's costs and burdens of study participation. This ideal is difficult to achieve in practice; the IRB's test as to whether or not the payment proposed is acceptable is whether it creates on undue influence.

Summary:

Study instruments and tools must be provided at the time of protocol submission. Information that establishes the validity of the instrument/tool should be included in the protocol.

Information about the validation of study tools assists the IRB in its deliberations about the scientific validity of the proposed study.

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