Help!

The Help! section is the first place investigators, study coordinators and IRB members should go to find answers to questions related to the IRB-approval process. Help! provides explanations about the research ethics, the intricacies of the research regulations, the IRB-approval process and topics related topics to conducting clinical research. While the IRB is a regulatory committee and not a clinical research review committee, the IRB must assure that all research that is conducted at CHOP is scientifically sound. This site therefore, provides resources about clinical research to point investigators in the right direction when designing their studies.

Help! Sections

  • Principal Investigator Responsibilities

    Investigators assume important regulatory responsibilities when they serve as the Principal Investigator. This is particularly true of those who hold an IND or IDE and are therefore, sponsor-investigators. These pages provide an in-depth discussion of all of the principal investigator's responsibilities for the conduct of human subjects research.

  • What Must Be Reviewed by the IRB

    The CHOP IRB permits investigators to apply the definitions of research and human subjects in order to determine whether or not their proposed activities meet the definition of human subjects research.Investigators are frequently unsure whether or not their proposed project meets the definition of human subjects research and therefore requires review by the IRB.

  • Preparation for Study Submission

    To prepare for a submission to the IRB, the investigator must develop a protocol, consent form(s), recruitment materials (written or printed in alternative media), and complete the IRB's electronic application in eIRB. In addition, investigators might need to have prior scientific review or wish to request a waiver of consent, assent or HIPAA authorization. This page provides links to the various directions for preparing the required materials and waiver requests.

  • Criteria for IRB Approval

    These pages delineate the regulatory requirements for research funded by the federal government or regulated by the FDA. The related webpages also discuss the specific ways in which the CHOP IRB deviates from the regulatory requirements for non-federally funded research.

  • During and After the Study Approval Period

    During the approval period investigators are required to submit progress reports at least annually (Continuing Review), obtain IRB approval for any changes in the research and to report notable events (SAEs, unanticipated problems involving risk to subjects, protocol deviations, etc.) that occur in accordance with the IRB's guidelines.

  • Special Topics

    This page includes links to discussions of special topics including Certificates of Confidentiality, Registries & Repositories, Honest Brokers, Sharing Data and Specimens others, Behavioral Research, Incidental Findings, Investigational Drugs and Devices, Emergency Use of Investigational Drugs and Devices, Recruitment vs Screening, and Payments to Subjects.

  • HIPAA and Research

    The Privacy Rule or HIPAA contains basic practices for protecting the privacy of patients' health information which are implemented across the CHOP health-care system. HIPAA also contains specific requirements for research with human subjects and their protected health information (PHI).

  • IRB Reliance Agreements

    Increasingly, funding agencies and investigators conducting multi-center research are seeking to work with a single, central IRB rather than multiple local IRBs. The CHOP IRB has several Master Reliance agreements in place – Penn, PEDSnet, Pediatric Central IRB (COG) – and has negotiated single-study reliance agreements for many other studies.

Summary:

Every principal investigator should be thoroughly familiar with their responsibilities. Tasks may be delegated but the PI will be held responsible for the actions of each and every member of the study team.

Summary:

The CHOP IRB permits investigators to apply the definitions of research and human subjects in order to determine whether or not their proposed activities meet the definition of human subjects research.

Investigators are frequently unsure whether or not their proposed project meets the definition of human subjects research and therefore requires review by the IRB. The most frequent questions received by the IRB concern the following:

Summary:

To prepare for a submission to the IRB, the investigator must develop a protocol, any relevant consent form(s), recruitment materials (written or printed in alternative media), and complete the IRB's electronic application in eIRB. The related pages provide directions for preparing these materials.

Summary:

The Children's Hospital of Philadelphia has chosen not to apply all of the requirements of the Common Rule (45 CFR 46) to all human subjects research under the institution's Federal Wide Assurance (FWA). Research that is funded by the federal government must meet all of the requirements of the Common Rule. In addition, research that is regulated by the FDA must adhere to its regulations for the protection of human subjects and other relevant FDA regulations (e.g., 21 CFR 50, 54, 56, 312, 314, 812, and 814).

Summary:

During the approval period investigators are required to submit progress reports at least annually (Continuing Review), obtain IRB approval for any changes in the research and to report notable events (SAEs, unanticipated problems involving risk to subjects, protocol deviations, etc.) that occur in accordance with the IRB's guidelines.

Summary:

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.

Summary:

The privacy provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) have been in effect since April 2003. The Privacy Rule or HIPAA contains basic practices for protecting the privacy of patients' health information which are implemented across the CHOP health-care system. HIPAA also contains specific requirements for research with human subjects and their protected health information (PHI). Definitions of HIPAA terms can be found in the HIPAA Glossary.

Summary:

Both OHRP and the FDA permit an IRB the option to review research or to rely on another IRB to serve as the Reviewing IRB. For multi-site research, the NIH and other funding agencies have increasingly encouraged, or even mandated, that all sites rely on a central IRB. A reliance agreement between the Reviewing IRB and the Relying Institution can be in effect on a per trial basis or can be part of a Master Reliance Agreement.

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