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Institutional Review Board

The Philadelphia Department of Public Health has a long history of participating in research to improve services and care for the good of the public. As required by Department policy, medical ethics and federal regulations, all research that involves human subjects must be reviewed by an Institutional Review Board (IRB) prior to implementation and on an ongoing basis.

What studies must be submitted for review by the IRB?
All research involving persons receiving services directly from or funded by/through:
Also any research:

  • involving data, staff, or specimens from the Medical Examiner's Office, or
  • submitted with a request for review by other City departments.

What studies must also be submitted to the Health Commissioner’s Office Review Committee?
All research involving:


  • Philadelphia Department of Public Health data
  • Persons receiving services directly from or funded by/through the Department
  • Proposals for research that will result in publication and/or conference presentation

Studies must include an investigator or collaborator working for Philadelphia Department of Public Health.

Health Commissioner’s Office Review Committee

What studies require a Data License Agreement (DLA)
  • the Principal Investigator/CO-PI (applicant) works at a non-City entity,
  • the Principal Investigator/CO-PI (applicant) will share/transmit City data to any non-City entity,
  • the Principal Investigator/CO-PI (applicant) intends to publish the results of the study.

DLAs must be approved by the Philadelphia Law Department. Applicants should contact Assistant City Solicitor Benjamin Mishkin (benjamin.mishkin@phila.gov) for more information.

Applicants should be prepared to provide the following documentation: 1) their IRB application materials, 2) the IRB’s approval or waiver letter, 3) a list of all data points/variables sought, 4) a narrative description of the study (if not included with the IRB application materials), 5) a letter of support from the data-contributing City Department, and 6) any state- or federal-level approvals, if necessary.

If a DLA is required, the data will not be released unless/until the DLA is fully executed.
How do I submit a study to the IRB?
Requests for IRB exempt study determination may be submitted at any time, and should preferably be submitted at least two weeks prior to a scheduled meeting submission deadline. All new studies that require IRB approval must be reviewed by the full committee at a regularly scheduled meeting. Investigators are encouraged but not required to attend the IRB meetings at which their applications are reviewed.

Information and forms:

  • Description of types of submissions
  • Forms for submissions, including exempt, new, revisions, continuing review, and closure reports
How do I submit revisions and other materials to the IRB?
  • Description of types of submissions
  • Forms for submissions, including exempt, new, revisions, continuing review, and closure reports
I am an external researcher requesting City generated data. Do I need any other approvals?
The Office of the Deputy Mayor for Health and Opportunity and its departments require departmental approval for external research requests. Find out more.
Are there special regulations and requirements for research involving prisoners?

Research involving prisoners is subject to additional regulations and requirements, both Federal and State. The Pennsylvania Criminal History Records Information Act (CHRIA) severely limits access to prisoner health records, even with the prisoner’s consent. Researchers proposing studies involving prisoners or data about prisoners are urged to familiarize themselves with these requirements and to obtain approval from the Philadelphia Department of Prisons for their proposed research before applying for IRB approval.



Resources

Federal Regulations

Links