The Department of Public Health participates in research to improve services and care for the public. All research studies that involve human subjects must be reviewed by the Institutional Review Board (IRB) before and during the study.
The following studies require review by the IRB:
All research involving people receiving services directly from or funded by/through:
- Philadelphia Department of Behavioral Health and Intellectual disAbility Services (DBHIDS).
- Philadelphia Department of Human Services (with limited exclusions; please ask for guidance).
- Philadelphia Department of Public Health.
- Philadelphia Office of Homeless Services.
- Philadelphia Prison Health Services.
Also any research:
- Involving data, staff, or specimens from the Medical Examiner’s Office.
- Submitted with a request for review by other City departments.
This applies whether or not the study is a multi-site study.
The following studies also require review by the Health Commissioner’s Office Review Committee:
All research that:
- Involves Department of Public Health data.
- Involves people receiving services from the Department.
- Involves people receiving services funded by the Department.
- Will result in a publication or conference presentation involving the Department.
These studies must include an investigator or collaborator working for the Department of Public Health.
A study requires a Data License Agreement (DLA) from the Law Department if any of the following apply:
- The principal investigator or co-principal investigator (applicant) works at a non-City entity.
- The principal investigator or co-principal investigator (applicant) will share City data with any non-City entity.
- The principal investigator or co-principal investigator (applicant) intends to publish the results of the study.
The Law Department must approve all DLAs. Applicants should contact Divisional Deputy City Solicitor Chris Malcarney (firstname.lastname@example.org) for more information. DLA applicants will also submit a data review form. They should be prepared to provide:
- Their IRB application materials.
- The IRB’s approval or waiver letter.
- A list of all data points or variables sought.
- A narrative description of the study (if not included with the IRB application materials).
- A letter of support from all City departments contributing data.
- Any state- or federal-level approvals, if necessary.
If a DLA is required, the Department of Public Health will not release data unless and until the DLA is fully executed.
Special regulations and requirements for research involving prisoners:
Research involving prisoners is subject to additional federal and state regulations and requirements. 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 learn about these requirements. If the study will involve prisoners in City facilities, you must get approval from the Philadelphia Department of Prisons before applying for IRB approval.
Where and when
All new studies that require IRB approval must be reviewed by the full committee at a regularly scheduled meeting.
Application submission deadlines are generally two weeks before a scheduled meeting of the IRB.
|Application submission deadlines||Meeting schedule|
|January 18, 2019||February 5, 2019|
|March 15, 2019||April 2, 2019|
|May 17, 2019||June 4, 2019|
|July 19, 2019||August 6, 2019|
|September 13, 2019||October 1, 2019|
|November 15, 2019||December 3, 2019|
Meetings begin at 1 p.m. and are open to the public.
Meetings are held at:
Medical Examiner’s Office
321 University Ave.
Philadelphia, PA 19104
Meeting dates may change without notice. Contact the IRB Office to confirm a meeting date: (215) 685-0869.
Investigators are encouraged to attend the IRB meetings at which their applications are reviewed.
Before your study begins
To submit a new study to the IRB, complete a proposal submission application. The application must include:
- An executive summary.
- Consent or assent forms.
- Materials for participant recruitment or distribution.
- The full research protocol or grant proposal.
- Any data collection instruments (surveys, measurement scales, etc.)
- The principal investigator’s conflict of interest form.
All consent and assent forms must adhere to informed consent requirements.
Investigators must also submit proof of human subjects research training taken within the last three years.
Managers of the City unit(s) involved must approve all studies. You may submit a unit approval form or a letter from the unit manager.
Please be sure to number the pages on all study documents for review.
You must inform all participants that they are being included in research, except for studies that qualify for a waiver. They must receive all pertinent information about that research and their rights. Investigators should review the informed consent requirements and complete an informed consent form.
Please note that federal requirements for informed consent will change for studies reviewed on or after January 21, 2019.
Waiver or alteration of informed consent and waiver of Health Insurance Portability and Accountability Act (HIPAA) authorization
Federal regulations allow limited human subjects research without written informed consent. An IRB may also approve a waiver of HIPAA authorization under specific situations. The Law Department’s HIPAA Privacy Unit will review HIPAA waiver requests. Refer to the summary information sheet for information on what waivers the IRB may permit. Complete section 5 of the proposal submission application, as appropriate. Be sure to provide justification for any requested waiver or alteration.
We recommend that you get a third party opinion from a children’s rights advocate when requesting waiver of parental consent for minors participating in research. This person should not be involved in the project. They should review the study requirements for the child and determine if there is any extra risk to the child by their participation without parental consent.
You should submit any requests for an exempt study determination with the proposal submission application. We recommend that you submit the exemption request at least two weeks before an application submission deadline. This allows time to make a full IRB study submission if the IRB determines that the study is not exempt.
Submitting revisions to an approved study:
The IRB will approve a study for a specific period of time (usually one year). During the period of your study, you may choose to submit revisions based on the study’s progress or other factors. Proposed revisions must be reviewed and approved before they go into effect.
Submitting a continuing review of an approved study:
All approved studies require a continuing review by the IRB. Investigators should submit update reports to the IRB between 20 to 60 days before the study is scheduled to expire.
Submitting a closure report:
Upon completion of an approved study, the principal investigator should submit a closure report to the IRB.