Research studies require different levels of review based on the criteria outlined in this section.

Institutional Review Board (IRB) review

Research must be submitted to the IRB when it involves people receiving services from, or funded by/through, these City entities:

• Department of Behavioral Health and Intellectual disAbility Services (DBHIDS)
• Department of Human Services (with limited exceptions; ask for guidance)
• Department of Public Health
• Office of Homeless Services
• Prison Health Services.

Research must also be submitted to the IRB when it:

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

This applies whether or not the study is a multi-site study or has been approved by another IRB.

Health Commissioner’s Office (HCO) Review Committee

Some studies must be submitted to the HCO Review Committee in addition to the IRB. This includes 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.

For details, see the Health Commissioner’s Office Review Committee Submission Form.

Data License Agreements (DLA)

You must get a 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 submit a request through the City’s privacy review portal. For questions about the process, email HIPAAprivacy@phila.gov. Applicants should be prepared to provide an application to use City data for research. You will also need to include:

• Your 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 (PDF) 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 your study will involve prisoners in City facilities, you must get approval from the Philadelphia Department of Prisons before applying for IRB approval.

Most new studies that require IRB approval must be reviewed by the full committee at a regularly scheduled meeting. Minimal-risk studies that involve only materials collected for non-research purposes may be eligible for expedited review, and can be submitted at any time. Please review the requirements on the proposal submission application.

For studies requiring full review, application submission deadlines are generally one month before a scheduled meeting of the IRB.

To confirm a meeting date, call the IRB office at (215) 685-0869.Investigators are encouraged to attend the IRB meetings at which their applications will be reviewed.

Applications due at 3 p.m. on:	For the IRB meeting at 1 p.m. on:
January 19, 2024	February 6, 2024
March 15, 2024	April 2, 2024
May 4, 2024	June 4, 2024
July 6, 2024	August 6, 2024
September 1, 2024	October 1, 2024
November 3, 2024	December 3, 2024
January 4, 2025	February 4, 2025

You must submit your study to the IRB before it begins. To submit a new study, complete a proposal submission application. Your application must include:

• An executive summary
• Consent forms and, if children are involved, assent forms
• Materials for participant recruitment or distribution
• The full research protocol or grant proposal
• Any data collection instruments (surveys, measurement scales, etc.)
• Conflict of interest forms for key personnel.

Investigators must also submit proof that they have taken human subjects research training within the last three years. City employees can access training through the City’s Learning Management System (LMS). The course is listed as “PDPH IRB – NIH Human Subjects Training.” Investigators without access to this site can email the IRB office for a link to the course.

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.

The PDPH IRB does not accept routine exclusion of potential research participants who do not speak English. Investigators must provide justification for exclusions based on language proficiency.

Be sure to number the pages on all study documents for review.

Informed consent

All consent and assent forms must adhere to informed consent requirements.

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. Please use or refer to the informed consent template.

Federal requirements for informed consent changed in 2019. To learn more, visit the U.S. Department of Health and Human Services regulations for the protection of human subjects in research.

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.

Exemptions

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.

You’ll also need to submit documentation to the IRB throughout your study.

Continuing review of approved studies

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.

Revisions to approved studies

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.

Closure reports

Upon completion of an approved study, the principal investigator should submit a closure report to the IRB.