Activities that Do Not Meet the Regulatory Definition of Human Research The first question one should consider when assessing the requirement for IRB review is whether the activity meets the regulatory definition of human research. Anyone unsure about IRB review requirements and whether their proposed activity constitutes “human research” requiring IRB review should contact the Office of Regulatory Affairs. The IRB staff will determine if the activity is human research. If an activity does not meet the regulatory definition of human research, the IRB will, upon request, issue a letter stating that the project does not require IRB review or approval. Refer to the IRB Guidance: Is IRB Review Required?
Human research must be reviewed by a convened meeting of the IRB unless the research is determined to be exempt or is eligible for expedited review. Final review category and submission requirements will be determined by the IRB.
Convened Board Review The work of reviewing submissions is divided among 8 IRBs. IRBs 1-5 & 7 review general medical research. IRB 8 reviews social and behavioral research. IRB 6 serves Pennsylvania Hospital. If the protocol requires review by the full IRB at a convened meeting, the PI will be notified of the assignment of the protocol to an appropriate IRB within two days of receipt by the IRB.
In general, this assignment will be to the next scheduled meeting of an appropriate IRB (provided that the submission is complete). The IRB will review no more than 25 agenda items at each meeting (including new submissions, continuing reviews, amendments, unanticipated problems posing risks to subjects or others, or previously tabled protocols). Agenda items in excess of 25 will be assigned to the next scheduled meeting of an appropriate IRB.
Expedited Review Federal regulations (45 CFR 46.110, 21 CFR 56.110) allow the IRB to review certain applications on an expedited basis if they meet specified criteria. All expedited protocols must be reviewed by the IRB at least once per year. Additionally, the standard requirements for informed consent (or its waiver, alteration, or exception) apply to all IRB approvals regardless of the type of review - expedited or convened IRB.
An expedited review consists of a review of research involving human subjects by the appropriate IRB Executive Chair or his/her designee. In reviewing the research, the reviewer may exercise all of the authorities of the convened IRB except that the reviewer may not disapprove the research. Additionally, the reviewer may refer the application to the convened IRB for a standard review as warranted.
If the change represents more than minimal risk to subjects, it must be reviewed and approved by the IRB at a convened meeting. For a modification to be considered minimal risk, the proposed change would increase the risk of discomfort or decrease the benefit. The IRB must review and approved the proposed change at a convened meeting before the change can be implemented unless the change is necessary to eliminate an immediate hazard to the research participants. In the case of a change implemented to eliminate an immediate hazard to participants, the IRB will review the change to determine that it is consistent with ensuring the participant's continued welfare.
Increase in target enrollment for investigator initiated research or potentially Phase I research
Expanding inclusion or removing exclusion criteria where the new population may be at increased risk
Revised risk information with active participants
Minor risk revisions that may affect a subject's willingness to continue to participate
Increase in target enrollment at Penn where overall enrollment target is not exceeded or potential sponsored research
Expanding inclusion or removing exclusion where the new population has the same expedited risk as the previous, based on similarities of condition
Revised risk information with subjects in long-term follow-up
Minor risk revisions with no subjects enrolled to date
Exempt Research Federal regulations at 45 CFR 46.101(b) and 21 CFR 56.104 describe categories of research that may qualify for exemption from IRB review. The IRB makes the final determination of exemption.
If a study qualifies for exemption, the research protocol will be approved for a three years. At the end of the three year period, the PI may request renewal of the protocol.
Research activities may commence as soon as the letter granting exempt status is received from the IRB. Investigators are required to submit to the IRB changes in the protocol that may change the level of review.
Within approximately 10 business days following receipt of the submission, the investigator will be notified of the IRB’s decision; or the IRB will request additional information needed to determine the exempt status.
Continuing Review The IRB Application for Continuing Review must be submitted no later than six weeks prior to the expiration date for convened board review and no later than two weeks for expedited review.
NOTE: No research related activities may occur after the protocol expiration date unless the PI contacts the IRB and the IRB Executive Chair (or authorized designee) determines that it is in the best interest of subjects to continue during the lapse in IRB approval.
Modifications to a Research Protocol
Federal regulations require that modifications in approved research, during the period for which approval has already been given, may not be initiated without prior IRB review and approval except where necessary to eliminate apparent immediate hazards to human subjects. Sometimes modifications are noted or recognized after they occur. These changes will be reviewed by the IRB as events that may represent unanticipated problems involving risks to participants or others and to determine whether the change was consistent with ensuring the participants’ continued welfare.
The IRB categorizes modifications into 3 types: Amendments, Deviations, and Exceptions.
An amendment is a permanent, intentional action or process that revises/amends/modifies a previously approved research protocol. Information relating to protocol amendments will be provided to research subjects when the information may relate to their willingness to continue to be a part of the research. Investigators or sponsors must submit requests for changes to the IRB in writing. Upon receipt of the protocol amendment, an IRB Administrator with the assistance of the IRB Executive Chair, or Senior IRB Administrative staff will determine the appropriate level of review.
Minor modifications are defined as those that do not materially affect an assessment of the risks and benefits of the study and do not substantially change the specific aims/design of the study. Submit all modifications using the Modification Submission Form.
A one time, intentional action or process that departs from the IRB approved study protocol, intended for one occurrence.
If the action disrupts the study progress, such that the study design and results would be compromised, and the action compromises the safety and welfare of study subjects, prior documented IRB approval is required.
A one time, unintentional action or process that departs from the IRB approved study protocol, involving one incident and identified retrospectively, after the event occurred. If the impact on the protocol disrupts the study design or compromises the safety and welfare of the subjects, the deviation must be reported to the IRB within 10 business days.
When the IRB reviews the exceptions and deviations, a determination will be made as to whether information related to protocol changes should be provided to participants when such information might relate to their willingness to continue to take part in the research. The investigator will be advised if subjects need to be informed.
School District of Philadelphia approval required to conduct research within the school district:
The School District of Philadelphia frequently receives requests from outside individuals and agencies to conduct research studies. While it is District policy to cooperate with researchers whose projects might benefit education, it is incumbaent on the District to ensure that such activities do not interfere with the instruction, or require excessive pupil or staff time. For this reason, all requests to conduct studies research studies in schools, utilizing questionnaires, surveys, interviews, focus groups, and/or requests for student data, are screened by the Office of Research and Evaluation's Research Review Committee. Ultimate responsibility for authorization rests with the Director of the Office of Research and Evaluation and the Chief Accountability Officer. Policies, procedures, & forms may be found on the School District of Philadelphia, Office of Research & Evaluation's website . Additional information