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Institutional Review Board (IRB)

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

Drexel University has three internal Institutional Review Boards (IRBs). The IRBs are composed of faculty and professional staff members as well as representatives from the local community.

Protocols requiring committee approval may be internally or externally designed and funded. On this website you will find the necessary forms and instructions to assist you in applying to the Drexel IRBs, as well as guidance on conducting human research in a manner that promotes protection of human subjects.

Investigators who plan to use an institutional review board other than the onsite Drexel IRB will submit to the external IRB in conjunction with the Human Research Protection Program (HRPP). After the HRPP confirms regulatory and institutional compliance, the researchers will then submit directly to the designated IRB. Learn more

Registering a study to Clinicaltrails.gov

Clinical trial as defined by ClinicalTrials.gov:

Interventional study (clinical trial): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

Please refer to protocols which fit this description, whether medical or social/behavioral, must be registered with ClinicalTrials.gov.

OHRP Human Subject Regulations Decision Charts

OHRP Human Subject Regulations Decision Charts [PDF]: The OHRP Decision Charts are intended to provide  guidance to investigators interested in non-human subjects research, exempt, expedited determinations and more. The Drexel IRB will need to review all applications and provided final determinations regarding the level of review.

Types of Reviews [PDF]

IRB Deadlines and Calendars

The deadlines and meeting dates listed below apply to human subjects research submissions that involve greater than minimal risk. Studies that involve minimal risk (e.g., expedited, exempt, non-human subjects determinations) are reviewed on a rolling basis and are not required to adhere to the IRB deadlines.

IRB #1 Adult Medical

The IRB #1 reviews medical studies that aim to examine the mechanisms of human disease, and which are conducted at Drexel University and Hahnemann University Hospital.

  • If the protocol will involve radiation and human subjects, visit Drexel University Radiation Safety for more information about radiation safety policies, procedures, and Radiation Safety Committee Review.
  • If the protocol will involve biological hazards, visit Drexel University Biosafety for more information about biosafety policies, procedures, and Institutional Biosafety Committee Review.

Items required to meet a submission deadline are as follow:

  1. New Full IRB applications
  2. Periodic reports/renewals (periodic reports must be received by the scheduled meeting deadline in advance with protocol expiration date).

All other IRB submission and approval requests such as modifications and new reportable events (adverse event/unanticipated problems, protocol deviations) for Full review protocols currently approved by the IRB do not have a deadline. Submissions to the IRB regarding the items noted above are scheduled for review at the next scheduled IRB meeting.

Please Note: New Expedited, Exempt, Letters of Determination and Case Report/Study application are reviewed when received and do not adhere to the deadline calendar.

DHHS IRB Registration:IRB 1[PDF]

IRB #1 Deadline and Meeting Calendar 2019

Deadline Meeting Date
11/26/18 12/17/18
12/24/18 01/14/19
01/21/19 02/11/19
02/18/19 03/11/19
03/18/19 04/08/19
05/20/19 06/10/19
06/17/19 07/08/19
07/22/19 08/12/19
08/19/19 09/09/19
09/23/19 10/14/19
10/21/19 11/11/19
11/18/19 12/17/19

IRB #3 Social Behavioral Educational

The IRB #3 reviews research that applies the behavioral and social sciences to the study of humans. Such research is commonly conducted in the following academic disciplines: education, sociology, psychology, anthropology, economics, political science, public health, and history.

Items required to meet a submission deadline are as follow:

  1. New Full IRB applications
  2. Periodic reports/renewals(periodic reports must be received by the scheduled meeting deadline in advance of protocol expiration date).

All other IRB submission and approval requests such as modifications and new reportable events(adverse event/unanticipated problems, protocol deviations) for Full review protocol currently approved by the IRB do not have a deadline. Submissions to the IRB regarding the items noted above are scheduled for IRB review at the next scheduled IRB meeting.

Please Note: New Expedited, Exempt, Letters of Determination and Case Report/Study applications are reviewed on a rolling basis and do not adhere to the deadline calendar.

DHHS IRB Registration: IRB 3 [PDF]

IRB #3 Deadline and Meeting Calendar 2019

Deadline Meeting Date
11/29/18 12/20/18
12/27/18 01/17/19
01/24/19 02/21/19
02/28/19 03/21/19
04/25/19 05/16/19
05/30/19 06/20/19
06/27/19 07/18/19
07/25/19 08/15/19
08/29/19 09/19/19
09/26/19 10/17/19
10/31/19 11/21/19
11/28/19 12/19/19

IRB #4 Pediatric Medical

Initial IRB submissions involving physicians/staff/patients/resources of St. Christopher’s Hospital for Children (SCHC) must first be printed, signed, and hand delivered to St. Christopher’s Hospital, Office of Research Support, Nelson Pavilion, 2nd Floor: Attn: Eusebia Cruz. The IRB will reject submissions via Coeus Lite that have not been reviewed and signed by SCHC Office of Research Support (ORS) and the investigator’s Department Head or designee.

Application must include signatures of PI/Co-PI and Section Chief. HRP-201 with training dates & FCOI forms are required for each submission. BAA/IIA may be required for non-SCHC/DU staff. ORS will

obtain signature of SCHC Director and Associate Chair for Research for Dept. of Pediatrics. For continued updates always refer to IRB website.

Note: Principal Investigators/Study Coordinators are encouraged not to wait until the deadline for SCHC Initial Review as revisions may be requested by ORS. Amendments, Progress Reports, Letters of Determination and/or submissions for the IRB that do not require signature from Department of Pediatrics and should be submitted directly to the IRB via Coeus Lite.

DHHS IRB Registration: IRB 4 [PDF]

SCHC Office of Research Support Submission Deadline IRB Coeus Lite Submission Deadline Meeting Date
11/26/18 12/06/18 12/19/18
12/24/18 01/03/19 01/16/19
01/28/19 02/07/19 02/20/19
02/25/19 03/07/19 03/20/19
03/25/19 04/04/19 04/17/19
04/22/19 05/02/19 05/15/19
05/27/19
06/06/19 06/19/19
06/24/19 07/05/19 07/17/19
07/22/19 08/01/19 08/21/19
08/26/19 09/05/19 09/18/19
09/23/19 10/03/19 10/16/19
10/28/19 11/08/19 11/20/19
11/25/19 12/05/19 12/18/19

Applications must include signatures of PI/Co-PIs, Section Chief, BAA/IIA for non-DU staff, and completed Trainings on HRP-201 prior to delivering to Office of Research Support (ORS) for initial review. ORS will obtain signature of SCHC Director and Associate Chair for Research, Department of Pediatrics. Always refer to IRB website: http://drexel.edu/research/human-research/humanSubjects/irb/ for continued updates.

NOTE: Principal Investigators/Study Coordinators are encouraged not to wait until IRB Deadline for SCHC Initial Review and should deliver completed application, as revisions may be requested by ORS.

Amendments, Progress Reports and/or changes requested by IRB does not require additional signature from Dept. of Peds and should be submitted electronically via Drexel COEUS Lite.