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The IRB is a group of people who have been appointed to a committee where the protection of the rights and welfare of those who agree to take part in research activities is a primary focus. The committee reviews all research activity that involves human subjects.
The committee is made up of at least 5 members with different experience and expertise and includes at least one member who is not affiliated with the institution, one member who is a non-scientist and one member who has a scientific background. The IRB may approve research, require modifications to secure approval of research, table research, defer or disapprove research.
Any research that meets the criteria the definition of research and the definition of HUMAN subject research must be reviewed by the IRB.
Understanding the definition of human subject research is critical to making the appropriate decision related to the activity you are interested in initiating.
The Einstein Healthcare Network (EHN) IRB observes the definition of human subjects provided by the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS).
Human Subject as Defined by DHHS: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through Intervention or Interaction with the individual, or (2) information that is both Private Information and Identifiable Information. For the purpose of this definition:
Human Subject as Defined by FDA: An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used.
To determine if the activity you wish to conduct meets the criteria of human research, refer to HRP 309 Human Research Determination.
If you are not sure if what you wish to do needs IRB review, contact a member of the IRB staff BEFORE you initiate any activity.
The convened IRB committee meets the third Friday of every month.
The meetings are held from 12p.m.-2p.m. in the Korman ground floor conference room, B-18.
A fee is charged for all research study submissions that require convened IRB review and that are sponsored by for-profit organizations. Specific details related to the fees can be found in the Investigator’s Manual in the Is there an application fee for IRB submissions? section.
At Einstein a study Principal Investigator must be an employee or agent of Einstein or have obtained permission to serve as Principal Investigator.
Physicians, researchers, other Einstein personnel and agents can serve as Principal Investigators. If at the time a protocol is submitted the Principal Investigator is a resident, a Co-Investigator who is an attending physician on the medical Staff must be included on the proposal.
For full details on Principal Investigator eligibility, refer to policy A0130.1
Any research staff member who is involved in the design, conduct, or reporting of the Human Research, and have (a) direct interaction with participants and/or (b) access to identifiable data must complete human subjects research training and also conflict of interest training.
At Einstein, the training that is accepted is available online and is provided by the Collaborative Institutional Training Initiative (CITI). Once completed, the training certificate is valid for two years. Every two years after completion of the initial training, study staff is required to complete a refresher course.
Approval will not be awarded for any study that includes study staff with training that will expire within 30-days of anticipated approval.
Details pertaining to what study staff are required to complete the training, are provided in the Investigator’s Manual section entitled ‘What training do my staff and I need to conduct Human Research’?
Use this link to access the instructions for completing the required training.
Research activities can only be initiated once IRB approval has been awarded.
On the Policies and Procedures webpage or in the Investigator's Manual.
A listing of materials/forms needed for each type of IRB submission can be found under IRB Submission Forms.
A complete list of all forms used for IRB submissions can be found under the IRB Submissions Instructions.
Administrative review of materials submitted for IRB consideration is conducted on a daily basis.
Once pre-review findings are resolved, the materials are placed on the next available Convened IRB agenda or are forwarded for expedited review depending on the nature of the research. Expedited review can be initiated any day of the week and is typically completed by the IRB chair person or by a member that the IRB chair designates. Full board review means that the convened committee must review the materials
Office of Research and Technology DevelopmentEinstein Medical Center Philadelphia5501 Old York RoadKorman Building, Room 100Philadelphia, PA 19141
The IRB Office is open from 7:30a.m.- 5:00p.m. for your questions, information, and feedback. Contact and location information for the IRB Office is as follows:
Office of Research and Technology DevelopmentEinstein Medical Center Philadelphia5501 Old York RoadKorman Building, Room 100Philadelphia, PA 19141Get Directions.Phone: (215) 456-7217Fax: (215) 456-8122
Any changes (includes changes in study staff) related to the research approved by the IRB must be submitted for IRB consideration/approval prior to initiating the suggested changes.
No research can be conducted beyond the approval period.
Refer to the Investigator Manual section entitled ‘What are my obligations as an investigator after IRB approval?’ for a detailed explanation of post approval responsibilities that must be addressed by the study team.
Is the activity you wish to undertake human subject research?
Who must be identified as study staff?
What materials must be submitted with a new protocol for IRB review?
Are all support materials included? (i.e. data collection sheets, surveys, questionnaires, recruitment plans)
Are the materials being submitted complete?
Beth Lynch, CIPSenior IRB AnalystPhone: 215-456-7217LynchBet@Einstein.edu