In order for a non-FDA regulated activity to be considered research under the HHS regulations, it must be both 1) a systematic investigation and 2) be designed to develop or contribute to generalizable knowledge. In order for research to be considered human research, it must involve living individuals about whom an investigator conducting research obtains 1) data through an intervention or interaction with the individual, or 2) obtains individually identifiable private information. All human research must have IRB approval before the study begins.
An FDA regulated clinical investigation or clinical trial must have IRB approval before the study begins.
The Downstate Medical Center is guided by the ethical principles set forth in the Belmont Report created by the National Commission for the Protection of Research Participants of Biomedical and Behavioral research. The three quintessential requirements for the ethical conduct of Human research are:
The US Federal regulations were established based on the principles of the Belmont Report. When applicable, the principles of the Nuremburg Code (PDF) and the Declaration of Helsinki may also apply to the research; particularly for transnational research.
All Downstate staff must follow the Downstate Code of Ethics. In addition, research professionals are expected to following the ethical principles of their scientific and professional disciplines.
All human research as defined above requires IRB approval before the activity begins. When it is not clear whether an activity requires IRB approval, please consult the "IRB Decision Aid" or call the IRB at (718) 613-8480 for guidance.
Some human research activities are exempt from federal regulations; however, the Downstate still has oversight of these activities. An exemption must be prospectively determined by the IRB. The IRB allows for one exception to the prospective determination: An independent determination by an investigator is acceptable solely for the purpose of making representations for reviews preparatory to research, which is automatically considered exempt. Even when research is exempt from federal regulations or when the activity does not meet the definition of human research, the HIPAA/HITECH regulations still apply, if Protected Health Information (PHI) is involved in a research activity. If PHI is involved, a HIPAA wavier, HIPAA Authorization, BAA, DUA, or other HIPAA instrument is usually required. Additional Downstate policies apply to exempt research.
A new study may qualify for expedited review if it presents no more than minimal risk to the research participants and it meets other specific criteria, as outlined in the IRB application form. The expedited review categories and applicability to both non-FDA regulated and for FDA regulated research and are fully described within the Federal Register: November 9, 1998 (Volume 63, Number 216).
Complete the IRB application form for expedited review and submit all required materials. The standard requirements for informed consent (or its waiver, alteration, or exception) apply to expedited review.
The following types of studies may not be expedited, at the time of initial or continuing review:
Although a study may qualify to be reviewed by expedited review during continuing review or an amendment, a study may not be expedited at the time of initial review if the research includes any of the following:
Even when a study qualifies for expedited review, the IRB may defer the initial review to the convened (full) board (for sensitive issues, study design concerns, etc.). In this situation, the study may continue to be reviewed by expedited review procedures for any follow-up required by the convened IRB or for the review that is carried out at the time of continuing review, unless the IRB otherwise determines the review must be carried out by the convened board.
Expedited review of a new study or continuing review of a previously IRB approved study entails designated review by the IRB Chair and/or a designated IRB Member (s) in lieu of a convened (full) IRB review and thus may shorten the time to approval; however, the project must still meet all requirements. There are no scheduled deadlines for submission, as the review process will start immediately.
An experienced IRB Member will review and may approve the research package. The IRB Member may require additional changes or make recommendations before approving the study. The IRB Member can refer the study to the IRB Chair, Vice-Chair or another experienced IRB Member, if the topic is out of their area of expertise. An IRB Member cannot disapprove the research, but they can defer it to full board review.
The IRB Chair has final approval authority, if there are any concerns. The IRB Chair cannot disapprove a project under the expedited review process, but may defer it to the convened IRB for a final decision.
For the purposes of the Downstate IRB policy, the PI listed on an IRB application must be a seasoned investigator with a field-specific terminal degree who is a Faculty Member at Downstate or who otherwise meets at least one of the following eligibility criteria:
A PI who is an external employee to Downstate and listed on a Downstate IRB application agrees to abide by Downstate policies for the duration of the study.
Please refer to the SUNY Downstate Medical Center Conflict of Interest website.
At the time of initial review and at continuing review, the IRB will make a determination regarding the frequency of review of the research protocols. All protocols will be reviewed by the IRB at intervals appropriate to the degree of risk but no less than once per year. In some circumstances, a shorter review interval (e.g., biannually, quarterly, or after accrual of a specific number of participants) may be required. The expiration date of the approval period will be entered in the electronic IRB submission and reporting system and the approval letter will reflect the expiration date. In specifying an approval period of less than one year, the IRB may define the period with either a time interval or a maximum number of research participants either studied or enrolled. If a maximum number of research participants studied or enrolled is used to define the approval period, it is understood that the approval period in no case can exceed one year and that the number of research participants studied or enrolled determines the approval period only when that number of research participants is studied or enrolled in less than one year.
The electronic IRB submission and reporting system (IRBNet) notifies the study team 60 days prior to the expiration of IRB approval. The PI must ensure a progress report is submitted in time for continuing review.
If a study expires before the IRB can review and approve the continuing review, the study team will get an automatic notice from the electronic IRB submission and reporting system stating the study has expired and all research must stop.
All required reportable events must be reported to the IRB within the deadlines specified in the Policy IRB-01. Please see definitions in IRB guidance materials for clarification of the event type or contact the IRB.
In order to close a study, submit a "Final Report" Form before the deadline for continuing review. Instructions for completed the form can be found within the form.
Please provide IRB with copies of presentations or publications at the time of study closure. If presentations or presentations are available after the study closure, they may be reported to the IRB for acknowledgement.