An FDA regulated clinical investigation or clinical trial is considered human research and therefore must have IRB approval before the study begins.
In order for a non-FDA regulated activity to be considered research under the Common Rule, it must be both 1) a systematic investigation (including research development, testing, and evaluation) and 2) be designed to develop or contribute to generalizable knowledge. Some demonstration and service programs may include research activities. In order for research to be considered human research (and thus requiring IRB approval before the study begins), the research must involve living individuals about whom an investigator (whether professional or student) conducting research either 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
For clarity, the following federal definitions in the Common Rule (45 CFR 46) are provided below and are used by Downstate when making the determination as to whether IRB approval is required:
In general, the DMC IRB uses the definitions in the Common Rule to determine if any non-FDA regulated activity requires IRB approval. The IRB retains final judgment as to whether a particular activity is covered by this policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report.
Even when research is exempt from HHS and FDA regulations or when the activity does not meet the definition of human research, the HIPAA regulations still apply, if 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.
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 - Application for a Determination Letter to State IRB Approval is Not Required or contact the IRB at (718) 613-8480 or IRB@downstate.edu for guidance.
In general, the activities that require prospective IRB review and approval are:
Activities that require IRB review and approval beyond the initial review include:
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.
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.
In addition, according to the federal regulations, some exempt human research requires "limited IRB" review by an IRB Member or IRB, so an investigator cannot conduct this type of review.
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.
The Downstate Medical Center IRB uses IRBNet for the electronic submissions and management of human research activities and required reporting. Please refer to the guidance for the IRBNet (IRB Application and Reporting System) for more details on how to use the system. Application forms and template materials are provided on the Electronics Submissions IRB website.
Guidance and policy can be viewed by clicking on tab within the IRB Menu for Policies & Guidance.
Information on required training and conflict of interest disclosures can be viewed by clicking on the tab within the IRB Menu for Training & Conflict of Interest.
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 For Expedited or Full Review and submit all required materials. The IRB will determine whether the study can be expedited. 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 Policy IRB -01, the PI listed on an IRB application must be an investigator who meets at least one of the following eligibility criteria:
A PI who is an external employee to DMC and listed on a DMC IRB application agrees to abide by DMC policies for the duration of the study.
Please refer to the SUNY Downstate Medical Center Conflict of Interest website.
In general, continuing review is not required for exempt research, unless the IRB determines otherwise and provides and expiration date for the IRB approval.
When the IRB reviews and approves research via expedited review, the effective date of the initial approval is the date on which an experienced IRB Member has reviewed and accepted as satisfactory the protocol or informed consent documents, or any other responsive materials, required by the IRB from the investigators. In such circumstances, the expiration date of the initial approval period, which is the date by which the first continuing review must occur, may be as late as one year after that effective date of initial IRB approval.
When the IRB reviews and approves research with conditions at a convened IRB meeting without requiring further review at a subsequent convened meeting, the effective date of the initial approval is the date on which the IRB Chair or an experienced IRB Member has reviewed and accepted as satisfactory all changes to the protocol or informed consent documents, or any other responsive materials, required by the IRB from the investigators. In such circumstances, the expiration date of the initial approval period, which is the date by which the first continuing review must occur, may be as late as one year after that effective date of initial IRB approval. However, the IRB may choose to set the expiration date of the initial approval period at one year from the date of the IRB meeting at which the research project initially was approved with conditions.
Please see the OHRP and FDA guidance referenced above for specific examples of various scenarios.
When a study is reviewed and approved by an external IRB, the DMC IRB will acknowledge the expiration date determined by the external IRB.
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.
Submit the appropriate "Application for Progress Report (Continuing Review)" to the IRB using IRBNet before the required deadline.
Instructions for completing the form can be found within the form.
In order to close a study, submit an "Application for Final Report (Study Closure)" to the IRB using IRBNet before the deadline for continuing review. Instructions for completing 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.