Frequently Asked Questions
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:
- Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the research participant or the research participant's environment that are performed for research purposes. The definition for "intervention" is defined by federal regulations. In general, the scientific definition of an intervention is the act of purposefully intervening, interfering or interceding with the intent of modifying some outcome. The regulatory definition is much broader.
- Interaction includes communication or interpersonal contact between investigator and research participant.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
- Identifiable private information is private information for which the identity of the research participant is or may readily be ascertained by the investigator or associated with the information.
- An identifiable biospecimen is a biospecimen for which the identity of the research participant is or may readily be ascertained by the investigator or associated with the biospecimen.
In general, the Downstate 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.
The PI listed on an IRB application must meet the eligibility criteria outlined for PI Status in Policy IRB-01. For complete details, refer to Policy IRB-01.
These criteria are also outlined in Step 3 of the IRB submission process.
IRB approval is required for all FDA regulated investigations.
The Downstate IRB uses the definitions in the Common Rule and the HIPAA regulations to determine if any non-FDA regulated activity requires IRB approval. The IRB retains final judgment as to whether a particular activity must obtain IRB approval under this policy consistent with the ethical principles of the Belmont Report.
Even when research is exempt 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.
For complete details, refer to Policy IRB-01.
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.
For complete details, refer to Policy IRB-01. In general, the following Downstate activities DO NOT require IRB review and approval; however, and IRB Decision Aid should be requested to formally document IRB approval is not required.
As a standard practice, the Downstate IRB applies the ethical principles set forth in the Belmont Report to all human research, as created by the National Commission for the Protection of Research Participants of Biomedical and Behavioral research. The three basic ethical principles of Human research are:
- Respect for persons: Recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy.
- Beneficence: Obligation to do no harm and to protect persons from harm by maximizing the anticipated benefits and minimizing possible risks.
- Justice: Distribute the benefits and burdens of research fairly
The principles of the Belmont Report are the foundation for the development of the US Federal regulations. When applicable, the principles of the Nuremburg Code 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 follow the ethical principles of their scientific and professional disciplines.
The Downstate IRB uses IRBNet for the electronic submissions and management of human research activities and required reporting.
For more information, see IRB Electronic Submission Process.
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 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.
For more information, see IRB Electronic Submission Process.
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.