SUNY Downstate Health Sciences University
Office of Research Administration
Frequently Asked Questions
What is human research?
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.
- NOTE: The above 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 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.
Who can be a Principal Investigator (PI) on a study reviewed by the Downstate IRB?
The PI listed on an IRB application must meet the eligibility criteria outlined for PI Status in Policy IRB-01. These criteria are also outlined in Step 3 of the IRB submission process.
When is IRB approval required for an activity?
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. If PHI is involved, a HIPAA Wavier, HIPAA Authorization, BAA, DUA, Certification for PHI of Decedents, Subject Recruitment Authorizations or other HIPAA instrument is usually required.
The activities that require prospective IRB review and approval are:
- Human research (including pilot studies, exempt research, clinical trials, or other clinical investigations, planned emergency research);
- The use of human specimens to evaluate the safety and effectiveness of an investigational agent;
- Use of HUD for a clinical or research purpose (except IRB approval is not needed for certain exceptions for emergency use, but notification to the IRB is required within 5 days of use);
- Expanded access (compassionate use, pre approval access) to an investigational drug/biologic for treatment (except IRB approval is not needed for certain exceptions for emergency use, but notification to the IRB is required within 5 days of use);
- Research activities that involve an interaction or intervention with a living individual;
- Research activities that involve obtaining, accessing, using, reviewing, sharing, analyzing, or disclosing PHI, individually identifiable private data, identifiable sensitive information, or personal data, regardless of whether it is recorded or eventually de-identified;
- Research activities involving the use, analysis or generation of identifiable biospecimens;
- Research requiring IRB approval as required by NYS Article 24A, the Common Rule, FDA regulations, or tribal law passed by an official governing body of the American Indian or Alaskan Native tribe; and,
- Any activity which meets the definition of research under the Common Rule, regardless of whether it is supported or conducted by a federal department or agency or regulated by the FDA or NY State.
Activities that require IRB review and approval beyond the initial review include:
- Amendments (any and all changes) to previously approved non-exempt research;
- Amendments (some changes) to previously approved exempt research, when required by this policy;
- Continuing review/progress reports, when required;
- Check-In reports, when required by the IRB;
- Reportable events;
- Closure (final) reports;
- Request for acknowledgments; or
- Other considerations, as described in this policy or regulations.
If the study is clearly "exempt," why is IRB approval required?
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.
Which activities do not require IRB review and approval?
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.
- An activity is limited to a "preparatory to research activity” (e.g., review of protected health information in preparation for research to determine if there are enough patients to recruit or records to review), IRB approval is not required. HOWEVER, if someone other than the patients’ clinicians are accessing the patient records, the investigator must complete the Researcher Certification for Reviews Preparatory to Research form and save it in the research record.
- Case Reports or Case Series Involving up to Three Individuals
- Activities when the workforce conducts activities which DO NOT make Downstate engaged in human research (see OHRP guidance: Engagement of Institutions in Human Subjects Research (2008)).
- However, the IRB recommends the project lead obtain a copy of the external IRB approval for the activity if it includes human research and approval from the Department Chair or Dean when an activity involves interactions or interventions by the outside investigators.
- However, human research occurring on Downstate property that is greater than minimal risk requires a local Downstate investigator on the research project. This requirement makes Downstate engaged and therefore requires local approval (or acknowledgment) by the Downstate IRB, through the IRB application process, which could include a request for “Application for External IRB Oversight”.
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected, do not need IRB approval.
- Public health surveillance activities may include the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. When such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products), the activities do not require IRB approval. Such activities, including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters), do not need IRB approval.
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes, do not need IRB approval.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions, do not need IRB approval.
- Clinical Care. Nothing in Policy IRB-01 is intended to limit the authority of a clinician to provide medical care, including to the extent the clinician is permitted to do so under applicable federal, state, local law (including tribal law passed by the official governing body of an American Indian or Alaskan Native tribe) or Downstate policy.
- Off-Label Use of an FDA Approved Drug or Biologic. If a clinician wishes to use an FDA approved drug/biologic off-label for non-research purposes, the decision to do so is a clinical decision that does not require IRB approval; however, the clinician must comply with any necessary hospital policies including, when applicable, obtaining approval from the Pharmacy. Off-label use for non-research purposes does not constitute research; therefore, the patient who receives the off-label drug or device cannot be a research participant. However, interventions or use of data from an off-label use for research must have IRB approval and may require an IND. For more information, see FDA Information Sheet: “Off-Label” and Investigational Use of Marketed Drugs, Biologics, and Medical Devices.
- Changes Necessary to Eliminate Apparent Immediate Hazards or to Protect the Life or Physical Well-Being of the Research Participant Enrolled in Previously Approved Research. Refer to Policy IRB-01 for full details and reporting requirements.
- Emergency Use of an Investigational or Unlicensed Drug, Biologic, or Device. Emergency use is the use of a test article (investigational or unlicensed drug, biologic, or device) for a patient in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval. Refer to Policy IRB-01 for full details and reporting requirements.
- In general, the following activities do not require Downstate IRB approval:
- A Healthcare Operations Activity (HOA), performance improvement activity, or training activity which is NOT designed to develop NOR contribute to generalizable knowledge. For more information, refer the definition of “generalizable” and the examples provided with the definition.
- Activities that do not involve systematic investigations.
- Activities limited to using data from deceased individuals, provided the data does not contain any PHI or involve accessing or using PHI.
- Activities limited to using data from individuals who have been deceased for more than 50 years.
- Activities that includes using or accessing PHI from individuals who have been deceased for less than 50 years, when a Researcher Certification for PHI of Decedents Form is submitted and approved by the Privacy Officer (or Downstate IRB).
- Activities limited to de-identified specimens obtained from a producer or supplier (e.g., commercial cell line).
- Activities are limited to a pilot activity, feasibility activity, or evidence based practice activity not involving human research as defined by this policy.
- Activities that DO NOT involve interactions or interventions, but include the following
types of data sets, including when such data is about any specimens:
- Limited data set when a Data Use Agreement (DUA) is in place, assuming the investigator cannot readily identify the individuals about whom the data pertains and does not have access to the key to any codes to identify the individuals (as noted below),
- De-identified data, or
- Coded private information when the code cannot be released to the investigators, for
example through one of the following:
- An agreement is in place to prohibit the release of the code to the investigators
- A written document or policy is in place to prohibit the release of the code to the investigators, or
- An Independent Honest Brokers Assurance Agreement is in place to prohibit the release of the code to the investigators.
What ethical principles should be followed in the design and execution of a research project involving research participants?
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 fair
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.
How do I electronically submit materials to the IRB?
The Downstate Health Sciences University IRB uses IRBNet for the electronic submissions and management of human research activities and required reporting.
How do I have my human research reviewed in an expedited manner?
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.
Will the IRB Office remind me of the need to apply for continuing review of my study?
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.