/ SUNY Downstate Medical Center
University Hospital of Brooklyn
College of Medicine
College of Health Related Professions
College of Nursing
School of Graduate Studies
Graduate Program in Public Health / IRB Decision Aid
(Application for aDetermination Letter to State that IRB Approval is NOT REQUIRED)
Whenever you are not sure how to answer a question, contact the IRB for help. Questions may be directed initially to:
  • IRB Chair, Phyllis G. Supino, EdD at (718) 613-8355
  • Executive Director, Kevin Nellis at (718) 613-8461
  • IRB Staff at (718) 613-8480
For additional guidance on human subjects research, see:
Privacy and HIPAA related questions may be directed to the Downstate Privacy Officer, Shoshana Milstein, at (718) 270-7470.
Information Security related questions may be directed to the Downstate Information Security Officer, David Loewy at (718) 270-2431.
For animal research, see:

This guidance incorporates HHS regulatory definitions as well as HIPAA, FDA, and other Federal and NY state regulations.

SIX TYPESOF REVIEW: / REQUIRED FORM:
Determination Letter (indicates IRB review is NOT required) / Use this form to document and request such a determination.
Exempt Review / Follow the instructions on the “Application for Exempt Review”
Expedited Review / Follow the instructions on the “Application for Expedited or Full Review”
Convened (Full) IRB Review / Follow the instructions on the “Application for Expedited or Full Review”
Use of a Humanitarian Use Device (HUD) for clinical purposes / Follow the instructions on the “Application for HUD for Clinical Purposes”
External IRB Review (some multi-site research) / Follow the instructions on the “Application for External IRB Oversight”

Three Key Definitions:

Researchmeans a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Research participantmeans 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. identifiable private information.

Human Research(also known as Human Subjects Research) means any activity that involves a research participant in a research activity. An IRB application is required for all Human Research.

Instructions for requesting an IRB Determination Letter:

  1. Provide a cover memo or e-mail requesting an IRB Determination Letter with the following information, as applicable to the project
  2. Name of project
  3. Responsible party(ies) and Department/School.
  4. Description of project and the suggested reasons it does not need IRB approval
  5. When applicable indicate that data was not collected specifically for the proposed research (e.g., for the use of secondary data).
  6. If using coded data, indicate the data will be coded, and provide the name of the individual who is not part of the project that is authorized to have access to the data. This person must remove all HIPAA identifiers listed in
  7. Indicate whether nominal risk is perceived or involved and if so, provide information as to how SUNY DMC will ensure that the safety, rights, and welfare of affected individuals are protected and provide any information regarding mitigation of risks.
  1. Include a copy of this form with the request.
  1. Provide any project related documents.
  1. The person submitting the request must e-sign the IRBNet submission (option1) or signbelow (option 2). By doing so you are attesting that all of the information provided is true and accurate to the best of your knowledge and you understand that if anything changes, the determination request must be amended.
  1. Submit the request to the IRB using either option outlined below:
  2. OPTION 1: IRBNet Submission
  3. Set up an IRBNet User Account, if you do not have one already, and submit the request in IRBNet.
  4. Instructions for obtaining an account are on the IRB website.
  5. Submit your request in IRBNet as a new submission. Follow instructions for submitting a new project, as outlined in the IRB Guidance “IRBNet™: IRB Application and Reporting System” Note: An IRBNet Registration Form is not required.
  6. OPTION 2: E-MAIL SUBMISSION:
  7. E-mail all documents to the IRB mailbox at nd the IRB will process the request in IRBNet for you.
  8. Please allow a few extra days for processing.
  9. Print and sign your name below to attest that all of the information submitted to the IRB is accurate to the best of your knowledge with the understanding that if anything changes, the request will be amended. Scan to a PDF so that the IRB has a record of your signature.

______/___/___

Print NameSignature Date

The following questions ARE INTENDED TOhelp you determine when an IRB Application is required or when an IRB Determination Letter must be requested:

note: If anything changes in the activity, a new determination must be made.

Type or Print Legibly:

Date:

TITLE of Activity:

Name of INVESTIGATOR/Project lead

Department or SCHOOL:

E-mail:

telephone:

Name of DepartMENT Chair or DEAN:

E-Mail address for Department chair or DEAN:

NOTE: The Department chair/Dean IS NOT REQUIRED TO e-sign the request in IRBNet; however, the IRB will send him/her a copy of the IRB determination letter.

Q1: Is the activity a systematic investigation?
Answer to Q1:
YES.
If you selected “YES,” go to Q2.
No.
If you selected “NO,” skip to Q5.
GUIDANCE FOR Q1:
In general, a systematic activity is planned, orderly, and methodical.
Answer “yes,” even if the activity is limited to the following:
development, testing, evaluation of future research (including a pilot study)
internal training or educational activity
oral history, ethnographic research, or journalism
performance or quality improvement or similar healthcare operations activity (including case studies)
Q2: Is the activity designed to develop or contribute to generalizable knowledge?
Answer to Q2:
YES.
If you selected “YES,” the activity meets the definition of “research;” however, the activity still needs to be considered “human research” to determine if an IRB application is required. Go to Q3.
YES; however, the activity is limited to Patient case reports or case series involving up to three (3) individuals, and there is no information about any other individuals, provided the presentation or publication does not have any identifiable information.
If you selected “YES; however, the activity is limited to Patient case reports or case series involving up to three (3) individuals, and there is no information about any other individuals, provided the presentation or publication does not have any identifiable information”, skip to Q10.
NO.
If you selected “NO,” skip to Q5.
GUIDANCE FOR Q2:
Activities designed to develop or contribute to Generalizable Knowledge are those designed to draw general conclusions or inform policy (i.e., knowledge gained from a study may be applied to populations outside of the specific study population). For conclusions to be generalizable, they must actually be disseminated for research purposes (or be part of a program of investigation that will be disseminated). A useful definition of dissemination is that the material will be shared beyond the local setting.
  • Obvious examples of dissemination are publication in a scholarly journal, presentation at a professional conference, or placement of a report in a library.
  • Examples that are not dissemination include oral presentation to a DMC Department in fulfillment of a DMC requirement, sharing of results with an agency that cooperated in information collection, or internal presentation for utilization and review purposes.
Examples of Generalizable Knowledge:
  • The findings from the activity involving a patient population at SUNY Downstate Medical Center can be applied to a population outside of the SUNY Downstate Medical Center.
  • The findings from a population within a healthcare network can be applied to a population outside of the network.
  • The findings of a student research project can be applied to other students in another school.
IRB applications are not required for quality improvement activities conducted by one or more institutions whose purposes are limited to: (a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes. For more information on quality improvement activities, see: .
Intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research. Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results.
Answer “Yes,” if the outcomes will be generalized for other organizations, programs or services.
Answer “Yes” if the activity is limited to oral history, ethnographic, or journalism, when the project involves stories that will or may draw broad conclusions about the population, cultures, norms and practices, even if no research hypothesis is being tested or validated.
Answer “No,” if the activity is limited to oral history, ethnographic, or journalism, when published materials will be limited to documenting or reporting on events, situations, policies, institutions or systems without the intent to form hypotheses, draw conclusions, or generalize findings.
Answer “No,” if the outcomes of the activity will remain specific to the SUNY Downstate programs or services, although other organizations may use the unpublished results for their own programs.
Answer “No,” if the activity is limited to an internal training or educational activity that is not designed to develop or contribute to generalizable knowledge (e.g., project with sole intent to meet course requirements, classroom activity that develops a survey tool without the intent to use the tool for research purposes).
Q3: Does the activity involve an intervention or interaction with a living individual?
Answer to Q3:
YES, FOR RESEARCH PURPOSES
If you selected “YES, FOR RESEARCH PURPOSES,” the activity meets the definition of “human research;” therefore, complete an IRB Application.
YES, FOR RESEARCH & OTHER PURPOSES.
If you selected “YES, FOR RESEARCH & OTHER PURPOSES,” the activity meets the definition of “human research;” therefore, complete an IRB Application.
YES, FOR RESEARCH; HOWEVER, THE INSTITUTION IS NOT ENGAGED IN HUMAN RESEARCH.
If you selected “YES, FOR RESEARCH; HOWEVER, THE INSTITUTION IS NOT ENGAGED IN HUMAN RESEARCH,” skip to Q6. You will also need to answer Q10c.
YES, FOR NON-RESEARCH PURPOSES ONLY.
If you selected “YES, FOR NON-RESEARCH PURPOSES ONLY,” go to Q4.
NO.
If you selected “NO.” go to Q4.
REGULATORY DEFINITIONS FOR Q3:
Interventionincludes both physical procedures by which data are gathered and manipulations of an individual or his/her environment.
EXAMPLES:
  • Physical procedures through which data are gathered
  • Collecting blood
  • Obtaining vital signs
  • Behavioral interventions
  • Evaluating an unknown psychotherapy procedure
  • Manipulation of research participants’ environment
  • Playing music in operating room to determine influence on patient outcomes
CAUTION: 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.
Interactionincludes communication or interpersonal contact between investigator and research participant.
EXAMPLES:
  • Communication
  • Face-to-face
  • Electronic (including online surveys without identifiers)
  • Interpersonal contact
  • Observations
  • Interviews

Q4: Does the activity involve obtaining, accessing, using, disclosing, or sharing any of the following?
  • Individually identifiable private information from a living individual
  • Education records that can be linked to any living individual
  • Protected Health Information (PHI) about any individual (living or deceased)
  • Substance abuse information that can be linked to any individual (living or deceased)
  • Genetic information that can be linked to any individual (living or deceased)
  • HIV related information that can be linked to any individual (living or deceased)
  • Identifiable specimens (living or deceased)
  • Use of human specimens to validate a medical device, diagnostic instrument, or laboratory test
Answer to Q4:
(a) YES, FOR RESEARCH PURPOSES.
If you selected “YES, FOR RESEARCH PURPOSES,”the activity meets the definition of “human research;” therefore, complete an IRB Application.
(b) YES, FOR RESEARCH & OTHER PURPOSES.
If you selected “YES, FOR RESEARCH & OTHER PURPOSES,” the activity meets the definition of “human research;” therefore, complete an IRB Application.
(c) YES, FOR RESEARCH; HOWEVER, THE INSTITUTION IS NOT ENGAGED IN HUMAN RESEARCH.
If you selected “YES, FOR RESEARCH; HOWEVER, THE INSTITUTION IS NOT ENGAGED IN HUMAN RESEARCH,” skip to Q6 and be sure to answer Q10c.
(d) YES, FOR NON-RESEARCH PURPOSES ONLY (e.g., for quality improvement, healthcare operations)
If you selected “FOR NON-RESEARCH PURPOSES ONLY,” go to Q5.
(e) NO.
If you selected“NO,” go to Q5.
GUIDANCE FOR Q4:
Choose one of the (a) or (b) “Yes”options to Q4, when a collaborating investigator(i.e., involved in the design, conduct, or reporting of the research, oris listed as aninvestigator on the research proposal or protocol) from Downstate providesany data (including data about specimens) that can readily identify the individuals from whom the data or the specimens were obtained or when a collaborating investigator from Downstate interacts or intervenes with research participants.
Choose option (c) if Downstate is not engaged (e.g., faculty member, employee, student or agent who is releasing either identifiable or de-identifiable materials to an external site, but is not conducting research at Downstate). Note: Option (c) may be checked if the Downstate faculty member, employee, student, or agent also receives or reviews de-identified or aggregate data from the external site.
NOTE: If the data is collected from the NYC Public School system, the NYC DOE IRB must also approve the research. See:
Private informationincludes 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. For example, if you are collecting a Medical Record Number (MRN), you are collecting individually identifiable private information.
PHI includes individually identifiable health information transmitted or maintained in any form or medium, including demographic information collected from an individual, that: A. Is created or received by a healthcare provider, health plan or healthcare clearinghouse; and B. Relates to the past, present or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present or future payment for the provision of healthcare to the individual; and 1. That identifies the individual; or 2. With respect to which there is a reasonable basis to believe the information can be used to identify the individual.
Note: PHI of an individual who has been deceased for more than 50 years is not considered PHI and is no longer covered under the HIPAA Privacy Rule.
Alcohol or substance abuse informationincludes information that is linked to an individual regarding their diagnosis, treatment, or referral of treatment for alcohol abuse, substance abuse, or chemical dependency.
Genetic information includes an individual's genetic tests, or genetic tests of family members (including an embryo or fetus) of the individual, the manifestation of a disease or disorder in family members of such individual; or any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by the individual or any family member of the individual.
Q5: Is the activity strictly limited to a “preparatory to research activity” (e.g., review of protected health information in preparation for research)?
Answer to Q5:
YES:
If you selected “YES,” complete a “Research Certification for Reviews Preparatory to Research,” if someone other than the patients’ clinicians are accessing the patient’s records or check the box below.
Form available at:
Check this box if only the patients’ clinicians are accessing the patient’s records.
CAUTION: Do not record any identifiers outlined in the De-identification Standard Requirements outlined in HIPAA-6 policy “De-Identification of Information.
HIPAA-6 Policy available at:
Always maintain this certification in your research records and submit this to the IRB, when an IRB application is submitted to the IRB. A HIPAA waiver is not required. This activity is automatically considered Exempt by the IRB, because identifiers are not recorded.
NO
If you selected “NO,” go to Q6.
Guidance for Q5:
If 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 patient's clinicians are accessing the patient records, they must complete a "Research Certification for Reviews Preparatory to Research form"
Example: An investigator needs to determine if she will have enough patients with sickle cell trait among the patient population, they can review medical charts to determine how many sickle cell trait patients are documented in the medical records; however, they cannot contact the patients or record any identifiers.
Under the HIPAA regulations this form is used to document the activity. It can be saved in the research records and provided to the IRB when an IRB application is submitted. The form will be requested by HIM if the investigator wanted to review manual charts.
Under the Common Rule this activity is "exempt" because identifiers are not recorded. Downstatepolicy IRB-01 (page 10) does not IRB review of a “preparatory to research activity.”
CAUTION: When carrying out a "preparatory to research activity” HIPAA identifiers CANNOT be recorded!!! For more information about this, refer to the de-identification standard within the HIPAA-6 policy.
Q6: Is the activity limited to referring others (e.g., patients, employees, prior research participants) from SUNY DMC to a new study?
Answer to Q6:
YES.
If you selected “YES,” go to Q7
NO.
If you selected “NO,” skip to Q9.
Q7: Regardless of where the activity will take place, will Downstate receive any Federal funding or support for this activity (including funds passed through another institution)?
YES. Check “yes” for Q8.
NO.
Regardless of the answer, go to Q8.
Q8: Are any activities carried out by a faculty member, employee, student, or agent that would result in SUNY Downstate being engaged in human research?
YES.