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Graduate Program in Public Health / IRB Training Requirements of Investigators and Key Personnel; and
Conflict of Interest (COI) Requirements for “Investigators for the Purposes of COI”
For more information, contact the SUNY DMC IRB at 718-613-8480. For verification of training or COI submissions of Downstate employees, please contact Nakih Gonzales at 718-270-4372 or
For any additional information on the Kings County Hospital Center (KCHC) process please contact one of the following KCHC Facility Research Coordinators:
· Bryce Petty:
· Alyssa Conigliaro:
· Dione Clarke:
Important noteS regarding Investigators from other institutions WHO AFFILIATE WITH SUNY DOWNSTATE IN CITI:
1) External employees who are considered an Investigator for the Purposes of COI must also complete an optional COI training module in CITI. When selecting the curriculum in CITI, be sure to select the COI course.
2) External employees may complete the optional HIPAA training in CITI in lieu of HIPAA training available through their institution. After completion of required CITI modules, the learner will be presented a list of optional modules, including HIPAA.
NOTE FOR THOSE WHO ARE NOT EMPLOYEED BY DOWNSTATE OR KCHC: Parallel IRB approval may be required by the employee’s institution’s IRB, if there is no IRB Reliance agreement with SUNY Downstate IRB. The employee must check with their own institution’s IRB, to ensure compliance with federal regulations and their own institutional requirements.
The PI must first determine who on the research team is considered an “Investigator for the Purposes of COI.” As defined in the SUNY DMC Research COI Policy, an “Investigator” for the purposes of COI is defined below:
Investigator- The project director, Principal Investigator, co-Principal Investigator, personnel who are considered to be essential to work performance or any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research. The PI is responsible for identifying all Investigators involved in their research activities. If the role of an individual is unclear and that individual is listed as an Investigator, compliance with all training and filing requirements will be expected. For more information, please see the DMC COI website at: http://www.downstate.edu/coi.
Note - Transient staff and trainees, such as medical students, residents and fellows, who may recruit patients and/or collect and handle data under supervision, but are not key to the design, conduct or reporting of research are not considered Investigators for purposes of COI. In addition, staff or trainees who merely implement a protocol developed by an Investigator or enter data into an electronic data capturing system are also not considered Investigators for purposes of COI.
TRAINING REQUIREMENTS:
Training / Who must take the training? / SUNY Downstate’s investigators and key personnel / KCHC’s investigators and key personnel· / Other Institution’s
investigators and key personnel
Human Research Protections training / All investigators and key personnel / 1) Register online for Collaborative Institutional Training Initiative (CITI) training at https://www.citiprogram.org/
2) Affiliate your account with SUNY DMC,
3) Choose anyone of three groups (See Appendix for detailed training modules)
-Group 1: Biomedical Investigators and Key Personnel, Basic Course
-Group 2: Social / Behavioral Investigators and Key Personnel
4) Sign up for supplemental (optional) training as desired or required.
5) Refresher training is required every 4 years.
DO NOT ATTACH CITI CERTIFICATES TO IRB APPLICATION. / Same as SUNY DMC – be sure to affiliate CITI account with SUNY DMC, so that the IRB can check results.
Complete the optional HIPAA and COI training modules, if needed.
(see HIPAA and COI details below) / Same as SUNY DMC – be sure to affiliate CITI account with SUNY DMC, so that the IRB can check results
-OR-
Provide copies of the Human Research Protections training required by the institution where the individual is employed.
HIPAA Compliance Training / All investigators and key personnel / For HIPAA training, SUNY Downstate employees may contact the Office of Compliance and Audit Services (OCAS) at 718-270-4033 or email to obtain a User ID to gain access to the training.
At the present time, The HIPAA Compliance Training does not expire, but it must have been completed in April 2013 or later.
The IRB will check the Downstate HIPAA training online; therefore it is not necessary to upload the training certificate in the IRB application.
NOTE: Downstate employees are no longer required to take CITI HIPAA training module. / Complete the optional CITI HIPAA training module offered through affiliation with SUNY Downstate.
-OR-
Attending Clinicians may provide copies of the HIPAA Compliance training module completed through People Soft at KCHC. / Complete the optional CITI HIPAA training module offered through affiliation with SUNY Downstate.
-OR-
Provide copies of the HIPAA Compliance training required by the employee’s institution.
Conflict of Interest (COI) Training / Only those designated by the PI as an “Investigator for COI purposes”
*Key personnel are not required to complete COI training. / Take the COI training required at Downstate: “Conflict of Interest (COI) and Research Misconduct Training.” To enroll investigators the PI must complete the OCAS “Research Compliance Training Registration - COI Intake Form” (located on IRBNet) and forward to
The IRB will check the Downstate COI training online, therefore it is not necessary to upload the training certificate in the IRB application
This training is valid for 4 years.
NOTE: Downstate employees are no longer required to take CITI COI training module. / Complete the optional CITI Conflict of Interest training module offered through affiliation with SUNY Downstate. / Complete the optional CITI Conflict of Interest training module offered through affiliation with SUNY Downstate.
-OR-
Provide copies of the COI training required by the institution where the individual is employed.
Dangerous Goods Shipping Certification / Individuals who are involved with shipping specimens, infectious substances, biological or hazardous substances / Enroll in free online training online provided by the Mayo Clinic: http://www.mayomedicallaboratories.com/education/online/dangerousgoods/index.html
Complete the Section 1 on Investigator Education and Training.
Individuals must pass this quiz with a score of 80% or greater in order to obtain a dangerous goods shipping certificate. Please attach a copy of the certificate to the submission.
The expiration date of the training is on the certificate.
GCP Training / Effective January 1, 2017, all NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management, and oversight of NIH-funded clinical trials must be trained in Good Clinical Practice (GCP). A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html
The NIH will accept any of the following:
· CITI GCP training (described above)
· NIAID GCP Learning Center website: http://gcplearningcenter.niaid.nih.gov
· National Drug Abuse Treatment Clinical Trials Network: https://gcp.nihtraining.com/
After completing the training, please submit copies of certificates with the IRB application, if the NIH or Sponsor requires IRB acknowledgement of such training.
Note: The IRB does not monitor GCP training; however, the Sponsor may request documentation before releasing funding.
DoD Training / For Department of Defense (DoD) funded research, check with the DoD sponsor to determine if any additional training is required. After completing the training, please submit copies of certificates with the IRB application, if the DoD sponsor requires IRB acknowledgement of such training.
Note: The IRB does not monitor DoD training; however, the Sponsor may request documentation before releasing funding.
CONFLICT OF INTEREST (COI) DISCLOSURES:
Note: COI Disclosures are NOT required for Exempt research, unless it is federally funded.
· The following applies to Downstate Employees, who are “Investigators for the purposes of COI”:
o Annual COI disclosure forms/questionnaires must be submitted on an annual basis and updated within 30 days of any material change to a Significant Financial Interest (SFI).
o Transactional disclosures/ questionnaires must be submitted at the time of a new IRB application, whenever an IRB amendment is submitted to add a new investigator (the new investigator must submit) and at the time of continuing review.
· KCHC and other external employees who are “Investigators for the purposes of COI” must provide COI determination letter at the time of initial review, continuing review or within 30 days of any material changes to a SFI.
· If a significant financial interest is disclosed, it must be reviewed by the SUNY DMC FINANCIAL COI Committee (fCOIC). If a management plan is required by the fCOIC, the IRB must review the management plan to ensure it sufficiently protects research participants. If an investigator has a SFI and holds a dual appointment at Downstate and KCHC, both institutions must approve the COI management plan.
Type ofConflict of Interest (COI) Disclosures / Who must submit? / SUNY Downstate Employees / Kings County Hospital Center (KCHC) Employees
· / Investigators and key personnel employed by other institutions
Annual COI Disclosures / Downstate employees designated by the PI as an “Investigator for COI purposes” / § To obtain access to SUNY DMC COI SMART, the PI must first complete the OCAS COI Training and Financial Disclosure Enrollment Form (see COI Training above). Enrollment will trigger the issuance of a User Name and (temporary) Password for SUNY DMC COI SMART (Disclosure form database). If you have not yet received your User Name and Password, you may check the status of this by contacting the Office of Compliance and Audit Services (OCAS) at 718-270-4033 or .
§ Complete an Annual COI disclosure in SUNY DMC COI SMART. The log-in screen is located at https://downstate.coi-smart.com/login.php If you forgot your Login ID or Password, you may request a re-set on the login screen.
§ For the SUNY DMC COI policy, see: http://www.downstate.edu/coi/index.html
§ To contact someone to answer questions regarding COI disclosures, please see: http://www.downstate.edu/coi/contact.html / N/A / N/A
Declaration of New Research Project or “Transactional Questionnaire” / Downstate employees designated by the PI as an “Investigator for COI purposes” / § Complete a new "Transactional Questionnaire" in SUNY DMC COI SMART (see access instructions above for Annual Disclosure filing), pursuant to all new / proposed research (subsequent to filing an annual disclosure) to attest that there are no material changes to the annual questionnaire on file. The exact name of the study must be included in the filing.
§ To contact someone to answer questions regarding Transactional Questionnaires, please see: http://www.downstate.edu/coi/contact.html / N/A / N/A
COI determination document (e.g. adjudication letter) / Non-Downstate employees designated by the PI as an “Investigator for COI purposes” / N/A / KCHC employees must complete the KCHC COI Disclosure Form, available in IRBNet and e-mail a copy of the form to Dr. Imah Jones at . Be sure to include the name of the study and indicate the research is being reviewed by the SUNY Downstate IRB. Dr. Jones will return the determination to the investigator making the request.
Once the (COI) determination document (e.g. adjudication letter) is issued by NYC+HH COI Committee, please add the document in the IRB submission package in IRBNet. If a management plan is needed for a Significant Financial Interest, the NYC+ HH COI Committee will develop a Management Plan to be shared with the SUNY Downstate IRB and the SUNY Downstate Conflict of Interest Committee.
The conflict of interest (COI) determination document (e.g. adjudication letter) from KCHC must include:
§ Name of the investigator
§ Name of the study
§ A statement that the institution is in compliance with federal regulations, effective August 24, 2012, for researchers who are applying for or have received research funding from the Public Health Service (PHS).
§ A statement about whether or not there are any Significant Financial Interests (SFI).
§ If there are any SFI’s, please provide a COI management plan approved by their employer. / Provide the conflict of interest (COI) determination document (e.g. adjudication letter) from their employer, which must include:
§ Name of the investigator
§ Name of the study
§ A statement that the institution is in compliance with federal regulations, effective August 24, 2012, for researchers who are applying for or have received research funding from the Public Health Service (PHS).
§ A statement about whether or not there are any Significant Financial Interests (SFI).
§ If there are any SFI’s, please provide a COI management plan approved by their employer.
Appendix: List of CITI Training Modules:
The following list of training options are provided, so individuals can select the appropriate group and optional modules based on their interests and roles.
Group 1: Biomedical Investigators and Key PersonnelBasic
(1ST TIME) / REQUIRED MODULES: (For leaners who registered on or after 11/15/2016)
Defining Research with Human Subjects - SBE (ID: 491)
Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680)
Consent with Subjects Who Do Not Speak English (ID: 17260)
Belmont Report and CITI Course Introduction (ID:1127)
Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2)
Informed Consent (ID: 3)
Records-Based Research (ID: 5)
Genetic Research in Human Populations (ID: 6)
FDA-Regulated Research (ID: 12)
Conflict of Interest Training Module (Various), if registered. – EXTERNAL EMPLOYEES MUST REGISTER FOR THIS, IF INVESTIGATOR FOR THE PURPOSES OF COI.
GCP Training Module (Various), if registered. (Optional for IRB approval; however, this may be required by NIH and other sponsors)
OPTIONAL MODULES:
Research and HIPAA Privacy Protections (ID: 14) – EXTERNAL EMPLOYEES MUST REGISTER FOR THIS (IF THEY DO NOT HAVE HIPAA TRAINING FROM THEIR OWN INSTITUTION
OTHER OPTIONAL MODULES:
NOTE: Supplemental modules are provided for general interest only.
Consent and Cultural Competence (ID: 17263)
Informed Consent and Incidental Findings in Research with Human Subjects (ID: 17342)
Overview of the Clinical Trial Agreement (CTA) (ID: 17356)
Understanding the Terms of the Clinical Trial Agreement (CTA) (ID: 17357)