University Hospital of Brooklyn
College of Medicine
College of Health Related Professions
College of Nursing
School of Graduate Studies
Graduate Program in Public Health
OHRP Federal Wide Assurance
(FWA) #: 00003624
OHRP IORG #: 0000064
/ SUNY Downstate IRB
Local Research Context Guidance
for External IRBs
The following information is provided as guidance for external IRBs that are reviewing research at the SUNY Downstate Medical Center (DMC). For more information, please contact the SUNY DMC IRB at 718-613-8461.
KEY POINTS:
- The PI at SUNY DMC must complete a “Request to Use an External IRB” form and submit it to the SUNY DMC IRB.
- Before the research can begin, the SUNY DMC IRB must acknowledge the external IRB approval.
- All required financial conflict of interest disclosures and applicable management plans for significant financial interests must be complete.
- All required human research protections training must be complete.
- All NY state regulations must be addressed.
- All Downstate Medical Center Ancillary reviews must be complete.
- For any additional information on the KCHC process please contact one of the following KCHC Facility Research Coordinators.
Contents
SUNY DMC IRB Application to Use an External IRB
Research Involving the Kings County Hospital Center (NYC Health + Hospital)
NY State Regulations
Financial Conflict of Interest Committee
Training
Department Chair
Ancillary Reviews by Downstate Medical Center
Research Involving Downstate Pathology Laboratories
Institutional Biosafety Committee (IBC) Approval
Pharmacy
Radiation Safety
Privacy Board Review
Data Security Officer
Research Participants with Limited English Proficiency (LEP)
Research Involving Children (Minors)
Research Involving NYC Public Schools
Research Involving Cognitively Impaired Adults
HIPAA Authorization Language
Genetics Testing
Specimen Storage
HIV Testing
Video/Audio Recordings
Costs Related To The Study
Informed Consent/HIPAA Authorization Signature Lines
Additional Protections Required By The DMC IRB When Using An External IRB
References
Author
Review and Approval History
SUNY DMC IRB Application to Use an External IRB
The PI at SUNY DMC must complete a “Request to Use an External IRB” form and submit it to the SUNY DMC IRB. Before the research can begin, the SUNY DMC IRB must acknowledge the external IRB approval. The SUNY DMC acknowledges the approval of the external IRB, once all local requirements are met, before the research may begin.
Before acknowledging the external IRB approval, the DMC IRB will confirm:
- An IRB Authorization (Reliance) Agreement has been fully executed for any research that is federally funded or supported, or when required by the External IRB between SUNY Downstate Medical Center (and Kings County Hospital Center, if applicable)
- All required ancillary reviews are complete
- All required training is complete
- All required Conflict of Interest disclosures are complete and approved
Research Involving the Kings County Hospital Center (NYC Health + Hospital)
The SUNY Downstate Medical Center often collaborates with Kings County Hospital Center (KCHC) and many of our employees may be appointed as faculty to both institutions. If employees from KCHC are included as investigators, making KCHC engaged in human research, please contact KCHC to determine if an IRB Authorization (Reliance)Agreement is required by KCHC. For any additional information on the KCHC process please contact one of the following KCHC Facility Research Coordinators:
- Bryce Petty:
- Alyssa Conigliaro:
- Dione Clarke:
NY State Regulations
In addition to Federal regulations, research conducted at SUNY DMC is subject to NY State regulations:
- New York Codes, Rules and Regulations, Title 14, Department of Mental Hygiene, Part 527, Rights of Patients
- New York Mental Hygiene Law, Article 81
- New York State PublicHealth Law, Article 24A –Protection of Human Research Participants *
*Note: The SUNY DMC voluntarily applies 45 CFR 46 and all subparts to all research; therefore, NY Article 24A does not apply. This may change when the changes to 45 CFR 46 are implemented in January 2018.
- New York State's Public Health Law 18: Access to Patient Records
- New York’s Family Health Care Decisions Act (FHCDA) (PublicHealth Law §29-CC)
- NY State Department of Health HIPPA Preemption Charts
- NYS 10 NYCRR Part 63 (HIV/AIDS Testing, Reporting and Confidentiality of HIV-Related Information
- NYS 1-2.13 NY Estates Powers and Trusts Law
- NYS Civil Rights Law Section 79-L (Confidentiality of genetic tests)
- NYS DOH HIPAA Preemption Charts
- NYC Department of Education IRB
Financial Conflict of Interest Committee
The SUNY DMC IRB will check COI disclosures. If any Significant Financial Interests are reported, they must be reviewed by the SUNY DMC fCOI Committee and a Management Plan may need to be implemented prior to final local IRB acknowledgement of External IRB approval.
For additional information refer to the IRB website information on Conflict of Interest.
Training
The SUNY DMC IRB will check all training requirements:
- CITI training (all investigators)
- HIPAA training (all investigators)
- Conflict of Interest (COI) Training (required by PI and all investigators deemed by the PI to be “Investigators for the purposes of COI”)
- Dangerous Goods Shipping Certification (required by individuals who are involved with shipping specimens, infectious substances, biological or hazardous substances
For specific details, please refer to the SUNY Downstate IRB Training website.
Department Chair
The Department Chair must review and approve the research.
Ancillary Reviews by Downstate Medical Center
Ancillary reviews by various departments may be required, depending on the nature of the study. To determine if a study requires ancillary review, please see details below or consult the instructions on the IRB application. At the discretion of the IRB, the IRB may consult with others or require ancillary review of a research application at any time.
Ancillary reviewers may request modifications of the research; however, any such modification must also be approved by the IRB.
A conditional approval letter may be issued by the IRB, when a specific type of required ancillary review is pending prior to the final approval of the research; however, a final approval letter cannot be issued until all applicable required ancillary reviews are complete.
For more information, please refer to the instructions on the IRB application form or additional IRB guidance materials.
Research Involving Downstate Pathology Laboratories
All research that involves the services of the Downstate Pathology Laboratories (Clinical Laboratory & Histology Lab) must be reviewed and approved by the Department of Pathology to determine the feasibility of using this service, before final IRB approval can be granted
Institutional Biosafety Committee (IBC) Approval
All research involving the use of Recombinant or Synthetic Nucleic Acid Molecules, infectious agents, human cells or body fluids, or hazardous substances must be reviewed and approved by the Institutional Biosafety Committee (IBC) to ensure that all applicable biosafety standards are met. The IBC will determine if the study requires approval from the NIH Recombinant DNA Advisory Committee. For more Information, please refer to the IBC website or contact Ms. Lydia Bailey at the IBC Office at (718) 270-3912
Protocols involving work with human-derived biological materials that are collected by and handled, processed, analyzed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory are exempt from IBC review. However, any work on human-derived biological materials (including packaging and shipping) in Research laboratoriesat DMC issubject to IBC review.
If your study requires Institutional Biosafety Committee approval or NIH Recombinant DNA Advisory Committee approval, your study cannot be approved by the IRB until you have received the applicable approvals.
Pharmacy
All studies involving a drug or biologic requires ancillary review by the Research Pharmacist.
Radiation Safety
Radiation Safety on the basis of safety, approves or denies, consistent with the limitations of the regulations and the license, all requests for authorization to use radioactive material within the institution.
If the study involves the Radiology Department or Radiation Oncology, the Department Chair signs the IRB application.
At the discretion of the IRB, the Radiation Safety Committee, Radiology Department Chair, or Radiation Oncology Chair may be requested to review a study, particularly if the study involves in-vivo or in-vitro radioisotopes or when the amount of ionizing radiation exposure exceeds the amount that a research participant may receive as part of his or her standard of care.
Approvals may be documented by an approval letter, memo, e-mail, or the appropriate person may electronically sign the IRB package once it is shared with him/her in the electronic IRB submission and reporting system.
Privacy Board Review
If the External IRB does not also serve as a Privacy Board, the SUNY DMC will review and approve HIPAA Research Authorizations and HIPAA waivers. The Downstate Privacy Officer may be available for upon request, through the Downstate IRB.
Data Security Officer
The Downstate Data Security Officer is available for ancillary reviews, upon request, through the Downstate IRB.
Research Participants with Limited English Proficiency (LEP)
The SUNY DMC serves many patients with LEP. If there is an anticipated therapeutic benefit to research participants of a clinical trial, the SUNY DMC expects investigators to be able to enroll these participants. If there are less than 5 individuals enrolled in any one given language, the SUNY DMC allows the use of short forms may be used. However, for complex clinical trials or when enrollment exceeds 5, the SUNY DMC expects translation of the informed consent document. Short forms and certificates of translations are available in the following languages, and may be used by other IRBs: Arabic, Chinese (Simplified), Chinese (Traditional), Hatian Creole, Russian, Spanish. The English template is also available.
Research Involving Children (Minors)
Persons who have not attained the legal age for consent to treatments or procedures involved in Research, under the applicable law of the jurisdiction (18yearsinthe StateofNewYork)in which the Research will be conducted.
Contrary to New York regulations related to waiving parental permission for clinical activities, parental permission must be obtained from the parent(s) or legal guardian(s) of children under the age of 18 for research purposes, unless the child is a parent him/herself, married, widowed, divorced, or has been granted emancipation by a court, or it is waived by the IRB.
If the IRB determines that a research protocol is designed for conditions or for a population for which parental or guardian permission is not a reasonable requirement to protect the research participants (for example, neglected or abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children participating in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research participants, and their age, maturity, status, and condition. For example, the IRB could require an independent advocate or an independent assent monitor. If this is proposed, it is strongly recommended that the research team include additional signature lines on the informed consent for child assent and for the independent advocate or assent monitor.
Research Involving NYC Public Schools
Any research conducted within the NYC Public Schools is subject to approval by the NYC Department of Education IRB. For more information see:
Research Involving Cognitively Impaired Adults
If the IRB approves the recruitment of Cognitively Impaired Adults, the potential legally authorized representative (LAR) must be a person from the following list (in order starting from highest priority) who is from the class that is in the highest in priority and who is reasonably available, willing and competent to act on behalf of the research participant.
- Court appointed guardian (highest authority)
- Healthcare proxy
- Spouse or domestic partner
- Adult child
- Parent
- Adult sibling
- Grandparent
- Grandchild
- Close relative or friend (lowest authority)
When obtaining LAR consent from an individual listed on Healthcare Proxy, an Investigator must review the Healthcare Proxy document to determine if the patient had specified any written information regarding participation in research, before obtaining informed consent and HIPAA Research Authorization from the patient’s designated Healthcare Proxy.
HIPAA Authorization Language
The SUNY DMC IRB encourages the use of HIPAA Authorization Language within the Informed Consent Document. If needed, the external IRB may adopt the following language:
What information do we keep private?
Federal law protects your right to privacy concerning Individually Identifiable Health Information (IIHI). There are certain things you need to know. IIHI is any information from your medical record or obtained from this study that can be linked to you and that refers to your mental or health conditions in the past, the present or the future.
In this study, we will keep your IIHI confidential and all data will be kept in a secure, limited access location. We will not reveal your identity in any publication or public presentation of the results of the study.
For this study we will create, use or report the IIHI from your medical records or research records.
The researchers, their staff and the staff of SUNY Downstate Medical Centerparticipating in the research will use your protected IIHI for this research study.
Your IIHI will be shared or viewed with the following persons or agencies for purposes related to the conduct of the research:
- The research staff approved by the Institutional Review Board (IRB)
- The IRB overseeing this study and the SUNY Downstate Medical Center IRB
- The sponsor(s) of this study, when applicable
- The Federal agencies that supervise the way research is conducted, such as the Department of Health and Human Services Office for Human Research Protections, the Food and Drug Administration, the National Institute of Health or other government agencies
- The Data Safety Monitoring Board that reviews the safety of this study
- The Institutional Review Board of SUNY Downstate Medical Center and the applicable DMC officials and staff who supervise the way research is done and run the business operations
- Your insurance company
- Collaborating research sites, if applicable
As required by law, your IIHI may also be shared by the research team with the relevant agency to:
- Report suspected child abuse or neglect
- Report certain communicable diseases
- Report a possible threat or harm to yourself or others
- Comply with a court ordered subpoena or other Federal/ State law.
You need to know that some of the individuals or groups mentioned above who may receive your health information may not be required by Federal privacy laws to protect your IIHI. They may share your information with others without your permission if permitted by the laws governing them. For example, the sponsor does not have the same obligations as your research team and may no longer protect your IIHI.
Some IIHI that is obtained in this study cannot be shared with you during the course of the research. However, this information can be shared with you at the end of the study.
You have a right to refuse to sign this form. While your health care outside the study, the payment for the health care and your health care benefits will not be affected if you do not sign this form, you will not be able to participate in the research described in this form.
How can you withdraw from the study?
You can withdraw from the study or withdraw this authorization for the use or reporting of your IIHI. You have to write to us to withdraw. Please write to:
SUNY Downstate Medical Center IRB
450 Clarkson Avenue
Brooklyn, NY 11203
If you withdraw, we will stop collecting and accessing your IIHI, but we will collect and report any adverse event (bad effect) that you had in the study. Your IIHI collected before you withdraw your authorization will still be used and reported. If you withdraw your authorization, you can no longer be in the study.
Genetics Testing
Under NY State law researchers must ask permission to contact a research participant in the future to obtain or share information related to genetic testing. The following language may be considered for the informed consent document:
After the genetic tests have been completed, we would like to be able to contact you in order to get more information from you that may be needed for this research and/or to explain the results of this research study. Under New York law, you must provide your consent to such future contact. The risks of allowing us to contact you are that we may have information that causes some emotional distress, but the benefits are that we may have information that could help you in your medical planning and decision-making.