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Human Subjects Research

As of 2014, all researchers must register with Research Navigator on the NYULMC Institutional Review Board (IRB) web page to submit online IRB applications.

Human Subjects Research Protocol

Purpose

Federal guidelines require that all individuals involved in human subjects research must be knowledgeable about the ethical principles of research involving human subjects. The NYU Office of Sponsored Programs (OSP) has designed a web-based tutorial and examination that covers that major principles of human subjects research and good clinical practice guidelines.  

Process

It is NYUCD policy that all full and part-time faculties take the OSP GCP tutorial and pass the exam. For new full and part-time faculty, the individual must take the tutorial and pass the exam within 30 days of official appointment to the NYUCD faculty. The tutorial and examination also applies to any student, resident, fellow, graduate student, staff, and agent of NYUCD involved in clinical research. All of these individuals must take the tutorial and pass the exam before the initiation of a clinical research investigation.

The NYULMC Human Subject Tutorial is located at: tools.med.nyu.edu/tutorials.

Involvement in research by principal investigators, co-investigators, investigators, students, and research staff applies to the following conditions:

  • Data collection
  • Data analysis
  • Subject recruitment
  • Evaluation of subjects
  • Subject/patient treatment or interview
  • Evaluation of patients' charts
  • Evaluation of x-rays, study casts, and other patient-related information
  • Collection and evaluation of subjects' biological samples, including blood, urine, feces, sweat, skin, tears, saliva, oral mucosa, gingival crevicular fluid, gingival tissue, and teeth.

A permanent record of the date of passing the tutorial will be kept with the NYUCD Office of Human Resources and the NYUCD Office of Quality Assurance. This confidential information will be combined with CPR certification, clinical licensure, DEA registration (if applicable) and other pertinent records to document the faculty/staff/student's research and clinical qualifications. It can be used prospectively to help recruit future research projects at the NYUCD.  

Purpose

The Chair/Chief is responsible for maintaining the teaching, clinical care, administration, and research roles of the Department/Division. He/she must balance of these activities with the existing faculty, staff, and financial resources of the Dept/Division. Therefore, he/she must be involved in any preliminary discussions regarding potential retrospective or prospective research investigations involving human subjects.

Process

The process of communication with the Chair/Chief applies to:

  • Investigator-initiated studies
  • Industry-sponsored studies
  • Graduate/pre-doctoral student-related studies
  • Multi-center studies

 

Regardless of the format of the study, the investigator must discuss the nature and extent of the potential investigation with his/her Department Chair. If the Chair is not available and/or the study requires initiation in a short period of time, the investigator should initiate discussion with the Vice Dean for Research, Dr. Louis Terracio.

Contact the Office of Research for further information regarding Human Subjects Research. 

Purpose

Any prospective or retrospective investigation requires a comprehensive description of the protocol (see below). A scientific/biological rationale for the study is indispensable and required by the IRB. A comprehensive protocol will ultimately guide the investigators in conducting a study that will yield potentially useful information that can be published and that will impact scientific knowledge. After approval from the NYUCD IRB and Research Proposal Oversight Committee, the research protocol will be submitted to the appropriate IRB. No study can be initiated at NYUCD before written approval of the protocol from the NYUSM IRB or the OSP IRB.

Process

All consent forms must contain, at a minimum, the following:

  • Introduction/Abstract
  • Objectives/Rationale
  • Methods and Procedures
  • Inclusion and Exclusion Criteria
  • Potential Benefits to Subjects
  • Potential Risks to Subjects
  • Subject Recruitment Strategies and Compensation
  • Study Management and Personnel
  • Confidentiality Statement
  • Data Analysis Strategy
  • Bibliography
  • Appendices

OSP IRB Applications

Application for Review by the University Committee on Activities Involving Human Subjects.
Retrieve form: www.nyu.edu/ucaihs/

NYULMC IRB Applications
NYU Langone Medical Center IRB Forms & Templates Library:
http://irb.med.nyu.edu/researchers/library/guidance

Purpose

This is a federally-mandated process whereby the research subject is informed about the risks and benefits of the study and gives non-coerced written consent to participate in the study. The written consent form accompanies the protocol in the IRB submitted materials. It MUST be written in 10th grade verbiage. If a significant number of potential study subjects do not use English as their primary language, then the consent form must be translated into the primary language and submitted to the IRB. No study can be initiated at NYUCD before written approval of the consent form from the NYUSM IRB or the OSP IRB.

Process

All consent forms must contain the following:

  • Statement that the study is a research study
  • Purpose
  • Procedures involved including time involvement of the subject
  • Risks or discomforts
  • Benefits
  • Treatment alternatives
  • Costs of participation including compensation
  • Confidentiality
  • Voluntary participation
  • Right to withdraw
  • Termination of participation
  • Compensation for subject injury
  • Significance of new findings
  • Conflict of interest
  • To whom questions may addressed

Special considerations in the informed consent process include vulnerable populations:

  • Pregnant women and fetuses
  • Children 0-12 years
  • Adolescents 13-18 years
  • Students and employees of NYU
  • Prisoners
  • Institutionalized/cognitively impaired persons
  • Adults with legal guardians 

Studies involved the following items also require special mention in the written consent form:

  • Videotaping
  • Collection and storage of biological samples for genetic analysis
  • HIV testing

OSP IRB Applications
Sample Language Consent Forms
Retrieve form: www.nyu.edu/ucaihs/

Purpose

Based upon Federal regulations from the Office of Protection from Research Risks, IRB Committees are now requiring that investigators demonstrate knowledge and familiarity with Good Clinical Practice and Clinical Research Guidelines. The first step in this process is for all individuals affiliated with a proposed project to take the Good Clinical Practice Tutorial and pass the examination (see above). This process starts before the development of a research project. The second step occurs when the Principal Investigator is preparing the IRB documents. The Principal Investigator must complete a "responsibilities list" acknowledging that he/she understands the responsibilities of protecting the rights and welfare of human research subjects and for complying with all Federal regulations underlying clinical research.

Process

For all research studies, the Principal Investigator must complete a Researcher Responsibilities List, and submit one copy to the NYUCD Office of Research.

Researcher Responsibilities List
Retrieve form : http://irb.med.nyu.edu/sites/default/files/irb2/guidance.how_.to_.investigator.responsibilities.2010.11.8.docx

Submit one copy to the NYUCD Office of Research and one copy to the NYUSM IRB office with all of the other IRB-related materials.  

Purpose

Federal regulations require investigators to disclose any significant financial interest that would reasonably appear to be affected by the proposed sponsored project. These disclosures must be made at the time of IRB submission. If the institutional official determines that a financial interest may "directly and significantly affect the design, conduct, or reporting" of the results, then the institution must implement procedures to manage, reduce, or eliminate the conflict of interest.

Process

For all sponsored research studies (e.g., NIH, industry, foundations), all investigators listed in the protocol (see above) must complete and submit a financial disclosure and conflict of interest statement. For protocols submitted to the OSP, these forms must be submitted to the NYUCD Office of Research for review prior to IRB submission. For protocols submitted to the NYUSM IRB, these forms must be submitted to the NYUCD Office of Research and the NYUSM IRB office.

OSP IRB Applications
Researcher's Disclosure Statement (Appendix 11).
Retrieve from: http://www.nyu.edu/research/resources-and-support-offices/getting-started-withyourresearch/office-of-sponsored-programs/forms-guides.html

NYUSM IRB

Investigator Financial Interest Disclosure Form
Retrieve from: http://cimu.med.nyu.edu/forms/investigator-financial-interest-disclosure-form.  

Purpose

Principal Investigators must describe techniques employed to recruit and retain subjects for their research investigation. This should include where subjects/patients will be recruited (e.g., in-patient unit, out-patient clinic, private practice, etc.), criteria for subject selection, and description of initial contact with subjects. Copies of all advertisements and other recruitment materials should be submitted with the protocol so that both can be reviewed at the same time. It is not uncommon for subjects to be paid for their participation in research, especially in the early phases of investigational drug or device research or in behavioral and epidemiological research that require a significant time commitment on the part of the subject. The investigator should describe the compensation plan in the protocol. Protocols that describe payments made only at the completion of the protocol could appear to be coercive. Therefore, it is common practice to offer the subject a partial payment at several intervals during the study, with the remainder provided at the completion of the investigation.

Subjects may also be reimbursed for out-of-pocket expenses related to participation (travel costs, parking expenses, child care, etc.). If such monetary compensation or reimbursement is to be offered, investigators should state the amount subjects are to receive.

Advertisements for recruitment include:

  • Internet communications
  • Flyers and pamphlets
  • Advertisements (written, audio, visual)
  • Written text of telephone recruitment

Process

The research protocol should include a description of the recruitment and reimbursement strategies to be employed in the study. The IRB must review these materials in order to approve the recruitment and reimbursement of study subjects, as well as the protocol and consent form.

OSP IRB Applications
A section of the protocol form is dedicated to subject recruitment and compensation: Application for Review by the University Committee on Activities Involving Human Subjects. Retrieve form: www.nyu.edu/ucaihs/
Written text of advertisements must accompany the IRB application.

NYUSM IRB Applications
Recruitment of Research Subjects.
Retrieve form: http://irb.med.nyu.edu/researchers/library/guidance.
Written text of advertisements must accompany the IRB application.  

Purpose

Federal regulations require Principal Investigators to report promptly to the IRB all "unanticipated problems involving risk to human subjects or others". These reports enable the IRB to monitor potential risks in studies that have been approved and to take appropriate action. Adverse events are "unanticipated problems" include risks of physical or psychological harm, unexpected threats to confidentiality, problems arising from the patient recruitment process and/or consent process, and adverse events as set forth in Adverse Event report. In studies, which employ interviews or the use of questionnaires, a subject's strong adverse reaction to questions could be considered an "unanticipated problem event as described below involving risk" and should be reported to the IRB.
The IRB requires that adverse events defined by the FDA as either "serious" adverse events or "unexpected" adverse events are reported to the IBRA.

Serious Adverse Event means any adverse experience associated with the study article that results in any of the following outcomes: death, a life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Unexpected Adverse Event is any adverse experience associated with the study article for which the specificity or severity is not consistent with the current investigator brochure, or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. "Unexpected" refers to an adverse experience that has not been previously observed.

Associated with the study article means that there is a reasonable possibility that the experience may have been caused by the study article.

Adverse events must be reported on the official form (see below) to the IRB within 7 days of occurrence, and significant adverse events must be reported immediately. All forms must be submitted to the NYUCD Office of Research. Industry-sponsored studies also require reporting of significant adverse events (SAE) immediately after occurrence.

The timing of reporting of AEs varies depending upon the type of study and the severity of the AE. An overview of timing of reporting is:

    Event                                                              When AE is to be reported to IRB

  • Adverse drug reactions                                        Within 15 calendar days
  • Unanticipated adverse device effects                Within 10 calendar days
  • Human gene therapy protocols                           Immediately
  • Unanticipated risks to subjects                           Immediately

For additional details of AE reporting, see the NYUSM site (see below).  

Process

Every clinical research study should anticipate the possibility of adverse events (AE) and significant adverse events (SAE), despite, in some circumstances, the extremely rare likelihood of an adverse event. All investigators associated with the clinical investigation must be familiar with the necessity to report AE and SAE to the IRB and other authorities (eg, NIH, industry sponsor) as dictated by the protocol.

OSP IRB Applications
No standard forms exist for the OSP IRB. Therefore, use the NYUSM forms (see below) or write a letter containing the pertinent information when reporting an AE or SAE to the OSP IRB.

NYUSM IRB Applications
Policy & Procedures of the IBRA
Retrieve from: http://research.med.nyu.edu/research-resources/important-forms-researchers

Serious Adverse Event Report to IBRA
Retrieve from: http://research.med.nyu.edu/research-resources/important-forms-researchers

 

Purpose

The purpose of these documents is to protect the needs, interests, and liability of investigators, the University, and sponsors. In order to protect both faculty publication rights and the University's patent rights, the sharing and transmittal of any research-related materials should be governed by agreement. Some of these policies extend to donated materials that may be used for clinical care, teaching, research purposes, in order to protect the faculty and the University.

Confidentiality Agreement
This agreement is implemented when investigations are sponsored by industry. It is designed to protect patents and other proprietary information held by the sponsor.

Commercial Agreement/Research Contract
This contract governs the responsibilities of the investigator, University, and sponsor regarding the conduct of the study. This includes indemnification of the investigator and NYU from any defects in drugs/materials/devices. It also indemnifies the sponsor from any investigator/University-related errors. The contract outlines the nature of data collection/analysis/publication, confidentiality issues, payment schedules, use of investigator and/or University name.

The major guidelines for a commercial agreement/research contract are:

  • freedom from interference in the conduct of the research;
  • no limitation on publications or the right to publish;
  • support for the ongoing research project;
  • obtaining a royalty-bearing license to practice the invention and/or the results of the research.

Material Transfer Award (MTA)
Protects the proprietary technology of the sponsor while indemnifying the investigators and University from defects in product.

Expedited Material Transfer Award for Donated Materials
This is applicable for donated materials, drugs, devices, and any other materials used in clinical care, teaching, and research. It includes indemnification of the investigator and NYU from any defects in any of the materials. It also indemnifies the sponsor from any investigator/University-related errors. This Expedited MTA outlines publication issues, and use of investigator and/or University name.

Process

All contracts, MTAs, Expedited MTAs, and Confidentiality Awards are processed through the Office of Industrial Liaisons (OIL) at the School of Medicine where they will undergo legal evaluation. No contract or agreement should be signed by a Principal Investigator until it has received legal approval from the OIL. Contact Dr. Louis Terracio for further information and assistance.

OSP IRB Applications

No standard forms exist for the OSP IRB. Therefore, use the NYULMC websites for further information and contact.

NYUSM IRB Applications

Guideline for Commercial Agreements.
Retrieve from: http://research.med.nyu.edu/research-resources/important-forms-researchers

Purpose

Research conducted at the NYUCD must be self sustaining. Therefore, budgetary preparation is a central tenet of the design of the investigation. Budgets must include the following items, and are described in detail in Budget Preparation Instructions.

  • Investigators and staff salary and benefits
  • Travel expenses
  • Consultant fees
  • Supplies
  • Biostatistical support
  • IRB preparation fees
  • Clinical operations costs
  • Indirect costs
  • Other expenses

Process

Principal Investigators must prepare a budget concurrently with the research protocol. The comprehensive budget, Budget Template must be used. Once the form has been approved, it is the responsibility of the Principal Investigator to obtain the signature of the Department Chair or the Division Chief as part of the routing of the final protocol submission. It will be the responsibility of the Office of Research to obtain signatures from the Dean of Research and the NYUCD Budget Office.  

Purpose

To review and provide guidance on the preparation NYUCD research documents that will be submitted to the OSP or SM IRBs. This committee consists of full-time members of the faculty of the NYUCD that are active researchers and/or serve on the OSP and SM IRB committees.

All research proposals prepared by NYUCD part- and full-time faculty must be reviewed by the College of Dentistry IRB and Research Proposal Oversight Committee prior to IRB submission.

Process

  1. The Principal Investigator submits a complete set of IRB documents (protocol, consent form, advertisement, etc.) to the Office of Research at the NYUCD.
  2. Principal Investigators are encouraged to submit their protocol two (2) weeks prior to the appropriate IRB deadline in order to assure a thorough and timely review by the IRB and Research Proposal Committee. However, the proposal must be submitted to the Office of Research for review a minimum of 3 days prior to the IRB submission deadline.
  3. The College of Dentistry Office of Research will arrange timely review by members of the IRB and Research Proposal Oversight Committee.
  4. The IRB Protocol Review Criteria Checklist (Appendix 18) with comments will be forwarded to the Principal Investigator. These comments and form will be saved in the Office of Research.
  5. Any exceptions to these deadlines must be reported immediately to the Office of Research for approval.  

Purpose

The Principal Investigator is ultimately responsible for timely submission of all IRB-associated documents before the IRB deadline. For the NYU Office of Sponsored Programs IRB, a summary is provided:

  • 1 original fully completed application
  • 19 copies of Application for Review by the Human Subjects Committee
  • 19 copies of consent form
  • 19 copies of the protocol
  • 19 copies of advertisements

For the NYU School of Medicine IRB, a summary is provided:

  • 13 copies of protocol review form
  • 13 copies of consent form
  • 13 copies of advertisements
  • 13 copies of the protocol
  • 7 copies of the investigator brochure for an industry-funded study
  • 5 copies of amendments

NOTE: all submissions to the NYU School of Medicine IRB must be made on 3-hole punched paper.

Process

The Principal Investigator and/or their staff are responsible for preparing the requisite number of IRB documents for timely submission to the IRB. A final copy of all IRB-associated documents must also be submitted to the NYUCD Office of Research at the time of IRB submission.

OSP IRB Applications
Human Subjects Review Dates.
View dates: www.nyu.edu/ucaihs/

Copy requirements Frequently Asked Questions www.nyu.edu/ucaihs/

IRB submission checklist: University Committee on Activities involving Human Subjects Checklist
Retrieve form: www.nyu.edu/ucaihs/

NYUSM IRB Applications
IRB submission deadlines.
View dates: http://research.med.nyu.edu/research-resources/important-forms-researchers

For copy requirements: http://research.med.nyu.edu/research-resources/important-forms-researchers

IRB submission checklist: Protocol Review Criteria Master Checklist
Retrieve form: http://research.med.nyu.edu/research-resources/important-forms-researchers

Purpose

Protocol Amendments
Principal Investigators cannot deviate from or change the approved protocol without the prior review and documented approval of the IRB unless the deviation is required to protect the welfare of subject(s). Deviation from IRB-approved consent documents and protocols is considered an IRB violation. Therefore, these deviations must be reported immediately to the IRB (forms provided below). Principal Investigators planning any change must submit to the IRB a request for approval of a change on the appropriate form (see below). These protocol amendments must indicate all modifications to the protocol and/or consent form since the last IRB approval. For commercially sponsored studies, Principal Investigators should obtain the sponsor's approval of the protocol as well as the IRB approval.

Annual Protocol Approvals
Principal Investigators must resubmit all clinical research protocol materials (cover document, protocol, consent, advertisement) on an annual basis to the IRB for continued approval (forms provided below). The IRB office sends renewal reminders to all Principal Investigators 2-3 months before the annual approval date. It is the Principal Investigator's responsibility to send all requisite renewal information to the IRB before the expiration date of the study. Failure to meet this deadline will force termination of the study. A continuation of a study without IRB renewal approval constitutes an IRB violation.

Protocol Closure
Principal Investigators must officially inform the IRB that the study has been terminated (forms provided below). Closure as defined by the IRB denotes that: (1) subject enrollment has ceased, (2) all subjects have either completed the protocol or have been withdrawn, and (3) all data analyses have been completed. If data analysis is continuing despite completion of data collection, then an Annual Protocol Approval must be obtained. If the study has been part of a multi-center clinical trial, if the NYUCD site has completed data collection and analysis, then the study can be closed even if data collection and analysis is ongoing at other sites or at the study sponsor.

Process

For protocol amendments, annual renewals, and study closures, the Principal Investigator must submit the appropriate documents to the IRB. For industry- and government-funded studies, the sponsor will require written documentation that protocol amendments and annual renewals have received IRB approval.

OSP IRB Applications
Request for Approval of an Amendment
Retrieve from: http://research.med.nyu.edu/research-resources/important-forms-researchers
The OSP IRB does not have a specific amendment form. Use the NYUSM forms or submit a letter that contains the pertinent information.

NYUSM IRB Applications
Request for Approval of an Amendment
Retrieve from: http://research.med.nyu.edu/research-resources/important-forms-researchers

Annual Renewals and Protocol Closure
Request for Reapproval or Study Closure
Retrieve from: http://research.med.nyu.edu/research-resources/important-forms-researchers

Review Process for Dental School for Human Subjects Applications Submitted to Washington Square IRB

Research involving human subjects requires oversight by an Institutional Review Board as defined by Federal Regulations. Research involving human subjects that is conducted in a "covered institution", an institution that uses electronic billing to credit cards or insurance companies also requires oversight by a Privacy Board, as defined by Federal Regulations. For research involving human subjects, the College of Dentistry and College of Nursing are considered a hybrid institution; meaning that some types research require oversight by both an IRB and a privacy board, while other types of research only require oversight by an IRB. The School of Medicine (SOM) has a privacy board that fulfills the review requirements for research involving patient care at an NYU facility. For research that does not require a privacy board, the IRB at Washington Square is the appropriate oversight committee.

If your proposed research will involve use of patient charts, interactions with patients, or some combination, then the research requires review by the IRB at the SOM. If your research involves interviews or surveys that are not connected with patient records, or de-identified cases in the Orthodontics department, or will be conducted out of the country, then review should be conducted by the board at Washington Square. If you are unsure which is the appropriate board, please contact Dr. Jane McCutcheon (email address below).

Applications to Washington Square (http://www.nyu.edu/ucaihs) should be completed, reviewed and signed by the faculty sponsor if applicable.

Original, fully completed and typed Application for Review by investigators includes:

  • Investigator's signature;
  • Faculty sponsor's signature (if required);
  • All applicable attachments (recruitment materials, consent or permission forms, institutional approval letters, research instruments, sponsored project proposals and any other additional materials).

The signature page should be submitted as a .pdf file. The remainder of the application should be submitted as a Word document.

Completed signed applications should be submitted to IRB.CD_CN@nyu.edu. Approval notifications, requests for additional information, and requests for changes will be sent by email to your NYU email account. For further information contact Dr. Jane McCutcheon at jam2@nyu.edu.