Please go to wrg.weill.cornell.edu to create a new study, or amendments and CRs for all currently active studies.
|IRB Protocol Forms|
|Assent Form for Minors||Microsoft Word|
|Informed Consent Form Template||Microsoft Word|
|Informed Consent Form Template - Genetic Testing||Microsoft Word|
|Informed Consent Form Template - Studies using a Humanitarian Use Device||Microsoft Word|
|Human Tissue Section and Request Form||Adobe PDF|
|Use of Drugs or Biological Agents Form||Microsoft Word|
|Planned Deviation Form (Protocol Exception Request)||Microsoft Word|
|Human Research Billing Analysis Form (HRBAF) |
All questions regarding this form should be directed to the Office of Billing Compliance at (646) 962-7539
|Statement of Compliance||Adobe PDF|
|WCMC Immediate Reporting Policy and FAQ||Go to Policy and FAQ|
|Immediate Reporting Form||Microsoft Word|
|Adverse Event & IND Safety Reporting Cumulative Table||Microsoft Word|
|Study Specific Report – Internal WCMC Use |
(formerly the Study Specific Financial Disclosure)
Information & Help
|Study Specific Report – External Non-WCMC Use||Information and Forms|
|Guidance for Conflicts of Interest in Informed Consent Form||Adobe PDF|
|Pathology Review - General Information||Adobe PDF|
|Pathology Review - FAQ||Adobe PDF|
|Pathology Review Instructions||Adobe PDF|
IRB Immediate Reporting Policy
Human Research Protections Program Immediate Reporting Policy
|Immediate Report Forms|
|Immediate Reporting Policy||Adobe PDF|
|Immediate Reporting Form||Microsoft Word|
|Adverse Event & IND Safety Reporting Cumulative Table||Microsoft Word|
|Protocol Deviations Guide||Webpage|
24 Hour Reporting Quick Guide
|Report Within 24 Hours|
|Any protocol deviation that was made in order to eliminate an apparent immediate hazard to a participant.|
|Breach of confidentiality|
Immediate Reporting FAQ:
Which incidents and information need to be reported within 24 hours?
XThere are two items that need to be reported within 24 hours:
• Any protocol deviation that was made in order to eliminate an apparent immediate hazard to a participant(s).
• Breach of confidentiality
- When is a harm considered "unexpected"?
XFor adverse events that don't involve devices, a harm is unexpected when its specificity and severity are not accurately reflected in the WCMC consent document, Investigator's Brochure (if applicable), or package insert (if applicable).
For devices, a harm is considered unexpected if it was not previously identified in nature, severity, or degree of incidence in the investigational plan or IDE application (including a supplementary plan or application).
- What if an amendment is needed?
XIf the PI or any committee/board determines that the Immediate Report requires an amendment to the protocol or consent, the PI has 30 days from the date of making the Immediate Report (or release of the sponsor amendment) to submit a protocol amendment to the IRB. If this requirement cannot be met, a request for an extension must be made.
- For Immediate Reports that are adverse events, does follow-up need to be submitted?
XWhen you receive more information about the adverse event and that additional event information continues to meet the reporting criteria for an Immediate Report, a follow-up report should be sent. Indicate in the description of the Immediate Report adverse event that it is a follow-up to the original submission and include both the original and follow-up information in the description of the event.
- What if the policy requires me to submit an Immediate Report to more than one committee (the IRB and the WCMC DSMB, for example) and only the WCMC DSMB has follow-up questions about the Immediate Report, but not the IRB? Do I have to send my follow-up response to both committees?
XNo, you do not need to send your response to both committees. Only send your response to the committee that requested the additional information.
- What if the study sponsor requires the submission of an adverse event, deviation or other type of information that doesn't meet the criteria for an Immediate Report?
XIf the information doesn't meet Immediate Reporting criteria, the information should be sent to the IRB as an acknowledgment as opposed to an Immediate Report. This will allow the IRB and other committees to focus on capturing and routing emergent risk information most effectively.
- What other adverse events, incidents and information will I need to report to the WCMC DSMB for Periodic Review?
XIf using the WCMC DSMB, you will be asked to submit an Adverse Event & IND Safety Report Cumulative Table for each study arm. You will also be asked to provide narratives for all serious adverse events and significant medical events under the Adverse Event Narrative Reporting Requirement. Refer to the WCMC DSMB Periodic Review Form, or email firstname.lastname@example.org.
- What other adverse events, incidents and information will I need to report to the WCMC IBC for the Annual Human Gene Transfer Reporting Requirement?
XIf your study is a human gene transfer study, you will be required to submit to the IBC your last annual report to NIH-OBA (refer to the NIH Guidelines for Use of Recombinant DNA Molecules, Appendix M-I-C-3) under the IBC's Human Gene Transfer Annual Reporting Requirement at the time of IRB Continuing Review. For additional information, refer to the IBC website, or email email@example.com.
As you are aware, certain adverse events and incidents must be immediately reported to NYPH Patient Services, Risk Management, and/or the Department of Health. Please refer to the following policies/offices to determine whether this event qualifies for reporting to any of the aforementioned groups.
NYPH-WCMC Patient Services
NYPH-WCMC Westchester Patient Services
IRB Human Subject Recruitment Policy
Policy for Subject Recruitment Materials and Advertising
March 25, 2015
Outreach to the general public for subject recruitment efforts is considered to be the first point of contact in the informed consent process. Actively advertising for research studies for the sole purpose of soliciting subject participation is not, in and of itself, an objectionable practice. When done correctly and under the guidance of an institutional review board, it can be a successful mechanism for study recruitment efforts.
Because recruitment is considered part of the informed consent process, the Weill Cornell Medical College Institutional Review Board (WCMC IRB) must review and approve all recruitment methods, as well as the content of the recruitment materials. Recruitment activities cannot be initiated until approval is received from the IRB. In addition, any changes to an approved recruitment tool must be submitted to the IRB for review as an amendment prior to implementing the changes.
The Joint Clinical Trials Office (JCTO) has established the following policies for utilizing advertising in seeking subjects to participate in research studies at WCMC/NYP.
Materials for advertising (paid and free) might include, but are not limited to:
- Table tents
- Social Media
- Online banners
- Video blogs
Investigators are required to prospectively provide the IRB with recruitment materials to be used in identifying potential subjects including:
- Content, including online sites
- Avenue of communication activities
- Final copy / audio / video of materials
Advertisements must include:
- Simple to understand lay language
- Words ‘research study’ to appear at or immediately near the top / beginning
- Main purpose of the research
- Basic eligibility criteria
- Tests / procedures spelled out (no acronyms)
- Study contact details (PI and/or research nurse or study coordinator) – name, phone, e-mail (if using a study e-mail address it must be @med.cornell.edu; Gmail, Yahoo, Hotmail, AOL, etc. are not allow)
- IRB protocol number and approval beginning / end date
Advertisements may include:
- Experimental / investigational drug (not approved by the FDA) – if applicable
- Placebo controlled study (i.e. inactive drug) – if applicable
- Brief list of potential benefits utilizing conservative language (not overpromising)
- Timeframe of commitment (e.g. one visit, once a week for 12 weeks, etc.)
- Compensation (no bolding or text larger than other content) – if applicable
- Study-related and/or all medical care included – if appropriate
Advertisements may not include:
- Language implying a favorable outcome or other benefits other than as approved in the informed consent form and protocol
- Claims that the drug or device is safe or effective for the purposes under investigation
- Claims that the test article is known to be equivalent or superior to any other drug or device
- Language such as “new treatment, drug or medication” without explaining test article is investigational
- “Free medical treatment” when the intent is only to say subjects would not be charged for taking part in the study
In accordance with the OHRP and FDA guidelines, the IRB does not require review or approval for brief Internet advertisements / postings when information is limited to the following information:
- Study title
- Purpose of the study
- Protocol summary
- Basic eligibility criteria
- Study site location(s) and how to contact the site for further information This practice is consistent with the current guidance on posting to the JCTO clinical trials website. It is important to note that informed consent and IRB approval must be obtained if any individually identifiable information will be used or obtained as part of the recruitment activities.
Recruitment materials are submitted for review and approval via the WCMC eIRB system (requires network or VPN access). We highly encourage you to include all documents in the initial submission in order to avoid potential delays in recruitment efforts during the study.
Upon receiving IRB approval, advertisements may be posted off campus, as appropriate, as well as on the WCMC & NYP campus in the following designated areas and publications:
- WCMC – News & Community listservs, JCTO website via Clinical Trials Summary Template, physician / clinic offices (with permission)
- NYP – Emergency Room (with permission, predetermined locations), display frames near most elevators (must include date posted, limited to two week intervals and can be reposted), bulletin board outside cafeteria, staffed table in cafeteria or Starr lobby
Please remember to retrieve or replace your materials after an amendment, continuing review or study termination.
Of note: Materials are prohibited from being posted or placed on walls, and in lobbies, restrooms, stairwells, hallways, and elevators except in display frames / locations designated for such announcements. In particular, flyers may not be taped to walls or elevators. Investigators and their research staff are required to adhere to these policies, non-compliance may result in the IRB / JCTO taking action to suspend subject recruitment for a study or an investigator.
For information about IRB approval for recruitment materials, please contact:
Alavy Sos, M.S.
Director, Institutional Review Board
Weill Cornell Medical College
Office for Research Integrity
For information about posting recruitment materials, please contact:
Manager, Subject Recruitment & Communications
Weill Cornell Medical College/NewYork-Presbyterian
Joint Clinical Trials Office
Human Subject (IRB) Links
For more helpful IRB information, please visit the following:
- OHRP (Office for Human Research Protections)
- Clinical Trials.gov
- National Cancer Institute
- National Institute of Health
- FDA (Food & Drug Administration)
- Center for Drug Evaluation and Research (CDER)
- FDA Guidance, Compliance, and Regulatory Information
- Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)
- Center for Devices and Radiological Health (CDRH)
- Device Advice: Comprehensive Regulatory Assistance
- Center for Biologics Evaluation and Research (CBER)
- Vaccines, Blood & Biologics: Guidance, Compliance & Regulatory Information
- FDA Clinical Trials and Human Subject Protection
- FDA Guidance Documents and Information Sheet
- FDA Regulations
- Guidance for Instiutional Review Boards and Clinical Investigators - Compilation of current FDA Guidance documents for IRBs, including investigator responsibilities. Includes information on both drug and device studies.
- FDA for Kids
- FDA's MedWatch
- President's Council on Bioethics
- Ethical, Legal, and Social Implications (ELSI) of Human Genetics Research
- Public Responsibility in Medicine and Research/The Applied Research Ethics National Association (PRIM&R/ARENA)
- Kids for Research
- Kids Health
- Human Genome
- Medline Plus
- Tri-Institutional Human Embryonic Stem Cell Research
- Clinical and Translational Science Center (WCMC)
IRB Policies and Procedures
|Institutional Review Board Policies and Procedures for Research Involving Human Subjects||Adobe PDF|
|IRB Policy on Consenting Non-English Speaking Subjects||Adobe PDF|
|Verification of Signatures on IRB correspondence||Adobe PDF|
|Immediate Reporting Policy|
For more information, click here.
|Human Subjects Recruitment Advertising Policy||Web Link|
|Policy Regarding Expiration of Approved IRB Protocols||Adobe PDF|
|Protocol Exception Requests||Web Link|
|Standard Operating Procedures (SOPs)|
|IRB Initial Submission and Review||Adobe PDF|
|Continuing Review||Adobe PDF|
|Use of a Central IRB||Forthcoming|
|Protocol Exception Requests||Web Link|
|IRB Submission Checklists|
|Full Board Initial||Word Doc|
|Expedited Initial||Word Doc|
|Continuing Review||Word Doc|
RDRC Forms and Policies
- Radioactive Drug Research Committee (RDRC) Program
- CFR - Code of Federal Regulations Title 21 (21 CFR 361.1)
- FDA 2915 Report on Research Use of Radioactive Drugs Study Summary
- To open the FDA PDF, please right click and save the file, then re-open with Adobe Acrobat.
- RDRC Application
OSRA Standard Operating Procedures
OSRA will post new and updated SOPs below as they are released to the community via the OSRA-updates listserv. Please email firstname.lastname@example.org to be added to OSRA-updates or with any questions or concerns.
|Submitting a Competitive Grant Application for OSRA Review (OSRA 0002)||Adobe PDF|
|Sponsor Pre-Funding "Just in Time" Requests (OSRA 0003)||Adobe PDF|
|OSRA Grant Application Review and Submission (OSRA 0004)||Adobe PDF|
|Submitting a Progress Report for OSRA Review (OSRA 0005)||Adobe PDF|
|eRA Commons Account Creation (OSRA 0006)||Adobe PDF|
|Electronic Routing Form Review and Approval (OSRA 0007)||Adobe PDF|
|Incoming Subawards (OSRA 0008)||Adobe PDF|
|Processing a Notice of Award (OSRA 0009)||Adobe PDF|
|Petty Cash Reimbursement on Grants (FINC0001)||Adobe PDF|
|Outgoing Subawards (OSRA0010)||Adobe PDF|
|NIH Continuous Submission (OSRA0011)||Adobe PDF|
|Revenue Classification Determination (OSRA0012)||Adobe PDF|
All forms can be viewed and printed as PDF documents (Adobe Acrobat Reader required).
If you need help completing forms contact the Office of Sponsored Research Administration (OSRA).
Downloads and Links
|Form name||Description||Download Link|
|Adobe Forms D (NIH) – WCM Template||The Adobe Forms D package is to be used for due dates on or after May 25, 2016. This template is provided for reference purposes only, and is not intended to be completed for submission to NIH. For up-to-date application packages, visit the NIH website: http://grants.nih.gov/funding/index.htm and search for the appropriate Parent Announcement or RFA.||Adobe PDF|
|Addendum to Outside Consulting Agreement||Outside Consulting Agreements are considered to be personal arrangements between the WCM faculty member and the Company. WCM University Counsel requires this non-negotiable Addendum be signed by the Company and incorporated into the faculty member’s Outside Consulting Agreement.||Microsoft Word|
|Advance Account Request Form||As described in the form, this is for new and competing grants where WCM is prime and award notice is pending release from the Sponsor or processing is otherwise delayed. Submit request to initiate the set-up of a new account in order to commence work and allocate expenditures appropriately.||Adobe PDF|
|Annual Compliance Checklist||Adobe PDF|
|Budget Template - OSRA|
OSRA's Standard Budget Template establishes a uniform model for use across all sponsored research funding. Use of this template will greatly assist OSRA as they review budgets and create accounts in SAP.
|Carryover Request Template Letter||Microsoft Word|
|Certificate of Registration for Use of Recombinant DNA or Transgenic Animals||Microsoft Word|
Template A: Outside Entity to Faculty/Investigator CDA
Template B: Cornell to Outside Entity CDA
|Template A: This template should be used when the sponsor of a potential study is providing confidential information to a WCM scientist/investigator. |
Template B: This is template should be used when a WCM scientist/investigator is providing confidential information to a potential sponsor.
|Consulting Agreement Template|
A consulting agreement is required for consulting services budgeted on a sponsored project. The attached agreement is a non-negotiable template to be signed by individuals outside WCM with the role of consultant on a funded sponsored project.
|Cost Sharing Form||If institutional or Departmental funds will be used to support a portion of this project, please explain on the Cost Sharing Form.||Adobe PDF|
|DHHS Rate Agreement||Adobe PDF|
|Dissemination Plan Template||This template should be used by investigators submitting a human subjects/clinical trial proposal to NIH using Forms E.||Microsoft Word|
|Effort Reduction Template||For all grants where an effort reduction approval is being requested from the Sponsor. For NIH, effort reductions greater than 25% should be submitted for key personnel named in the Notice of Award. For subawards and other Sponsors, follow the prime/sponsor agreement or notice of award guidelines.||Microsoft Word|
|Equipment Survey Form||On a proposed sponsored project, complete this form for each proposed equipment purchase costing $5,000 or more. The Equipment Survey Form allows the Institution to confirm that the equipment is not already available on Campus.||Adobe PDF|
|Export Controls Checklist||"Export Controls" are those federal laws and regulations that govern the transfer or disclosure of goods, technology, software, services, and funds to restricted foreign countries, persons and entities (including universities). Your response to the questions in this checklist will help the Grants & Contracts Office and the Office of University Counsel determine whether any aspect of your sponsored research project activities will be subject to export control regulations.||Adobe PDF|
|Foreign Exchange Risk Acceptance||Adobe PDF|
|Grant Transfer Checklist for PI Transferring FROM WCM to NEW INSTITUTION||This form should be completed by the Weill-Cornell Principal Investigator leaving WCM that wishes to transfer his/her grant(s) and/or contract(s) from WCM to another organization when allowed by sponsor policy.||Microsoft Word|
|Grant Transfer Checklist for PI Transferring TO WCM from FORMER INSTITUTION||This form should be completed by the new Weill-Cornell Principal Investigator transferring his/her grant(s) and contract(s) to WCM from another institution.||Microsoft Word|
|Guidance for Conflicts Disclosure||Adobe PDF|
|Hospital Facilities Form||If a sponsored research project will be using any New York Presbyterian Hospital Facilities (space, ancillaries, personnel, data or information systems), a Principal Investigator must detail this use on the Hospital Facilities form.||Adobe PDF|
|Human Research Billing Analysis Form||Principal Investigators are required to submit one Human Research Billing Analysis Form per research protocol at the time of the IRB submission application for new protocols and again at the time of continuing review. The purpose of completing and submitting a Human Research Billing Analysis Form is to prospectively identify the list of services required by the study protocol, and indicate when the services will occur, who will provide the service, how the service is to be billed and in general terms, specify payment responsibility.||Microsoft Excel|
|Human Subjects Protection Training Verification Form||The Human Subjects Protection Training form is completed to confirm that all WCM key personnel listed on a sponsored research project have completed the CITI "Biomedical Research Investigators and Key Personnel Course" web-based training.||Adobe PDF|
|Laboratory Safety Registration (replaces Research Safety Checklist / IBC Registration)||The "Research Safety Checklist/IBC Registration" and "Research Safety Checklist/IBC Registration - Short Form" have been replaced by the "Laboratory Safety Registration". Submit the Laboratory Safety Registration where prompted to upload the "Research Safety Checklist/IBC Registration". Environmental Health and Safety will assist researchers with obtaining your required IBC approvals for all of your laboratory's rDNA and biohazard work; Radiation Safety Committee approvals for all radioactive non-human use work; and the Research Safety Checklist for safety program implementation within the laboratory. Follow the link on the right to download the "Laboratory Safety Registration," follow all form instructions, and contact EHS at email@example.com or (646) 962-7233 with questions about the form.||Adobe PDF|
|Material Transfer Agreement (MTA) - Simple Letter Agreement (SLA)||Microsoft Word|
|No Cost Extension Template||Microsoft Word|
|No Cost Extension Template (Non-Federal Sponsors)||Microsoft Word|
|Pre-Award Costs Request Template||For new, competing and non-competing grants for which a notice of award has been received with a later than anticipated start date and allowable pre-award costs is being requested.||Microsoft Word|
|Request for Reduction in Indirect Costs||For any instance where a sponsored research project does not provide an approved indirect cost rate, please complete this waiver request.||Adobe PDF|
|Scope of Work Form|
If a sponsored research project’s scope of work will involve any existing intellectual property and/or is likely to generate intellectual property, please indicate the details on the Scope of Work form. This form should not be used for subawards and consortiums where a scope of work is required.
|Statement of Intent to Establish a Consortium Agreement||A statement of intent form is required for all subcontract sites participating on a WCM grant application. Please have the form completed and signed by your collaborator's central business office.||Adobe PDF|
|W-9 Form||Adobe PDF|
|WBS Element Request Form||The purpose of this form is to ensure that all WBS elements (for new, competing and supplemental applications) are created with the appropriate levels of SAP access.||Adobe PDF|