A: A. Submit a cover memo outlining all of the changes being made and the rationale for those changes. The more details you provide, the easier the review will be for the reviewer. If the amendment comes from the sponsor, the sponsor summary of changes, while useful, is not sufficient. The IRB requires a brief summary from the PI. Remember to change all relevant sections of the WCMC IRB documents that are affected by the amendment (e.g. if you are adding a co-investigator*, update the co-investigator list on the WCMC IRB protocol; if you are removing a co-investigator, strike-out the investigator's name; changes to risks should be indicated in both the WCMC IRB protocol and consent form, etc.). Anytime WCMC IRB documents are being revised, highlighted and clean copies must be included with the submission. Note: The PI must sign in the signature section of the WCMC IRB protocol thus acknowledging all changes made with each amendment submitted.

* When adding co-investigators, submit a Study Specific Financial Disclosure form for each added investigator, and ensure that they have passed the CITI Course in the Protection of Human Research Subjects or its equivalent.

A: In order to submit a consent form to the IRB translated into a language other than English, you must have the IRB approved consent form (written in English) translated (and back translated) by a certified translating service that provides you with a certificate of translation. Please note that if you are recruiting the general NYPH-WCMC hospital population, you should have your consent forms translated into the 4 main languages of the general hospital populations: English, Spanish, Chinese-Mandarin and Russian.

A: Submit a cover memo, the grant in its entirety, and the WCMC IRB protocol that will be used to carry out the research, to submit2irb@med.cornell.edu. All deadlines and corresponding IRB meeting dates apply to grant reviews.

A: In order to obtain a 310 form, your grant must be reviewed by the IRB. You must submit a cover memo, the grant in its entirety, and the WCMC IRB protocol that will be used to carry out the research, to submit2irb@med.cornell.edu.

A: Yes, you will need to submit the new protocol for review at the same time you are submitting the grant for review.

A: Expedited review means the submission (e.g. new protocol, amendment and/or continuing review) will be reviewed by one member of the IRB. As such, expedited submissions do not have specific submission deadlines. It is important to note that expedited review does not necessarily mean that the submission will be reviewed quicker than a full board review. Please allow a minimum of 10 business days for issues raised/approval to be communicated to the research team.

A: Expedited reviews are reserved for minimal risk studies that fall into designated categories. Please download categories here.

A: Retain a copy of the IB for your records and then send a copy to the IRB office. Send a brief cover letter with the WCMC Principal Investigator's name, protocol title and WCMC protocol number. It is also important to identify in the cover letter whether or not the changes have any impact on the consent form or WCMC IRB protocol. Make sure you attach a sheet that details all of the changes in the new IB. If a description of changes did not come with the packet you received from the sponsor, call the sponsor and request it. The IB will be returned to you if all of the above is not present in one package. If a consent form change is necessary, thus constituting an amendment to the protocol, please include both a version of the form highlighting the changes and a clean copy (non-highlighted) for stamping. You will receive an acknowledgement letter from the IRB office within 5-10 business days of submitting unless full board or expedited review is required.

A: You must download and fill out the Continuing Review Application Form from the IRB forms webpage. At the end of the form there are instructions for what to include depending on the status of your study. Note: It is not sufficient to include the continuing review form alone unless your study has been completed and you are ready to close out the study.

A: The IRB suggests that you submit any materials at least two meeting cycles (6-8 weeks) before the study expires. Please refer to the deadlines and respective IRB meetings to make this determination: http://www.med.cornell.edu/research/rea_com/irbschedule.html.

A: It depends on how long the study approval has lapsed. Submit your continuing review as soon as possible and be sure not to enroll any new subjects in your study until the continuing review has been approved. If the approval period for the study has lapsed more than fourteen days, please contact Dr. Rosemary Kraemer, Director of the Human Research Protections Program, 212-821-0630 / rtkraeme@med.cornell.edu for guidance.

A: When writing/designing a flier, brochure, or any other form of advertising, it is important to remember the audience you are writing for. Since you are writing to recruit potential research subjects, keep the language as simple as possible (lay terms) so potential subjects understand what you are advertising and whether it applies to them. The key elements to include in any advertisement are:

• The words 'research study' must appear at or immediately near the top/beginning of the advertisement
• The main purpose of the research (and/or condition under study) must be stated
• Provide the basic eligibility criteria (e.g. age range, sex, healthy individual)
• State the tests/procedures involved in the study (not just acronyms, i.e. not MRI, but instead magnetic resonance imaging (MRI)
• Give the time or other commitment requirements
• State 'compensation' will be provided and not 'pay' if subjects are to be given money/gift for their participation in the study
• Have a contact name (i.e. Research Coordinator or Principal Investigator) and phone number listed for more information
• If applicable, state that this is an experimental drug (not approved by the FDA)
• If applicable, state that there is a placebo arm of the study and what is meant by 'placebo' (i.e. inactive drug)
• At the bottom of the advertisement, provide the IRB protocol number and date of approval of the advertisement
• If applicable, any possible benefits should be presented in a conservative manner without exaggeration
• Do not use terms like "treatment", "medication", "doctor", instead use research terms like "study drug", "researcher/research team", etc. Potential subjects must not get the impression that the study will be a course of treatment for them.
• Do not suggest to potential subjects that they are in danger if they do not participate.

On the cover page you submit to the IRB, always remember to include all WCMC IRB protocol numbers to which the advertisement applies as well as all of the corresponding PI names and research study titles.

A: An adverse event (AE) is defined as any occurrence that has unfavorable and/or unintended effects on research subjects, regardless of severity or study-relatedness. AE's may manifest as new findings (signs, symptoms, diagnoses, laboratory results) or alterations in pre-existing conditions.

AE's must be monitored throughout the entire course of a study, as well as during a reasonable follow-up period after study completion. Investigators must notify the NYPH-WCMC IRB in writing within 10 calendar days of the occurrence of all adverse events that meet the criteria of both unexpected and related (or probably related) to participation in the research.

A: First, make sure that a record of the adverse event is kept in the research subject's files and added to the study's AE cumulative table. Then, use this algorithm to determine whether your adverse event should be reported to the IRB (and IBC, WCMC DSMB, or CTSC, as applicable) within 10 calendar days.

For more information about adverse event reporting and what should be submitted, email submit2ae@med.cornell.edu, see the revised policy here: http://www.med.cornell.edu/research/rea_com/irb_adv.html.

A: WCMC IRB has cooperative agreements with the following institutions: Columbia University, Cornell Ithaca, Rogosin Institute, Hospital for Special Surgery (HSS), Memorial Sloan Kettering Cancer Center, National Cancer Institute CIRB.
Write a cover letter briefly outlining the study (i.e. what is involved, the investigators involved, tests to be conducted and how WCMC will be involved in the research). Make sure that both the WCMC Principal Investigator's signature and Departmental Chair's signature are on the cover letter. Attach copies of all approved paperwork from the cooperative institution (i.e. the approval letter, their stamped consent form, the protocol approved by the institutions' IRB; for protocols from Columbia, this includes the Human Subjects Protocol Data Sheet and the Human Subjects Study Description Data Sheet). Also, please submit a copy of the WCMC consent form you plan to use here at WCMC (template available at: http://www.med.cornell.edu/research/for_pol/ins_rev_boa.html). If you plan to advertise at WCMC, attach a copy of the advertisement/flier. Send this packet to the IRB office. (If there are questions, call the IRB office at 212-821-0577). Because Cornell is considered a covered entity per the HIPAA security law, all protocols that take place at WCMC need to have a HIPAA determination. You will be contacted after receipt of your packet to discuss what HIPAA paperwork you will need to complete in order to be HIPAA compliant. (For more information about HIPAA: http://www.med.cornell.edu/research/for_pol/hip_for.html.)

A: Some human subjects research does not require IRB review. The Office of Research Integrity makes the final exempt status determination; the PI and/or research team should not determine for themselves that a study is exempt. The request for exemption can be downloaded here: http://www.med.cornell.edu/research/for_pol/ins_rev_boa.html. A single PDF document should be emailed to submit2irb@med.cornell.edu. Studies qualify for exemption if they fulfill one of the following categories:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices. Examples include: a) Research on regular and special education instructional strategies, OR b) Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.


2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: a) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, AND b) Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.


3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under number 2 (above) of this section, if: a) The human subjects are elected or appointed public officials or candidates for public office; OR b) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.


4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: a) Public benefit or service programs; b) Procedures for obtaining benefits or services under those programs: c) Possible changes in or alternatives to those programs or procedures; OR d) Possible changes in methods or levels of payment for benefits or services under those programs.

5. Taste and food quality evaluation and consumer acceptance studies: a) If wholesome foods without additives are consumed; OR b) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

A:

1. Not referencing the protocol number, PI, and title of study on all correspondence with the IRB office.


2. Submitting documents in formats other than PDF.


3. Submitting handwritten documents/changes to documents.


4. Scanning the entire document rather than converting from Word to PDF. Scanned signature pages are acceptable but should be combined with the converted PDF document. In the near future, the IRB will require digital signatures (created using Adobe).
Sending submissions in pieces. The IRB does not retain incomplete submissions. Whenever the IRB requests that you resubmit, incorporate missing pieces into the complete single PDF.

5. Not including a memo indicating what you are submitting to the IRB.


6. Attaching multiple documents when emailing to submit2irb@med.cornell.edu. The IRB requires a single PDF document with bookmarks that separate files.


7. PI not responding to issues raised by the IRB point-by-point. Do not leave any questions unanswered.