A: Submissions should be emailed to the IRB as a single PDF document with bookmarks indicating separate files. The email address is submit2irb@med.cornell.edu. Instructions for PDF conversion and placing bookmarks can be found here: "IRB Electronic Forms & E-Submission Instructions"

A: This is the order in which you should bookmark your single PDF document:

1. WCMC IRB Protocol Application or IRB Expedited Protocol Application
2. Consent/Assent Forms/Oral Consent Script
3. Recruitment Notices/Advertisement Materials
4. HIPAA form
5. Study Specific Financial Disclosure Form (for all personnel listed on the study including the PI)
6. HRBAF
7. Data Collection Sheets, Surveys, Questionnaires, Psychological Tests, Interview Forms, Scripts, etc.
8. FDA correspondence (If applicable)
9. Sponsor Protocol (If applicable)
10. Investigator's Brochure (If applicable)
11. Grant (NIH or other) (If applicable)

If your study requires you to use the Department of Pathology or the Department of Pharmacy, you will need to obtain those approvals and send to the IRB prior to release of final approval.

Tip: If any questions or sections of our IRB protocol form are not applicable to your study, please indicate by inserting "NA".

Tip 2: If you are using digital signatures in Adobe, combine all documents before obtaining signatures. Combining the documents after signatures have been obtained will render your document "unsecure" and signatures will be lost.

A: You will receive a personalized email confirmation of receipt indicating who your contact person for the submission will be and the meeting date the submission will be reviewed (if the submission will be reviewed by the full board). Please make note of your submission contact, as it will prove to be extremely useful when you are following-up.

A: Yes. Do not hold up submitting a protocol on time for that reason. We realize Department Chairs travel or may not be available, so you can "owe" the signature to the IRB office. Submit all "owed" signatures/documents directly to your submission contact at the IRB.

A: Most protocols take an average of 2 meeting cycles, which equals 6-8 weeks. Some may take more time. Please take this schedule into consideration to allow adequate time for your submission to be reviewed and approved. See deadlines/IRB meeting dates here: http://weill.cornell.edu/research/rea_com/irbschedule.html.

A: No. Once you submit your response, one member of the IRB will be responsible for the review. There are no deadlines for these issues/responses. Be sure to include a cover memo with a detailed point-by-point response to all issues raised. Also, include a highlighted and a clean copy of all WCMC IRB documents changed. Note: The PI must sign in the signature section of the protocol every time the protocol is changed, acknowledging those changes.

A: Yes. Responses to deferrals will be reviewed at the next board meeting. See deadlines/IRB meeting dates here: http://weill.cornell.edu/research/rea_com/irbschedule.html. Be sure to include a cover memo with a detailed point-by-point response to issues raised. Also, include a highlighted and a clean copy of all WCMC IRB documents changed. Note: The PI must sign in the signature section of the protocol every time the protocol is changed, acknowledging those changes.

A:

1. Any documentation previously requested by the IRB (e.g. signatures, study specific financial disclosure forms, Human Research Billing Analysis Form with all required signatures, HIPAA form, etc.).
2. Resolution of conflicts as instructed by the Conflicts Management Office.
3. Contract execution (between WCMC and sponsor).
4. Study personnel who have not taken the CITI course/refresher course in the Protection of Human Research Subjects or its equivalent.

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: Expected enrollment of non-English speaking subjects:  For those studies where the recruitment efforts will target a certain population such that the PI expects a significant proportion of subjects will be non-English speaking, the IRB shall require a translated consent document to be prepared.  In order to ensure that the translation is accurate, an affidavit of accuracy from the translation service or a back translation from the translated consent to English by a third party (i.e., an individual not an investigator on the protocol) is required.  When non-English speaking subjects enroll, they must be given a copy of the translated consent document.  Subjects and witnesses must sign the translated document.

Unexpected enrollment of a non-English speaking subjects:  If a PI decides to enroll a subject into a protocol for which there is not an existing IRB-approved informed consent document in the prospective subject's language, the procedure for obtaining oral consent of non-English speaker may be used.  A short form consent document in both English and the subject's language must be reviewed and approved by the IRB.  A certificate of accuracy or a back-translation of the short form by a third party should be included with the submission.  An English short form consent and translated versions can be found on our intranet website at http://intranet.med.cornell.edu/research/consent_forms.html.  Detailed procedures for consenting non-English speaking subjects be found on our website at http://www.med.cornell.edu/research/for_pol/ins_rev_boa.html.

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://weill.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.

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 7 calendar days. Submit using the Adverse Event Reporting Form to submit2irb@med.cornell.edu and attach the current consent form and any applicable documentation as a single PDF. Note that if your study uses the IBC, WCMC DSMB or CTSC, the PI is required to CC reports to each applicable committee at submit2ibc@med.cornell.edu, submit2dsmb@med.cornell.edu and ctscrsa@med.cornell.edu.

For more information about adverse event reporting and other information that the PI must submit promptly, see the revised policy here: http://weill.cornell.edu/research/rea_com/irb_adv.html.

A: WCMC IRB has cooperative agreements with the following institutions: Columbia University (except from the Department of Psychiatry), Cornell Ithaca, Rockefeller University, Hospital for Special Surgery (HSS), Memorial Sloan Kettering Cancer Center, National Cancer Institute CIRB. If you would like to submit a protocol under the cooperative agreement with one of the above institutions, where their IRB would be the IRB of record, please submit the following:

• 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 the WCMC Departmental Chair's signature are on the cover letter.
• Include 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). Do not forget to include clean copies of all documents that need the WCMC IRB stamp.
• If you plan to recruit out of WCMC, submit a copy of the WCMC consent form you plan to use here at WCMC.
• If you plan to advertise at WCMC, attach a copy of the advertisement/flier.
• Because WCMC is considered a covered entity per the HIPAA security law, all protocols that take place at WCMC need to have a separate HIPAA determination.
• Submit Study Specific Financial Disclosure Forms for all investigators (both at WCMC and the IRB of Record).
• Submit the Human Research Billing Analysis Form for WCMC.
• If the study involves Human Tissue, the "Human Tissue Section and Request Form" must be completed and signed by Rebecca Baergen.

All WCMC specific IRB forms can be downloaded here:
http://weill.cornell.edu/research/for_pol/ins_rev_boa.html).

Submit as a single PDF with bookmarks to submit2irb@med.cornell.edu.

A: A Certificate of Confidentiality (CoC) helps researchers protect the privacy of human research participants enrolled in sensitive research.  CoCs protect against compulsory legal demands, like court orders and subpoenas, for identifying information or identifying characteristics of a research participant.

Sensitive information includes (but is not limited to) information relating to sexual attitudes, preferences, or practices; information relating to the use of alcohol, drugs, or other addictive products; information pertaining to illegal conduct; information that, if released, might be damaging to an individual's financial standing, employability, or reputation within the community or might lead to social stigmatization or discrimination; information pertaining to an individual's psychological well-being or mental health; and genetic information or tissue samples.

Researchers should apply for CoCs after IRB approval.  Subjects must be told about the protections afforded by the CoC and any exceptions to those protections.  This should be done in the consent form.  If the study is being done internationally and the data is maintained within the U.S., then one can apply for a CoC.  If the data is maintained outside of the U.S., a CoC would not be effective.

A: If the NIH funds the research, applying for a CoC is through the funding institute.  If research is not supported by the NIH, applications should be sent through the NIH Institute or Center that funds research in an area similar to the project.  Please click on the following link for more information:  http://grants.nih.gov/grants/policy/coc/appl_extramural.htm.

A: Some human subjects research does not require IRB review. The Office of Research Integrity and Assurance 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://weill.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.