Who Can Be an Investigator
- Who can be a Principal Investigator (PI) on an IRB protocol?
XFull time WCMC faculty employees can be PIs on all categories of IRB protocols. Employees of New York Presbyterian Hospital (Pharmacists, RNs and Fellows) can be PIs on IRB protocols that involve retrospective reviews or surveys. They are not permitted to be PIs on protocols that involve patient care. This serves to clarify the information that is in our existing IRB policy guide that can be found on our website.
- Can students be investigators on IRB protocols?
- How do I submit to the IRB?
- What documents do I need to submit for a new study to be reviewed by the IRB?
XThis 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)
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.
- What happens once I submit to email@example.com?
XYou 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.
- Can I submit the protocol without the Department Chair's signature?
XYes. 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.
- What is the average time for a new full board protocol to be reviewed and approved?
- My protocol came back from the IRB meeting with "Modifications Required" (formerly known as "Non-substantive Issues"). Does this mean it is required to go to another meeting?
XNo. 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.
- My protocol came back from the meeting "Deferred" (formerly known as "Substantive Issues"). Does this mean it is required to go to another meeting?
XYes. Responses to deferrals will be reviewed at the next board meeting. See deadlines/IRB meeting dates. 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.
- What can put a hold on IRB approval release?
X 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.
- How do I submit an amendment to my protocol?
XSubmit the amendment form 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: In addition to signing the amendment form, 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 Report for each added investigator, and ensure that they have passed the CITI Course in the Protection of Human Research Subjects or its equivalent.
Responses to Issues Letters
- When are responses to issues letters due?
XIf your protocol received a status of "modifications required" or "deferred," the issues letters must be responded to within 60 days of receipt of the letter. This response can be in the form of either a full response to all of the issues in the letter, or a request for a 30 day extension. A reminder that the response is due will be sent via e-mail one week prior to the due date.
Enrolling Non-English Speaking Subjects
- How do I enroll non-english speaking subjects?
X 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. Detailed procedures for consenting non-English speaking subjects be found on our website.
- I received a priority score and I qualify for a "just in time" grant from the NIH. How do I get the grant reviewed by the IRB?
- I need a 310 Form, how do I go about obtaining it?
- Can I submit a grant for review if I do not yet have an approved protocol at WCMC?
X Yes, you will need to submit the new protocol for review at the same time you are submitting the grant for review.
- What does expedited review mean?
X 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.
- What type of study qualifies for expedited review?
Compassionate vs. Emergency Use
- What is Compassionate Use?
X The FDA does not include the phrase "compassionate use" in its regulations, but it is commonly used by the research community. FDA has mechanisms to allow for access to investigational drugs or devices for patients who do not meet the inclusion requirements for a clinical investigation of an investigational drug or device but for whom the treating physician believes the drug or device may provide a benefit in treating and/or diagnosing their disease or condition. Expanded access can be sought for an individual patient or group of patients. Granting access to investigational drugs or devices for such patients requires prior FDA approval and IRB concurrence. Also, the sponsor must agree to provide the investigational drug or device for the expanded access. Patients must have a serious disease or condition for which there is no alternative treatment. For access to Investigational New Drugs (IND), FDA refers to compassionate use requests for individual patients as "single patient IND" studies (wider use would usually takes place under a "treatment IND" or "treatment protocol" under an existing commercial IND). For access to investigational devices, the FDA regulations allow for "compassionate use" with prior FDA approval and the approval of the investigational device sponsor and review by the IRB. Depending on the IND or IDE, compassionate use of drug or device may require submission of an IRB application and review by a convened IRB. The following FDA regulations and guidance pertain to "compassionate use": Food, Drug, and Cosmetic Act; Section 561 Expanded Access to Unapproved Therapies and Diagnostics; Regulation-21 CFR 812.35(a); Guidance www.fda.gov/cdrh/devadvice/.
- What is Emergency Use?
X Emergency use allows physicians to use unapproved drugs or devices in emergency situations. Importantly, emergency use can only happen once per drug or device per institution; any additional use requires an Investigational Device Exemption (IDE) or an Investigational New Drug (IND) application and the submission of a research protocol to the IRB. Although emergency use is not research, it does require reporting to the IRB and concurrence (but not approval) by the IRB chairperson. All of these criteria must be satisfied for emergency use:
1. The patient has a life-threatening disease or serious condition requiring immediate use
2. No generally accepted alternative for treating the condition is available
3. The physician has substantial reason to believe that the patient will benefit
4. There is no IND or IDE in place and no time to use existing procedures to obtain FDA approval of an IDE or IND
5. The physician is not part of an IND or IDE study of the drug or device
6. Independent assessment form an uninvolved physician
- How do I obtain an approval for Emergency Use of an unapproved drug or device?
X Within five days after the emergency use of the drug or device, the physician must submit the following information to the IRB: (1) documentation that the case was a life-threatening situation; (2) concurrence of another physician; and (3) whether or not informed consent was obtained (and if not, what efforts were made to obtain consent). This information should be sent to the Chairs of the IRB, Dr. David Behrman or Dr. Peter Goldstein, with a cc notification to Rosemary Kraemer (Director, HRPP) and Milda Plioplys (IRB manager). The Chair of the IRB, if acceptable, will send an email acknowledging the Emergency Use Request. Upon receipt of the above documentation, a letter will be sent by the IRB acknowledging the Emergency Use of the Drug or device.
The following FDA regulations and guidance pertain to emergency use: Regulation: 21 CFR 56.104(c), 21 CFR 50.23, 21 CFR 812.35(a)(2), 21 CFR 812.150(a)(4); Guidance: Federal Register/vol.50, No. 204/Tuesday, October 22, 1985
Acknowledgement of Receipt
- The study's sponsor has sent me an Investigator's Brochure (IB) that I need the IRB to acknowledge. What do I need to include when I send it to the IRB office?
X 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.
- What do I need to submit for the continuing review of my study?
X 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.
- How far in advance of the expiration date of my study should I submit the materials for a continuing review?
- I just realized that my study has expired, what do I do?
X It depends on how long the study approval has lapsed. Submit your continuing review as soon as possible. No study related activities can continue beyond the WCMC IRB expiration date, including subject recruitment, enrollment, intervention and data analysis. 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, 646-962-8200 / firstname.lastname@example.org for guidance.
However, OHRP guidance suggests that study intervention for subjects already enrolled can continue past the expiration date if the IRB determines that it is in the best interests of subjects already enrolled to continue participating in the research (for example, when the research interventions hold out the prospect of direct benefit to the subjects or when withholding those interventions poses increased risk to the subjects). While this determination may initially be made by the investigator, WCMC requires that the investigator must seek confirmation that the IRB agrees with this determination as soon as possible.
If you submit your continuing review such that the IRB will be unable to conduct continuing review prior to the expiration date, and you believe it is in the best interest of the subjects to continue study intervention, please send your request to the IRB. If the IRB agrees that it is in the best interests of the subjects to continue with the study intervention, then the request for an extension will be granted. If the IRB concludes that it is not in the best interest of the subjects to continue the study intervention, or that there will not be an increased risk to the subjects, then the request will not be approved. All requests for continuing review and approval submitted after current approval expiration must include an explanation of why the approval lapsed and the steps the investigator will take to ensure it does not happen in the future.
- What are the key elements I need to include in an advertisement?
X 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.
If you are adding a recruitment tool that has not been previously approved by the IRB, please fill out the amendment form and submit the recruitment tool for review. Make sure to update the IRB protocol to include this new method of recruitment.
Adverse Events (AE's)
- What is an adverse event (AE)?
X 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.
- Someone participating in my study has had an adverse event. What do I need to do?
X 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, you need to determine whether the adverse event has to be immediately reported to the IRB (and IBC, WCMC DSMB, or CTSC's TRAC, as applicable). Immediate reporting means either "within 7 days" or, if (immediately reportable) death, "within 24 hours."
All 3 of the reporting criteria must be met for immediate reporting to the IRB. The 3 criteria are in section (b) of the policy. Only if all 3 have been met, submit immediately and list on cumulative table. Otherwise, list on the AE/IND Cumulative Table for submission to the IRB at the time of Continuing Review.
To make this determination, take into consideration all information available to you about the event and consult with the monitoring mechanisms you indicated in your IRB-approved protocol, as needed (e.g., research team, medical monitor, DSMB, etc.).
Submit using the Adverse Event Reporting Form to email@example.com 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 firstname.lastname@example.org, email@example.com and firstname.lastname@example.org.
For more information about adverse event reporting and other information that the PI must submit promptly, see the revised policy.
See OHRP's Guidance (PDF file).
See the FDA's Guidance (PDF file).
- Adverse events reporting for studies a Humanitarian Device Exemption:
X As per the FDA guidelines that went into effect July 8, 2010, user facilities must submit reports to the IRB whenever a Humanitarian Use Device (HUD) may have caused or contributed to a death and whenever a HUD may have caused or contributed to a serious injury.
As of July 25, 2011, the IRB is requiring that all protocols involving HUDs and Humanitarian Device Exemptions (HDE) adhere to our immediate reporting policies regarding adverse events. Please make sure to include adverse events not immediately reportable per WCMC policy in the cumulative Adverse Event (AE) Table at the time of annual continuing renewal. Please also note that it is not necessary to report device-related adverse events that occur at sites external to WCMC. Please refer questions to Rosemary Kraemer: email@example.com.
For more information regarding our policies on immediate reporting, please refer to the following links: http://www.med.cornell.edu/research/for_pol/forms/AE_Reporting_Policy_revised_6-2010.pdf
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110 194. htm and 21CFR803.30 and 814.126(a)
Using The Cooperative Agreement
- I would like to submit a protocol involving an institution that we have a cooperative agreement with. What do I need to do to get it approved here at WCMC?
X • Fill out the Cooperative form that can be found on the IRB forms page.
• 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.
Submit as a single PDF with bookmarks to firstname.lastname@example.org.
Certificate of Confidentiality (CoC)
- What is a Certificate of Confidentiality?
X A Certificate of Confidentiality (CoC) helps researchers protect the privacy of human research participants enrolled in sensitive research. They are issued by the National Institutes of Health to protect identifiable research information from forced disclosure, allowing researchers and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative or other proceeding, whether at the federal, state or local level.
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. 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 in the informed consent form. If a certificate is granted after a study has already begun to collect data from subjects, that data would also be covered by the certificate once it is issued. While there is no requirement to re-consent subjects if the information was not included in the original informed consent document, researchers are encouraged to provide information about the protections given by the CoC to those subjects who were not told about the protections when they were first consented.
- How do I apply for a CoC?
- Does all human subjects research require review by the IRB?
X 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. A single PDF document should be emailed to email@example.com. 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.
5. 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.
6. 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.
Increasing Study Enrollment
- What do I do if I want to increase enrollment or increase the number of charts I will be reviewing as part of my research study?
X Submit a request for an amendment to the approved protocol. If you required immediate approval, then please submit a protocol exemption request and then separately, submit an amendment to increase the number of subjects to be enrolled. If you have already enrolled more subjects then approved, you will also need to submit a protocol deviation form in addition to the amendment. (All forms are available here).
Case Reports for the IRB
- Do Case reports have to be reviewed by the IRB?
X In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. A case report would have to be reviewed by the IRB is if it meets the criteria for human subjects research, specifically, the definition of research. According to the Common Rule (45CFR46, Subpart A), research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Most case reports, because they only involve one patient report, would not be considered to be a systematic investigation, and therefore would not qualify as human subjects research that needs to undergo IRB review.
However, the decision as to whether a case report needs to be reviewed by the IRB should not be made by the author(s), but by the Office of Research Integrity and Assurance. If you have a case report that you would like to publish, please send the completed manuscript to Dr. Rosemary Kraemer, Director of the Human Research Protections Program at firstname.lastname@example.org. She will consult with the Chairs of the IRB and the Institutional Official to determine if the case report qualifies as human subjects research that needs IRB review. The decision is usually made in 24 to 48 hours. If it is determined that it does not need IRB review, you will receive an e-mail stating this. If it is determined that IRB review is necessary, then an IRB application will need to be submitted for review.
Emailing patient/research subject information
- Can I send patient or research subject information over WCMC email?
- What are some common mistakes that can delay the processing of a protocol?
X 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).
5. 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.
6. Not including a memo indicating what you are submitting to the IRB.
7. Attaching multiple documents when emailing to email@example.com. The IRB requires a single PDF document with bookmarks that separate files.
8. PI not responding to issues raised by the IRB point-by-point. Do not leave any questions unanswered.