IRB - Frequently Asked Questions (FAQs)

1. Is my project research?
   
2. Does my research require IRB approval?
   
3. What is the IRB's authority?
   
4. How long does IRB review take?
   
5. What can I do to help the IRB process move quickly?
   
6. What happens after I submit my IRB application?
   
7. May I recruit participants for my study before IRB approval?
   
8. May I advertise to recruit participants for my study?
   
9. May I pay study participants?
   
10. What if there are changes to my study after I receive IRB approval?
    
11. What if adverse events occur among participants in my study?
    
12. How do I renew or close a study?
    
13. What is emergency use?
    
14. My project uses only medical records to collect data. Will I need IRB approval?
    
15. What if my research involves other sites besides NYU, many with their own IRB?
    
16. What is a cooperative agreement?
    
17. What is an MPA?
    
18. What is the link between the grant proposal and the IRB application for funded projects?
    
19. What is different about proposals going to the NIH?
    
20. Do I need to work with the grants and contracts staff too?
    
21. What is minimal risk?
    
22. What is informed consent and when is it needed?
    
23. What is assent and when is it needed?
24. What if my study qualifies for exemption? Do I still need IRB approval?

Is my project research?
Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge.

In the clinical setting, it is important to make a distinction between research and practice. They are frequently carried out together. This is the case when a clinical research activity evaluates the safety and efficacy of a treatment. Practice includes interventions that can reasonably be expected to enhance the well-being of a person through diagnosis or treatment. In contrast, research involves testing a hypothesis and drawing conclusions. Usually the research activity is described in a formal plan (protocol) that identifies the objectives and procedures to reach the objectives.

In addition to clinical research, other types of research are also conducted at NYU. One is survey research, which involves interacting with individuals to gather information using questionnaires or interviews. Another involves the collection of data from identifiable private information sources, e.g., medical records, so that analysis of the data will yield conclusions. Yet another involves bench or laboratory research, e.g., the use of surgical and laboratory specimens that would otherwise be discarded.

Your project is most likely research if it contains any of the elements described above.

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Does my research require IRB approval?
All research projects involving human subjects require IRB review and approval. A human subject is a living individual about whom the investigator collects data through direct intervention or interaction, or from sources such as medical records, clinical databases, billing records and pathologic or diagnostic tissue specimens. Data from these sources is called identifiable private information.

At NYU, human subjects are patients, families or other individuals, e.g., the patient’s classmates, who are asked to participate in a project. Staff members may also be subjects.

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What is the IRB’s authority?
The IRB has the authority under federal regulation and institutional policy to approve, require the modification of or disapprove research activities being conducted at NYU. It also has the authority to suspend or terminate research that was previously approved in which unforeseen harm to subjects occurs, or that is not being conducted as approved by the IRB.

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How long does IRB review take?
Because of funding agency requirements, we recommend that you allow 60 days for review. A well-prepared application will hasten the process. Many projects can be approved in less than 60 days if the application is complete and comprehensive.

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What can I do to help the IRB process move quickly?
We recommend strongly that researchers consult with IRB staff before submitting an application. Pre-review can identify potential questions and issues that may arise during the review process. If you would like to have a pre-review done, send an e-mail request to the IRB office and attach the application to your message. The pre-review can also be done in person by appointment. Feel free to call at 212.263.4110 or drop by the IRB office located in the Manhattan VA Medical Center on the 10th floor in the West Wing.

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What happens after I submit my IRB application?
When a new application is received in the IRB office it is screened for completeness and readiness for review. An IRB staff person contacts the researcher if additional information is needed. Once a completed application has been received, it is assigned for full, expedited or exempt review status, and IRB review can be scheduled. See categories of review for further details.

If your application requires review by the full IRB, a member of the IRB staff will contact you about a time for review, and the study will be added to the IRB meeting agenda. One member of the IRB is designated as primary reviewer for the study, and will lead the discussion during the meeting. It is possible that the primary reviewer will contact the principal investigator prior to the meeting with questions about the study.

The IRB agenda is mailed eight days in advance of the meeting date. Please go to the Meeting Schedule for this year’s dates.
For all studies, within one to two weeks after IRB review, a letter is sent to the principal investigator documenting the IRB’s actions and recommendations. After addressing the IRB’s conditions for approval and submitting materials that respond to these concerns, the researcher will receive a copy of the final IRB approval. The research may proceed only after the study has received final approval.

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May I recruit participants for my study before IRB approval?
No. Research subjects are not to be approached until the IRB has given final approval to the application.

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May I advertise to recruit participants for my study?
The IRB must review and approve any materials you plan to use to recruit research participants before you begin contacting individuals. This includes advertisements that appear in the newspaper, on radio or television or on the Internet. Flyers, letters of approach and telephone scripts must also be approved.

Recruiting materials should provide basic information about the study, including the time involved, the primary purpose of the research, e.g., testing an experimental drug, and an overview of procedures and testing. They should fairly represent study participation. The materials should also describe potential benefits to participants and compensation when applicable.

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May I pay study participants?
Whether or not individuals and families are paid for participating in research can depend on a number of factors, including availability of funds and the extent of effort on the part of study participants.
The IRB’s primary consideration in looking at remuneration plans involves the effect that coercion or undue inducement could have on a prospective participant’s ability to make an informed, voluntary choice about taking part in research. This is especially important when participation may include significant discomfort or the assumption of risk, and when involving children in a study.

In some instances researchers choose to offer non-monetary incentives, like gift certificates for toys or meals at a fast-food restaurant. If expenses for travel, lodging or meals are incurred the IRB will recommend that reimbursement be provided to participants.

If compensation or the use of incentives is to be part of your study, it is important to include specific information in the IRB application and to provide detailed information about payment, including terms, in the informed consent document. Procedures for payment or distribution of incentives should be established before the first participant is recruited.

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What if there are changes to my study after I receive IRB approval?
You are required to obtain IRB approval before implementing any changes to an approved study. The only exception to this requirement is when an immediate change is made to eliminate a risk or hazard to a subject. In such a case the change must be submitted to the IRB as soon as possible for review.

Minor changes to a study not involving greater than minimal risk usually undergo an expedited review by a subcommittee of the IRB. Major changes to a study require full IRB review. A member of the IRB staff can answer your questions about modifications. Refer to modifications section or the web site for further details.

What if adverse events occur among participants in my study?

Definitions

Serious Adverse Event means any adverse experience 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 drug 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 EVENT REPORTING REQUIREMENTS

Other adverse events, e.g. other adverse drug reactions that are reported in the investigator's Annual Report submitted to Sponsors, should be included in the investigator's Request  for Reapproval or Study Closure submitted for the IRB's review.

PRINCIPAL INVESTIGATORS AND SPONSOR-INVESTIGATORS HAVE ADDITIONAL REPORTING REQUIREMENTS TO SPONSORS, THE FDA, OHRP, NIH/OBA, AND OTHER COMMITTEES, AS APPLICABLE, AND SHOULD CONSULT THE APPLICABLE FEDERAL REGULATIONS AND AGENCY GUIDANCE FOR THESE REQUIREMENTS.  INVESTIGATORS SHOULD ALSO BE AWARE OF LOCAL FACILITY REQUIREMENTS FOR REPORTING ADVERSE EVENTS ASSOCIATED WITH PATIENTS SEEN AT THE LOCAL FACILITY.

Forms

The IRB Reportable Events Form should be used for all adverse event reporting to the IRB, with an attached copy of information provided to the Sponsor.  In the adverse event report, the investigator should assess the need for changes to the protocol and/or consent form.

IRB Review Procedures

All adverse event reports will be reviewed according to the IRB procedures discussed in Section IX.A. of the Policies and Procedures.  The Principal Investigator and Institution Official will receive written notice of any action taken by the IRB and the reasons for that action.

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How do I renew or close a study?
Federal regulations require that the IRB review all ongoing studies at least yearly. In some instances the IRB may choose to review a study more frequently.

Please go to Continuing Review for more information.

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What is emergency use?
Emergency use, sometimes called "compassionate use," is the use of an investigational drug or device for a single subject in a life-threatening situation. No standard acceptable treatment is available in such an instance, and there is not sufficient time to obtain full IRB approval.

Further use of the same drug for the same indication requires prospective review by the full IRB. Please refer to Emergency Use of an Investigational New Drug for more information.

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My project uses only medical records to collect data. Will I need IRB approval?
Yes, use of medical records or clinical databases for research purposes requires IRB review. Generally, if you will be gathering information from sources that already exist (retrospective review) and need to collect identifiers like patient name and medical record number so the data can be linked to individuals, your project qualifies for expedited review. Please go to Expedited Review for more information.

What if my research involves other sites besides NYU, many with their own IRB?
If any part of the project includes NYU patients, families, staff (as research subjects) or facilities the NYU IRB reviews it. Dual IRB review may be required for other institutions. However, NYU IRB has several cooperative agreements with local IRBs that reduce the need for dual review.

What is a cooperative agreement?
A cooperative agreement is an agreement reached between NYU and another research institution to delineate the responsibilities of each institution with regard to IRB activities. NYU has not entered into cooperative agreements with any other institutions.

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What is an MPA?
A multiple project assurance (MPA) is an agreement between NYU and the Office for Human Research Protections (OHRP), acting on behalf of the Secretary of the U.S. Department of Health and Human Services. The agreement provides written assurance that the hospital will comply with federal laws and regulations as well as state and local laws regarding the protection of human subjects in research. To see NYU's MPA, go to Multiple Project Assurance.

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What is the link between the grant proposal and the IRB application for funded projects?
The funding agency often expects the IRB to review and approve the use of human subjects as described in the grant proposal. Before funding can take place, the agency requires certification of approval from the IRB. Except for proposals that are being submitted to the NIH, an IRB application must be pending approval in the IRB office before the grant proposal can be released to the funding agency. Most funding agencies, including federal agencies, allow 60 days for the IRB to notify the agency of final approval.

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What is different about proposals going to the NIH?
Beginning with proposals submitted in June 2000, the National Institutes of Health (NIH) have revised the policy that requires IRB approval within 60 days of grant submission. IRB approval is no longer required before NIH peer review. Following peer review, those proposals that are likely to be funded based on the scores they receive need to proceed with IRB review and approval. No NIH grant award will be made without approval from the IRB.

If you submit a funding proposal to the NIH for research that will be based at NYU and involves human subjects, you will receive a letter from the Office of Research Administration. It will notify you that, if the score received during peer review indicates it will likely be funded, you will need to proceed with the IRB approval process. The IRB application will be due in the Office of Research Administration no less than 60 days before the NIH requires IRB certification.

There may be circumstances when the NIH requires, or you think it is desirable, to submit an IRB application before NIH peer review takes place. For example:

• The research involves multiple sites.
  
• The research is controversial.
  
• You anticipate the IRB process will be extensive or lengthy.
  
• IRB certification is required by the NIH before peer review because of timing or funding considerations.
  

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Do I need to work with the grants and contracts staff too?
All local research institutions have a grants and contracts office that requires institutional review and sign-off of funding proposals, only one part of which is IRB approval. To ensure approval, it is important that the appropriate grants and contracts staff be involved from the outset. For further information, please contact The Office of Research Grants Administration and Research Services at http://www.med.nyu.edu/ogars/

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What is minimal risk?
The federal regulations define minimal risk as follows: The probability and magnitude of harm or discomfort anticipated by participating in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Procedures that may involve a small degree of risk for a healthy child may involve a higher risk to a child with an illness or a condition. For example, obtaining blood samples from a hemophiliac child may involve higher risk than venipuncture involving a child without such a condition. On the other hand, children who suffer from chronic illness may not be as traumatized by invasive procedures as comparatively healthy children who have not had as much exposure to medical care.

The definition of minimal risk is an important criterion used in approving research with children. Please see Regulations for Research with Children for more information.

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What is informed consent and when is it needed?
In almost all cases, consent must be obtained from the research participants or their legally authorized representatives (parents or guardians) before participation in research begins.

The informed consent process is a basic ethical obligation for researchers. It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to questions the subject may have and ensuring that the subject or the legal representative (parent or guardian) understands the information. In addition, the process includes obtaining the subject’s voluntary agreement to participate in the research, indicated by the subject’s signature on the written consent document. After the subject’s signature is obtained the informational process should continue as the situation or the subject may require, both during and after the study.

The IRB may approve a waiver of consent in limited circumstances. Consent may be waived if the IRB determines:

• That no more than minimal risk to research participants would be involved.
  
• That the rights or welfare of participants would not be adversely affected.
  
• That the research could not be practicably conducted without a waiver.
  
• Additionaly, regulations require that if appropriate there be a plan to provide research results to subjects after conclusion of the study.

For further information about informed consent, go to Consent Form Preparation.

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What is Assent and when is it needed?
Because children have not yet attained legal age, the parent or legal guardian is asked to give permission for participation whenever a child is asked to take part in research. Federal regulations require, however, that children be asked to provide assent, or agreement to participate in the research, whenever they are capable of doing so. Age, maturity and psychological state need to be taken into account when determining whether to ask for assent.

Out of respect for developing persons, it is important to involve children in the decision-making process whenever possible. Though they may not be able to give legal consent, they have the ability to assent or to dissent. It is important to keep in mind that a child’s failure to object to participation should not automatically be construed as assent. Assent implies the affirmative agreement of the child.

Usually children who are age seven and older are asked to sign an assent form, which is written in language appropriate to the ages and conditions of study participants. The assent form should include a description of the study and describe the inconveniences and discomforts subjects may experience.

Generally, children age 14 and older are asked to read and sign the informed consent form if it is written at a reading level that is appropriate to the child. For further information go to Assent Form Preparation.

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What if my study qualifies for exemption? Do I still need IRB approval?

Although the IRB currently reviews all research involving human subjects, the regulations provide that certain human research activities, detailed below, may be eligible for a determination of “exempt” status by the IRB.

A Principal Investigator may request exemption from review by submitting an Application for Exemption from Review. A Principal Investigator must obtain such a determination from the IRB prior to initiating the study. See the discussion on Exemption from IRB Review in the Policies and Procedures for more information on the IRB’s procedure for conducting such review.

An exemption from IRB review does not equate to an exemption from the HIPAA requirement for authorization or waiver of authorization when the research involves a covered entity’s protected health information. Researchers who receive an exemption determination but whose research involves protected health information must still submit a HIPAA authorization form (or a request for waiver of HIPAA authorization), or, if applicable, HIPAA forms for conducting research involving decedents’ information or research using a limited data set. Researchers who wish to review protected health information (e.g., medical records) to prepare a research protocol must submit the appropriate HIPAA form for IRB approval.

Research may be exempt from review when the only involvement of human subjects in the research falls into one of the following categories:

• Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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. However, when a study involves children being interviewed, questioned or surveyed, that study must be reviewed by the IRB and may not be exempt. Similarly, studies involving children and observation of public behavior in which the Principal Investigator (or other investigator) participates in the activities being observed must be reviewed by the IRB.
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures (e.g. anonymous questionnaire), interview procedures, or observation of public behavior that is not otherwise exempt if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
• 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: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
• Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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.

Anonymous data are data that have been stripped of ready identifiers, including linking codes. Data may be anonymized to render a protocol eligible for IRB exemption if the investigator or data source strips the data of ready identifiers. The investigator or data source who anonymizes the data must be someone who has prior authorization to access the data (e.g., a hospital or treating physician). Importantly, however, anonymized data are not automatically considered de-identified data under the Privacy Rule.

Under the Privacy Rule, a covered entity may share data without restriction only if the data have been “de-identified.” De-identified data may contain linking codes if such codes are not derived from any identifier (e.g., SSN or Medical Record number) and are not used for any other purpose, provided that the covered entity does not disclose the code key to the researcher or anyone else. Although de-identified data may contain linking codes that meet the above criteria, a de-identified data set may not contain any of the 18 identifiers listed in the Privacy Rule. Researchers may not de-identify protected health information used in research for the purpose of using or disclosing the de-identified data to parties not identified in the authorization form, waiver application, or data use agreement, without the written approval of the NYU IRB.

The Privacy Rule permits a covered entity to disclose a limited data set to a researcher without authorization or waiver if the researcher has signed a data use agreement containing certain required elements. Limited data sets are not de-identified data, but permit the researcher to receive certain identifiers that must be otherwise be removed to render data de-identified (the identifiers permitted in a limited data set are listed in the Privacy Rule). Researchers who are seeking a limited data set from a covered entity should submit a signed copy of the covered entity’s data use agreement form to the NYU IRB along with the research protocol.