Submitting to an Institutional Review Board

Human Research Regulatory Affairs Submitting to an Institutional Review Board
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Human Research Regulatory Affairs Submitting to an Institutional Review Board

There are several steps researchers need to take before submitting a new study request to an institutional review board (IRB), whether the IRB is within NYU School of Medicine or is one of the external IRBs we have contracted with.

Does Your Study Involve Human Subjects?

Before you begin a study, you should first determine whether your project meets the definition of human subjects research. The U.S. Department of Health and Human Services (HHS) Office for Human Research Protections provides graphic aids and guides that can help you determine whether a project involving human subjects must be reviewed by an IRB according to HHS regulations.

Federal regulations stipulate that an IRB does not need to review research if it does not involve human subjects. If your study does not qualify as human subjects research, your sponsor or a publication may require certification confirming this. In this instance, you complete our self-certification form or the quality improvement self-certification form.

The self-certification form may then be used as documentation that your study is not human subjects research and does not require IRB review according to both federal regulations and our policy. If you submit non–human subjects research to the IRB for review, you are asked to withdraw your submission and complete the self-certification form.

Which Type of Initial Review Does Your Study Require?

If your research does involve human subjects, the IRB can determine whether your research is exempt from IRB review or, if it is not exempt, requires full board or expedited review.

Full Board Review

Human subjects research that is not classified as exempt or expedited requires full IRB review at a convened meeting. Investigators should allow a minimum of three weeks for an application to be scheduled for review at a convened meeting.

A full board meeting may be canceled by the chair for the following reasons:

  • an insufficient number of applications requiring full board review
  • an NYU Langone holiday
  • an inability to secure a quorum
  • a scheduled meeting is deemed unnecessary or otherwise inappropriate

NYU School of Medicine’s IRB uses a primary reviewer system for full board reviews. At least one week before the meeting, IRB members scheduled to attend receive the application materials, including the application itself, the informed consent documents, and other materials such as advertisements and recruitment letters. Members designated by the chair as primary reviewers also receive the complete grant application, protocol, and (for investigational drug or device studies) the investigator’s brochure.

Primary reviewers lead the discussion of each project at a full board meeting. The board determines whether the project meets the criteria for approval or whether revisions to the study design are required. Informed consent documents are reviewed for accuracy, clarity, and the inclusion of required and optional elements of consent. At the discretion of the chair, voting may be by written ballot or a show of hands.

Majority rule determines the status of projects, which are placed by those present at the meeting into one of the following categories:

  • approved as submitted
  • conditionally approved, pending receipt of required minor revisions to study procedures, informed consent documents, or other written materials
  • deferred, pending review at a subsequent full board meeting after receipt of significant additional information or revisions
  • not approved

Written minutes of each full board meeting are provided and include the following information as it applies to each researcher’s own project:

  • attendance
  • the number of votes (without individual identification) to approve, table, disapprove, or abstain
  • the basis for requiring changes in or disapproving the research
  • the length of time until the next review
  • a summary of the discussion of controverted issues and their resolution

Expedited Review

Research activities that present no more than minimal risk to human subjects and involve only procedures listed in one or more of the categories shown below may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110 in the HHS regulations. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for expedited review when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

The categories on this list apply regardless of the age of subjects, except as noted. Expedited review may not be used when identification of the subjects or their responses, or both, would reasonably place them at risk for criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, or reputation or when it would be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

The expedited review procedure may not be used for classified research—that is, research requiring a security classification from the federal government—that involves human subjects. Investigators are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review used by the IRB—expedited or full board.

Research involving the following categories may be eligible for expedited review.

  • clinical studies of drugs and medical devices if one of the following conditions is met:
    • research on drugs for which an investigational new drug application (21 CFR Part 312) is not required (this does not include research on marketed drugs that significantly increase the risks or decrease the acceptability of the risks associated with their use)
    • research on medical devices for which either an investigational device exemption application (21 CFR Part 812) is not required or the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling
  • collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from either of the following:
    • healthy, nonpregnant adults who weigh at least 110 lb. from whom the amounts drawn do not exceed 550 mL in an 8-week period and are collected not more frequently than twice per week
    • other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected, from whom the amount drawn does not exceed the lesser of 50 mL or 3 mL per kg in an 8-week period and is collected not more frequently than twice per week
  • prospective collection of biological specimens for research purposes by noninvasive means, including the following examples:
    • hair and nail clippings taken in a nondisfiguring manner
    • deciduous teeth taken at time of exfoliation or if routine patient care indicates a need for extraction
    • permanent teeth taken if routine patient care indicates a need for extraction
    • excreta and external secretions (including sweat)
    • uncannulated saliva collected in either an unstimulated or stimulated way by chewing gum base or wax or by applying a dilute citric solution to the tongue
    • placenta removed at delivery
    • amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
    • supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
    • mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
    • sputum collected after saline mist nebulization
  • collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. (Medical devices employed must be cleared/approved for marketing; studies intended to evaluate the safety and effectiveness of medical devices, including studies of cleared devices used for new indications, are generally not eligible for expedited review.) Studies involving the following may be eligible:
    • physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy
    • weighing or testing sensory acuity
    • MRI
    • electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography
    • moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual
  • research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes such as medical treatment or diagnosis. (Note: some research in this category may be exempt from the HHS regulations for the protection of human subjects, according to 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
  • collection of data from voice, video, digital, or image recordings made for research purposes
  • research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: some research in this category may be exempt from the HHS regulations for the protection of human subjects, according to 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
  • continuing review of research previously approved by the convened IRB according to any of the following:
    • where the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, and the research remains active only for long-term follow-up of subjects
    • where no subjects have been enrolled and no additional risks have been identified
    • where the remaining research activities are limited to data analysis
  • continuing review of research not conducted under an investigational new drug application or investigational device exemption where categories two through eight do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified

In addition, expedited review is appropriate for minor changes in protocols and consent forms proposed for previously approved research during the period (one year or less) for which approval is authorized. Changes affecting risk, benefit, discomfort, or subject protections are not “minor” changes. Minor modifications include, for example, administrative changes to the protocol, adding follow-up calls when gathering initial data by telephone, or certain changes in the scheduling of medications.

The Health Insurance Portability and Accountability Act (HIPAA), known as the privacy rule, allows an IRB to use expedited review procedures to grant a waiver or alteration of authorization when the research involves no more than minimal risk to the privacy of research subjects. Minimal risk is determined by reference to criteria enumerated in the privacy rule. The expedited procedures that an IRB may use to grant a waiver or alteration of authorization are the same as those permitted when an IRB grants a waiver of consent (such as review and approval by the chair of the IRB or the chair’s designee); however, the IRB’s findings justifying a waiver of authorization must be documented separately from its findings justifying a waiver of informed consent, where applicable.

Investigators who believe that their study is eligible for expedited review should indicate the specific category of eligibility on the application for new protocol review form. The IRB chair or designee determines whether expedited procedures are used. If they are to be used, the reviewer conducts a review according to the procedures and criteria set forth in the IRB’s policies and procedures manual.

Exempt Status Determination

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.

As a principal investigator, you may request exemption from review by submitting an application before 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. Note that 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. Covered entities are defined in the HIPAA rules as health plans; health care clearinghouses; and health care providers who electronically transmit any health information in connection with transactions for which HHS has adopted standards.

Researchers who receive an exemption determination but whose research involves protected health information must still seek a waiver of authorization from the IRB or submit one of the following to the IRB for approval: a researcher representation form (for reviews preparatory to research or research involving decedents’ information) or a data use agreement form (where a limited data set will be used).

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

  • research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or 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 information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk for criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation (Note: 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 (such as an anonymous questionnaire), interview procedures, or observation of public behavior that is not otherwise exempt if the human subjects are elected or appointed public officials or candidates for public office or if 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 that are conducted by or subject to the approval of department or agency heads and that are designed to study, evaluate, or otherwise examine public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs
  • taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or an agricultural chemical or environmental contaminant at or below the level found to be safe, by the U.S. 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

Data anonymization makes a protocol eligible for exemption from IRB review. For a protocol to qualify as “anonymized,” the data may not contain any ready identifiers or any linking code or field. Anonymized data are not automatically considered deidentified data under the privacy rule.

Under the privacy rule, a covered entity may share data without restriction only if the data have been deidentified. Deidentified data may contain linking codes not derived from any identifier (such as a social security number or medical record number) and not used for any other purpose, provided that the covered entity does not disclose the code key to the researcher or anyone else. Although deidentified data may contain linking codes that meet the above criteria, a deidentified data set may not contain any of the 18 identifiers listed in the privacy rule. Researchers may not create deidentified data for the purpose of using or disclosing such data to parties not identified in the authorization form, waiver application, or data use agreement, without the approval of the privacy officer.

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 deidentified data but permit the researcher to receive certain identifiers that must otherwise be removed to render data deidentified (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 completed data use agreement form to the privacy officer for approval.