GENERAL INFORMATION

Introduction to the Institutional Review Board

The Institutional Review Board (IRB) is a committee whose purpose is to ensure that the rights and welfare of human subjects are protected in all medical, behavioral and social sciences research. In accordance with federal and state regulations governing research, an IRB must review and approve research involving human subjects prior to its initiation. It is the responsibility of the IRB to determine whether proposed research exposes subjects to unreasonable or unnecessary risk, to review informed consent forms and process, and to monitor the progress of research. In its deliberations, the IRB will use the ethical principles as detailed in the Belmont Report (1979).

The institution has a Federal Wide Assurance which assures the Department of Health and Human Services (DHHS) that it will follow procedures to assure the protection of all human subjects involved in research projects. The Assurance is a formal agreement between the Office for Human Research Protections and an authorized Institutional Official for NS-LIJHS. This Assurance applies to all research involving human subjects regardless of source of funding or support conducted at NS-LIJHS, as well as to research conducted elsewhere by physicians, students, staff, or other representatives of the NS-LIJHS in connection with their institutional responsibilities. There is a cooperative amendment in place which allows the NSUH and LIJ IRBs to be reciprocal in their review of research. A copy of the Assurance is available in the Appendix B.

Before a research project involving human subjects is initiated, it must first be reviewed and approved by one of the IRBs, and then conducted according to the procedures and guidelines set forth in this document, which are consistent with Federal and State regulations governing research. This includes all research involving human subjects,including but not limited to drug studies, diagnostic studies (invasive or non-invasive), in vitro studies utilizing clinical specimens, collection of discard tissue, retrospective or prospective chart review, certain quality assurance activities, surveys,and behavioral studies regardless of whether or not the research is funded by an outside agency. Research involving the use of existing data must be approved prior to the initiation of the protocol used to analyze the data. This is considered a retrospective study, and while there are no clinical procedures involved, the use of data previously collected from human subjects is considered research and must be approved by the IRB prior to the data analysis.

The IRB Chair or designee has the authority to act on behalf of the IRB when immediate action is required prior to a convened IRB meeting to protect the rights and welfare of human subjects. The IRB Chair or designee, in conjunction with Institutional Official (if necessary) has the authority to evaluate and provide a resolution for emergent issues related to human subject protections that are not covered by these policies. Any such action will be brought to the attention of the convened IRB at the next meeting. The IRB also has the authority to promulgate or amend policies and procedures as necessary for the proper protection of human subjects in research.

Investigators bear the primary responsibility for ensuring that research protocols meet the standards established by both Federal and State regulation and the Institutional Review Board. Compliance with these regulations helps to ensure the protection of human subjects and the integrity of the North Shore-Long Island Jewish Health System as a research institution.

Policies, guidance, procedures and information related to the conduct of research are presented in this document as a resource and guide to educate NS-LIJHS investigators on the issues governing human subjects research, as well as to assist them in the process for submitting their research protocols to the IRB. The Office of the IRB may be contacted at 516-562-3101.

Federal Regulations referred to throughout these policies and procedures are as follows:

45 CFR46 (i.e. Title 45 Code of Federal Regulations Part 46:Protection of Human Subjects), hereafter referred to as the Common Rule, which applies to research involving human subjects conducted by the Department of Health and Human Services (DHHS) or supported in whole or in part by DHHS (available at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm).

21 CFR50 (Protection of Human Subjects) and 21 CFR 56 (Institutional Review Boards), which apply to all research involving products regulated by the Food and Drug Administration (FDA), including research and marketing permits for drugs, biological products, or mechanical devices for human use, food and color additives, or electronic products. Federal funds do not need to be involved. Available at http://www.fda.gov/oc/gcp/regulations.htmland Protection of Human Subjects - New York State Consolidated Laws, Public Health, ARTICLE 24-A .http://public.leginfo.state.ny.us/menugetf.cgi?COMMONQUERY=LAWS

45 CFR 160 and 164 (Health Insurance Portability and Accountability Act), which governs the use and disclosure of private health information. Available at http://privacyruleandresearch.nih.gov/.

What Type of Activity is Considered Research?

Any activity which includes a systematic design, using a scientific approach or protocol for the purpose of drawing conclusions, and which could add to generalizable knowledge in a particular area, constitutes research.

Generally, whenever data is to be collected for evaluation, there is research activity involved. Whenever human subjects are involved, either directly or indirectly (e.g. chart reviews, use of pathological specimens, etc.), the research must be reviewed by the IRB. This is true even if there is no deviation from the standard of care that would otherwise be applied. The individuals about whom information is aggregated for analysis are considered human subjects, even if they receive no experimental treatment. Whenever results are to be published, or a paper or poster is to be presented at a professional meeting, the activity constitutes research involving human subjects. Certain Quality Management/Performance (QA/PI) Improvement projects may meet this criteria.

For further guidance, see: Does the activity qualify as research and does it need to be submitted to the IRB?

When in doubt, contact the Office of the IRB (516-562-3101) to help determine whether a particular project constitutes "research involving human subjects" or requires submission to the IRB.

What is a human subject?

According to federal regulations, (45CFR46.102):

Human subject means a living* individual about whom an investigator (whether professional or student) conducting research obtains:

• Data through intervention or interaction with the individual, or
• Identifiable private information.

According to FDA regulations, (21CFR50.3):

Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

  *Note: New York State law does not distinguish between living and deceased individuals in its definition of human subject.


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When must a submission be made to the IRB?

Before a research project involving human subjects is initiated, it must first be reviewed and approved by one of the NSLIJHS IRBs, and then conducted according to the procedures and guidelines set forth in this document, which are consistent with Federal and State regulations governing research.

IRB approval is required regardless of whether the study in question is to be supported by funds from outside granting agencies or private sources, or by Institutional funds, or considered to be minimal risk; approval is likewise required when no specific funding is involved. For studies which have been submitted for potential funding, regardless of the funding source, the IRB must receive and review the full grant application as submitted. No subject may be enrolled into a research study prior to IRB written approval. This includes all research involving human subjects (see What Type of Activity is Considered Research?), including but not limited to drug studies, in vitro studies utilizing clinical specimens, collection of discard tissue (including anonymous specimens), chart review, certain quality assurance investigations, and behavioral studies.

For further guidance, see:  Does the activity qualify as research and does it need to be submitted to the IRB?

For collaborative research projects undertaken by faculty and staff of the Health System, submission to a NSLIJHS IRB is required regardless of whether or not the protocol has been reviewed by another IRB.

For industry sponsored studies sited by Biomedical Research Alliance of New York (BRANY) for any NS-LIJHS researcher, approval by the BRANY IRB may be sufficient. The BRANY IRB shall notify the Office of the IRB of any such approvals.

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The IRB may request documentation of IRB approval or determination of exempt status from collaborating sites.

The Distinction Between Research and Clinical Care

The Belmont Report defines the Ethical Principles and Guidelines for the Protection of Human Subjects of Research and is commonly accepted as the standard by which all research involving human subjects should be conducted.  All NSLIJHS IRBs have assured the Office for Human Research Protections that they will comply with the ethical principles put forth in the Belmont Report.  One of the areas specifically addressed in the Belmont Report is the boundary between clinical care and research, and the following excerpt provides a distinction between the two:
 

“It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research.  The distinction between research and practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called “experimental” when the terms “experimental” and “research” are not carefully defined.

For the most part, the term “practice” refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.  The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals.  By contrast, the term “research” designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).  Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research.  The fact that a procedure is “experimental”, in the sense of new, untested or different, does not automatically place it in the category of research.  Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective.  Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation be incorporated into a formal research project.

Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy.  This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects”.   (The Belmont Report, Office of the Secretary; “Ethical Principles and Guidelines for the Protection of Human Subjects of Research”.  The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979)

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Policy 1: IRB Review and Approval: Categories of Review

POLICY:
The IRB shall review, require modification, and approve or disapprove all human subjects research. The IRB will comply with federal regulations at 45 CFR 46.111 (DHHS) and 21 CFR 56.111 (FDA), institutional policies, state regulations, and the terms of the Federal-Wide Assurance (FWA) between NSLIJHS and DHHS in order to determine whether protections for human research subjects are adequate.

The IRB will utilize three categories of review to approve research:
 

• Exempt - Research reviewed by IRB Chair/designee but NOT subject to continuing review
• Expedited Research reviewed by IRB Chair/designee, subject to continuing review
• Full Board Research reviewed by full IRB committee, subject to continuing review

Exempt status will be determined by the staff of the IRB in conjunction with the IRB chair/designee, according to criteria outlined in 45 CFR 46.101 (b).

Expedited review shall be used for research activities that meet the criteria outlined in 45 CFR 46.110 and 21 CFR 56.110. The IRB Chair or designee shall have the same authority as the IRB except they may not disapprove the research. A research activity may be disapproved only after full-board review

Full board review at a convened IRB meeting with a quorum present will be required for all new research protocols that do not qualify for exempt or expedited review.

The IRB Chair or designee will determine the appropriate category of review based on the type of research to be conducted. Continuing review, protocol and consent form modifications, adverse event reports, and other related research activities will be reviewed by expedited or full-board review procedures as appropriate, using criteria at 45 CFR 46.110 and 21 CFR 56.110.

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1.1  Exempt Review

Guidance:

The term “exempt” means the research will be reviewed for approval by the IRB chair or designee and will not be subject to continuing review under federal regulations.
 
Note: Research involving prisoners is not eligible for exempt review.

The following categories of research will generally qualify as exempt:
 
1. 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.

 
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior
 
However, if the following conditions exist, the research described in paragraph 2 CANNOT be considered exempt:

• 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 of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.

Note: The exemption for research involving survey or interview procedures or observation of public behavior does not apply to research involving children, EXCEPT for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

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 paragraph 2 above, if;
 

• a) The human subjects are elected or appointed public officials or candidates for public office
• b) Federal statute(s) require 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 in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects. 

NOTE:  The sources must exist at the time of the proposed research.  Samples from tissue banks must be anonymous to the investigator.

5. Research and demonstration projects that are conducted by or subject to the approval of Department or Agency heads, and which are designated to study, evaluate, or otherwise examine:

• Public benefit or service programs, when the following criteria are met:
  
  • a) The program under study must deliver a public benefit (e.g. financial or medical benefits as provided under the Social Security Act) or service (e.g. social, supportive, or nutrition services as provided under the Older Americans Act);
  • b) The research or demonstration project must be conducted pursuant to a specific federal statutory authority; and
  • c) There must be no statutory requirement that the project be reviewed by an IRB.
• 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.

 
6. Taste and food quality evaluation and consumer acceptance studies if:

• a) Wholesome foods without additives are consumed or
• b) 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 to the U.S. Department of Agriculture.

 
Criteria used to determine if a research project qualifies as exempt from continuing review may be found at 45 CFR 46.101 (b).  Final determination of exempt status will be made by the staff of the IRB in conjunction with the IRB Chair or designee.

PROCEDURE

When an investigator believes his study meets the criteria for research exempt from continuing IRB review, he must submit it as such to the Office of the IRB  (see Policy 2:  How to Prepare a Protocol for IRB Review).

If the application qualifies for exempt review, the Office of the IRB will notify the investigator in writing of its determination.  The letter will cite the specific category under which the research qualifies as exempt, and will be signed by the IRB chair or designee.

If a protocol does not qualify as exempt, the investigator will be advised in writing to submit the protocol to the IRB for either expedited or full board review.

Research to be considered for exempt status is not subject to deadline dates.  Protocols will be reviewed as they are submitted to the IRB.  If it is determined that a protocol does not qualify as exempt and requires expedited or full-board review, the protocol may be resubmitted under the appropriate category.  Deadline dates apply to the submission for full board review only.
 

Note: Protocols classified as exempt are not subject to continuing review.  However, it is the investigator’s responsibility to notify the IRB of any changes or modifications that are made in the research study design, procedures, etc.  Such changes may necessitate a new IRB submission.  Protocols approved as exempt will be assigned an IRB protocol number that must be referenced on all correspondence with the Office of the IRB.

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1.2  Expedited Review

GUIDANCE

The IRB will use the expedited review procedure to review research activities that:

• Present no more than minimal risk to subjects; and
• Involve only procedures listed in one or more of the categories allowed by DHHS, available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.110.

 
Note: These categories have been provided by DHHS as areas of research that may qualify for expedited review.  Although a specific research procedure may fall within these categories and be eligible for expedited review, the research may be determined to be greater than minimal risk after consideration by the expedited review procedure and may be referred to full IRB review.  The standard requirements for informed consent (or its waiver, alteration, or exception) apply to expedited review.

Research submitted for expedited review is not subject to meeting cycle deadline dates.  Protocols are reviewed as they are submitted.  The term “expedited” refers to the type of review mechanism that is employed and does not necessarily mean “quicker”.  If it is determined that a protocol does not meet the criteria for expedited review and required full-board review, deadline dates would apply to the resubmission.

PROCEDURE

Refer to Policy 2:  How to Prepare a Protocol for IRB Review for directions on how to submit a protocol for expedited review.  If a research protocol meets the criteria below and is eligible for expedited review, the IRB chair or designee(s) with the appropriate expertise to review the protocol will carry out the review.  The full protocol, including the consent form and all pertinent source material, will be considered.  The IRB chair or designee(s) will have the same authority as the IRB in reviewing the protocol, with the exception that the protocol cannot be disapproved via this procedure.  A decision for disapproval must be rendered by the full committee using the procedure for full IRB review.  When a protocol is approved through expedited review, the specific permissible category under which it qualifies will be cited in the approval letter and the IRB meeting minutes.

After a new research protocol has been considered for expedited review, the Office of the IRB will send written notification to the PI with one of the following decisions:

• APPROVED:  Protocol approved as submitted with no modifications required.  The approval letter will include the date that the study approval expires as determined by the IRB and any other conditions that apply.
• CONTINGENT APPROVAL:  Protocol requires minor revisions that do not affect the safety of the research subject.  The IRB Chair/designee may approve the study upon receipt of the satisfactory revisions.  If no revisions are received by the IRB within 120 days, the protocol will be withdrawn from consideration.
• TABLED:  Protocol does not qualify for expedited review or substantive issues regarding the protocol and/or consent form must be addressed.

NOTE: A protocol is not approved until all required modifications are received and approved by the IRB.  There may be no activity on the project until these modifications have been approved by the IRB, and the approval letter has been received by the PI indicating approval and permission to begin the study.  The term of the approval will be indicated, as well as the date that the study approval expires.  Any special conditions that have been applied to the research will also be indicated in the approval letter.  Each protocol will receive an IRB Protocol Number; this number must be included on all future correspondence.

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1.3  Full Board Review

  GUIDANCE

Full Board review refers to review at a convened IRB committee meeting where a quorum is present (a quorum is the presence of greater than half of the voting membership including at least one member whose primary concerns are in non-scientific areas).  Approval of research is by a majority vote of the quorum.  Should the quorum fail during a meeting (e.g., loss of a majority through recusal of members with conflicting interests, early departures, or absence of a non-scientific member), the IRB may not take further actions or votes unless a quorum is restored.

PROCEDURE

A primary reviewer system is used for new applications.  The full protocol, including the consent form, all pertinent source material, and all required IRB forms, is assigned to a primary reviewer and secondary reviewer(s) for their consideration.  The reviewers will be selected according to the specific expertise needed to review the protocol properly.  In addition to scientific expertise, consideration will be given to special issues and populations when reviewers are assigned whenever possible (e.g. gender-specific studies will be assigned to at least one reviewer of the gender under study, research involving a special population will be assigned to someone familiar with that population).  The entire committee will receive a copy of the protocol summary, IRB submission forms (as appropriate); consent form, and advertising materials.

The primary reviewer is responsible for presenting the protocol at the IRB meeting and for detailing any issues and concerns, including those of secondary reviewers.  Following committee discussion, the primary reviewer will make a recommendation to the Committee for a vote of:

• APPROVAL: Approved as submitted with no modifications required. The approval letter will include the date of approval expiration and any other conditions that apply.
• CONTINGENT APPROVAL:  Protocol requires minor revisions that do not affect the safety of the research subject. The IRB Chair/designee may approve the study upon receipt of the satisfactory revisions without further review by the convened IRB.  If no revisions are received by the IRB within 120 days, the protocol will be withdrawn from consideration.
• TABLED:  Substantive issues regarding the protocol and/or consent form must be addressed. The investigator’s response to initial review requests must be reviewed by the IRB at a convened meeting.  If the PI does not respond within 120 days, the protocol will be withdrawn from consideration.
• DISAPPROVAL:  Questions are of such significance that the IRB feels approval of the study to be unwarranted. Review of a previously disapproved protocol that has been revised and resubmitted requires full-board review.

After a protocol is approved, the committee will determine the appropriate interval for continuing review. See Policy 6: Continuing Review of Ongoing IRB-Approved Research.
A letter will be sent to the principal investigator from the Chair or designee detailing the decision of the IRB, along with any additional comments that are appropriate.  The term of the approval will be indicated, as well as the date that the study approval expires.
 

Note: A protocol is not approved until all required modifications are received and approved by the IRB.  There may be no activity on the project until these modifications have been approved by the IRB, and the approval letter has been received by the PI indicating approval and permission to begin the study.  The term of the approval will be indicated, as well as the date that the study approval expires.  Any special conditions that have been applied to the research will also be indicated in the approval letter.  Each protocol will receive an IRB Protocol Number; this number must be included on all future correspondence.

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1.4 The Appeal Process

GUIDANCE/PROCEDURE

A PI may appeal a decision made by the IRB within 120 days of the date of the decision letter from the IRB.  The appeal must be made in writing and sent to the IRB Chair or Office of the IRB along with any supporting materials.  The Chair and Office of the IRB will review the appeal and decide whether additional information is necessary to present at the IRB meeting.  The appeal will be brought to the next convened meeting of the IRB.  The Chair may invite the PI to attend the meeting to give a presentation of the protocol and to address problematic issues.  Written notification of the IRB’s decision of the appeal will be sent to the PI following the meeting.

A decision for disapproval after appeal is final.  If significant modifications are made to a previously disapproved protocol it may be submitted as a new protocol.  The IRB Chair has the authority to determine whether a previously disapproved protocol has been amended sufficiently to warrant review as a new protocol.

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Policy 2: How to Prepare a Protocol for IRB Review

POLICY:

In order for a protocol to be placed on the IRB meeting agenda, it shall be submitted on or before the deadline date and conform to all of the requirements. If the submission is incomplete (does not conform to all requirements, including signatures, etc.), the IRB office shall notify the principal investigator (PI) of the deficiencies and/or return the submission to the PI.

The principal investigator must be on staff within the North Shore-Long Island Jewish Health System (NSLIJHS). Studies originating from another institution that will include a NSLIJHS site investigator must be reviewed by the NSLIJHS IRB and have a designated principal investigator from NSLIJHS. All documents associated with the study should consistently list the designated on-site PI first. Students doing research must have a mentor from the Health System to oversee the conduct of the research listed on the protocol application as a co-investigator. This includes all residents and students (medical, nursing, administrative, etc.). If the student is not on staff at NSLIJHS, the mentor must be listed as the PI. The IRB does not recognize the designation of co-principal investigators. There must be one PI who has overall responsibility for the study; all others are co-investigators or sub-investigators.

In addition to the designation of a PI, all research protocols submitted for IRB review must list all co-investigators who will be involved in the research; only those individuals so listed may recruit subjects and participate in the study. An investigator may not participate in research until he/she has complied with institutionally mandated researcher registration and researcher education. Based on current regulatory requirements, the IRB may mandate additional education prior to an individual's involvement in research. Protocols involving more than one area of expertise must include co-investigators from the appropriate disciplines to ensure proper execution and oversight of the protocol. If the protocol involves a special area of investigation, including radioisotopes, animals, biohazards, rDNA, investigational drugs, or the utilization of the General Clinical Research Center (GCRC), it is the responsibility of the PI to contact and receive approval from the appropriate committees or individuals with oversight responsibility in these areas (see Consultations and/or Approvals for Research Projects).

If the research will be conducted in the General Clinical Research Center (GCRC), approval by the GCRC Advisory Committee (GAC) is required prior to IRB submission.

GUIDANCE:

The forms to be submitted are specific to the review category for which the research activity qualifies. The IRB may request additional forms as necessary. Investigators may email submission packets to irb@nshs.edu for processing before any or all required signatures are obtained.

The forms required as part of the IRB packet are discussed below. If the research has been submitted as a grant proposal for potential funding, a copy of the complete grant application must be submitted.

A description of the IRB forms is available below. All forms must be accompanied by:

• a research protocol
• data collection forms (if appropriate)
• a consent form (if applicable- see Policy 5: Informed Consent)
• any other written information to be provided to subjects
• an investigator's brochure (if available)
• advertising or recruitment materials
• survey and/or other research instruments
• a copy of FDA Form 1572 (if appropriate)

2.1 IRB Submission Forms

GUIDANCE:

The following is a description of the IRB forms that are needed for submitting an application to the IRB. The forms that are required will vary depending on the category of research (as explained above).

In addition to the following descriptions, a QA checklist provides a list of items necessary for the IRB submission, including the forms and other attachments. This checklist must be included with full-board and expedited submissions.

IRB Form 1 - Proposal Flow Sheet

This form will act as the cover sheet for the IRB submission. It includes the names and contact information of the principal investigator and the study coordinator along with their department(s) and affiliation. The principal investigator is responsible for the accuracy of the information contained within the materials as submitted and, upon approval, assures compliance with the requirements set forth in Policy 11: Research Investigators. The title of the protocol as listed on this form should be consistent with the title as listed on all other documentation pertaining to the protocol. Additional required approvals (see Consultations and/or Approvals for Research Projects) must be indicated on this form. IRB approval will not be granted until all required approvals have been documented. Studies involving the use of the General Clinical Research Center (GCRC) must be approved by the GCRC Advisory Committee(GAC) prior to submission to the IRB. All other approvals may be pursued prior to or simultaneous with IRB submission.

The department chair (not division chief), or assigned designee, for each clinical department represented must sign this form on the line labeled for department chair(s) approval (e.g. if investigators are from Pediatrics and Medicine, then both chairs need to sign the form).

The signature of the department chair certifies that the:

• research is consistent with the goals of their department,
• department endorses the activity as scientifically meritorious
• investigator(s) has/have the appropriate credentials to conduct the study properly.

In certain circumstances, the signature of the appropriate administrator/director who is overseeing the research may be substituted if the investigator(s) are from an ancillary service department. For members of the Feinstein Institute for Medical Research, the signature of the head of the center of excellence may be required in addition to or in lieu of a department chair.

IRB Form 1A - Study Personnel- Documentation of Required Education

This form provides a list of study personnel; their role on the project, department, division, affiliation; and individual certification dates (or completion dates) for mandatory education in human subject protections. Only those who have completed all mandated education will be given IRB approval to participate in the research study.

IRB Form 2 - Protocol Summary

This form is distributed to the IRB membership and provides a protocol summary to assist in the review process. This form must include a description of the protocol (similar to an abstract). Since the IRB consists of people from various medical and non-medical backgrounds, the language used should be at a level that all members can understand. This form is not to be given to subjects.

IRB Form 2A - Chart Review Research Plan

This form can be used in lieu of a protocol for a retrospective chart review considered for exempted or expedited review. It should include:

• a description of the scientific question,
• the rationale for conducting the study,
• the approximate number of charts/records that will be reviewed,
• research methods,
• statistical analysis,
• a detailed description of how privacy and confidentiality will be maintained consistent with HIPAA and federal requirements.

A bibliography must be included. The data collection form that will be used to record the data from the chart/record must be attached.

IRB Form 3 - Conflict of Interest Questionnaire

This form is used to identify potential conflicts of interest or any appearance of a conflict of interest that may exist for study personnel. (See Conflict of Interest Policy). This form must be completed individually by all study personnel listed on IRB Form 1a. In some instances, the IRB may request a Conflict of Interest Questionnaire from collaborating investigators at other institutions. If a potential conflict is disclosed, the form will be forwarded to the Conflict of Interest Committee for review and recommendation.

IRB Form 4 - Application for Approval for Research Involving Human Subjects (ARIHS)

This form is used to summarize pertinent issues regarding the use of human subjects in research and must be filled out for all projects (except those qualifying for exempt review), regardless of whether it is determined that consent is required, and regardless of whether the project qualifies for expedited review (i.e. research involving the use of specimens, prospective chart reviews, questionnaires,etc. that retain identifiers). The form must be signed by the PI and provide all the information required under HH regulations at 45 CFR 46.111, as follows:

The first section of this form contains questions that are relevant to all proposals. The sections that follow request additional details in the following areas:

Section A -Behavioral Interventions
Section B - Invasive/Non-Invasive Procedures
Section C -Drugs/Placebos/Biologics/Other Agents
Section D - Medical Devices
Section E - Withdrawal/Withholding of Therapeutic Procedures
Section F - Collection of Biological Specimens
Section G - Minors or Decisionally Impaired Subjects
Section H - Threat/Embarrassment/Deception/Sensitive Information
Section I -Research Qualifying for Expedited Review

All relevant sections must be completed. Any irrelevant sections should be marked NOT APPLICABLE (N/A).

The final section of the form requires the signature of the PI indicating compliance with regulatory requirements.

IRB Form 4a  - Application for Determination of Exempt Status

This form must be used when applying for review of research that may qualify as exempt from IRB continuing review according to Federal Regulation [45 CFR 46.101(b)]. See Exempt Overview. This form includes a description of the categories of research that are eligible for exempt status.

IRB Form 4b  - Request for Waiver of Consent/Elements of Consent

This form is used when requesting a waiver of informed consent or specific elements of informed consent. The first section lists the categories that are eligible for a complete waiver of informed consent. In order to qualify for a waiver, the first or second set of criteria must be met.

The second section lists the categories that are eligible for a waiver of elements of informed consent. This is for studies where consent will be obtained, but a request is being made to waive certain elements of such.

IRB Form 4c  - HIPAA Compliance

This form discusses HIPAA and the circumstances under which HIPAA authorization (which is most often combined with the research consent form) may be waived. This may include a complete waiver of HIPAA authorization, or a partial waiver for the recruitment portion of a study only. If a limited data set will be used a Data Use Agreement will be necessary.

IRB Form 5  - Projected Utilization of Pharmacy Resources for Clinical Research Protocol (Only to be completed for studies using medication, placebo or dietary supplement)

This form is used by the Pharmacy to identify facilities or services, in excess of study staff, that will be utilized in conducting the research protocol. This form must be signed by the PI. The Office of the IRB will forward it to the appropriate pharmacy for acknowledgement.

IRB Form 6 - Fee Form

An application and processing fee is charged for each new research, demonstration or education protocol involving human subjects in EXTERNALLY FUNDED studies requiring IRB review. Complete this form if the project falls into this category. All NIH funded research, single-patient use,emergency use and internally funded protocols are fee-exempt. Contact the Office of the IRB if you are not sure whether a study is fee-exempt.

For a complete description of the different categories of review, see Policy 1: IRB Review and Approval:Categories of Review.

PROCEDURE

For guidance on how to submit a protocol to the IRB,click on the following links:

Full Board Review

Expedited Review

Exempt Research

2.2 Guidance and Contacts:
Consultations and/or Approvals for Research Projects

Research projects may require consultations and/or approvals from various services and committees in order to comply with institutional requirements for approval by the IRB. Additionally, projects submitted to outside agencies frequently require approvals from committees that have been established to comply with federal, state or other regulations. The following is a list of institutional services and committees (see IRB Form 1 - Proposal Cover Sheet) with a description of their functions and contact numbers.

:All protocols that will utilize the General Clinical Research Center (GCRC) must be reviewed and approved by the GAC prior to IRB submission. This is a mandatory pre-submission approval. The Director of the IRB will consider exceptions to this policy on a case-by-case basis.

For consultation and information regarding the GAC contact the Administrative Director of the GCRC at (516)562-1045.

Committee for Participant Protection (COPP):  All protocols submitted to the Tissue Acquisition Program (TAP) must first be reviewed by the COPP. For consultation and information regarding the COPP, contact the TDP Project Coordinator at (516) 562-1019.

Cancer Services Research Review Committee (CSRRC): All adult cancer studies must be approved by the Cancer Services Research Review Committee (CSRRC) prior to submission to the IRB. For information regarding the CSRRC, contact the Oncology Research Program Manager at (516) 734-8913.

Emergency Medicine Research Committee (EMRC):  All Emergency Medicine studies must be approved by the Emergency Medicine Research Committee (EMRC) prior to submission to the IRB. For information regarding the EMRC, contact the NSUH Senior Director of Research at 516-562-2926.

Investigational Drugs: All protocols involving drugs under an IND (i.e. drugs not approved for marketing, drugs under investigation for a new indication or dosage, etc.) must be reviewed by the Pharmacy and Therapeutics (P&T) Committee. Protocols are reviewed from the standpoint of subject/patient safety.

For consultation and information regarding procedures for approval of studies involving drugs with an IND contact the Chairman of the P&T Committee, at (516) 562-4680 (NSUH) or (718) 470-7430 (LIJ).

Radioactive Materials: All research involving the use of radioisotopes must be reviewed and approved by either the Radioisotope Utilization, Radioactive Research and Radiation Safety Committee (RURRARS) at NSUH or the Radioisotope Utilization and Radiation Safety Committee at LIJ to assure safe and acceptable use of radioactive materials. Protocols are reviewed from the standpoint of radiological health, as well as safety of patients and working personnel, and any other factors that the committee may wish to consider related to the use of radioactive materials.

For consultation and information regarding procedures for approval for research involving radioactive materials contact the Chief of Nuclear Medicine, at (516) 562-4400 (NSUH) or (718) 470-7081(LIJ).

Recombinant DNA: All protocols involving infectious agents, recombinant DNA used for novel gene therapy, and/or genetically engineered organisms must be reviewed and approved by the Institutional Biosafety Committee (IBC). Protocols are reviewed from the standpoint of biological safety and containment with regard to patients and working personnel as well as any other factors that the committee may wish to establish for use of such material. All gene therapy protocols, including multicenter clinical trials, must be reviewed by the IBC (prior to or concurrent with review by the IRB). Gene therapy protocols to be submitted to the Food and Drug Administration(FDA) for IND approval must be approved by the IRB prior to FDA submission.

For consultation and information regarding procedures for approval from the IBC, contact the IBC Chair at (516) 562-1141.

Additional services available:

Biostatistical Consultation: The Division of Biostatistics is available to all staff for advice on research design and analysis. The IRB strongly recommends that such advice be sought during the planning stage of any project. The director (or his designee), Division of Biostatistics, can review research and provide guidance for proposals prior to their consideration by the IRB for appropriateness of research design, sample size, and proposed analysis.

For information regarding a biostatistical consultation contact the Director of Biostatistics at (516)240-8300.

 
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