Empire State University Procedures for the Protection of Human Subjects in Research

I. Statement of Principles

II. Definitions

III. Institutional Responsibilities

Scope of responsibilities
Collaborating sites
Performance sites
Provision of resources
Education and training
Administrative oversight

IV. The Institutional Review Board

Membership of the IRB
IRB appointment
IRB membership lists and qualifications

V. IRB Functions and Operations

General principles of IRB review
IRB responsibilities
Responsibilities of the IRB chair

VI. Institutional Review Board Review Process

Scope of review
Levels of review
1. Expedited review
2. Full-committee review
Protections for vulnerable populations
IRB actions
IRB Review Process
1. Initial review
2. Continuing review
3. Modifications
Criteria for IRB approval of research
General requirements for informed consent
Appealing an IRB decision

VII. Determining which Projects Require Review More Often than Annually

VIII. Determining Dates

IX. Procedures for Reporting IRB Findings and Actions to Investigators and the Institution

X. Procedures For Ensuring Prompt Reporting to the IRB, Appropriate Officials and Department or Agency Head and OHRP of (a) Unanticipated Problems Involving Risks to Subjects or Others, (b) Serious or Continuing Noncompliance with 45 CFR 46 or the Requirements or Determinations of the IRB or (c) Suspension or Termination of IRB approval

XI. Review by University

XII. Suspension or Termination of IRB Approval of Research

XIII. Reviewing Reports of Adverse Events

XIV. IRB Policy for Research Conducted Without IRB Approval

XV. Research Lacking Definite Plans for the Involvement of Human Subjects

XVI. Research Undertaken Without the Intention of Involving Human Subjects

XVII. IRB Records

XVIII. Responsibilities of the Investigator

Preparation of human subjects review form
Submission of the human subjects review form
Reporting modifications in the research
Apprising research subjects of findings that may affect participation
Complying with IRB decisions
Providing consent forms to all subjects
Retention of signed informed-consent documents
Submission of adverse-events reports and reports of unanticipated problems involving risk
Attending IRB meetings

Appendices:

Federal Wide Assurance (FWA)
IRB roster
Forms

I. Statement of Principles (45 CFR 46.103)

Empire State University ensures that the rights and welfare of human research subjects are adequately protected in research activities conducted under its auspices. In order for the university to fulfill its responsibilities and to comply with federal and state law and regulations, all human-subjects research, including student research, conducted under university auspices must receive appropriate review and approval. In its Federal Wide Assurance, on file with the Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services, the university assures compliance with all requirements of Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46), including subparts B, C and D. No distinctions in the monitoring of research will be drawn between funded and nonfunded research, or between research conducted by faculty, students, other university personnel or affiliated researchers.

The university is guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, "Ethical Principles and Guidelines for the Protection of Human Subjects of Research" (The Belmont Report).

II. Definitions

Empire State University has adopted the definitions included in the federal regulations on the protections of human subjects in research (45 CFR 46.102).

Research: A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute “research” for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human subject: A living individual about whom an investigator (faculty, staff or student) conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information.

Minimal risk: The probability and magnitude of harm or discomfort anticipated 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.

Institutional official: The provost/executive vice president for academic affairs of Empire State University.

III. Institutional Responsibilities

Empire State University encourages and promotes constructive communication among research investigators, the IRB, the provost/vice president for academic affairs and human subjects as a means of maintaining a high level of awareness regarding safeguarding the rights and welfare of the subjects. The university assumes responsibility for communicating and explaining these policies to faculty, students and other personnel, and for providing procedural guidelines to effect their observance.

A. Scope of Responsibilities

B. Collaborating Sites

The university will comply with the requirements set forth in 45 CFR 46.114 regarding cooperative research projects. When research covered by the university's Federal Wide Assurance is conducted at, or in cooperation with, another entity, all provisions of 45 CFR 46.114 remain in effect for that research. The university may enter into a joint review arrangement, rely upon the review of another qualified IRB that adheres to similar standards of human subjects protections, or make similar arrangements for the purpose of meeting the IRB review requirements and obviating duplication of effort. Such arrangements must be (a) in writing, (b) approved and signed by the institutional official (or designee) of the university and (c) approved and signed by correlative officials of each of the cooperating institutions. These arrangements may be entered into on a case-by-case basis if arrangement is needed for the review of a single research project; or, for ongoing cooperative research, a more formal arrangement may be entered into, e.g., a memorandum of understanding detailing the joint review mechanism(s).

C. Performance Sites

D. Provision of Resources

The university will provide the IRB with resources, meeting space, professional staff and support staff to carry out its responsibilities efficiently and effectively.

E. Education and Training

Empire State University ensures that the IRB chair, IRB members, provost/vice president for academic affairs, human subjects investigators and relevant administrative personnel complete appropriate initial and continuing education related to the protection of human subjects before reviewing or conducting human-subjects research. All new IRB members and research investigators are required to complete the Collaborative IRB Training Initiative (CITI) Web-based tutorial or its equivalent, as approved by the IRB chair. All IRB members and research investigators with ongoing projects will complete a continuing-education program every three years, either through CITI or university-sponsored seminars in which experts in the field of human subjects research are invited to speak. The Empire State University website also makes available information regarding human-subjects protections on its IRB web page.

F. Administrative Oversight

The provost/vice president for academic affairs serves as the institutional signatory official for the university’s FWA. The Office of Academic Affairs will exercise appropriate administrative overview to ensure that the practices and procedures designed for the protection of the rights and welfare of human subjects are effective and in compliance with the requirements of 45 CFR 46.103 and this policy. A copy of this manual will be available at the Office of Academic Affairs and on the Institutional Review Board (IRB) website, and will be sent to faculty, staff or students requesting copies.

IV. The Institutional Review Board (IRB)

A. Membership of the IRB (45 CFR 46.207)

Empire State University has established its IRB meeting the following requirements:

comprised of at least five members from diverse backgrounds to promote complete and adequate review of research activities commonly conducted at the university
sufficiently qualified through the experience, expertise and diversity of its members, including consideration of race, gender and cultural backgrounds and sensitivity to issues such as community attitudes and issues related to vulnerable populations, to promote respect for its advice and counsel safeguarding the rights and welfare of human subjects
able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law and standards of professional conduct and practice and shall, therefore, include persons knowledgeable in these areas
includes at least one member whose primary concerns are in a nonscientific area and at least one member whose primary concerns are in a scientific area
includes at least one member who is not otherwise affiliated with the university and who is not part of the immediate family of a person who is affiliated with the university.

No IRB member may participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. The IRB may, at its discretion, invite individuals with competency in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. When research is reviewed that involves a vulnerable population, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration is given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

B. IRB Appointment The provost/vice president for academic affairs, or designee, shall make appointments to the IRB. The provost/vice president for academic affairs, or designee, also shall appoint the chair of the IRB.

C. IRB Membership Lists and Qualifications (45 CFR 46.103.b(3))

The names, qualifications and affiliations of the members of the IRB shall be on file with the U.S. Office for Human Research Protections (OHRP), in accordance with the requirements of the university’s Federal Wide Assurance and at the Office for Academic Affairs. All changes in IRB membership will be reported to OHRP as appropriate.

V. IRB Functions and Operations

A. General Principles of IRB Review

The IRB has the responsibility and authority to review, approve, disapprove or require changes in and monitor research activities involving human subjects. No individual involved in the conduct and/or supervision of a specific project shall participate in IRB review, except to provide information.
No involvement of human subjects in research, including recruitment, is permitted until the IRB has reviewed and approved the research protocol and informed consent has been obtained. It is the responsibility of the investigator to obtain approval from the IRB prior to the initiation of any research, including pilot or pretest studies, involving the use of human subjects.
All activities involving humans as research subjects must provide for the safety, health and welfare of every individual. Rights, including the right to privacy, must not be infringed. No subject in a research activity shall be exposed to unreasonable risk to health or well-being.
An individual does not abdicate any rights by consenting to be a research subject. A subject has the right to withdraw from a research project at any time, or can refuse to participate without loss of benefits to which the subject would otherwise be entitled. Further, a subject has the right to receive appropriate professional care, to enjoy privacy and confidentiality in the use of personal information and to be free from undue embarrassment, discomfort, anxiety and harassment.
The direct or potential benefits to the subject, or the importance of the knowledge to be gained, must not preclude consideration of the inherent risks to the individual.
The confidentiality of information received from subjects in experiments or respondents to questionnaires or surveys shall be fully protected, both during and after the conduct of a research activity, within the limits of the law.
Subject participation in projects must be voluntary. Informed consent must be obtained from all subjects and must be documented (unless the requirement for documentation of consent is specifically waived by the IRB). Consent methods, appropriate to the risks of the research, must be used to obtain the subjects’ informed consent (45 CFR 46.116).
In research involving more than minimal risk or substantial stress or discomfort, such risk, stress or discomfort shall be carefully explained to the subject before his or her participation and be justified by the expected benefits of the research. The investigator shall be satisfied that the explanation has been understood by the subject; and the written consent of the subject (unless otherwise waived by the IRB), containing the substance of the explanation, shall be obtained and kept as a matter of record.

B. IRB Responsibilities (45 CFR 46.109)

The IRB shalll:

review all research involving human participants and has the authority to approve, require modifications in (to secure approval) or disapprove all research activities, including changes in previously approved human-subjects research
require that information given to subjects as part of informed consent is in accordance with 45 CFR 46.116
require documentation of informed consent or may waive documentation
notify investigators in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval of research activity.
in case of disapproval or request for modifications to the research activity, include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing
conduct continuing review of human-subjects research at intervals appropriate to the degree of risk, but not less than once per year, and has the authority to observe or have a third party observe the consent process and the research
submit to the Office of Grants and Contracts certification of IRB review and approval for all federally sponsored research involving human subjects, to be forwarded to the appropriate federal department or agency
in compliance with the time and manner prescribed, forward certifications or IRB review to DHHS or other federal department or agency.

C. Responsibilities of the IRB Chair

The provost/vice president for academic affairs has assigned compliance with federal regulations and university policy regarding human subjects research to the IRB chair. The IRB chair’s responsibilities include:

receive from investigators all research protocols that involve human subjects and keep investigators informed of review decisions
forward certification of IRB approval of proposed research to the appropriate federal department or agency only after all IRB-required modifications have been incorporated to the satisfaction of the IRB
inform the IRB of all approved expedited reviews
provide advice on (a) the preparation of the Human Subjects Review Form and other documents and (b) other advice that will facilitate the IRB review process
maintain and arrange access for inspection of IRB records
ensure constructive communication among research administrators, department heads, research investigators, human subjects and institutional officials as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects
arrange for and document that each individual who conducts or reviews human subjects has ready access to this policy, copies of 45 CFR 46, regulations of other federal departments or agencies as may apply, the Belmont Report and all other pertinent federal policies and guidelines related to the involvement of human subjects in research
ensure (a) solicitation (or confirmation where applicable assurances to comply already exist), receipt and management of all assurances of compliance (whatever the appropriate format) and (b) certifications of IRB review (where appropriate) for all performance sites of this institution (including those listed the Federal Wide Assurance) and subsequent submission of new documents to the proper federal department or agency authorities as a condition for involvement of each site in human-subjects research activities sponsored by the Department of Health and Human Services or any other federal department or agency.

VI. Institutional Review Board Review Process

IRB review and approval is required for any research involving human subjects that is conducted by or under the direction of faculty, staff or students under the auspices of Empire State University or academic requirements; or is performed with or involves the use of records, facilities or equipment belonging to the university.

A. Scope of Review (45 CFR 46.108(b))

Except when an expedited review procedure is applicable, the IRB shall review proposed research at convened meetings at which a majority of the members are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.

B. Levels of Review

Research projects conducted at Empire State University are reviewed at one of two levels as determined by the IRB, those being expedited or full IRB review, depending on the IRB’s determination of the project’s risk to the human subjects and on the federal guidelines that define the categories of review.

1. Expedited Review (45 CFR 46.110)

Research activities that (1) involve minor changes in previously approved research or (2) present no more than minimal risk to human subjects, and involve only procedures listed in one or more of the categories in 63 FR 60364-60367 may be reviewed by the IRB through expedited review procedure.
For protocols eligible for expedited review, the university follows the OHRP recommendation that documentation for initial and continuing reviews conducted under the expedited review procedure include (a) the specific permissible categories justifying the expedited review and (b) documentation of the review and action taken by the IRB chair or designated reviewer and (c) any findings required under the HHS regulations.
The expedited-review procedure is carried out by the IRB chair or one or more experienced IRB reviewers. In reviewing the research, the reviewer(s) may exercise all of the authority of the IRB except the reviewer(s) may not disapprove the research. The reviewer(s) may refer research protocols to the full committee whenever the reviewer(s) believes that full-committee review is warranted. A research activity may be disapproved only after review in accordance with full-committee review procedures.
The types of minor changes in previously approved research which can be approved under an expedited-review procedure include those which, in the judgment of the IRB reviewer, make no substantial alteration in (i) the level of risks to subjects, (ii) the research design or methodology, (iii) the number of subjects enrolled in the research, (iv) the qualifications of the research team, (v) the facilities available to support safe conduct of the research or (vi) any other part of the research that would otherwise warrant review of the proposed changes by the convened IRB.

2. Full-committee Review

If the IRB chair or the expedited reviewer determine that a protocol needs full review, all IRB members receive and review the protocol application form (with sufficient detail to make the determinations required under 45 CFR 46.111), the proposed informed-consent document and any recruitment materials, including advertisements, intended to be seen or heard by potential subjects. Documents for review are normally sent to the IRB at least two weeks prior to the scheduled meeting.

Attendance of the investigator at the IRB review meeting in which his or her research activity is scheduled for discussion is encouraged.

C. Protections for Vulnerable Populations

The university requires more stringent safeguards for certain research activities and subjects likely to be vulnerable to coercion or undue influence such as:

pregnant women
prisoners
children
physically or mentally handicapped persons
economically or educationally disadvantaged persons
fetuses and neonates
other potentially vulnerable groups.

D. IRB Actions The IRB will come to one of three determinations regarding an application:

Approved: The protocol approval requires the approval of the reviewer if in expedited review, or of a majority of the IRB’s quorum if in full-committee review. If the vote of the IRB is not unanimous, the minority opinion will be recorded in or attached to the minutes.

Tabled pending modifications: Approval cannot be granted until further information is provided or specific changes are made. When the new information is submitted, the protocol is reviewed by the IRB again.

Disapproval: Notice of the disapproval is sent to the principal investigator and includes the reasons for the disapproval and information about reconsideration.

All IRB initial-review and continuing-review protocols shall be distributed to the appropriate members of the committee.

The distributed materials will consist of the full IRB protocol, a proposed informed-consent document, any relevant grant application(s), the investigator’s brochure (if one exists) and any recruitment materials.
When it is determined that consultants or experts will be required to advise the IRB in its review of a protocol, the research protocol also will be distributed to the consultants or experts prior to the meeting.
For full-committee review, a majority of the membership of the IRB constitutes a quorum and is required to be present in order to convene for the review of research protocols.
For a research-protocol to be approved, it must receive the approval of the majority of those voting members present at the convened meeting.
Should a quorum fail during a meeting, (e.g., loss of a majority through recusal of members with conflicting interests or early departures, or absence of a nonscientist member), the IRB will not take further actions or votes unless the quorum can be restored. In addition, an IRB member whose concerns are primarily in nonscientific areas must be present before the IRB can conduct its review of research.
No IRB member may participate in the IRB’s initial or continuing review of a project in which the member has a conflicting interest, except to provide information requested by the IRB. An IRB member with a conflict of interest will absent him/herself from the meeting/conference call, which will be noted in the minutes.

Approval of the proposed research usually is granted for a period of 12 months commencing on the date of the approval. Based upon the degree of risk to human subjects, the IRB may require a shorter approval period or a report on research progress at specific intervals. Refer to Section J: Determining Which Projects Require Review More Often than Annually.

E. IRB Review Process

1. Initial Review (45 CFR46.103(b)(4)

In conducting the initial review of proposed research, the IRB obtains information in sufficient detail to make the determinations required under 45 CFR 46.111. Materials provided to the IRB include the full protocol, a proposed informed-consent document, any relevant grant application(s) and recruitment materials, if any.
All materials are submitted to the IRB administrator. Protocol information is entered into a Lotus Notes database.
The IRB administrator conducts an administrative pre-review of the submission to ascertain whether all the information has been submitted. If additional information is required, the IRB administrator contacts the investigator to inform him/her of the additional information needed. When this information is submitted, the entire packet is forwarded to the IRB chair or primary reviewer.
The IRB mandates that any applicable state or local laws and/or regulations which provide additional protections for human subjects be followed.

2. Continuing Review

The IRB is required to reevaluate research projects at intervals appropriate to the degree of risk, but not less than once a year. For research involving no more than minimal risk, the approval period is generally one year. For research involving greater than minimal risk, the IRB will determine the appropriate approval period. The approval letter from the IRB will indicate the approval period and the date for submitting a request for continuation.
For research with a one-year approval period, investigators must request a continuation for the approval yearly if the activity lasts more than one year. Only three continuations will be granted for a given project. After four years, the project must be resubmitted, as a new protocol, to the IRB for review and approval.

At least two months prior to the expiration date, each investigator is sent a reminder email. The email contains:

the protocol number
date of last review
date by which continuing review must be completed
date of the next IRB meeting
a link to the forms needed
questions regarding whether the protocol must be continued
a request to submit appropriate documentation for the review.

Continuations are reviewed under the full-review process, unless the protocol falls under a category of research acceptable for review under the expedited review process. The IRB receives all the information provided by the investigator requesting the continuation of:

(a) a summary of any adverse events or unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research, or complaints about the research since the last IRB review

(b) the number of subjects accrued

(c) a summary of any relevant recent literature, findings obtained thus far, amendments or modifications to the research since the last review and any other relevant information, especially information about risks associated with the research

(d) a copy of the current informed-consent document.

The IRB receives a copy of the complete protocol including any modifications previously approved by the IRB.

3. Modifications

All modifications to currently approved research are required to have IRB review and approval prior to implementation. Minor changes that do not increase the risk to research subjects may receive an expedited review. Modifications to approved research projects that may affect the risk to subjects are forwarded to the full IRB for review. All modifications must be included with the original protocol. This procedure ensures that a full protocol is available for review by the IRB.

Review of a change in a protocol ordinarily does not alter the date by which continuing review must occur. This is because continuing review is review of the full protocol, not simply a change to it.

F. Criteria for IRB Approval of Research

Risk/Benefit (45 CFR 46.111.a.1-2): In order to approve research covered by this policy, the IRB shall determine that the following requirements are satisfied:

risks to subjects are minimized by using procedures consistent with sound research design and which do not unnecessarily expose subjects to risk
risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result from the research
in evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research (as distinguished from risks and benefits that may result from therapies subjects would receive even if not participating in the research)
the IRB will not consider long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility
the IRB will examine study design or scientific merit of a proposed study only within the context of its risk/benefit analysis.

Equitable Selection and Recruitment (45 CFR 46, 111 a.3):

Selection criteria should consider all populations that might potentially benefit from the research. Utilization of populations based solely upon ready availability should be avoided.
The IRB will take into account the purposes of the research and the setting in which the research will be conducted and will be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
The proposed research will specify criteria for inclusion or exclusion, if any, and the rationale for such inclusion or exclusion.

Vulnerable populations and coercion: When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards will be included in the study to protect the rights and welfare of these subjects. (45 CFR 45.111(b))

Data monitoring: When appropriate, the research plan shall make provision for monitoring the data collected to ensure the safety of subjects. (45 CFR 46.111.a.6)

Privacy protection: When appropriate, there will be adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (45 CFR 46.111.a.7)

Informed-consent process: Unless waived by the IRB according to 45 CFR 46.116(d), informed consent will be sought from each prospective subject or the subject’s legally authorized representative and will be appropriately documented, in accordance with and to the extent required by 45 CFR 46.116 and 117. (45 CFR 46.111.a.4 and 5)

G. General Requirements for Informed Consent: (45 CFR 46.116)

No investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek informed consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive, or appear to waive, any of the subject's legal rights, or releases, or appears to release, the investigator, the sponsor, the institution or its agents from liability for negligence. In seeking informed consent, the following information shall be provided to each subject:

a statement that the study involves research
explanation of the purpose of the research
expected duration for subject’s participation
description of the procedures to be followed
identification of any procedures that are experimental
description of any reasonably foreseen risks or discomforts to the subject
description of any benefits to the subject or to others
disclosure of appropriate alternative procedures or courses of treatment, if any
procedures to protect confidentiality of participation and data
for research involving more than minimal risk, an explanation of any compensation and whether any medical treatments are available, if injury occurs, and whom to contact
contact for answers to questions about the research
contact for answers regarding participants’ rights as a human subject
that participation in the research is voluntary
refusal to participate will not involve penalty or loss of benefits to which subject is entitled
subjects may discontinue at any time without penalty.

Additional information, where appropriate:

state whether the particular procedure may involve risk to the subject (or fetus, if participant is pregnant) which are currently unforeseeable
anticipated circumstances in which the subject’s participation may be terminated by the investigator without regard to the subject's consent
additional costs to the subject from participation
consequences of a subject’s decision to withdraw and procedures for orderly termination
statement of significant findings developed during the course of the research which may relate to the subject’s willingness to continue participation
the approximate number of subjects involved in the study.

Informed consent will be documented by the use of the written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy of the form will be given to the subject or representative.

Waiving Consent: (45 CFR 46.116 (d))

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

the research involves no more than minimal risk to subjects
the waiver or alteration will not adversely affect the rights and welfare of the subjects
the research could not be practicably carried out without the wavier or alteration
whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Criteria for Waiver of Documentation of Informed Consent (45 CFR 46.117(c))

An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern
that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

If the IRB exercises this waiver provision, these findings and their justifications will be clearly documented in IRB minutes or expedited review record.

H. Appealing an IRB Decision

If an investigator believes an IRB decision to be unfair, unsubstantiated or unduly restrictive on his/her proposed research, the investigator should first discuss the matter with the chair of the IRB. The investigator should be prepared to present reasons that he/she believes the proposed research is in compliance with university policy and federal regulations for the protection of human subjects.
If the issue cannot be resolved satisfactorily by negotiation, the investigator may appeal the decision, in writing, to the IRB. In developing an appeal, the investigator is encouraged to seek the advice or opinion of an objective, qualified consultant (or consultants) to support the claim that the proposed research is in compliance with human-subjects policy and regulations.
The investigator must appear before the IRB to present the appeal and any supportive material or documentation obtained through consultation. Based upon this appeal, the IRB will issue a final recommendation on the proposed research.

VII. Determining Which Projects Require Review More Often than Annually

The IRB conducts continuing review of approved research at intervals appropriate to the degree of risk, but not less than once per year. The IRB may request review more frequently than on an annual basis on protocols that are determined to present significant physical, social or psychological risks to subjects. 45CFR46.103(b)(4). This determination is documented in the minutes of a full-board convened meeting.

VIII. Determining Dates

The regulations make no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval. Therefore, continuing review and reapproval of research must occur on or before the date when IRB approval expires. Empire State University follows OHRP guidance on continuing review dates. When continuing review occurs annually and the IRB performs continuing review within 30 days before the IRB approval period expires, the IRB may retain the anniversary date as the date by which the continuing review must occur.

IX. Procedures for Reporting IRB Findings and Actions to Investigators and the Institution

The IRB chair promptly conveys the IRB’s determination and any needed action regarding the proposed research and any modifications or clarifications as a condition for IRB approval to the investigator by email and letter. When the revisions or modifications are received, the IRB administrator sends the modifications to the IRB chair or primary reviewer for that protocol who reviews the investigator’s response. If it is determined that the information adequately addresses the IRB concerns, the protocol is approved and the modification is incorporated into the written protocol.The IRB chair then affixes the approval and expiration dates to all approved consent forms with the stipulation that copies of these dated documents must be used in obtaining consent. This procedure helps to ensure that only current, IRB-approved consent documents are presented to subjects and serves as a reminder to the investigators of the need for continuing review.The approval status is then entered into the IRB’s database.

X. Procedures for Ensuring Prompt Reporting to the IRB, Appropriate Officials and Department or Agency Head and OHRP of (a) Unanticipated Problems Involving Risks to Subjects or Others, (b) Serious or Continuing Noncompliance with 45 CFR46 or the Requirements or Determinations of the IRB and (c) Suspension or Termination of IRB Approval

The IRB immediately reports (a) any unanticipated problems involving risks to subjects or others, (b) any serious or continuing noncompliance with 45 CFR 46 or the requirements or determinations of the IRB and (c) any suspension or termination of IRB approval to the institutional official. When reports are received by the IRB, they are immediately investigated. Materials relevant to the report are brought before a full convened IRB meeting. This process may take less than one week, and no more than two weeks. The institutional official receives copies of all review material and IRB correspondence and promptly reports to the supporting agency or department and OHRP. (45 CFR 46.113)

XI. Review by the University (45 CFR 46.112)

Research covered by this policy that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by officials of the university. However, university officials may not approve the research if it has not been approved by the IRB.

XII. Suspension or Termination of IRB Approval of Research (45 CFR 46.113)

The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator and to the institutional official. The institutional official will report promptly the suspension or termination to OHRP, the sponsor and any other applicable federal agencies.

XIII. Reviewing Reports of Adverse Events

The IRB is responsible for reviewing reports of any adverse events to research subjects or any unanticipated problems that involve risk to human subjects in the course of approved research. Upon the receipt of an adverse event, the IRB will determine whether the study should be modified to reduce the level of risk to subjects, or whether the consent form should be modified to include a description of activities or procedures that could result in adverse effects.

XIV. IRB Policy of Research Conducted Without IRB Approval

Research activities involving the use of human subjects under the auspices of Empire State University may not be conducted without prior review and approval by the relevant IRB. The IRB cannot give its approval or disapproval of research that already has been conducted.

XV. Research Lacking Definite Plans for the Involvement of Human Subjects (45 CFR 46.118)

Applications and proposals for grants, cooperative agreements or contracts lacking definite plans for involvement of human subjects will not require IRB review and approval prior to award. However, except for research exempt or waived under 45 CFR 46.110(b), human subjects may not be involved in any project supported by such awards until IRB review and approval has been certified to the appropriate federal department or agency.

XVI. Research Undertaken Without the Intention of Involving Human Subjects (45 CFR 46.119)

In the event that research is undertaken without the intention of involving human subjects, but is later proposed to involve human subjects in the research, the research first shall be reviewed and approved by the IRB prior to involving human subjects. If funded, certification is submitted to the funding agency and OHRP.

XVII. IRB Records (45 CFR 46.115)

The IRB administrator, or, when appropriate, the IRB, shall prepare and maintain adequate documentation of IRB activities including the following:

copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposed research, approved sample consent documents, progress reports submitted by investigators and reports of injuries or harm to subjects
minutes of IRB meetings which shall be of sufficient enough detail to show attendance at the meetings; actions taken by the IRB; the votes on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution
records of continuing review activities
copies of all correspondence between the IRB and the investigators
a list of IRB members in the same detail as described in 45 CFR 46.103(b)
written procedures for the IRB in the same detail as described in 45 CFR 46.103(b)(4) and (5)
statements of significant new findings provided to subjects as required by 45 CFR 46.116(b)(5).

The records required by this policy will be retained for at least three years, and the records relating to research that was conducted shall be retained for at least three years after the completion of the research. Research records will be secured appropriately. All records shall be accessible for inspection and copying by authorized representatives of supporting departments or agencies at reasonable times and in a reasonable manner.

XVIII. Responsibilities of the Investigator

In accordance with the provisions of Empire State University's Federal Wide Assurance, research investigators who conduct human-subjects research under the auspices of the university(faculty, staff, students and affiliated researchers), acknowledge and accept their responsibility for protecting the rights and welfare of human-research subjects and the information about these individuals. When the investigator is a student, responsibility for the conduct of the research and for the welfare and supervision of human subjects lies with both the student and the faculty advisor. All student research must have a faculty advisor.

A. Preparation of Human Subjects Review Form

Research investigators shall prepare the IRB protocol form that includes a complete description of the research protocol. In the form, investigators shall make provisions for the adequate protection of the rights and welfare of prospective research subjects and ensure that pertinent law and regulations are observed. The IRB protocol form is available at the Office of Academic Affairs, the Office of Grants and Contracts or on the university's IRB website. Research investigators shall include the proposed informed consent form(s) and copies of all relevant information and documentation (questionnaires, test instruments, recruitment tools, scripts, debriefing statements, contact letters, etc.).

B. Submission of the Human Subjects Review Form

It is the responsibility of each investigator to bring all proposed research activity involving the use of human subjects or activity involving data collection from or about human subjects to the attention of the university's IRB for review and approval.
If it is unclear if a proposed research project involves human subjects, the investigator is strongly encouraged to consult the IRB chair. Final authority for making the determination on whether the research is human-subjects research rests with the IRB.

C. Reporting Modifications in the Research

Research investigators are responsible for promptly reporting any changes in the research protocol to the IRB. Changes in research during the period for which IRB approval already has been given shall not be initiated by research investigators without IRB review and approval, except where necessary to eliminate immediate hazards to the subject(s). In most cases, requests for minor modifications will be reviewed on an expedited basis in accordance with established IRB procedures. A request for a major modification will be considered at a full IRB meeting. An application for modification includes the submission of all proposed changes with a rationale for each proposed change.

D. Apprising Research Subjects of Findings that May Affect Participation

E. Complying with IRB Decisions

Research investigators are responsible for complying with all IRB decisions, conditions and requirements.

F. Providing Consent Forms to All Subjects

Research investigators are responsible for providing a copy of the IRB-approved and signed informed-consent document to each subject at the time of consent, unless the IRB has specifically waived this requirement.

G. Retention of Signed Informed Consent Documents

Research investigators are responsible for retaining the informed-consent documents signed by human-research subjects in a manner approved by the IRB. It is required that principal investigators keep all records for a minimum of three years following completion of the research activity.

H. Submission of Adverse Event Reports and Reports of Unanticipated Problems Involving Risk

I. Attending IRB meetings

Research investigators are encouraged to attend IRB meetings in which their human-subjects protocol or research activities are under review.

Appendices:

Federal Wide Assurance (FWA)
IRB roster
IRB protocol form