Institutional Review Board (IRB)

All research and teaching activities conducted under University auspices and involving human participants must comply with any applicable federal, state, and local laws and regulations even if no sponsored funds are used. This applies to all members of the University community (i.e., faculty, staff, students, Research Foundation employees).

The SUNY Cortland IRB institution encourages constructive communication, transparency and collaboration for ensuring research is conducted ethically and participants are protected from risks. The IRB fosters a culture of compliance at SUNY Cortland by mentoring individual investigators, hosting professional learning opportunities, and providing oversight of all research activities involving human participants.

Authority and Responsibility of the IRB

The Institutional Review Board (IRB) is a committee established to protect the rights and welfare of human participants involved in research activities. The IRB implements federal, state, and local laws and regulations requiring the review and monitoring of human participant research in accordance with the policies outlined in 45 CFR 46.

Review by an IRB is the cornerstone of an institution's program for the protection of human participants. IRBs are responsible for ensuring that the rights and welfare of research participants are adequately protected.

IRB Responsibilities in the Institutional Context

The IRB has the authority to approve, require modifications to, or disapprove all research activities at SUNY Cortland. The goal of the IRB is not only to guarantee compliance with existing laws and regulations but also to assist campus researchers in the planning and implementation of their projects.

IRB members function with the highest level of professional and personal integrity. Protocol review focuses solely on ensuring that all research fully meets the requirements outlined by the Office of Human Rights Protections and other relevant authorities. All campus stakeholders (i.e., administrators, faculty, staff, students) are expected to meet all requirements, whether research is funded or unfunded.

The responsibility for the protection of human participants does not rest solely with the IRB. It is a shared responsibility between the Campus Administration, the IRB, and the investigator. Each has a crucial, yet distinct, role. Research that has been approved by the IRB may be subject to further review and approval by Campus Administration. While Campus Administration may require additional measures beyond IRB approval, campus administration cannot waive IRB review or override decisions made by the IRB, (e.g., IRB approval has been denied).

Membership of the IRB

The SUNY Cortland has established its IRB of twelve members in accordance with federal requirements. All of the members of the IRB have experience and knowledge concerning the local research context, including the ability to consider the ways in which individual identities and larger social context may increase vulnerability for specific research participants. The members of the IRB are sensitive to such issues as community attitudes and are able to gauge the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and local standards.

The IRB is sufficiently qualified through the experience, expertise, and diversity of its members to promote respect for its determinations about safeguarding the rights and welfare of human participants.

The IRB is able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB membership also includes individuals who are knowledgeable about and experienced in working with participants who have increased vulnerability to coercion or undue influence, especially those populations (e.g., children with disabilities) who are frequently the focus of research at SUNY Cortland.

The SUNY Cortland IRB includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. Additionally, the IRB includes at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

Appointment to the IRB

The Provost makes appointments to the IRB for three-year terms that begin at the start of the academic year. Recommendations for new members are solicited from the Dean of each school, ensuring that in addition to meeting the federal requirements described above, pools of candidates also represent the full scope of academic disciplines and research at SUNY Cortland.

IRB Membership Lists, Qualifications, and Affiliations

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 Federal Assurance Form - and in the office of the Human Protections Administrator. All changes in IRB membership are reported by the Human Protections Administrator to OHRP as appropriate.

Training of IRB Administrators and Members

The Institutional Signing Official (Provost), the Human Protections Administrator and IRB Chair are required to complete CITI IRB Administration Training. In addition, the Human Protections Administrator, IRB Chair, and all IRB Members must complete all basic social and behavioral sciences modules of the CITI Course for the Protection of Human Subjects and maintain current certification. All IRB members are to be familiar with SUNY Cortland Policies and Procedures and the local research context. All training is to be completed before reviewing protocols.

The Provost and Vice President for Academic Affairs serves as the SUNY Cortland Institutional Official (IO) is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance. The IO is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. The IO represents the institution named in the Federalwide Assurance (FWA).

Administratively, the IO is responsible for:

1. Designating the IRB that will review research covered by the institution's FWA;
2. Appointing IRB members and chair. Suspending or terminating the IRB membership of any individual (including the chair) if it is determined that they are not fulfilling their responsibilities and or obligations;
3. Providing sufficient resources, space, and staff to support the IRB's review and record keeping duties;
4. Providing training and educational opportunities for the IRB and investigators;
5. Setting the "tone" for an institutional culture of respect for human participants;
6. Ensuring effective institution-wide communication and guidance on human participants research;
7. Ensuring that investigators fulfill their responsibilities as detailed in this policy document;
8. Encouraging that all staff engaged in the conduct or oversight of human participants research participate in educational activities;
9. Serving as a knowledgeable point of contact for OHRP, or delegating this responsibility to another appropriate individual;
10. Implementing appropriate oversight mechanisms to ensure compliance with DHHS regulations and effective administration of the HRPP.

The Human Protections Administrator (HPA) at SUNY Cortland serves as the primary contact for investigators at SUNY Cortland, and the OHRP. The HPA is responsible for the administration of the IRB. Because of the Human Protections Administrator’s responsibilities, to avoid even the appearance of conflict of interest, this individual may not serve as a voting member on any committee or group that provides funding to faculty, staff, or students to conduct research at SUNY Cortland.

Administratively, the HPA is responsible for:

1. Being the point of contact for correspondence addressing human subjects research with the OHRP, FDA and other agencies as applicable, including reports to federal agencies;
2. Developing and regularly reviewing policies and procedures for effective and efficient administration of the Human Research Protections Program (HRPP);
3. Overseeing daily operations of the IRB and HRPP in accordance with the SOPs.
4. Reviewing and signing memoranda of understanding and cooperative agreements between the institution and other organizations and independent researchers, including those that establish reliance on IRBs of record for collaborative research (e.g., IRB Authorization Agreements, Individual Investigator Agreements);
5. Performing periodic evaluation of the performance of the IRB chair, members, staff
6. Developing and implementing an educational plan for IRB members, staff and investigators, ensuring they are knowledgeable to evaluate and conduct research in accordance with ethical standards and all applicable regulations;
7. Promoting communication among the research administrators, department heads, investigators, clinical care staff, human participants, and institutional officials to maintain a high level of awareness regarding the ethical conduct of research and safeguarding the rights and welfare of subjects;
8. Educating the members of its research community in order to establish and maintain a culture of compliance with federal regulations and institutional policies relevant to the protection of human subjects.
9. Ensuring that IRB records are being maintained per DHHS regulations and that the records are accessible, upon request, to authorized DHHS officials. For institutions relying on another IRB, records may be retained at the IRB site;
10. Ensuring the prompt reporting of adverse events involving human participants, serious noncompliance, or issuances of suspension or termination of research notices to the appropriate institutional officials, OHRP, and sponsoring federal department or agency head.

The IRB Chair coordinates the activities of the Full Board in consultation with the Human Protections Administrator. Because of the IRB Chair’s responsibilities, to avoid even the appearance of conflict of interest, this individual should not serve as a voting member on any committee or group that provides funding to faculty, staff, or students to conduct research at SUNY Cortland.

Administratively, the IRB Chair is responsible for:

1. Working with the Human Protections Administrator to promote the activities of the IRB on the SUNY Cortland campus, provide training and mentoring to researchers, to facilitate the appropriate and timely review of research.
2. Directing the convened meetings of the IRB by:
   1. Setting agendas for convened meetings of the IRB in consultation with the Human Protections Administrator;
   2. Ensuring that a quorum is present before research is reviewed, and that each IRB member has received all pertinent material prior to the meeting;
   3. Providing ample opportunities for IRB members and investigators to actively and equally participate in the discussion of all protocols.
3. Performing oversight and audits of research reviewed though the expedited review process

Individuals affiliated with SUNY Cortland (faculty, staff, or students) are conducting human participants research when:

• they engage in data collection from a living person (or persons);
• they intend to apply what they learn to another individual(s) now or in the future; and,
• the intent of the data collection (research) is to communicate results to others off-campus so that they can benefit from the knowledge gained.

Much of the scholarly activity conducted by faculty, staff, and students at SUNY Cortland, in the area of social and behavioral sciences, fits the federal definition of human participants research. In addition, a few teaching activities meet this definition. As an example, studies of teaching effectiveness to be published, communicated, or disseminated off-campus require IRB review. Undergraduate research activities and undergraduate thesis projects require IRB review when the intent of the activity is the creation of generalizable knowledge.

The Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP) established regulations (45 CFR 46) that govern the way research is conducted. SUNY Cortland possesses a federalwide assurance, an agreement with the federal government binding the university to comply with these regulations. OHRP has published guidance and periodically releases additional documents that explain how the regulations are to be applied by local Institutional Review Boards (IRB), which review and monitor research at colleges, universities, and other institutions. The basic process of requesting IRB review at SUNY Cortland is outlined in the table below.

Sequential Outline of IRB Procedures at SUNY Cortland

SUNY Cortland’s IRB recognizes the importance of training to ensure ethical conduct in all research activities. Federal agencies including the Department of Health and Human Services (DHHS) and the National Institutes of Health (NIH) have developed training requirements or recommendations to ensure that institutions, IRB members, and investigators, are adequately educated about human participant protections (HPP) so that they can meet the obligations of their respective roles.

Anyone who is involved in research design, participant recruitment, or the gathering of information from participants is to be considered key personnel. Key personnel can include faculty, staff, students, or administrators. Key personnel also include individuals whose data management responsibilities, analysis tasks, and dissemination activities require direct access to participants or participants’ personally identifiable data. All key personnel are required to complete training prior to conducting human participant research.

To satisfy training requirements, SUNY Cortland has subscribed to the Collaborative Institutional Training Initiative (CITI) Program. The CITI Program includes basic modules as well as optional modules for specific areas of research for which special rules and regulations may be required (e.g. research using the internet, international research, research involving children, biomedical research). The IRB may determine that individuals are required to complete additional modules depending on the scope of a specific research protocol.

Faculty must ensure that graduate and undergraduate students working with human research participants complete appropriate training and that they fully understand their duties under federal and state regulations.

Levels of IRB Review

Research proposals are reviewed at one of three levels, depending upon the investigator(s) and IRB’s understanding of

1. the sample population;
2. the risk to participants posed by the research topic and methodology;
3. the federal guidelines that define the categories of IRB review.

The federal definition of minimal risk provides the benchmark for considering the degree of risk research activities pose. Minimal risk means that 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. This includes the performance of routine physical or psychological examinations or tests. When participants could be vulnerable to coercion or undue influence (e.g., college students in a classroom setting), additional safeguards must be in place to protect the rights and autonomy of these participants. While the investigator makes the initial determination on the level of risk and selects a review category (i.e. exempt, expedited or full-board review), the IRB will make the final determination, The categories of review are summarized below:

Category I – Exempt Review

The IRB has adopted the DHHS procedure for identifying exemptions as cited in 45 CFR §46.104. According to these regulations, exempt review involves research involving less than minimal risk to participants and involves one of the activities cited in the Federal Regulations above or on the IRB Applications page. These include the following activities, subject to some limitations (see full regulation for additional details):

1. Research conducted in established or commonly accepted educational settings
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior.
3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal, written responses, including data entry or audiovisual recording.
4. Secondary research for which consent is not required, including research with private information or identifiable biospecimens collected for some other initial activity.
5. Research and demonstration projects are conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads.
6. Taste and food quality evaluation and consumer acceptance studies.
7. Storage or maintenance of secondary research.
8. Secondary research for which broad consent is required.

Category II – Expedited Review

To qualify for expedited review, the research must involve no more than minimal risk to participants and correspond to a category appropriate for expedited review (see federal register), or represent a minor change in previously Full Board approved research that involves no additional risks to research participants, in accordance with DHHS regulations 45 CFR §46.110. Research categories for expedited review can be accessed online and can be found within SUNY Cortland’s Expedited Protocol application.

Category III – Full Review

Any research that does not fit Category I or Category II must be submitted for full review. Any aspect of a research study, including recruitment, sampling, participant characteristics, method/procedure, measures, storage plan, or dissemination could necessitate a full review. Examples of research projects that typically prompt a full review include, but are not limited to the following:

1. Research with vulnerable populations (e.g., minors, incarcerated people, pregnant people, people with diminished cognitive capacity);
2. Research involving psychological or physiological intervention or non-curricular, interactive research in schools;
3. Research involving deception or incomplete disclosure (unless the deception is minor and the study does not involved sensitive topics or vulnerable participants- see section on deception for more information) ;
4. Research about sensitive or stigmatized topics or behaviors (e.g., child abuse, sexual violence, or illicit drug use);
5. Projects that involve possible coercion or that unduly induces or entices consent (e.g., excessive compensation, inequitable relationship, etc.)

IRB Applications, Appendices, and Other Required Documents

IRB Applications and instructions are available online. DHHS regulations (CFR §46.111) detail the criteria that must be satisfied in order for the IRB to approve research. Investigators are to complete the application appropriate for the level of review, as each application has been designed to elicit the information required to classify and review the research.

The investigator is responsible for providing to the IRB documents, materials, and information about the research in sufficient detail to make the determinations required under DHHS regulations at CFR §46.111. These criteria include:

1. Risks to subjects are minimized (e.g., procedures are consistent with sound research design, and do not unnecessarily expose subjects to risk, and proper safeguards are used);
2. Risks to subjects are reasonable in relation to anticipated benefits;
3. Selection of subjects is equitable;
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative (to the extent required by CFR §46.116) – see next section for critical details;
5. Informed consent will be appropriately documented (to the extent required by CFR §46.117);
6. There are adequate provisions to protect the privacy of research participants;
7. Data security procedures comply with the laws and regulations for all locations in which research-related activities are occurring.

Materials submitted for Expedited or Full review, at minimum, include a protocol application, legally effective informed consent document (as well as child assent when applicable), and Appendix A (signature page). Other materials may be required, when applicable to the research. These include, but are not limited to, copies of a grant/fellowship proposal, copies of surveys, measures, or descriptions of equipment or apparatus to be used in the research. References for published measures that are widely used (e.g., Wechsler Adult Intelligence Test; Beck’s Depression Inventory) can be submitted in lieu of reproducing the entire instrument. Photographs or diagrams of apparatus and equipment can be helpful, particularly images that demonstrate how the apparatus/equipment would be used by the researcher and participants.

Appendix B, is to be submitted when there are co-investigators, research staff, and/or research assistants. Should a SUNY Cortland investigator become involved in DHHS-supported multicenter clinical trials, the IRB should receive and review a copy of the DHHS-approved sample informed consent document and the complete DHHS-approved protocol.

Protocols that are deemed exempt from review are not required by DHHS regulations 45 CFR §46.110 to have a signed informed consent document. However, SUNY Cortland’s IRB requires that participants are adequately informed about what they will be doing if they agree to participate in an exempt study. This means that, in addition to requiring an exempt protocol application and Appendix A (signature page), PIs must also explain in their application how participants will get information about the study. Examples include an information page or script to be read to participants that includes the components typically required in Legally Effective Informed Consent (described in the section below).

Legally Effective Informed Consent is Required

Informed consent is not a single document that researchers ask participants to sign. Informed consent is best described as an active, ongoing process of sharing information between the investigator and the prospective participant. This exchange of information can occur through any type of communication medium. The informed consent process should ensure that all critical information about a study is completely disclosed, and that prospective participants or their legally authorized representatives adequately understand the provisions of consent and the research procedures so that they can make informed choices. Informed consent must be documented. Participants must sign a consent form, and the researcher is required to store the signed consent form, except when a waiver has been approved by the IRB.

Because IRB review requires that IRB members focus on the research, from the perspective of the participant, the primary reviewer begins their protocol review by reading recruitment materials and the consent form, using the OHRP consent form checklist to ensure that the participants obtain all required information (Consent Form Checklist). Then the primary reviewer reads the materials and protocol (IRB application). Investigators are urged to keep information consistent across these documents, using the informed consent (assent) as the key document.

Legally Effective Informed Consent, at a minimum, must include the following:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others that may reasonably be expected from the research;
4. For research involving interventions or treatments, a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
   1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
   2. A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

All applicable elements [at minimum, CFR §46.116 (a through f)] must appear in every informed consent and every child assent. An investigator must provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate in the research, and minimize the possibility of coercion or undue influence. The consent and assent information given to the participant or their representative must be in plain language. No informed consent, whether oral or written, may include any exculpatory language through which the participant or their representative is made to waive or appear to waive any of their legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

The approval date for each document and the expiration date for the research protocol must appear on all recruitment materials and consent documents, unless this requirement is explicitly waived by the Full Board.

Recruitment and advertisement activities are part of the informed consent process. All types of communication about a study must be pre-approved by the IRB in the same format that participants will interact with them. Examples of recruitment materials include a research brochure, flyer, newspaper advertisement, press release, email, or news-related story about the study that contains contact information for the researcher. Public relations stories, press releases, and other forms of news/journalism about research are subject to IRB review when the public may respond to the story by contacting the researcher to volunteer for the study. Prospective participants should have ample opportunity to ask questions and seek clarification from the investigator. They should be able to freely choose whether to initially enroll in the research, or later to withdraw from the study.

The consent procedures and forms must be revised when deficiencies in accuracy or completeness are noted, when new information about risks/benefits becomes available, or when other additional information becomes known that will improve the consent process. All revisions must be reviewed and approved by the IRB prior to the revised consent being utilized.

Research Involving Children: Parental Consent and Child Assent

The potential risk posed to child participants is evaluated differently from risks presented to adults. The provisions for consent/assent must respect these differences. Under CFR §46.408(b) the IRB may find that the permission of one parent is sufficient for research to be conducted under CFR §46.404 or CFR §46.405. Where research is conducted under CFR §46.406 or CFR §46.407, permission must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when one parent has sole legal responsibility for the care and custody of the child.

Even though children are unable to provide legally effective informed consent to participate in research, adequate provisions must be made for soliciting their assent, after securing the consent of the parents/guardians (CFR §46.408, CFR §46.402(c)). Assent refers to a child’s affirmative agreement to participate in research. Effective child assent contains the elements of legally effective informed consent, in vocabulary a level the child can understand [CFR §46.116 (a through f)]. Assent is to be sought from any child who is able to communicate in some way. Assent can include a signature on documents, verbal agreement, or behavioral cues of voluntary participation. Failure to refuse to participate cannot, in itself, be construed as assent (CFR §46.402(b)). Even where the IRB determines that the participants are capable of assenting, the IRB may still waive the assent requirement under certain circumstances in accordance with CFR §46.116 and CFR §46.408(a).

By regulatory definition, children are “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” (CFR §46.402(a)). In the United States, the legal age of adulthood is a matter of state and local law; in a large majority of states, including New York, 18 years of age is the legal age of adulthood. This is not true in every state, locality, or territory. Multisite research and international research must respect the laws applicable to the site where the data is collected. State law also may address specific circumstances in which a person younger than the age of adulthood is legally authorized to consent to medical procedures: for example, some states allow children younger than the legal age of adulthood to consent to the provision of reproductive health care. Certain states provide a mechanism for the emancipation of minors through which a child younger than the legal age of adulthood may gain certain civil rights, which could include the legal ability to consent to research participation.

The definition of children also takes into account the particular interventions or interactions involved in the proposed research (e.g., surveys, blood tests). For example, in some places individuals who are 16 years of age may legally consent to certain clinical interventions or interactions. If the involvement of human participants in a proposed research activity consists of these interventions or interactions, then those individuals may be considered as adults for that purpose. If a proposed activity includes an intervention or interaction for which the subject has not yet reached the legal age of consent, however, that person must be considered a child.

Waivers to Document Consent

Sometimes an investigator will request a waiver to document informed consent. When this waiver is granted by the IRB, the researcher must provide the participant with all of the elements of consent in a written or verbal statement, but the participant does not sign a consent form. This waiver is most commonly used in online anonymous data collection, when the principal risk to participants would be potential harm resulting from a breach of confidentiality. Waivers of Consent In a few specific and more rare circumstances, a researcher may find that the study procedures require a consent process which does not include, or which alters, some or all of the elements of informed consent (e.g., unobtrusive observation of public behavior; use of deception to preserve the scientific integrity of a manipulation). Under some circumstances, defined at CFR §46.116 (d), the IRB can waive the provision of some or all of the elements of informed consent. This type of waiver requires review by the convened Full Board, even if the research is otherwise low risk. When participation in the study has concluded, full consent must be administered as part of a debriefing process.

Requests for either type of waiver should be adequately justified in the IRB application, in accordance with the requirements of CFR §46.116 or CFR §46.117. For assistance requesting a waiver of consent, contact the IRB.

Institutional Permission Letters

IRB approval only indicates that the research meets federal, state, and local ethical guidelines. IRB approval should not be confused with institutional approval to use facilities or resources. If institutional facilities or resources are required from SUNY Cortland, institutional approval is to be sought from SUNY Cortland administration (Dean or higher), in addition to IRB approval. For example, if an investigator plans to advertise the study through campus email, the IRB will need to approve the text of the email message to ensure that the language of the text is consistent with federal guidelines. However, IRB approval cannot grant permission to use the campus email resources.

Permission must be obtained from all off-site locations (e.g., schools, businesses, institutions) whose facilities or resources will be used to place advertisements, engage in recruitment activities, and collect data. If an investigator wishes to use an institution’s facilities or materials for participant recruitment or data collection, they must provide the IRB with documentation indicating approval from that institution.

A protocol is ready for submission when:

1. When required CITI training has been completed by the investigator and others associated with the research (e.g., co-investigators, faculty sponsor, students);
2. The principle investigator and all co-investigators, and the department chair or immediate supervisor, have signed Appendix A – Investigator Assurance (signature page); and,
3. It provides the IRB with information about the research in sufficient detail to allow the review required under DHHS regulations at CFR §46.111 (all applicable documents, letters, and materials as described in the previous section).

All IRB applications and supporting documents are to be sent to the IRB by email as a single PDF file.

Investigators are responsible for responding to communications from the IRB and are responsible for providing information/documents when they are requested. Except for originally signed documents, which should be sent through intercampus mail, all documents and information are to be sent via email. Email is the preferred method of communication, as OHRP requires documentation in writing.

Address:

• • SUNY Cortland IRB
  • PO Box 2000
  • Miller 303
  • Cortland, NY 13045

Email: irb@cortland.edu

The IRB Administrative Assistant serves as a liaison between the IRB and investigators. The IRB Administrative Assistant ensures that all communications among parties are documented in writing and stored in a central location, according to federal regulations (45 CFR 46) and OHRP guidelines. All applications, appendices, proposed consent forms, revisions to protocols, and materials are to be submitted to the Human Protections Administrator at the address listed above.. Forms, documents, and information sent to any other location cannot be considered for review.

SUNY Cortland uses a primary reviewer system. After submission to irb@cortland.edu, the primary reviewer conducts an in-depth examination of all information and documents. At this stage, the reviewer confirms the classification of the research (exempt, expedited, full review) and ensures that the IRB has enough information in sufficient detail to meet DHHS regulations for review at CFR §46.111. Next, the primary reviewer examines the proposed consent/assent document(s), to make sure that they are legally effective. Should the primary reviewer find that revisions or further documentation is required, they will contact the primary investigator, in writing, to request revisions or amendments. IRB review is suspended until the requests have been satisfied by the investigator.

Once a protocol file is complete, the action the IRB takes depends upon the level of review. Exempt protocols are reviewed by the Human Protections Administrator or IRB Chair to determine whether the research is exempt from IRB review. Expedited protocols are reviewed by a member of the IRB and audited by a second member of the Full Board (typically the IRB Chair or Human Protections Administrator). A summary of all exempt and expedited protocols is reviewed by the Full Board. Full review applications are forwarded to the IRB Chair or Human Protections Administrator and will be placed on the agenda for the next available Full Board Meeting. The IRB will notify the investigator of the location, date, and time of the full board protocol review. Investigators are invited to this meeting to speak to their protocol and answer any questions that the board may have. After the protocol review, the IRB Chair will notify the investigator of the determination made by the Full Board and next steps in the approval process.

OHRP has identified the following responsibilities of all investigators, including faculty sponsors of student led research:

1. Investigators have the primary responsibility for protecting the rights and welfare of human research participants and are responsible for complying with all applicable provisions of their institution's Assurance.
2. Investigators are expected to be knowledgeable about the requirements of the DHHS regulations, applicable state law, their institution's Assurance, and institutional policies and procedures for the protection of human participants. If doing international research, investigators are expected to be knowledgeable about the country(ies) in which research activities are being conducted.
3. Investigators are to conduct research according to the IRB-approved protocol and to comply with all IRB determinations.
4. Investigators are to obtain and document the informed consent of each participant or their legally authorized representative, unless the IRB has explicitly waived these requirements.
5. Provide a copy of the IRB-approved informed consent document to each participant or the participant's legally authorized representative at the time of consent, unless the IRB has specifically waived this requirement. All signed consent documents are to be retained for at least three years after the completion of the research and according to institutional policy.
6. Request proposed changes in previously approved human participants research activities to the IRB. The proposed changes may not be initiated without prior IRB review and approval. Proposed changes are to be submitted at least 7-10 working days in advance of planned execution for exempt and expedited research and four weeks for full review.
7. Report to the IRB a detailed description of any adverse event or incident that may have negatively affected a participant or others involved in the research study, whether that event or incident is directly or indirectly related to participation in the research. This could include any new information that changes the level of risk, serious or continuing non-compliance with the DHHS regulations, or harm to participants (including physical, psychological, economic, or social harm). This reporting should occur immediately upon discovery and no later than three working days after discovery.
8. When unforeseen circumstances pose a potential hazard to the research participant(s) that was not addressed in the original review, all research activity must cease until the protocol can be modified to address the new risks and the modifications have been reviewed and approved by the IRB.
9. Report the progress of approved research as prescribed by the IRB.
10. If a physician affiliated with SUNY Cortland engages in human participant research, they may provide emergency medical care to a research participant without prior IRB review and approval, to the extent permitted by federal, state, or local law. However, such activities may not be considered research nor may the data be used in support of research, except to the extent required by FDA regulations. Investigators should consult with the IRB to ensure that activities that meet the regulatory definition of non-exempt human participant research undergo IRB review and approval prior to the initiation of the activities.

Modifications to Existing Protocols

Investigators are not permitted to implement any protocol changes without prior IRB review and approval. All changes to a research project must be submitted to the IRB as a modification request. Modifications are categorized as either major or minor and are distinguished based on the type of changes proposed.

Minor modifications to exempt and expedited studies can typically be reviewed and approved within one to two weeks. Some examples of minor amendments include:

• Addition or removal of study personnel other than the principal investigator
• Addition of another recruiting site (e.g., data will be collected at another school in the same district)
• Minor revisions to recruitment materials and method such as a change to the phone number or the addition of a newspaper ad when using language similar to an already approved flyer
• Minor revisions to survey, interview, or focus group instruments that do not fall outside the scope of the original approved instruments such as wordsmithing, addition of clarifying questions, addition of very similar questions to those previously approved, or deletion of questions.

Major changes, especially those that change the level of risk or benefit, will require a more extensive review. Here are some examples of major changes:

• Change in principal investigator
• Change in funding source
• Any change to study purpose or procedures
• Changes to study population targeted for recruitment
• Changes in recording and/or securing of identifiable data and personal information
• Changes to the risks involved in the study
• Safety issues (if there is an unforeseen immediate risk to participants, all research must cease).
• Extension of the study duration

Review of Exempt and Expedited Protocol Changes

Proposed changes to exempt and expedited protocols that do not increase risk or decrease benefits will be reviewed using exempt or expedited procedures, consistent with the initial submission. Modifications that do increase the level of risk to participants may require a reclassification of the protocol and review at a higher level. For example, adding children as participants to an existing protocol would require that modification to be reviewed by the full board.

Review of Full Board Protocol Changes

Review of proposed changes to full board protocols must be conducted by the IRB at Full Board meetings.

Research Review and Continuation

The IRB conducts a continuing review of approved research at intervals appropriate to the degree of risk, but not less than once per year. IRB approval expires automatically after a year, unless the PI requests continuing review prior to the end of the approval period specified by the IRB. When an investigator fails to secure continuation for a protocol prior to the expiration date, the research must stop. Enrollment of new participants, new data collection, or analysis of identifiable data cannot continue for expedited and full-board protocols after the expiration of IRB approval.

The investigator must plan ahead to meet required continuing review dates. The information must be received by the IRB with sufficient time to review the request. If data collection is completed and investigators are only analyzing unidentifiable data, requesting a continuation from the IRB is not required. However, investigators must be certain to maintain the data as specified in the informed consent and application protocol.

Expedited research continuation requests are evaluated by the IRB using expedited procedures, not less than once a year for a total of three years. After three years, a new protocol must be submitted.

Full review research continuation requests are evaluated by the Full Board, using full review procedures, at intervals appropriate to the degree of risk, but not less than once a year. If the research study is closed to enrollment, all interventions have been concluded, and the only research activities are the monitoring participants or data analysis, then a continuation request for the research may be reviewed on an expedited basis.

Requests for continuing review for expedited and full board protocols must include:

1. the number of participants enrolled in the study;
2. a summary of any adverse events or unanticipated problems;
3. any withdrawal of participants from the research;
4. any complaints about the research since the last IRB review*;
5. a summary of any relevant recent literature;
6. preliminary or interim findings (published or unpublished);
7. planned amendments or modifications to the research since the last review;
8. any relevant multi-center trial reports (if applicable);
9. any other relevant information, especially information about risks associated with the research;
10. a copy of the current informed consent document and any newly proposed consent document; and
11. copies of new measures, materials, apparatus, or any other materials that may assist the IRB in their review.

*This information should be submitted at the time the incident occurs. If the information was not forwarded to the IRB at that time, the completion of a Reportable New Information form will be required.

Adverse Events in Research

When there is a report of harm to any participant, or when there is a report of a circumstance that raises risk beyond what was originally anticipated and described in the protocol, the issue is discussed by the Full Board at their next regularly scheduled meeting. If the circumstance is time urgent, the IRB Chair will call an emergency meeting of the Full Board. In all cases, regardless of the findings, the Human Protections Administrator will prepare an incident report for the Provost. This report includes a summary of the circumstances, the IRB’s discussion, findings, and suggested actions. IRB actions could range from education, or auditing research records on a more frequent basis, to temporarily suspending or completely stopping the research. The Provost’s Office may take further action, consistent with union agreements and human resource policies and procedures. In compliance with federal, state, and local human subjects’ regulations, the Provost’s Office will allocate resources appropriately to address any harm to participants.

The Provost’s Office, in consultation with the IRB Full Board, reports to OHRP unanticipated problems, any serious or continuing noncompliance with 45 CFR Part 46, or the requirements or determinations of the IRB, and any suspension or termination of IRB approval. The Provost’s Office will comply with OHRP timelines for reporting, upon completion of an independent investigation into the allegations.

Reportable New Information

Investigators must report any unanticipated problems (including adverse events), newly identified information, and instances of noncompliance immediately to the SUNY Cortland IRB using the Reportable New Information Form. The IRB needs to be notified of any deviation from the approved protocol, even those that seem manageable or very minor. Early reporting of any problems provides an opportunity for the IRB and/or institution to assist the investigator with necessary modifications to protect both research participants and future data collection.

If the research is externally funded, the PI should not contact a research sponsor. The RSPO will determine the appropriate procedures for reporting to the funding agency. SUNY Cortland complies with OHRP recommendations for reporting unanticipated adverse events on all research (funded or not funded). See OHRP Guidance Document, "Reporting Incidents to OHRP". When required by OHRP regulations, the Institutional Official reports all incidents to OHRP.

Internet research is bound by the same regulations (federal, state, local) as any other kind of research. In fact, internet research can raise additional ethical and logistical concerns, which are outlined below.

• Most internet research conducted at Cortland involves the administration of anonymous surveys. If these surveys focus on routine daily life activities and are non-controversial, the research is typically classified as exempt. A waiver request for documentation of informed consent is routinely granted, since requesting signed consent would pose more risk to participants (e.g., confidentiality risk) than the anonymous questionnaire.
• Because internet research is not necessarily restricted by geography or national borders, researchers must ensure that they are complying with the data privacy laws and regulations in those jurisdictions from which they are recruiting participants. As an example, a study recruiting participants from social media would have to meet data protection regulations found within the General Data Protection Regulations (GDPR) for participants responding from a European country, unless that study is explicitly delimited to people living in the United States.
• Researchers are responsible for ensuring and documenting for the IRB that all software, web-hosting, data storage, and other internet applications used in their research meet appropriate standards for data security. SUNY Cortland sponsors several applications for conducting internet research including SelectSurvey and Formstack. The use of other online survey applications require the investigator to demonstrate that those platforms meet the necessary data security provisions. Additionally, when the purchase of other survey platforms is planned, prior approval must be obtained from SUNY Cortland Information Resources. When grant money is being utilized to purchase software, approval must also be sought from the Research and Sponsored Programs Office.

Research using Crowdsourcing Platforms

Investigators using crowdsourcing platforms (e.g., Prolific, MTurk) to conduct survey research must still provide explicit details about participant recruitment and other research methodology. Specifically:

• A step-by-step description of all recruitment processes from initial study advertising through the completion of data collection must be provided.
• Screenshots of the survey and any other information for participants must be included in the application exactly as it will appear on the platform.
• Compensation/remuneration must be consistent with the platform’s policies and SUNY Cortland IRB guidance.

Student research assistants and student employees cannot be asked to use crowdsourcing systems that require creating an account, entering personal information, or being audio or video recorded, unless that platform’s data handling practices are compliant with FERPA regulations. As an example, Prolific is not FERPA compliant.

Compensation is benefits that are given to research participants that they would not otherwise get that are used to increase research participation. Researchers must determine if compensation is appropriate for their study. Incentivising research subjects for their participation is an acceptable practice, provided that the compensation is not so significant that it could be coercive. Non-monetary benefits or other opportunities assigned on the basis of participation in a research study (e.g. extra course credit, entry in a raffle to win a prize, gift cards) also count as compensation. Recruitment materials cannot focus on compensation as a benefit of research participation, or use exaggerated or enticing language to describe incentives. Information about compensation should be secondary to information about the study purpose and methodology.

When considering incentives, researchers need to be sufficiently familiar with the study population to evaluate how compensation might affect decisions around participation. The IRB will assess the appropriateness of incentives based on the entire context of the research study, including the study population. This will include consideration of the participants’ medical, employment, and educational status, and their financial, emotional, and community resources.

Researchers must also disclose the terms and conditions of compensation in all recruitment and informed consent documentation, including a description of the conditions under which a participant would receive partial or no payment. Research studies that involve data collection over long periods of time (weeks to months) should have a plan that explains how compensation will be prorated for participants who withdraw before the end of the study. Often compensation is awarded at interim points in the study (e.g., a partial payment is awarded once initial interviews are completed).

For research in which data is collected at a single time, researchers must be prepared to pay all participants who appear for the session, even if they do not complete that session because participants have a right to withdraw from a research study without penalty.

Ultimately, the IRB will use four questions when determining the appropriateness of compensation:

1. Are all conditions in keeping with standards for voluntary and informed consent?
2. Is the compensation offered reasonable, based upon the complexities and inconveniences of the study and the particular subject population? Often researchers use local minimum wage as a benchmark for compensating participants for completing mundane tasks.
3. Are volunteers asked to assume extra or unusual risks for which there ought to be additional incentives? Please note that compensation may not be used to offset risks to participants.
4. Should the IRB monitor participant recruitment to determine that coercion or undue influence is not a factor?

Reimbursement should be given to research participants to cover the costs of participating in the study, as a way to make research recruitment more equitable. Ideally, participants should not incur expenses (e.g., parking fees, cab fare, mileage, fees for services, postage, babysitting, etc.) to participate in a research study that are not paid for or reimbursed by the researcher. Any expenses that participants will incur must be clearly outlined in the research protocol and explained in the consent documents. Reimbursement for expenses is not considered compensation. For special considerations related to compensation for student participants (i.e., extra credit in a course) see the Research with SUNY Cortland Students section (pg. 29).

Program evaluation is data collection solely intended to inform program development or implementation, does not meet the federal definition of research, and is not subject to IRB review. As an example, the collection and reporting of data required by SUNY or participation in federal assessment initiatives does not require IRB review. When conducting evaluation of SUNY Cortland programs, the Institutional Research and Analysis Office should be consulted about existing data before new efforts are initiated (Phone: 607-753-5565).

If program evaluation is also intended to create generalizable knowledge that will be disseminated beyond local stakeholders then it is classified as research and requires IRB review.

Data collection for program evaluation not requiring IRB review should still mirror the ethical standards required in research, particularly with respect to informed consent, voluntary participation, and the right of participants to withdraw.

Research conducted in foreign countries must be reviewed and approved by the SUNY Cortland IRB. In addition international research typically must also be approved by the local equivalent of an IRB. Where there is no equivalent research ethics board or committee, researchers must work with local NGOs, researchers, or community leaders to ensure that the project is consistent with cultural and legal expectations, and provide documentation that the research meets local ethical standards.

Application materials must include copies of the informed consent document(s), any survey or interview questions, and recruitment materials in both English and the language(s) in which they will be provided to participants.

As part of its review, the IRB will also require letters of local approval from each international site where the research will be conducted (e.g. local schools, hospitals, or treatment facilities). Researchers are urged to plan for the additional time that will be needed to obtain and document local support and review, and for the SUNY Cortland IRB to then review these important documents.

Both the U.S. and host country standards for protecting human participants must be respected through the IRB review, approval process, and the conduct of the research. Where the two sets of standards present a conflict, the research must meet the higher standard. In particular, while the SUNY Cortland IRB will not impose American standards for written documentation on other cultures, it cannot relax standards for ethical conduct of research or for a meaningful consent and/or assent process, including ensuring additional protections for vulnerable populations. Vulnerable populations will be defined based on the local context and culture. It is imperative that the researcher be familiar with these, and be able to explain both specific vulnerabilities and safeguards for participants in the application.

Although data protection laws are not specifically under the IRB’s domain, there are restrictions on bringing identifiable data into and out of many countries. The European Union, for example, has stringent regulations (GDPR) surrounding what kind of identifiable information can be taken out of Europe and brought to the United States. These apply to electronic data that will be housed on U.S. servers as well. Data export laws may also affect human participants research in countries with which the U.S. has embargoes or trade restrictions, such as China, Iran, Russia, and North Korea. Investigators must seek additional approval for international research from the Research and Sponsored Programs office. PIs should be aware that this process can take several months, and in some circumstances international data protection policies cannot be met sufficiently to allow research in those countries to be approved.

Researchers must clearly convey their data confidentiality and privacy plans to potential study participants. Data are considered anonymous only if no one, not even the researcher, can connect the data to the participant. Data cannot be considered anonymous if researchers collect any direct identifiers. Direct identifiers include but are not limited to:

1. Participant names
2. Geographical elements (such as a street address, city, county, or zip code)
3. Dates related to the health or identity of individuals (including birthdates, date of hospital admission or discharge, date of death, or exact age of a patient older than 89)
4. Telephone numbers
5. Fax numbers
6. Email addresses
7. Social security numbers
8. Medical record numbers
9. Health insurance beneficiary numbers
10. Account numbers
11. Certificate/license numbers
12. Vehicle identifiers
13. Device attributes or serial numbers
14. Digital identifiers, such as website URLs
15. IP addresses
16. Biometric elements, including finger, retinal, and voiceprints
17. Full face photographic images
18. Other identifying numbers or codes

Direct identifiers may also include other unique individual characteristics (e.g. race, occupation, socioeconomic level) that make it possible to identify an individual from a pool of subjects. The research protocol and informed consent document must clearly specify how direct identifiers will be coded or de-identified in the research analysis and dissemination.

Data are coded when a link exists between a unique code and an individual participant’s identifiers. Generally, the data is collected with a “Study ID,” and a linkage file is maintained where the Study ID is associated with the subject’s identifiers. The code should not be a combination of information related to the individual, such as initials, date of birth, etc.

Data are considered de-identified when any direct or indirect identifiers or codes linking the data to the individual participant’s identity are destroyed. De-identification can occur by removing the code from the dataset or destroying the linkage file. At this point, no data can be linked back to an individual participant by anyone involved in the research.

Researchers must disclose the limits of confidentiality in their consent form, and if researchers have direct contact with the participant, they should make the participant aware of these limits verbally as well.

Mandated reporting is the legal responsibility to report instances of suspected abuse, neglect, self-harm, or harm to others that are encountered in the course of fulfilling professional obligations. These reports are often made to government authorities (e.g., child protective services), although sometimes they are made to the individual’s supervisor or a 3rd-party institution. Laws for mandated reporting vary by state and profession. Additionally, workplaces (such as SUNY Cortland) have their own policies that must be followed.

Mandated reporting responsibilities can directly conflict with obligations to protect confidentiality in research. There are circumstances in which a researcher may be bound by law to report their findings to an entity outside of the research team.

Researchers must explain any professional reporting responsibilities that could reasonably be expected to arise in a specific study, The consent and/or assent document must be tailored to the study population and the potential issues. Specific language to help potential participants understand reporting mandates might be related to:

• Possible child abuse or neglect
• Suspected suicidal behavior or other self-harm
• Potential Title IX violations
• Justice-involved participants
• Responsibilities of student researchers who are not mandated reporters

Suspected abuse or neglect of youth, or any other potential concern related to research participants must be reported to the faculty sponsor and the Human Protections Administrator. Researchers who conduct research with vulnerable populations, such as neglected or abused youth may be required to complete additional training sessions before engaging with study participants. SUNY Cortland requires mandated reporter training for all faculty and staff to help them understand their responsibilities under Title IV. Researchers can also consult with the IRB Office, Title IX, or Human Resources to ensure that planned research is in compliance with all relevant reporting requirements.

SUNY Cortland students (e.g., undergraduates, graduate students, those in certificate programs, etc.) may be recruited for research participation with specific additional safeguards described in the following section. All student research participants must be eighteen years of age. Otherwise, parental consent as well as student assent are required.

Students may not be required to participate in research as a course requirement. Students may be offered course credit or extra credit to participate in research provided that an alternate non-research assignment is also available. Alternate assessments must be equivalent in terms of time commitment and credit awarded.

Recruitment of students as research participants must be designed to minimize the possibility of undue influence. Students should not be selected as study participants solely on the basis of convenience when they would not otherwise be appropriate for inclusion. In general, potential participants should be solicited broadly from the population of individuals meeting the conditions for study, rather than by personal solicitation of specific individuals. As an example, a study exploring college student engagement with social media should not recruit participants solely from an investigator’s own classes or department unless there is a reasonable justification provided in the study inclusion/exclusion criteria.

Investigators must consider strategies to ensure voluntary participation when the participants of research include students who receive instruction directly from the investigator(s). Strategies to minimize the potential influence of an investigator when conducting research with their own students include recruitment by general announcements, postings or sign-up sheets, or other methods that allow a student interested in participation to initiate contact with the investigator(s). Recruitment and consent documents must make clear that a student’s decision about research participation will not affect their course grade or other opportunities or decisions from the faculty investigator(s) or academic department.

Unless they are engaged in pedagogical research, investigators should not recruit students who are currently enrolled in one of their own classes. Faculty who are conducting research about their own teaching practices may not ask students who are currently enrolled in one of their courses to participate in that research. Faculty should consult with the IRB about ethical ways to engage in pedagogical research with current students in their courses or program.

The Family Educational Rights and Privacy Act (FERPA) is a federal law regarding the privacy of student records and the obligations of the institution, primarily in the areas of release of the records and the access provided to these records. FERPA gives parents certain rights with respect to their children's education records. These rights transfer to the student when they reach the age of 18 or attend a school beyond the high school level. Any educational institution that receives funds under any program administered by the U.S. Secretary of Education must meet FERPA requirements. Institutions that fail to comply with FERPA may lose federal funding.

Education Records

Education records are defined as records, files, documents, and other materials that contain information directly related to a student and are maintained by an educational agency or institution or by a party acting for such agency or institution. Education records take many forms, including paper and electronic.

Education records include things like:

• graded papers
• exams
• transcripts
• class rosters
• notes from a conversation with a student
• computer screens displaying student information
• emails containing information about a student
• sole possession (lap drawer) records
• peer graded papers
• online forums (e.g., Brightspace chats)
• law enforcement unit records
• medical records
• employment records (unless employment is based on student status)
• alumni records

Student Information Not Subject to FERPA Restrictions:

Schools may disclose, without consent, “directory” information, however, students have the right to request that their information be excluded from this list. Directory information includes such things as:

• name
• address
• email address
• phone number
• major
• dates of attendance
• admission or enrollment status
• campus
• school
• class standing
• degrees & awards
• activities
• sports
• athletic information

Access to Student Records

School officials may not disclose a student’s education records, or allow inspection of these records, without written permission of the student or parent unless such action is covered by exceptions permitted by FERPA. A notable exception is disclosing information to school officials determined by the institution to have a legitimate educational interest. Access to student records by SUNY Cortland officials is restricted to that portion of the student record necessary for the discharge of that person’s assigned duties. For example, a faculty member would have access to student grades from courses they teach, but would not have access to student financial aid or disciplinary records. Faculty members are not allowed to use student assignments or grades from courses they teach in their research unless they get explicit signed consent from the student. For the use of FERPA-protected educational records, a signed written release needs to be obtained and must:

• Specify the records that may be disclosed
• State the purpose of the disclosure, and
• Identify the party or class of parties to whom the disclosure may be made.

Note that in instances where research is determined to be Exempt from IRB review, researchers must still comply with the more restrictive FERPA regulations and obtain signatures from research participants for the release of FERPA-covered information. The IRB does NOT have the authority to waive any part of this requirement. When signed releases are obtained to access student records, they should be stored with data and other consent forms for the duration specified in the IRB application.

Approval to use student educational record data in research is contingent on the agreement to:

• Use the information only for purposes of the approved research project. Any new use of the information requires new approval.
• Provide adequate protection for the information to ensure that it is not compromised or subject to unauthorized access.
• Ensure that no one outside of the research team members who are specifically listed on the protocol have access to the personally identifiable information.
• Ensure that all data shared in aggregate form is properly de-identified to avoid unauthorized disclosure to third parties.

Students as Research Assistants, Co-investigators, and Primary Investigators

There are multiple ways in which students can become involved with research at SUNY Cortland. Both graduate and undergraduate students can work with faculty as assistants or co-investigators on faculty-led research. In both of these cases it is the responsibility of the faculty member to ensure that, in addition to the required CITI training modules, the student has the necessary training and oversight to ethically conduct the research. All research assistants, and co-investigators must also be listed on Appendix B of the IRB application.

Student-led data collection projects meet the federal definition of research and require IRB review if the intention of the data collection is to develop generalizable data for publication or dissemination outside of the SUNY Cortland campus. If the purpose is to help students to gain experience with research methodology or to demonstrate academic mastery by collecting data that will not be generalized to other populations or settings (as is typically the case with undergraduate honors theses), IRB review is not required.

Students serving as the primary investigators for research are required to have a faculty sponsor. The faculty sponsor is responsible for supervising the development of the IRB application and the conduct of the research itself. Faculty are also required to ensure that the data is appropriately stored and then later destroyed in accordance with the data security plan detailed in the protocol.

Investigators should consult with campus department heads before conducting research on those departments or offices, or their constituents. The department heads are responsible for determining how their office will engage with the research, and what time or resources the department is willing to offer to the project. IRB approval of a research study does not compel other campus constituencies to assist with that research project.

Any investigator(s) not affiliated with SUNY Cortland who wish to conduct human participants research with the campus community using SUNY Cortland resources (e.g., recruitment emails that are to be sent to students in a specific major) must first identify a SUNY Cortland faculty or staff member to serve as a liaison. This liaison must be CITI certified and be knowledgeable about the research discipline and SUNY Cortland IRB requirements. The outside investigator must submit a copy of the IRB application and approval letter from the originating institution to the SUNY Cortland IRB for review to ensure SUNY Cortland’s requirements have been me t, and that no further review is required. The outside investigator(s) will receive written authorization from the IRB granting approval to conduct the study at SUNY Cortland.

Visiting Faculty and Staff

Visiting faculty or staff members who wish to conduct human participants research during their exchange program are required to follow SUNY Cortland’s institutional review policies. New projects initiated at SUNY Cortland must be submitted to the IRB. Visitors’ existing research that has been approved by the IRB of their home institution may also be subject to review by SUNY Cortland’s IRB. As an example, research data collected in another country may be required to meet additional data protection laws when transferred by a visiting faculty member to the United States. Please contact the IRB with any questions about whether an exchange visitor’s participation in a research project requires additional IRB review.

Review of Exempt and Expedited Protocols

The SUNY Cortland IRB uses a primary reviewer system for protocols that are classified as exempt or expedited. A primary reviewer is one or more designated members of the IRB who may approve an exempt or expedited protocol, request modifications, or refer that protocol to the Full Board for a more detailed review.

The IRB administrative assistant reviews submitted applications to determine the appropriate level and specific category of review. Exempt and expedited protocols are forwarded to a primary reviewer(s). The primary reviewer(s) will take up to two weeks to review the protocol and respond to the investigator with either an approval for the study or requested modifications. Investigators are invited to meet with a primary reviewer to discuss any questions they have about a review.

If an investigator disagrees with any requested modification of a study or application made by a primary reviewer, the full board will review that protocol to make the final determination.

Each month during the Full Board meeting the board conducts an audit of the approved exempt and expedited research studies approved since the last meeting. As part of its oversight responsibility, the IRB can require full board review of any application previously classified and exempt or expedited protocol approved under the Primary Reviewer process outlined above.

Review of Full Board Protocols

Reviews of full board research must be conducted by the IRB at convened meetings at which a quorum of the members of the IRB are present. The quorum must include at least one member whose primary concerns are in non-scientific areas (i.e., not involved in human participants research), except when approved expedited protocols are audited. Additionally, the IRB chair or administrator may choose to bring in outside subject matter experts to advise on the review of protocols when current board members do not have relevant subject matter expertise. The outside reviewers will serve as ex-officio members of the IRB during the full board review.

Determinations by the full board protocols require a majority vote of the quorum. Should quorum be lost during a meeting (e.g., through recusal of members with conflicting interests, or early departures, or absence of a nonscientist member), the IRB may not take further actions or votes unless quorum is restored. Board determinations may include Approval, Contingent Approval, Resubmission, and Disapproval:

Approval, Contingent Approval, and Resubmission

After the Full Board IRB meeting the IRB Chair or Administrator will communicate the decisions of the board to the investigator via email within five working days of the meeting. The IRB often sets conditions under which a full board protocol can be approved. If the modifications are minor, and do not affect either risk to participants or study methodology, the IRB can conditionally approve the research and designate an IRB member to review required modifications. When these revised materials are received, the IRB Chair or Administrator verifies that the modifications appropriately address the requirements of the contingent Full-Board approval, and an approval letter for the study is issued. All revised documentation is made available to the Full Board as part of normal audit processes.

If substantive revisions are required, the PI will be invited to revise and resubmit their protocol for another review by the Full Board at a subsequent meeting. Investigators are again invited to be present at the Full Board meeting when their protocol is discussed and answer questions about their research.

Anytime modifications are required, the Human Protections Administrator, IRB Chair, or another designated member of the IRB is available upon request to assist investigators with the revision.

Disapproval of Protocols

If a proposal fails to meet any criteria used by the IRB for approval of research, the IRB may disapprove the application. Disapproval cannot be given through the primary review procedure. A study proposal may only be disapproved by majority vote at a convened meeting of the IRB. If a primary reviewer believes that an exempt or expedited study cannot be modified to meet all criteria for approval, they contact the IRB administrative assistant who adds the item to the next regularly scheduled Full Board meeting.

Criteria for disapproval may include but is not limited to the following:

• The study violates any laws or regulations of the United States, the state of New York, or the State University of New York.
• Risks to participants outweigh the benefits to participants or society.
• Unnecessary risks are created.
• Selection of subjects is inequitable.
• Procedures for obtaining and documenting informed consent are inadequate.
• Payment or other offered inducements are coercive or otherwise inappropriate.
• The study is flawed to the degree that meaningful conclusions cannot be derived.

When the Full Board of the IRB determines that a research protocol cannot be altered or modified to meet federal, state, and local guidelines for human participant research, the protocol will be disapproved. Under federal guidelines, there is no appeal process for that protocol. Institutional officials (e.g., President, Provost, Deans, Department Chairs) may not approve research that has been disapproved by the IRB.

Should an investigator choose to prepare a new protocol for a research study that has been disapproved, they should seek guidance from the IRB and colleagues in their discipline to address the issues, methods, or procedures related to the disapproval. Investigators who believe that issues with their protocol cannot be resolved by the full board are encouraged to speak with the Human Protections Administrator, IRB Chair, and the Provost (campus signing authority).

Expiration of IRB Approval

Research protocols are typically approved for one year from the approval or research start date. In some instances, the IRB may determine that a protocol requires more frequent review due to elevated potential risk to participants, or if noncompliance has been an issue with past research. If the IRB decides more frequent review is necessary, the investigator can ask the board to revisit that determination at each continuation review.

Continuing Review of Exempt Research

Once a protocol has been confirmed to be exempt from IRB review, it is not required to undergo continuing review. Investigators must alert the IRB of changes to their study by submitting a modification. The IRB will either make a determination that the proposed modifications do not impact exemption status, or require that the modified protocol be submitted for an expedited or full board review.

If an adverse or unforeseen event occurs with an exempt research study, principal investigators must report the event to the IRB. While an exempt determination has no expiration, investigators must follow closeout procedures when research activities have been completed (see Closeout of Protocols).

Continuing Review of Expedited and Full Board Research

If research activities will continue past an expedited or full board protocol’s approval, the IRB must receive a continuation request before the expiration date of that protocol. Continuation requests can be submitted to extend the research for a total of five years. If the research is going to continue beyond five years, the investigator must submit a new application to the IRB. Requests for continuing approval of expedited protocols are evaluated using the primary reviewer process. Continuation of Full Board protocols requires the review and approval of the Full Board.

Continuation requests must include updated information about the study, including:

1. The number of participants enrolled.
2. A summary of adverse events and any unanticipated problems involving risks to participants or others. This information should be submitted at the time the incident occurs. If the information was not forwarded to the IRB at that time, the investigator is obligated to provide that information at the time of continuing review.
3. Any withdrawal of participants from the research.
4. Any complaints about the research since the last IRB review. This information should be submitted at the time the incident occurs. If the information was not forwarded to the IRB at that time, the investigator is obligated to provide that information at the time of continuing review.
5. A summary of any relevant recent literature.
6. Preliminary or interim findings, either published or unpublished.
7. Planned amendments or modifications to the research since the last review.
8. Any relevant multi-center trial reports, if applicable.
9. Any other relevant information, especially information about risks associated with the research.
10. A copy of the current informed consent document and any newly proposed consent documents.
11. Copies of new measures, materials, apparatus, or any other materials that may assist the IRB in their review.

Study closure is required within a reasonable time frame of completion of expedited and full board research. A protocol is eligible for closure if enrollment of participants is permanently closed; any and all participant interventions and interactions are complete, including collection of long-term follow-up data/samples; no additional identifiable private information will be obtained; and any analysis of identifiable private information is complete. Additionally, an approved study that will not be initiated must be closed. Please complete a Study Closure Form and submit it to the IRB.

Investigators must maintain human participant research records–including signed and dated consent documents, if obtained–for at least three years after completion of a study. Records may need to be kept longer if other regulatory requirements apply. For funded research, confirm the sponsor’s records retention requirements before disposing of human research records. If multiple regulations apply, keep the data for the longest required amount of time.

For exempt research, investigators should notify the IRB via email when a study is complete. The completion of a Study Closure Form is not required.

IRB may audit research projects (exempt, expedited, full board) at any time to ensure the rights and welfare of research participants are protected and that the research complies with federal regulations, state laws, and institutional policies. Audits can be conducted by the Human Protections Administrator, IRB Chair, or their designee. In cases where there is a potential conflict of interest, or specific expertise is needed, the Human Protections Administrator may appoint an external auditor.

During routine audits the focus is on ensuring proper documentation, record keeping, data analysis, and adherence to applicable Federal regulations and IRB policy in order to monitor, measure, and improve the effectiveness of the human research protection program. An audit may include a site visit to the place where the research is being conducted, a review of research related documents, and interviews with key research staff. The audit assesses compliance with study procedures, identifies errors and omissions, and is a means to provide the investigator with recommendations for corrections and improvements in order to protect the rights and welfare of research participants.

A for-cause audit is typically initiated after complaints or concerns about a study have been raised by a research participant, research team member, or someone else affiliated with the research or the university.

Except in cases where the safety of participants is a concern, or where the IRB specifically requests an unannounced audit, audits will be scheduled within a two week timeframe at the convenience of the researcher.

After an audit, the investigator is informed of the result of the review in a written report from the IRB administrator or chair. The written report is also sent to other institutional officials as appropriate. Should any problems or deficiencies be identified in the audit, the audit report will contain steps and timelines for remediation.

No IRB member may make decisions about the IRB's initial or continuing review of any project in which they have a conflicting interest. IRB Members must disclose to the Human Protections Administrator or Chair when they have a conflict and must recuse themselves from the review process of any protocol when:

• They are an investigator or co-investigator;
• Their spouse or significant other is an investigator or co-investigator;
• They have an identified financial conflict of interest;
• When they are a member of a group that has funded any portion of the study
• When they feel that they cannot provide an unbiased opinion.

The report of the conflict of interest and the subsequent recusal for full board reviews will be noted in the meeting minutes. By necessity, the IRB Chair and Human Protections Administrator may remain present during Full Board discussions, but are to stay silent on a protocol when a conflict exists, except to provide information concerning policy and procedure as required.