This manual contains the operating policies and procedures of the Institutional Review Board (IRB) at Syracuse University. The manual is designed to provide guidance to the IRB in decision-making and to inform members of the university community and other interested persons and bodies of the IRB’s role and functioning.

The IRB is committed to two key principles. The first is that research undertaken by faculty, students, and staff at Syracuse University must meet the highest standards of ethical conduct. The IRB recognizes that the conduct of ethical research and the protection of participants in research studies represent a shared responsibility among faculty and student investigators, department heads, deans, and university officials, and research support staff as well as the IRB. Accordingly, the IRB seeks to foster among members of the university community an atmosphere in which the design and implementation of research studies are based on internalized values regarding ethical conduct.

The second principle is that the IRB should establish safeguards and implement policies and procedures to ensure, to the extent possible, that all research conducted at Syracuse University is in compliance with applicable federal regulations and policies, in accord with the university’s Federalwide Assurance of Compliance with DHHS Regulations for Protection of Human Research Subjects (FWA)[1]. It is important that all members of the university community understand that unethical research conduct and a failure to follow established policies and procedures are not only wrong, but also threaten the ability of all investigators at the university to conduct research[2].

The IRB acknowledges the inherent tension between its educational and regulatory compliance roles. To those unfamiliar with the Syracuse University’s IRB’s decision-making and deliberations, IRB requirements may seem rigid and bureaucratic. The IRB operates in the context of regulations and does not have the authority to waive or modify requirements, unless explicitly provided for in the regulations. Further, in its policies and procedures as well as its decisions on specific applications, the IRB may require certain safeguards that go beyond the minimum requirements of the regulations. This reflects the IRB’s experience reviewing hundreds of research protocols and having encountered potential and actual harms to human beings that were unanticipated by investigators. It also reflects the orientation of the IRB. Although the IRB supports the research mission of the university and believes that research can benefit society, it also is aware that the pursuit of knowledge, the extrinsic and intrinsic rewards that accompany research productivity, and the influence of external funding have caused some investigators and some institutions to ignore or downplay risks to research participants[3]. The IRB’s primary responsibility is to protect the rights and welfare of those who participate in research.

The IRB cannot eliminate the tension between its dual roles. However, the IRB’s actions and decisions are not arbitrary and are based on rationales derived from applicable regulations or its experience and judgment.

A final note on the policies and procedures outlined in this manual: the IRB is guided by proportionality. Within the discretionary decision-making permitted by the regulations, the IRB attempts to carefully weigh protections against risks. The greater the potential risks to participants, the greater the oversight exercised by the IRB and the greater the protections it will impose on investigators, whether or not these are required by the regulations. The vast majority of research conducted at Syracuse University is social and behavioral in nature. Although this research can bring harm to human beings, it does not pose the risks, including disease, injury, or death, associated with unethical medical, genetic, and pharmaceutical research documented in the ethics literature and the media[4]. No research is risk free, but studies carrying minimal or negligible risks should not be held to the same standards and safeguards characterizing high-risk research[5].

Steven J. Taylor, Ph.D.

1. INTRODUCTION Top

The IRB’s policies and procedures are guided by three key documents: (1) the Belmont Report; (2) federal regulations governing the protection of human subjects in research; and (3) the Federalwide Assurance of Compliance with DHHS Regulations for Protection of Human Research Subjects.

1a. The Belmont Report

The National Research Act, passed by Congress in 1974, created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research[6]. The National Commission wrote the Ethical Principles and Guidelines for the Protection of Human Subjects of Research, referred to as the Belmont Report, which was published in the Federal Register in 1979. The Belmont Report provided the basis for federal regulations and described three ethical principles for the conduct of research involving human beings. Ethical research requires a careful balancing of these three principles.

Respect for Persons. The principle of respect for persons acknowledges the autonomy of human beings and provides for protections for persons with diminished autonomy (e.g., children, prisoners, and people who are limited in their ability to make conscious decisions). The IRB seeks to assure respect for persons by requiring informed consent by research participants.

Beneficence. Beneficence requires researchers to avoid bringing harm to research participants and to take steps to maximize the benefits of research and minimize risks. The IRB assesses the risks and benefits of human research.

Justice. Justice requires fairness in the selection of participants in research. The IRB reviews applications to make sure that the inclusion or exclusion of people in research is fair and equitable.

1b. Department of Health and Human Services (DHHS) Regulations at 45CFR46

The IRB’s policies and procedures are based on the “Common Rule,” a set of regulations adopted by 16 federal departments and agencies in 1991. In addition, the IRB closely follows policies and guidance provided by the U.S. Office for Human Research Protections (OHRP), the federal agency charged with ensuring compliance with the regulations[7].

1c. Federalwide Assurance of Compliance with DHHS Regulations for Protection of Human Research Subjects

In accord with 45CFR46, Syracuse University has provided DHHS with an assurance that it will comply with federal regulations for human subjects protections. This assurance, known as the FWA, covers the responsibilities of the university, the IRB, and investigators. Ben Ware, Vice President for Research, as the authorized Syracuse University representative, signed the FWA. Under the FWA, all research involving human subjects at Syracuse University—not just federally funded research--is subject to IRB review and approval.

2. RESEARCH SUBJECT TO IRB REVIEW Top

The IRB has jurisdiction over all “research” at Syracuse University involving “human subjects.” This section of the manual provides definitions of research and human subjects to clarify the scope of IRB authority.

2a. The Definition of Research

Research is defined by federal regulations as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This definition may include qualitative and quantitative research studies, surveys, case studies, experiments, interventions, analysis of specimens, demographic and epidemiological research, program evaluations, oral histories, secondary analyses of documents and records, and other methods associated with the biomedical, behavioral, and social sciences.

Research Versus Non-Research. The IRB recognizes that researchers and non-researchers might use the same procedures and techniques in pursuit of their goals. For example, both may rely on written responses to questions, interviews, observations, videotaping, and document analysis. Research is characterized by an intent to share knowledge with others in professional, scholarly, or scientific publications or forums[8]. Journalism[9], art, literature, and music do not fit the definition of research subject to IRB review. Practitioners in these fields engaged in normal professional practice are not expected to submit their planned work to the IRB. However, journalists and others who use the methods of social and behavioral science to contribute knowledge to members of their professions are expected to undergo IRB review.

Evaluations. Evaluations are subject to IRB review if they fit the definition of research provided above: a systematic investigation designed to contribute to generalizable knowledge. Not all evaluations fit this definition. Evaluations conducted exclusively for quality assurance, quality improvement, or accountability purposes are not research and do not require IRB review. In these evaluations, there is no intention to share knowledge and information with external audiences. For example, a faculty member conducting a routine course evaluation or a department surveying the satisfaction of graduates to improve program quality would not be required to go through the IRB; a faculty member or administrator evaluating a program or teaching strategy with a view towards reporting the results professionally would be required to have the evaluation approved by the IRB.

Covered Research. All research conducted by faculty, staff, and students in conjunction with their official roles at Syracuse University is subject to IRB review. Student research used to fulfill any requirements for their degree programs, including but not limited to thesis and dissertation research, must be approved by the IRB, with exceptions as noted below. Faculty and staff research must be approved by the IRB, whether or not the research is externally funded.

The IRB has no jurisdiction over research conducted by members of the university community independently of their official roles and responsibilities. Faculty, in particular, may undertake research projects on their own as private contractors. Such research will be deemed independent of their official roles and responsibilities and not subject to IRB review if: (1) the research is conducted on their own time and not reimbursed by the university or through university accounts; (2) the research is conducted without the use of university space, materials and supplies, and secretarial or staff support; and (3) any research publications, reports, or presentations will not list the faculty member’s position and affiliation with Syracuse University.

IRB approval is not required for university members to act as consultants on research, if they do not obtain, receive, or possess identifiable private information.

Research Conducted at Syracuse University by Investigators from Other Institutions. Syracuse University officials and faculty sometimes are approached by investigators at other institutions for cooperation in their research. For example, department heads or deans might be asked to assist in the distribution of surveys to faculty or students. This research does not fall under the jurisdiction of the IRB unless: (1) university facilities, including physical space, and resources will be used; (2) university officials are actively engaged in or actively cooperate with or encourage participation in the research; or (3) university officials, faculty, staff, or students intend to use the findings or results of these studies for their own purposes.

The release of private, confidential information about members of the Syracuse University community for research requires IRB approval. IRB approval is not required for university offices or officials to inform members of the university about research or provide them with information about contacting investigators if they wish to participate.

The Chair of the IRB serves in an advisory capacity to university officials and faculty with regard to research conducted by investigators from other institutions at Syracuse University that does not fall under IRB jurisdiction (e.g., the Chair can provide advice on such matters as the risks and benefits of the proposed research, informed consent, etc.).

Research by Syracuse University Investigators at or in Cooperation with Other Institutions. The Syracuse University IRB is required to review all research involving human subjects by university investigators and cannot delegate this responsibility to IRBs at other organizations without a formal agreement approved by the federal government. Investigators sometimes conduct research at or in cooperation with other organizations that have their own IRBs. In such instances, investigators should expect to be required to submit separate applications to the relevant IRBs. Syracuse University’s IRB makes independent determinations regarding the approval of applications. However, the Syracuse University IRB will not approve research that has been disapproved by another IRB that is exercising its appropriate authority.

In research requiring approval by multiple IRBs, Syracuse University’s IRB does not require the research to be approved by other IRBs before it reviews and approves the research. The research cannot be conducted until the investigator submits documentation of approval by the other authorized IRB(s).

Student Projects: Research Versus Pedagogy. Many research methods courses at Syracuse University require students to complete projects as a way of teaching them research methods and skills. Institutional Review Boards at institutions of higher education vary according to whether they require student projects to be reviewed and approved. Syracuse University’s IRB does not require student projects conducted in research methods courses to be reviewed if the purpose of these projects is pedagogical in nature. Activities not intended to provide generalizable knowledge are not subject to IRB review[10].

Students are not permitted to continue projects conducted for a research methods course after the semester has ended without IRB approval.

Students in graduate methods courses, in particular, sometimes use projects to refine their research interests and provide a foundation for a thesis or dissertation. A project initially conducted to learn research methods may yield data that the student subsequently wishes to use to contribute to knowledge. In order to use these data for theses, dissertations, or other research purposes, students must either: (1) demonstrate that individuals provided informed consent for the project at the time, through procedures approved by the instructor; or (2) obtain consent from people to use previously collected information according to procedures approved by the IRB (i.e., an application for exemption, expedited review, or full IRB review). Instructors of methods courses requiring student projects are encouraged to send a memo to the IRB Chair listing the students and their research projects and indicating that the projects were conducted under the instructor’s supervision and in accord with procedures approved by the instructor. The Chair will provide a memo verifying that the student projects did not require IRB approval.

Student projects in courses are subject to IRB review if they are designed at least partially to provide data for research purposes. For example, instructors may enlist students to assist in data collection or analysis for their own research or may design seminars in which a goal is for students to collaborate in research that will be submitted for publication. These projects constitute research and must be submitted to the IRB for approval beforehand.

Grant Applications. The IRB does not require investigators submitting proposals for externally funded research to have their proposals reviewed and approved by the IRB. However, research specified in proposals cannot be conducted without IRB approval. Although the IRB does not require investigators to submit grant proposals for approval, they should be advised that funders or the Office of Sponsored Programs may require research to be approved by the IRB prior to the submission or awarding of a grant or contract or the expenditure of funds for preparatory activities.

Pilot Studies. Investigators sometimes conduct pilot studies designed to develop or refine research procedures and instruments. Although data collected through pilot studies may not be used in research reports and publications, pilot studies represent part of the research process that leads to the development of or contribution to generalizable knowledge. As such, pilot studies require IRB review and approval. Experts reviewing draft research procedures or instruments are not considered human subjects, and IRB approval is not required for this.

In making determinations on pilot studies, the IRB recognizes that standards of scientific merit appropriate for a full-scale study (e.g., sample size and composition) may not be appropriate to impose.

2b. The Definition of Human Subjects Top

Human subjects are defined in federal regulations as “living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” Intervention includes both physical procedures by which data are gathered and manipulations of the person or person’s environment for research purposes. Interaction includes communication or interpersonal contact between the investigator and people. Private information includes information about behavior that occurs in a context in which people can reasonably expect that no observation or recording is taking place and information provided by people for specific purposes (e.g., a medical record) that they can reasonably expect will not be made public. Private information must be individually identifiable for the activity to constitute research involving human subjects.

Public Use Data Files. Research involving public use data files that are stripped of all identifiers prior to being made publicly available does not involve human subjects and does not require IRB review or an application for exemption. Research involving public data containing identifiable private information does involve human subjects, under the federal definition. Such research may qualify for an exemption from IRB review.

Third Parties. In the course of their research, investigators sometimes collect information about persons other than the participant who has provided informed consent to be part of a study. For example, medical histories often collect information about conditions and diseases among a person’s relatives or sociological, anthropological, or psychological research may obtain information about people’s experiences with and perspectives on others in their lives. Persons who are not the primary subjects of research, but about whom information is collected are sometimes referred to as third parties or secondary subjects. A question that has been examined by many IRBs and OHRP is: when do third parties become “human subjects” from whom informed consent must be obtained?

Investigators have an ethical responsibility to avoid exposing any persons to unnecessary risks or undue harms, whether or not they are research subjects. Information collected about third parties generally should be recorded in a manner that protects their identities, and special steps must be taken to safeguard confidentiality in the case of sensitive information that could cause harm to persons unless this jeopardizes the rights and welfare of the research participants.

The IRB considers on a case-by-case basis the circumstances under which third parties should be considered research subjects. In reaching this determination, the IRB considers the following factors: (1) the amount of private information collected about third parties; (2) the sensitivity of that information; (3) the ability of investigators to maintain the confidentiality of third parties; (4) the welfare of the originally designated research subjects; and (5) the right of the originally designated research subjects to provide information on their personal life experiences. Third parties normally are not considered research subjects from whom consent must be obtained unless information obtained about them pertains to their personal behavior unrelated to the interests and experiences of the originally designated research subjects.

Expert Opinion. Faculty, staff, and students sometimes solicit the opinions of experts through phone or face-to-face interviews, surveys, and panel discussions. Experts are persons who, by virtue of their training or expertise, have information and knowledge in a substantive area beyond that of the average person and who regularly share this information and knowledge through consultation, teaching or public speaking, or publications and written reports. For IRB purposes, experts are not human subjects when asked to provide information and opinions within their areas of expertise. Communications with experts on non-private information do not require IRB approval.

Autobiography or “Auto-ethnography”. In sociology, anthropology, and related disciplines, postmodern ethnography, autobiography, or auto-ethnography is a narrative method in which the investigator and “subject” are one and the same. That is, the investigator reports on his or her own experiences and perspectives. In this form of narrative reporting, the investigator is not considered a research subject, and IRB approval is not required.

3. IRB ROLES AND AUTHORITY Top

3a. Institutional Authority of the IRB

The FWA, signed by the Vice President for Research at Syracuse University, the authorized institutional representative, creates the authority of the IRB. The FWA provides assurances that Syracuse University will comply with all federal regulations and provide authority to the IRB to make determinations regarding human subjects protections in research.

3b. Purpose and Authority of the IRB

The IRB is responsible for the review of all research conducted using human subjects at Syracuse University. Specifically, the IRB makes determinations regarding: (1) exemptions from IRB review; (2) expedited IRB approval; (3) full IRB approval; (4) modifications or amendments to protocols approved by the IRB; (5) continuing reviews of approved protocols; and (6) actions regarding adverse events and untoward incidents.

The IRB has the authority to approve, require modifications in, or disapprove all research activities involving human subjects. The IRB also has the authority to observe or monitor ongoing research as necessary to protect human subjects and to suspend or terminate approval of previously approved research.

Although the Vice President for Research, deans, department heads, and other university officials or bodies may have the authority to disapprove research activities approved by the IRB or to set more stringent requirements on research protocols, research disapproved by the IRB cannot be conducted.

Corrective Steps and Sanctions. In accord with the authority of the IRB to approve, require modifications in, or disapprove research involving human subjects, the IRB has the authority to suspend or terminate approval of previously approved studies and withhold future approval of protocols submitted by investigators who have committed unethical research conduct.

Suspension or termination of approval of research or withholding of future approval shall be made by a majority of members at a convened IRB meeting at which a majority of IRB members are present. Grounds for suspension or termination include: (1) serious breaches of IRB policies and procedures by an investigator; (2) adverse events causing physical, psychological, social, or other harms to subjects; (3) changes in the risks and benefits of a study encountered during the conduct of the research; and (4) other circumstances, which, in the judgment of the IRB, require action in order to protect human subjects from harm. The Chair of the IRB has the authority to temporarily withdraw approval of a study when necessary to protect human subjects until the full IRB can be convened. The office of Research Integrity and Protections will report suspension or termination of approval made by the full IRB immediately to OHRP.

The IRB may also impose sanctions or require investigators to undertake corrective actions as a condition of continued approval of research when minor violations of IRB policies and procedures have occurred. Minor violations include: (1) deviations from IRB policies and procedures or unauthorized changes in a previously approved protocol that have not placed participants at significantly increased risk or resulted in direct harm; and (2) a failure of investigators to respond to inquiries or requests from the IRB or the Chair in timely fashion. Sanctions and corrective actions include: (1) destruction of collected data; (2) completion of additional training in human subjects protections as specified by the IRB; (3) letter of apology to research participants and representatives of external organizations; (4) memorandum addressed to the IRB explaining the actions of the investigator, acknowledging a violation of IRB policies and procedures, and providing assurances that future violations will not occur; (5) the submission of a plan of correction to address deficiencies in human subjects protections; (6) an acknowledgement in published work or work submitted for publication that the research did not conform to IRB policies and procedures; (7) a formal memorandum of censure from the IRB to the investigator and, where appropriate, the investigator’s department head or dean; and (8) other actions warranted by the specific circumstances surrounding the violation. Sanctions or corrective actions may be imposed by either the Chair, in consultation with one or more members of the IRB, or the full IRB at a convened meeting. Sanctions or corrective actions will be reported to the full IRB and recorded in IRB minutes.

3c. The Principal Investigator Top

The IRB recognizes one Principal Investigator (PI) for each project. The PI must be a member of the faculty or an administrative department head at Syracuse University. On research conducted by students, a faculty member must serve as PI and assume responsibility for exercising appropriate oversight of the student’s research.

The PI, including faculty members in the case of students, must personally review and sign all applications, amendments, continuations, and documentation submitted to the IRB. The PI must identify key personnel involved in the conduct of research, monitor their activities, inform the IRB of proposed changes in approved research, adverse events, and untoward incidents, and respond in timely fashion to inquiries or requests from the IRB.

All official IRB correspondence is addressed to the PI. Faculty members overseeing student research should make arrangements to keep students informed of IRB determinations.

PIs, research staff, and students are encouraged to communicate informally with the Chair or the Office of Research Integrity and Protections when they have questions about IRB policies or procedures. Formal communications, including applications for exemption and expedited or full IRB review, continuation applications, amendments, and notification of adverse events, must be communicated in writing, on forms developed by the IRB, and submitted to the IRB office. The IRB communicates to PIs regarding initial and continuing reviews and amendments through memoranda following a standard format.

Undergraduate Research Projects

The IRB acknowledges the educational value of involving undergraduate and graduate students in research projects. The IRB also notes that ethical human research emerges from the use of sound research methods. Consequently, the IRB applies the same standards to student research as is does to research conducted by faculty.

Faculty members supervising and approving students’ research are responsible for the ethical conduct of this research.

The IRB recommends that faculty members sponsoring undergraduate research (e.g., honors theses) develop with these students research projects that carry either minimal risk (i.e., qualified for expedited review) or that meet one of the federally approved categories for exemption. Students can learn research perspectives, methods, and skills without putting human beings at risk. Faculty members should have compelling reasons for sponsoring undergraduate research projects that carry more than minimal risk and will be expected to even more closely supervise such research and propose an appropriate oversight plan in the IRB application.

3d. Appeal of IRB Determinations Top

The Chair or his or her designee makes determinations on exemptions, applications submitted for expedited review, continuations of minimal risk research, and modifications or amendments that do not alter the risks and benefits of research. A list of approved exemptions, applications approved for expedited review, and approved continuations is provided to each member of the IRB, and copies of all applications are available for review by IRB members. Upon the motion of any member at a convened IRB meeting, the full IRB, by majority vote, may disapprove any of the exemptions, applications, continuations, or amendments approved by the Chair or designee.

Exemptions and expedited reviews are optional procedures that are authorized, but not required, by federal regulations. These have been established by the IRB as a convenience for investigators who conduct research carrying no more than minimal risk. Because disapproval of exemptions and applications for expedited review do not prevent investigators from conducting their research (they can submit applications for full IRB review), the Chair’s or designee’s decisions on these may not be appealed to the full IRB. Nor does the full IRB have the authority to grant approval to exemptions or expedited applications disapproved by the Chair or designee. Thus, the full IRB may impose stricter standards for review than the Chair, but may not lower the standards used by the Chair in considering exemptions or applications for expedited review. Investigators whose applications for exemption or expedited review have been denied may informally ask the Chair to reconsider his or her decision, providing, if appropriate, additional information.

The Chair or designee may provide one of three decisions on applications for expedited review: (1) Approval; (2) Provisional Approval, pending required changes, additional information, or a rationale for the procedures; and (3) Hold for Full Committee. The Chair may not disapprove applications for IRB approval without providing for an opportunity for full IRB review.

The full IRB makes one of four determinations on applications, continuations, and amendments: (1) Approval; (2) Provisional Approval, pending required changes, additional information, or a rationale for procedures; (3) Postponed (tabled, pending further information); and (4) Withheld (disapproved). When provisional approval is provided, the required revisions or requested information is recorded in the minutes and sent in writing to investigators. When applications are disapproved, the IRB provides specific reasons, which are recorded in the minutes and sent to investigators.

Investigators who have been required to make revisions in their applications or whose applications have been disapproved may request from the IRB further information regarding its reasons or may ask the IRB to reconsider its decision. Such requests must be made in writing and will be considered by the IRB at its next convened meeting, if submitted according to the published deadline for submission of materials to the IRB. At its discretion, the IRB may invite investigators to meet with the IRB or a subcommittee composed of members to collect more information or to explain the reasons for its decisions. The IRB will provide investigators with a written explanation of its reasons or its decision upon reconsideration. The IRB’s decision will be final, and no further appeals can be made.

Department heads, deans, or other university officials may be interested in the IRB’s decisions regarding applications submitted by individual investigators. With the investigators’ approval, the IRB will provide officials with copies of communications between the investigator and the IRB[11].

3e. IRB Policies Top

The IRB's policies are drafted by the IRB Chair, or designee, and approved by a majority of members present at a convened IRB meeting at which a quorum is present. The policies may be changed or revised as warranted by the majority of the IRB at the convened meeting.

When warranted and appropriate in specific situations, the IRB may waive any of its policies and procedures if: (1) the waiver is not inconsistent with federal regulations and (2) the waiver does not increase the risks to participants in research.

3f. Conflict of Interest Top

No IRB member may participate in the review of or vote on any initial or continuing application, amendment, or other matter involving research in which he or she has a conflict of interest. A conflict of interest is assumed to be present when the member is the Principal Investigator, faculty advisor, or member of a funded project on any research being reviewed by the Board or when the member has a financial interest in the sponsor of research under consideration.

Members shall excuse themselves from discussions at IRB meetings of an application or other matter in which they have a conflict of interest. This is recorded in IRB minutes. Members may provide information requested by the IRB prior to or after formal deliberations.

The Chair excuses him- or herself from reviewing applications for exemption or expedited review and amendments or continuations when a conflict of interest is present. The Chair appoints another IRB member to review such applications or research activities, and this is indicated in forms indicating the IRB’s actions.

All IRB members are encouraged to avoid the appearance of a conflict of interest that would compromise their ability to make a fair, impartial, and ethical decision on any IRB matter and to excuse themselves from decision-making in such instances.

3g. Training and Development Top

Each IRB member is expected to undertake appropriate training and educational opportunities to remain current on research ethics and federal regulations and policies. IRB members have been provided and are expected to review the following documents: (1) the FWA; (2) the Belmont Report; (3) The IRB Handbook; (4) the 1993 Institutional Review Board Guidebook written by OPPR (the predecessor to OHRP); and (5) and Protecting Study Volunteers in Research: A Manual for Investigative Sites. In addition, IRB members are provided copies with other articles, reports, and policies by the Chair and the Director of the Office of Research Integrity and Protections.

IRB members are expected to undergo annual training, education, or development activities. Each member must demonstrate and report to the Office of Research Integrity and Protections at least one of the following activities: (1) attendance at a protection of human subjects conference or workshop; (2) completion of web-based IRB training, as recommended by the Chair and Director of the Office of Research Integrity and Protections; or (3) other equivalent activity, as approved by the Chair.

The Director of the Office of Research Integrity and Protections and Chair monitor current discussions and developments in research ethics, the protection of human subjects, and federal requirements through reviews of OHRP regulations and policies, participation in workshops or conferences, and reviewing and participating in discussions of ethics and IRB policies on an Internet IRB listserv. The Director and Chair report to the IRB at meetings or through written materials on major new developments related to the IRB.

Portions of at least two IRB meetings per academic year are devoted to in-service training conducted by an IRB member or outside consultant.

4. EXEMPTIONS FROM IRB REVIEW Top

In accord with federal regulations, certain categories of research may be exempt from IRB review[12]. Determinations regarding exemption from IRB review are made by the Chair or a designee and not by investigators.

Investigators can apply for an exemption by completing a standardized form developed by the IRB (see http://orip.syr.edu/humanresearch.php). The form requires investigators to indicate the category under which an exemption is requested and to provide a brief narrative description of the proposed research. In making determinations on exemptions, the Chair or designee evaluates whether the narrative description of the research is consistent with the categories for exemption contained in federal regulations.

Exemptions are approved for a maximum of five years after approval. To continue research after that time period, investigators must apply for another exemption or complete a regular IRB application.

Exemptions are approved for specific research studies conducted by specific investigators. Departments cannot receive blanket exemptions for unspecified research (e.g., surveys, public observation) to be conducted in the future.

4a. Exempt Categories Top

The form on the IRB's web site (IRB Exempt from Review Application form) contains the exempt categories as specified in federal regulations excluding category 6[13]. The following are general guidelines used to interpret these categories[14]:

Category 1. The research must be conducted in a commonly accepted educational setting (e.g., classroom, conference facility) as opposed to a laboratory or similar setting and involve commonly accepted educational practices (e.g., forms of instructional methods) as opposed to psychological manipulations or non-instructional interventions.

Category 2. The research (educational tests, surveys, interviews, observations of public behavior) is conducted anonymously (names and identifying information are not recorded) and involves the collection of benign information that could not be damaging to a person. “Public behavior” is defined as behavior in places that any person can visit without special permission (e.g., street corners, parks, restaurants, concerts) or Internet communications in public forums. Observations of the public behavior of children do not qualify for exemption if the investigator interacts with them.

Category 3. The research (educational tests, surveys, interviews, or observations of public behavior) is conducted among elected or appointed public officials or candidates for office.

Category 4. The research involves the study of data (in existence prior to the research) that are publicly available or that are recorded in a manner in which they cannot be linked with individuals (e.g., there is not a master list of subjects that links them to identification numbers).

Category 5. This category refers to research conducted or approved by federal departments or agency heads and determined to be exempt by those departments and agencies. To qualify for exemption under this category, investigators would be required to provide appropriate documentation from federal departments or agencies.

4b. Responsibilities of Investigators of Exempt Research Top

Since exempted studies are considered human subjects research, investigators are expected to adhere to ethical standards for the conduct of research. Specifically, investigators are expected to obtain informed consent (when appropriate given the nature of the research), take all necessary steps to minimize risks and maximize research benefits, and ensure the equitable selection of subjects (when warranted). Investigators who are found by the IRB to have committed ethical breaches in their research will have the exempt status of their studies revoked and may be denied the ability to apply for exemption in the future.

Investigators of exempt studies may not make substantive changes in the design of their studies, including changes involving investigators, research instruments and procedures, the location of their research, and sources of subjects or data, without written approval of the IRB. Changes should be requested via written memorandum.

5. TYPES OF IRB REVIEW DETERMINATIONS Top

Unless determined to be exempt, all human subject research at Syracuse University or by university faculty, staff, or students must be prospectively reviewed and approved by the IRB. Approval must be obtained prior to the formal recruitment of participants, obtaining informed consent, or initiation of research activities.

All applications, continuations, and amendments to the IRB must be in writing and on approved forms (or in the case amendments, memoranda) and submitted to the IRB office. Investigators should not send formal communications to the Chair or any member of the IRB. Applications and other formal materials are stamped, with the date, upon receipt at the IRB office. All applications for initial review are assigned a consecutive number with a two-digit prefix corresponding to the year.

Regardless of the nature of review, investigators are notified in writing of the IRB’s determinations. Written notification is typically provided to investigators within one week of the IRB’s determination.

5a. Application Cover Sheet Top

Before an application for expedited or full IRB review can be given final approval, an Application Cover Sheet must be submitted to the IRB (see ORIP Human Research Page). The application must be signed and dated by the Principal Investigator or, in the case of student research, the faculty advisor and the student. The PI, or faculty and student, must certify on the Application Cover Sheet that the Belmont Report, the FWA, and The IRB Handbook have been reviewed.

5b. Expedited IRB Approval Top

Research activities that present no more than minimal risk and involve only procedures in categories approved by federal regulations may be eligible for expedited IRB approval. Determinations regarding expedited IRB approval are made by the Chair or his or her designee on a standard review form. The Chair or designee may seek the advice of another IRB member or consultant who has specific expertise in the area of research described in the application.

For purposes of expedited review, minimal risk refers to the risks of everyday life (e.g., providing information to others about one’s attitudes and other non-confidential issues) or those associated with routine medical and psychological tests. The expedited review procedure may not be used where identification of participants or their responses would reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, or reputation, or be stigmatizing unless reasonable protections will be implemented to minimize these risks. Expedited approval may not be given for classified research.

The Chair or designee makes one of three decisions regarding applications submitted for IRB review: (1) Approval; (2) Provisional Approval (pending required changes or the receipt of clarifying information or rationales, as specified on the review form); or (3) Hold for Committee. When the decision is made to refer the application to the full IRB, the Chair or designee gives the reason(s) on the review form.

Categories for Expedited IRB Review. OHRP has identified categories of research that may be reviewed through an expedited review procedure. The Chair or designee must determine that research in these categories has no more than minimal risk. A brief description of eligible categories corresponding to research commonly conducted at Syracuse University follows.

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, nonpregnant adults who weigh at least 110 pounds (the amount drawn may not exceed 550 ml in an eight week period and collection may not occur more frequently than two times per week) or from other adults and children, considering age, weight, health, and the nature of collection (the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an eight week period and collection may not occur more frequently than two times per week).
Prospective collection of biological specimens for research purposes by noninvasive means.
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Examples include: physical sensors applied to the surface of the body or at a distance that do not involve the input of significant amounts of energy or invasion of privacy; weighing or testing sensory acuity; magnetic resonance imaging; electro cardiology, ultrasound, and Doppler blood flow; and moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
Research involving materials, data, documents, records, or specimens that have been collected or will be collected solely for nonresearch purposes.
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research involving survey, interview, oral history, focus group, or program evaluation. Participant observation, field work, or ethnography may qualify under this category if the research is conducted in an overt fashion (i.e., the investigator does not conceal his or her identity as a researcher).

5c. Full IRB Review Top

Human research not eligible for exemption or expedited review is reviewed by the IRB at a convened meeting[15]. A majority of the IRB members, including at least one member whose primary concerns are not scientific, must be present to conduct a convened meeting. For purposes of having a quorum (a majority of IRB members) at meetings, Syracuse University faculty on official leave in conjunction with a sabbatical are not counted. For research to be approved, it must receive the approval of a majority of those members present at the meeting where a quorum is in attendance.

Convened meetings are scheduled for 10 months per year, from September through June. The schedule is set in the spring for the following academic year and publicized on the IRB’s web site (http://orip.syr.edu/irb_schedule.php.) The deadline for submission of materials for full IRB is 10 days prior to the scheduled meeting. Members are sent applications and other materials for review immediately after the deadline for submission. Members are expected to review all materials prior to the meeting.

IRB meetings are conducted by the Chair or, in rare circumstances, a designee. The Chair presents an initial review of the research, indicating preliminary questions or concerns, if any, about the submitted research, followed by a discussion among all IRB members. In its review, the IRB considers the following review criteria: (1) Adequacy and Completeness of the Application; (2) Research Design; (3) Subject Selection; (4) Risks and Benefits; (5) Minimization of Risks; (6) Privacy and Confidentiality; (7) Additional Safeguards for Vulnerable Subjects; (8) Consent; and (9) Additional Considerations. Whenever possible, the IRB attempts to reach consensus on reviewed research. IRB decisions are recorded as unanimous when consensus has been achieved. When members are unable to reach consensus on a decision, the decision is made by majority vote, with members voting for approval or disapproval (or abstaining), or required changes, identified in the minutes.

The IRB makes one of four decisions on reviewed research: (1) Approval; (2) Provisional Approval (the IRB authorizes the Chair or another member to review and approve required revisions); (3) Postponed (tabled, pending further information); or (4) Withheld (disapproved). When appropriate (the research is not fatally flawed or devoid of merit, but might be able to be strengthened), the IRB may provide recommendations or suggestions to investigators to improve their research design or methodology.

The IRB meets in executive session. The Chair may permit persons not affiliated with the IRB to attend meetings, upon request. Investigators or their collaborators are not permitted to be present at IRB meetings during deliberations on their research. However, the IRB may decide to invite investigators to the meeting to answer questions about their research[16].

5d. Continuing Reviews Top

The IRB conducts reviews of all approved research on at least an annual basis. Investigators receive timely notification of the deadline for renewal of their research applications and are instructed to complete a renewal form in order to continue their research. Investigators who wish to continue their research must submit to the IRB a current copy of the informed consent form (or script in the case or oral consent) and must provide a summary of findings regarding risks and benefits to subjects and answer a question regarding unforeseen difficulties in their research. The form must be signed and dated.

Research initially reviewed and approved on an expedited basis is eligible for expedited renewal. Research approved at a convened IRB meeting must be renewed at a convened meeting unless the IRB determined, during initial review, that the research involves no more than minimal risk and no additional risks have been identified (these continuation applications may be reviewed on an expedited basis).

Approval of research must be renewed no longer than 365 days after initial approval. For research initially approved on an expedited basis, the date for the renewal will be calculated according to the date on which the Chair or designee provided final initial approval. For research not eligible for continuation on an expedited basis, the date for renewal will be calculated according to the date on which the convened IRB provided approval or provisional approval. Once approval has expired, the research cannot continue and investigators must submit a new application, regardless of the reasons for missing the deadline (e.g., the investigator was on leave or the renewal notice was never received). Under federal regulations, the IRB does not have the authority to grant an extension of the deadline for renewal.

The IRB may require research to be renewed at an interval less than 365 days when it has determined: (1) the research involves a high level of risk to subjects; (2) the research involves an intervention or procedure that is highly experimental in nature; (3) the investigator has violated IRB policies and procedures in the past; or (4) the investigator’s initial application required substantial revisions and changes prior to receiving IRB approval such that the IRB believes that the investigator requires ongoing guidance to protect subjects.

Once approval of research has expired, investigators may not enroll new subjects, conduct follow-up data collection on enrolled subjects, or, in the case of research that involves ongoing risks in the analysis stage, conduct data analysis. Continuation of research activities after approval has expired may result in formal suspension or termination of approval by the IRB and additional sanctions or corrective steps, as determined by the IRB.

Research may be renewed up to five years after initial approval on either an expedited or full IRB basis. After five years, investigators must submit a new IRB application to continue their research. The IRB, or Chair on expedited approvals, may grant a one-time extension, no longer than three months, of this five year limitation when circumstances warrant (e.g., an investigator is in the final stages of completing a five year externally funded study).

5e. Amendments Top

Any substantive changes or modifications in research approved by the IRB on an expedited or full IRB basis must be approved by the IRB. Investigators must request an amendment via formal memo prior to making any changes or modifications.

The Chair or his or her designee reviews all amendments. Approval will be provided by the Chair or designee if the changes are minor and do not alter the risks and benefits to subjects, affect the equitable enrollment of subjects, or modify informed consent protections. Examples of minor changes include the substitution of one research instrument for a comparable one or the replacement of a co-investigator with an investigator with equivalent qualifications. If the requested modifications in research are not minor and represent a significant revision in the approved research or increase the risks to subjects, the Chair or designee will refer the amendment to the full IRB for consideration at a convened meeting unless the amended research would qualify for expedited review.

Investigators are notified in writing of IRB decisions on amendments. If an amendment is not approved, the IRB provides the reasons for its decision.

5f. Reviews of Adverse Events, Unanticipated Risks, and Harms to Subjects

Investigators are required to report immediately any adverse events, unanticipated risks, or harms to subjects. Adverse events, unanticipated risks, and harms include, but are not limited to, death, life-threatening adverse reaction to drugs or a research intervention, hospitalization or prolongation of hospitalization, serious injury, incapacity, congenital anomaly, severe psychological distress and trauma, and violations of confidentiality and privacy that result in or threaten an individual’s financial standing, employability, insurability, reputation, and social and family relationships.

In the event of an adverse event or other untoward incident, the investigator shall notify the Office of Research Integrity and Protections and IRB by phone immediately, followed by a detailed written memorandum explaining the nature and scope of the harms and the reason for their occurrence. The investigator shall cease research activities, pending a full review by the IRB. Based on its review, the IRB may suspend or terminate approval for the research, impose sanctions on the investigator, or require the implementation of corrective steps. The research may not be resumed without formal, written approval by the IRB.

In the event of serious adverse events or incidents, the Office of Research Integrity and Protections will inform OHRP immediately by writing.

6. IRB REVIEW AND APPROVAL CONSIDERATIONS Top

Investigators must complete the IRB’s Application to the Institutional Review Board for the Protection of Human Research Subjects (see ORIP Human Research Page) to obtain approval for all human research not eligible for exemption. This application form is used for both expedited and full IRB reviews. The form must be signed and dated by the Principal investigator or, in the case of student research, the student and his or her faculty advisor. This section of the handbook specifies the criteria the IRB uses to review applications and the conditions that must be met by investigators to obtain IRB approval.

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