Institutional Review Board Links
IRB Fact Sheet
Guidelines
Exempt Review
Expedited Review
Full Protocal Review
User Guidelines
Informed Consent Form (sample)
Informed Consent Form (checklist)
Pre-Institutional Review Board Introduction
Contact IRB Review Board

Institutional Review Board Guidelines

I. JURISDICTION OF THE IRB

The IRB is a University standing committee established by Charleston Southern University to protect the rights and welfare of human and animal research subjects recruited to participate in research activities conducted under the auspices of the University. The IRB has the authority to approve, require modifications in, disapprove, or suspend all research activities that fall within its jurisdiction as specified by federal regulations and policies of the University and affiliated institutions.

The IRB functions independently of, but in coordination with, other university committees. For example, Graduate Council may be consulted in research that is conducted for master's thesis credit. The IRB, however, makes its independent determination whether to approve or disapprove the protocol based upon whether or not human subjects are adequately protected.

Charleston Southern University's IRB reserves the right to review all research, even research that is exempt from review under the federal regulations. The IRB has jurisdiction over all research, thereby providing broader protection than that required by the federal regulations. The IRB's authority to approve, require modifications in, or disapprove research derives from both federal law and university policy.

In brief, research as defined as the collection of data for the purpose of broadening the knowledge base of a discipline. The information gathered is intended to potentially be available for professional presentation or publication. Research does not include information gathered only for the assessment of a particular program in which the information will be only viewed by individuals directly involved with the program. Research also does not include information gathered only for use within the classroom situation.

Research that has been reviewed and approved by the IRB may be subject to further review and disapproval by officials of the institution. Those officials may not, however, approve research if it has been disapproved by the IRB. Furthermore, approved research is subject to continuing IRB review and must at a minimum be re-evaluated annually and more frequently in some cases.

The IRB reviews all research; as such it is not concerned with whether or not a particular activity is performed with therapeutic intent. This includes, but is not limited to, development of protocols that guide research that is conducted for therapeutic purposes. The IRB conducts risk/benefit assessments for research on therapies, for example, determining if the risks of a study are justified by a therapy provided as part of the study. Benefit alone is not used to justify risks presented by the research.

II. ESTABLISHMENT OF THE INSTITUTIONAL REVIEW BOARD

The Provost established the Charleston Southern University IRB effective January 2003 as a University standing committee. Its mandate was to establish policies and procedures for the IRB.

A. MEMBERSHIP

Dr. Bonnette, Provost, appointed faculty representing six disciplines to the IRB, for example, Dr. Christina Sinisi – Chair (psychology), Dr. Peter Yaun – Secretary (education), Dr. John Harper (kinesiology), Dr. Marian Larisey (nursing), Dr. Beth McConnell (criminal justice), and Dr. Al Parish (business). Additionally, two non-affiliated members are selected from the community as off-campus members. The voting members consist of six University faculty and two non-affiliated professionals from the community, per Federal Guidelines. Additional, non-voting members include personnel from the Grants Office and Institutional Research and Development. When indicated, for example, in research projects involving a “vulnerable category of subjects,” the IRB invites assistance from professionals with expertise in the vulnerable category, i.e., handicapped children, mentally disabled persons, children, prisoners, pregnant women, and etc.

The IRB maintains a list of current members by name, earned degrees, representative capacity, indications of experience (including board certifications and licenses) sufficient to describe each member's chief anticipated contributions to IRB deliberations. In addition, any employment or other relationship between each member and the institution, i.e., full-time employee, stockholder, unpaid consultant, or board member is indicated on the membership list. IRB membership is reported to the head of the department or agency supporting or conducting the research, unless the department or agency has accepted the existence of a Department of Health and Human Services (DHHS) -approved Assurance. A current membership list is provided to DHHS's Office for the Protection of Research Risk.

When an IRB member is also an investigator on a research project or activity, the investigator-as-member cannot participate in the review and approval process for any project in which he or she has a present or potential conflict of interest. Where the investigator-member has a conflicting interest, he or she is present only to provide information requested by the IRB. He or she is absent from the meeting room during the discussion and voting phases of the review and approval process and IRB minutes reflect that these requirements are met.

The IRB chairperson is selected by the voting IRB membership. Which is it? Should it be? Appointed or voted ? One of the Chair's tasks is making the IRB a respected part of the institutional community. The Chair must be fair and impartial, immune from pressure either by the institution's administration, the investigators whose protocols are brought before it, or other professional and nonprofessional sources. It is the Chair's responsibility to determine when a proposal requires expedited, exempt or full review or to call meetings of the IRB when the need arises.

B. RECORD KEEPING

The IRB prepares and maintains adequate documentation of IRB activities. In addition to the written IRB procedures and membership lists, copies of all research proposals reviewed, minutes of IRB meetings, records of continuing review activities, copies of all correspondence between the IRB and investigators, and statements of significant new findings provided to subjects are maintained by the IRB. Minutes of IRB meetings contain attendance at each meeting; actions taken by the IRB; the vote on actions taken (including the number of members voting for, against, and abstaining); the basis for requiring changes in or disapproving research; and a written summary of the discussion of controversial issues and their resolution are retained for three years. Records pertaining to research that is conducted are retained for three years after completion of the research. All records are accessible for inspection and copying by authorized representatives of the department or agency supporting or conducting the research at reasonable times and in a reasonable manner.

C. Institutional Responsibilities

CSU's IRB will review and approve research at its facilities involving human subjects. Before any human subjects research is conducted, the IRB will provide the department or agency conducting the research a written assurance that it will comply with requirements of the Policy; the Assurance must be approved by the department or agency; CSU must certify to the department or agency head that the research has been reviewed and approved by the IRB. The IRB is guided by the principles expressed in the Nuremberg Code (1947), The Declaration of Helsinki (1950) and The Belmont Report (1979) (Ethical Principles and Guidelines for the Protection of Human Subjects of Research) and: Title 45 CFR, OPRR Protection/Human Subjects; 21 CFR 50, FDA Protection of Human Subjects; 21 CFR 56, FDA Institutional Review Board; 21 CFR 312; 21 CFR 812, OPRR Guidebook, and CSU's Assurance of Compliance with DHHS . These documents are available to IRB members and investigators.

Specification of quality standards in the conduct of research is an important function of CSU's leadership. Insistence upon well-conceived and well–conducted research is evident both in written policies and actions of CSU's officials, i.e. the IRB. Research that is conducted so poorly as to be invalid exposes subjects and CSU to unnecessary risk. Approval procedures are devised such that CSU supports well-designed and properly executed research.

D. The Assurance

As CSU is involved in biomedical and/or behavioral research, it has a set of principles and guidelines in place that govern the institution, the faculty, and staff, in the discharge of responsibilities for protecting the rights and welfare of human subjects taking part in research conducted at, or sponsored by, CSU, regardless of the source of funding. CSU's assurances applicable to federally supported or conducted research contain a statement of principles formulated by CSU that meet the standards of The Belmont Report. The set of principles is readily available to all staff or faculty personnel who have need of it and it is part of the staff or faculty manual. It is written in a clear, concise, and unambiguous language that is understandable to its intended audience.

E. Staff, Space, and Supplies

The University will provide the IRB with meeting space and staff sufficient to support the IRB's review and record keeping duties.

F. Communication

The University assures that open channels of communication are maintained at all levels. This is important so that staff, subjects, and other interested parties have a means of communicating information about the conduct of a research project directly to appropriate institutional officials. It is vital that IRB members, department heads, and other officials with responsibility for oversight of research have open and ready access to the highest levels of authority within the institution.

G. Institutional Procedures and Guidelines

1. Federal Policy Requirements

CSU will prepare written procedures and guidelines to be followed by the IRB when conducting its initial and continuing review of research, and for reporting its findings and actions to the investigator and the administration of the institution. The procedures provide guidance for determining which projects will require review more often than annually and which projects require verification from sources other than the investigator that no material changes have occurred since the last IRB review. The guidelines delineate procedures for ensuring prompt reporting to the IRB, by the investigator, of proposed changes in a research activity. Also included are procedures for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject.

The institution's written procedures ensures prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of: (1) any unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliance with the Federal Policy or the requirements or determinations of the IRB; and (2) any suspension or termination of IRB approval.

2. The Authorized Institutional Official

The point of responsibility for the oversight of research and IRB functions is the Provost. The Provost has the legal authority to act and speak for the institution, and ensures that the institution is effectively fulfilling its research oversight function. The Provost appoints the Chair and members of the IRB who are delegated the responsibility for oversight of research .

3. Other Institutional Personnel

Training new personnel is a basic responsibility of CSU. All new personnel are trained in the applicable institutional policies and mechanisms for the approval of research and for reporting problems with research projects in progress. Personnel involved in the conduct of research will receive additional training in institutional expectations and specific regulations pertaining to research. Training designed to enhance the development of high quality proposals is encouraged. IRB members and others charged with responsibility for reviewing and approving research will receive detailed training in the regulations, guidelines, and policies applicable to human subjects research. Attendance at workshops and other educational opportunities focused on IRB functions are encouraged and supported to the fullest extent possible. Training in good research practices and in methods for minimizing risk is provided. Since research conducted by others may have a bearing on research projects conducted by or at the institution, journals and other research-related materials are available to staff either in the library or thorough the IRB.

4. Internal Audits

Internal audit procedures of the IRB assure CSU's administration that its policies and procedures are being adhered to and that they are proper in scope and content. Evaluation of activities and functions is an accepted management tool, and the monitoring of institutional high-risk areas such as research is good policy. Audits allow the early identification and correction of problems. CSU ensures that reporting of noncompliance is accomplished and that appropriate follow-up measures are taken. CSU has developed IRB policies to provide for the following:

• Institutional policies that are in compliance with applicable regulations and that promote appropriate review and approval.

• Open channels of communication that are relevant to the process.

• Comprehensive procedures for monitoring research and conducting audits of the research process.

• Through training of personnel in policies and procedures\related to research with human subjects.

• Institutional support of educational activities related to the design, conduct, and approval of research.

III. PRINCIPAL INVESTIGATORS

IRB CONSIDERATIONS

The qualifications of the principal investigator are considered when reviewing proposals. The investigator's professional development is taken into account and related to the degree of protocol complexity and risk to human subjects. The IRB may require less experienced research investigators to be sponsored by seasoned researchers. Proposals that require skills beyond those held by the principal investigator are modified to meet the investigator's skills, have additional qualified personnel added, or be disapproved.

Research investigators will prepare protocols giving complete descriptions of the proposed research. The research plan includes provisions for adequate protection of the rights and welfare of prospective subjects and ensures that pertinent laws and regulations are observed. Samples of informed consent documents are included with protocols. Research investigators are responsible for obtaining informed consent and ensuring that no human subject will be involved in the research prior to obtaining the consent.

The research plan addresses quality assurance standards set by Charleston Southern University. In addition, applicable external standards for quality assurance are met. External standards are of particular concern for research conducted in clinical facilities. Appropriate reviews for scientific merit are conducted before the research is approved. Mechanisms for monitoring the progress of the research are in place.

Research investigators, through their research design, determine whether the proposed research involves human subjects. When it is not clear whether the research involves human subjects, investigators must seek assistance from the IRB in making this determination, for example, require that all research protocols involving human subjects be submitted to the IRB for review. The IRB then determines whether the research is exempted from IRB review under the applicable regulations and institutional policies, and whether full or expedited IRB review is appropriate.

Researchers are responsible for complying with all IRB decisions, conditions, and requirements. Research investigators are responsible for reporting the progress of the research to the IRB and/or appropriate institutional officials as often as and in the manner prescribed by the IRB but no less than once per year. Current IRB policies reflect the following:

Principal investigators - appropriate qualifications, experience, and facilities to ensure that all aspects of the project and follow-up are conducted rigorously and with due regard for the safety and well-being of the subjects.

Comprehensive procedures through which the researchers monitor projects and report problems to the IRB.

Investigators' past records with regard to approved research.

IV. COMPLIANCE / NONCOMPLIANCE

A. INTRODUCTION

Two basic approaches exist for ensuring compliance with human subjects regulations. The Food and Drug Administration (FDA) uses a system of inspections and audits; other DHHS components rely prospectively on assurances of compliance that are negotiated with institutions by OPRR. This divergence in approach reflects the respective agencies' mandates: FDA is regulatory (it regulates the pharmaceutical, biologic, and device industry, whether or not those substances or devices are used for research purposes, as well as the marketing and use of investigational drugs); other DHHS agencies, such as National Institute of Health (NIH), are research supporting. FDA regulations provide specific administrative action and sanctions for noncompliance. This Section deals primarily with compliance under DHHS regulations.

An Assurance is a written document negotiated with OPRR on behalf of the Secretary of DHHS. According to DHHS the Assurance sets forth the means by which an institution will comply with DHHS regulations. Assurances are given as a condition of receipt of DHHS support for research involving human subjects. An Assurance approved by OPRR commits the institution and its personnel to full compliance with the DHHS human subjects regulations. While recognizing both individual and institutional responsibility for compliance with the regulations, OPRR generally negotiates Assurances only with institutions, which are ultimately responsible for ensuring that the regulatory requirements are met. Investigators and IRBs, however, also retain responsibility for complying with the regulations.

B. IRB CONSIDERATIONS

1. The Regulations

DHHS regulations (and those of any other department or agency that has adopted the Federal Policy) require that CSU follow written procedures for ensuring that serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB will be reported to the IRB, appropriate CSU officials, and the head of the department or agency supporting the research. FDA requires that such reports be made to the IRB, appropriate institutional officials, and the FDA. CSU is responsible for establishing the mechanism through which instances of noncompliance will be reported to the department or agency. FDA interprets the law to require that the IRB itself notify FDA of instances of noncompliance if such reporting would not otherwise occur.

2. Internal Methods for Ensuring Compliance

To ensure compliance with the regulations, CSU has adopted internal audit or self-assessment procedures and practices designed to assure proper protocol and consent document preparation, protocol submission, review and approval by the IRB, and timely monitoring of protocol implementation. One example is the use of expiration date stamps on consent documents and protocols to ensure that the federal requirement of at least annual IRB review of each protocol is met. A second example is the use of standardized language, endorsed by CSU, which meets the regulatory requirements and which is customized and elaborated upon by the investigator in creating an appropriate informed consent document.

3. External Audits and Site Visits

CSU is committed to regulatory compliance that is fostered by routine site visits and audits conducted by federal officials. The IRB cooperates fully with FDA on-site inspections of IRB minutes and records and OPRR occasional site visits to assess the adequacy of Charleston Southern University IRB procedures for protecting human research subjects. In addition, the IRB cooperates with sponsors of research, such as the National Cancer Institute, and cooperative group research organizations, such as the Eastern Cooperative Oncology Group (ECOG), regularly audit their research performance sites. IRB minutes and records for conformance with applicable regulations are available for review by the pertinent groups. The IRB shares results of these audits OPRR and FDA as the on-site assessments are designed principally to instruct and educate.

4. Investigations Into Alleged Noncompliance

The IRB cooperates with warranted inquiries or investigations into alleged noncompliance with federal regulations by the FDA and OPRR. The need for site visits in connection with inquiries and investigations depends upon the seriousness and urgency of the circumstances, and whether on-site involvement is the most effective means of resolving the questions of noncompliance that have been raised.

Federal inquiries and investigations into alleged noncompliance with the regulations are not undertaken lightly by CSU and the IRB. Because experience has shown that these efforts are usually initiated in response to credible reports of inappropriate involvement of human subjects in research, the IRB facilitates inquiries and investigations into alleged noncompliance. Such reports can come from any source: IRB members, investigators, subjects, institutional personnel, or the media.

The FDA follows specific regulatory and administrative procedures regarding its determination of non-compliance, the imposition of sanctions, and appeal mechanisms. See for example, Compliance Program Guidance Manual, Chapter 48 - Bioresearch Monitoring - Human Drugs: Institutional Review Board.

DHHS regulations do not specify administrative actions for noncompliance with the human subjects regulations, except to state that material failure to comply with the regulations can result in termination or suspension of support for department or agency projects, and that DHHS will take terminations or suspensions of funding due to noncompliance into consideration when making future funding decisions. Appropriate OPRR procedures are as follows:

When OPRR initiates a compliance oversight evaluation, appropriate CSU officials are so advised, and they are informed as to the likely administrative course of events. Activities expected of the CSU are carefully explained initially and at appropriate times during the course of the evaluation. Except in rare circumstances when sound ethics dictates the need to act immediately, OPRR will take no action against CSU without first affording CSU an opportunity to offer information that might refute or mitigate adverse determinations. In all cases, appropriate CSU officials are afforded an opportunity to comment in writing before OPRR issues its findings.

Under DHHS regulations, documents related to compliance oversight evaluations may be subject to the provisions of the Freedom of Information Act (FOIA). In most cases, such documents are exempt from the disclosure provisions of the FOIA while the evaluation is in progress, and OPRR treats them with confidentiality. However, OPRR routinely advises appropriate DHHS officials concerning the status of its evaluations and may be required to inform members of Congress. Most documents related to compliance oversight evaluations become publicly available under the FOIA when OPRR issues its findings.

Under DHHS regulations, records, which can be retrieved by an individual's name or other personal identifier, are subject to the provisions of the Federal Privacy Act. Information regarding OPRR's compliance oversight activities is maintained only in a system of records identifying the institution under evaluation. Records are retrieved by institutional name or Assurance number. OPRR maintains no system of records related to compliance oversight activities through which records can be retrieved by individuals' names or other personal identifiers ...

OPRR's compliance oversight evaluations may result in one or more of the following outcomes:

• OPRR may determine that protections under CSU's Assurance of Compliance are in compliance with the DHHS Regulations or the PHS Policy....

• OPRR may determine that protections under CSU's Assurance of Compliance are in compliance with the DHHS Regulations or the PHS Policy...but that recommended improvements to those protections have been identified.

• OPRR may restrict its approval of CSU's Assurance of Compliance. Affected research projects cannot be supported by DHHS until the terms of the restriction have been satisfied. Examples of such restrictions include, but are not limited to:

• Suspending the Assurance's applicability relative to some or all research projects until specified protections have been implemented;

• Requiring prior OPRR review of some or all research projects to be conducted under the Assurance;

• Requiring that some or all investigators

conducting research under the Assurance receive appropriate human subject or animal welfare education;

(e) Requiring special reporting to OPRR.

• OPRR may withdraw its approval of CSU's Assurance of Compliance. Affected research projects cannot be supported by any DHHS component until an appropriate assurance is approved by OPRR.

• OPRR may recommend to appropriate DHHS officials or PHS agency heads

• that CSU or an investigator be temporarily suspended or permanently removed from participating in specific projects, and/or

• that peer review groups be notified of CSU's or an investigator's past noncompliance prior to review of new projects.

• OPRR may recommend to DHHS that CSU or investigators be declared ineligible to participate in DHHS-supported research (Debarment). If OPRR makes this recommendation, the Debarment process will be initiated in accordance with the procedures specified at 45 CFR 76.

5. Noncompliance by Investigators, IRBs, and Institutions

Investigators

Research investigators are the most frequent source of noncompliance with human subjects regulations. The most common lapses in investigator compliance include unreported changes in protocols, misuse or nonuse of the informed consent document, and failure to submit protocols to the IRB in a timely fashion. Problems such as these are often caused by communication difficulties. With investigator goodwill, these cases can be resolved by the IRB without jeopardizing the welfare of research subjects.

Occasionally, an investigator will either avoid or ignore an IRB. Such cases present a more serious challenge to the IRB and to the institution. Regardless of investigator intent, unapproved research involving human subjects places those subjects at an unacceptable risk. When unapproved research is discovered, the IRB and CSU should act promptly to halt the research, assure remedial action regarding any breach of regulatory or CSU human subject protection requirements, and address the question of the investigator's fitness to conduct human subject research. Beyond the obvious need to protect the rights and welfare of research subjects, the credibility of the IRB is clearly at stake. In addition, any serious or continuing noncompliance with DHHS human subjects regulations or the determinations of the IRB must be promptly reported to OPRR or the department or agency head.

IRBs

IRB noncompliance occurs whenever the IRB deviates from the duties imposed upon it by the federal regulations. Such deviations include the inadequate review of research protocols by failing to ensure that the consent document and process provide sufficient information to allow prospective subjects to make an informed decision whether to participate in the research; failing to ensure that the research design includes adequate monitoring of the data and any additional safeguards necessary to protect the welfare of particularly vulnerable subjects; and failing to conduct continuing review of research at intervals appropriate to the degree of risk. To meet regulatory responsibilities, the IRB must maintain adequate records of IRB business and hold their meetings with a majority of members present, including a nonscientific member. A demonstrated inability to carry out IRB responsibilities in accordance with DHHS regulations can be cause for the suspension or withdrawal of approval of an institution's Assurance.

Institutions

Although CSU is accountable for the actions of individual investigators and the IRB, institutional noncompliance is more broadly described as a systemic failure of CSU to implement practices and procedures contained in CSU's Assurance. Prime examples are the failure of CSU to ensure that the IRB is appropriately constituted and functions in accordance with the regulations, that the IRB receives appropriate institutional support and staffing, and that investigators meet their obligations to the IRB. Systemic failure to abide by the terms and conditions of CSU's Assurance will result in withdrawal of approval of the Assurance.