UNCG Export Control Guidelines
Export Control Guidelines
Export Control laws are complex and specific to each circumstance. Rules, regulations, and laws related to export control are updated frequently. This manual is meant to serve as a guide to provide basic information related to export controls. It should not be relied upon exclusively nor should it be considered legal advice. For further information related to export controlled items or research, please contact UNCG’s Export Control Official.
AECA Arms Export Control Act
AES Automated Export System
BIS Bureau of Industry and Security
CCL Commerce Control List
CFR Code of Federal Regulations
CJ Commodity Jurisdiction
DDTC Directorate of Defense Trade Controls
DoD Department of Defense
EAR Export Administration Regulations
ECCN Export Control Classification Number
ECO Export Control Official
ITAR International Traffic in Arms Regulations
OFAC Office of Foreign Assets Control
OSP Office of Sponsored programs
PI Principal Investigator
RPS Restricted Party Screening
SDN Specially Designated Nationals and Blocked Persons List
TCP Technology Control Plan
USC United States Code
USML United States Munitions List
Overview of Export Regulations
1.2 Ethical Principes: The Belmont Report
THE BELMONT REPORT
It is the duty of UNCG Institutional Review Board to review and make decisions regarding all protocols, regardless of funding, for research involving human participants. The primary responsibility of the IRB is the protection of research participants from undue risk and from deprivation of personal rights and dignity. This protection is best assured by consideration of three principles, which are the touchstones of ethical research:
that voluntary participation by the participants, indicated by free and informed consent, is assured;
that an appropriate balance exists between the potential benefits of the research to the participants or to society and the risks assumed by the participants; and
that there are fair procedures and outcomes in the selection of research participants.
These principles are referred to as respect for persons, beneficence, and justice.
RESPECT FOR PERSONS: VOLUNTARY PARTICIPATION AND INFORMED CONSENT
One of the most important elements in any research involving human research participants is the assurance of voluntary informed consent. Any person who is to be a research participant, whether that research is designed for his/her own direct benefit or for the advancement of scientific knowledge in general, must understand as completely as possible what is to be done and what the associated potential risks and benefits are. The person must give his/her consent freely, without pressure or inappropriate inducement. The IRB at UNCG strives to ensure voluntary informed consent of research participants through careful review of the recruitment and consent processes, and of the consent form or information sheet to be used with participants.
The informed consent concept is extended to those studies in which participants are not able to give personal consent for themselves. In such cases, the consent document is addressed to those who have been designated as responsible for the research participants’ well-being (e.g. parents of children). The IRB’s concern is to verify that the consent process and document are likely to assist these persons in making informed decisions which are in the best interest of the research participants. The capacity for truly informed and voluntary participation in research varies widely among study populations. At one extreme, there may be ample understanding and manifest freedom from coercion; at the other, there may be degrees of understanding and freedom that affect the consent of potential participants. The IRB must exercise special care when considering participants whose ability to give free and informed consent may be compromised in any way.
BENEFICENCE: THE RISK-BENEFIT RATIO
The IRB is charged with deciding, for any proposed activity which falls under its jurisdiction, whether: “The risks to the participant are so outweighed by the sum of the benefit to the participant and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept (those) risks” (Federal Register, May 30, 1974).
Assessment of the risk/benefit relation is a complex task. Risks of injury or discomfort to the individual can be physical, psychological, and/or social. There can be potential benefits to the individual, to a group to which the individual belongs, and/or to society. When reviewing applications, the IRB must carefully assess the types and degrees of both risks and benefits for a given participant population, as well as the investigator’s communication of these risks and benefits in the consent process and form. While the IRB is not charged with reviewing scientific design per se, it must sometimes do so in order to assess the risk/benefit ratio. If a study design does not seem adequate to attain the stated aim of the investigation, then no benefit can be anticipated from conducting the study, and there is no justification for placing any research participant at risk, however minimal. Thus the design of the study must be sound, and the nature and likelihood of all risks and benefits must be made clear in any application to the IRB.
JUSTICE: THE FAIR SELECTION OF RESEARCH PARTICIPANTS
Both the risks and the potential benefits of research should be spread fairly among potential individual research participants and groups of individuals participating in research. Study design and selection of participants should avoid bias for or against particular social, racial, sexual, or ethnic groups.
SHARING RESEARCH RISKS
The guiding principle in the ethical selection of research participant groups is that any risks of the research should fall upon the groups that might benefit from the research. If the results of a risky protocol might benefit the general population, it would be unethical to focus participant recruitment on vulnerable or disadvantaged groups (e.g. institutionalized people or prisoners, patients at free clinics primarily patronized by people unable to afford other medical care) simply because they are easily accessible or can be persuaded to participate. An undue share of research risks should not also burden groups already burdened by other factors. Rather, attempts should be made to include a fair sampling of the groups that might benefit from the study. When research involves persons whose autonomy is compromised, it is expected that the research bear some direct relationship to the conditions or circumstances of the research participant population. In addition, groups fully able to consider research risks and informed consent should be asked to face research risks before more vulnerable populations.
SHARING RESEARCH BENEFITS
In recent years, increasing attention has been paid to the rights of various groups to be included in research. In addition, researchers, ethicists, and public officials have recognized that because many clinical trials focus primarily on White middle-class research participant groups, the results of some trials have been of questionable value for members of other social, racial, sexual, and ethnic groups. As a result, both the National Institutes of Health and the Food and Drug Administration now require that study design include as broad a range of research participants as feasible and data be analyzed to uncover responses that differ between groups. Whereas women of child-bearing potential and pregnant and nursing women previously were routinely excluded from new drug trials, it is now required that whenever possible these women be asked to make their own choices after being fully informed of the risks of the research.
UNCG Export Control Procedures
Human Participant Research
For the purposes of this policy research involving “human participant research” is defined as an activity that meets the definition of “research” and involves “human participants” as defined by 45 CFR 46.102(d)&(f).
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition may be funded or unfunded, or may be conducted as a component of another program not usually considered research. For example, demonstration and service programs may include evaluation components, which constitute research activities under this definition.
For purposes of this part, the following activities are deemed not to be research:
- Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
- Public surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to hose necessary to allow a public health authority to identify, monitor, asses, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
For the purposes of this policy, a “systematic investigation” is an activity that involves a prospective research plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question. Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study sample), inform policy, or generalize findings.
For all federally funded research subject to the pre-2018 requirements: A living individual about whom an investigator (whether professional or student) conducting research obtains
- data through interventiona or interactionb with the individual, or
- identifiable private informationc.
For all federally and non-federally funded research subject to 2018: a living individual about whom an investigator (whether professional or student) conducting research obtains:”
- Information or biospecimens through intervention or interaction with individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens
aIntervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the participant or the subject’s environment that are performed for research purposes.
bInteraction includes communication or interpersonal contact between investigator and subject.
cPrivate information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants.]
An Institutional Review Board established in accord with and for the purposes expressed in this policy.
The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.
- For federally funded research subject to pre-2018 requirements: Information by which the identity of the human subjects is or may readily be ascertained by the investigator or readily be associated with the information
- For all federally and non-federally funded research subject to 2018 or hybrid requirements: Information or a biospecimen for which the identity of the human subject is or may readily be ascertained by the investigator or readily be associated with the information
Identifiable Private Information
Identifiable Private Information: private information for which the identity of the human subject is ormay readily be ascertained by the investigator or associated with the information
Identifiable Biospecimen: a biospecimen for which the identity of the human subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Legally Authorized Representative
Legally Authorized Representative (LAR): An individual, judicial, or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.
- For research NOT subject to FDA regulations and NOT subject to 2018 requirements: Where there is no applicable law addressing this issue, legally autborized representative means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective human subject to the human subject’s participation in the procedure(s) involved in the research.
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 or during the performance of routine physical or psychological examinations or tests.
The official notification by the institution to the supporting Department or Agency, in accordance with the requirements of this policy, that a research project or activity involving human participants has been reviewed and approved by an IRB in accordance with an approved assurance.
Clinical Trial: a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
When evaluating participant safety during exercise testing or training, intensity (how hard the activity is—whether it is mild, moderate or vigorous) is not and should not be the primary issue. The primary issue is the level of cardiovascular, cerebrovascular, or musculoskeletal risk to be experienced by the person who is going to engage in a given intensity of exercise. The most important aspect of keeping individuals safe is to screen them properly prior to exercise participation. Some individuals who possess high levels of fitness along with satisfactory health histories and no serious personal risk factors are able to participate in very high intensity exercise testing or training and are at minimal risk for a serious medical event as a result of this activity. Their risk as associated with testing or training is close to the risk present in normal, everyday activities. This is in comparison to other individuals who have significant heart disease with symptoms and who should not participate in even mild/moderate exercise testing or training without American College of Sports Medicine (ACSM) certified personnel (or other properly certified personnel) directly supervising all aspects of the activity with a physician in close proximity.
Agent of the University
Is anyone who has proper authority to make official representations on behalf of the University and/or bind the university to agreements.
Engaged in Research
When an UNCG employee or agent either intervene or interact with living individuals for research purposes or obtain individually identifiable private information for research purposes.
Appendix 1: Export Control Review Questions
3.1 Assurance of Compliance
UNCG holds a Federalwide Assurance (FWA; Number 00000216). A FWA is an assurance of compliance with the federal regulations for the protection of human participants in research that is federally funded. The FWA is also approved by OHRP for Federalwide use, which means that other departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely upon the FWA for the research that they conduct or support.
3.2 UNCG ORI
The UNCG ORI reports directly to the Director of the Office of Research Integrity (“Director”) and is supervised by the Vice Chancellor for Research and Engagement. The Vice Chancellor for Research and Engagement is the Institutional Official and the Signatory Official on the Federalwide Assurance. The Director has expert knowledge in regulatory issues regarding human participants and has delegated authority for some signatory privileges on behalf of the Institutional Official. The Director supervises the Associate Director who serves as the Human Protections Administrator, the primary point of contact and reviewer at UNCG for the Office for Human Research Protections, Department of Health and Human Services.
This office is staffed by other appropriate and knowledgeable individuals whose duties and responsibilities are found in their respective job descriptions, and whose performance is evaluated on an annual basis by the Director in accordance with UNCG Human Resource Standards.
3.3 North Carolina Law
UNCG and the UNCG IRB rely on the guidance of University Counsel for the interpretation and application of North Carolina law and the laws of any other jurisdiction where research is conducted as they apply to human participants research. University Counsel has indicated that currently there are no specific state laws that apply directly/solely to research.
Appendix 2: Technology Control Plan Template
4.1 Authority of the IRB
The UNCG IRB reviews all research conducted under the auspices of UNCG and has the authority to approve, require modifications in, or disapprove such research. The IRB is required to ensure that appropriate safeguards exist to protect the rights and welfare of research participants [45 CFR 46.111]. In fulfilling these responsibilities, the IRB is expected to review all research documents and activities that bear directly on the rights and welfare of potential participants in proposed research. The research protocol and consent/assent document(s) are examples of information/materials that the IRB should review. The IRB should also review the methods and materials that investigators propose to use to recruit participants.
Before any human participant is involved in research conducted under the auspices of UNCG, the UNCG IRB will give proper consideration to:
the potential risks to participants
the anticipated benefits to participants, others, and society
the importance of the knowledge that may reasonably be expected to result from the research
the informed consent process to be employed
The IRB has the authority to suspend, place restrictions on, or terminate approval of research activities that fall under its jurisdiction that are not being conducted in accordance with IRB requirements or that have been associated with unexpected adverse events. The IRB has the authority to observe or have a third party observe the consent process and the research if the IRB determines it to be indicated.
4.2 Jurisdiction of the IRB
The IRB jurisdiction extends to ALL research (funded and not funded) involving human participants conducted at UNCG, as well as research conducted elsewhere by UNCG faculty, staff, and students.
If an IRB chair, member, or staff person feels that the IRB has been unduly influenced by any party, they shall make a confidential report to the Director or Vice Chancellor for Research and Engagement, depending on the circumstances. The institution will conduct a thorough investigation and corrective action will be taken to prevent additional occurrences.
4.3 IRB Relationships
The IRB functions independently of, but in coordination with, other institutional regulatory committees. The IRB, however, makes its independent determination whether to approve or disapprove a protocol based upon whether or not human participants are adequately protected. The IRB has review jurisdiction over all research involving human participants conducted, supported, or otherwise participant to regulation by any federal department or agency that has adopted the human participants regulations.
The Research Advisory Commission (RAC) ensures a dialogue is maintained between the various compliance entities at the University. The committee will act in an advisory capacity to the Vice Chancellor for Research and Engagement, monitoring the effectiveness of existing integrity programs, developing new or revised policies as changes in requirements occur, and disseminating updated compliance information to the research community.
Institutional officials may NOT approve research if it has been disapproved by the IRB.
RELATIONSHIPS WITH OTHER INSTITUTIONS
UNCG may choose, on a case-by-case basis, to provide human research protection oversight for another institution or allow that institution to provide oversight over a study at UNCG. In order for a University to provide this oversight, a formal relationship must be established between the University and the other institution through a reliance agreement. This relationship must be formalized before the University will accept any human research proposals from the other institution.
In the conduct of cooperative research projects, UNCG acknowledges that each institution is responsible for safeguarding the rights and welfare of human participants and for complying with applicable federal regulations. When a cooperative agreement exists, UNCG may enter into a joint review arrangement, rely on the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.
When UNCG relies on another IRB, the Director will review the policies and procedures of that IRB to ensure that they meet UNCG standards. If the other IRB is part of an accredited Human Research Protections Policy (HRPP), then it will be assumed that the UNCG standards are being met.
When UNCG reviews research to be conducted at another institution, the particular characteristics of each institution’s local research context must be considered, either (i) through knowledge of its local research context by the UNCG IRB or (ii) through subsequent review by appropriate designated institutional officials, such as the Chairperson and/or other IRB members.
When UNCG is the coordinating center for a multi-center protocol, the IRB will require the UNCG PI to ensure that IRB approval has been obtained at each participating site prior to initiation of the research at that site. At the time of initial review, the IRB will assess the procedures for dissemination of protocol information (e.g. unanticipated problems involving risks to participants or others, protocol modifications, interim findings) to all participating sites.
Multi-site studies submitted to IRB by UNCG Faculty.
Because reliance agreements are on a case-by-case basis, all UNCG faculty research should be on file with the UNCG IRB if they are collaborating with another institution so that there is a record maintained at each site. IRB approval from that site, if applicable, should also be submitted to the IRB at the time it is received.
For nonexempt research involving human subjects covered by the Common Rule (or exempt research for which limited IRB review takes place as described in Section 5.5) that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution, the institution and the organization operating the IRB shall document the institution’s reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy (e.g., in a written agreement between the institution and the IRB, by implementation of an institution-wide policy directive providing the allocation of responsibilities between the institution and an IRB that is not affiliated with the institution, or as set forth in a research protocol)
Documentation specifying the responsibilities, which will outlined in the reliance agreement, that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy as described in 46.103(e)
RESEARCH AT CONE HEALTH
Cone Health System IRB has signed Authorization Agreements to rely on the IRBs at the University of North Carolina located at Greensboro, NC and Chapel Hill, NC (UNC School Systems) for review of research proposals in which investigators at UNC School Systems plan to collaborate with the Cone Health System (CHS).
Cone Health System asks that the UNC-A-01 IRB form be completed for studies using this Authorization Agreement. This form is located under the “Forms” link on the CHS IRB website: http://www.mosescone.com/IRB. Cone Health System would like to receive notification of annual renewals, closure notices, and SAEs/Unanticipated Problems for all Cone Health System patients. These submissions will be reviewed and placed in the appropriate file.
4.4 Roles and Responsibilities
4.4.1 CHAIRPERSON OF THE IRB
The Director, on behalf of the Institutional Official, recommends individuals to the Vice Chancellor for Research and Engagement to serve as Chairperson of the IRB. The Associate Provost, in consultation with the Provost for Academic Affairs and approval of the Chancellor, appoints a Chair of the IRB to serve for renewable two-year terms. Any change in appointment, including reappointment or removal, requires written notification.
The IRB Chair should be a highly-respected individual from within or outside the University fully capable of managing the IRB and the matters brought before it with fairness and impartiality. The task of making the IRB a respected part of the institutional community will fall primarily on the shoulders of the Chair and the Director of the ORI. The IRB must be perceived to be fair, impartial, and immune to pressure by the institution’s administration, the investigators whose protocols are brought before it, and other professional and nonprofessional sources.
The IRB Chair is a voting member of the IRB and counts toward quorum. The IRB Chair is responsible for conducting IRB meetings and is a signatory for correspondence generated by the IRB. The Associate Director of the ORI will serve as co-Chair if the Chair is unavailable to Chair an IRB meeting.
The IRB Chair may designate other IRB members (e.g., the Past Chair, ORI Director and, specific IRB members) to perform duties as deemed appropriate including reviewing and protocols with signature authority.
The IRB Chair advises the Director of the ORI about IRB member performance and competence.
The performance of IRB Chair will be evaluated on an annual basis by the Director and the Vice Chancellor for Research and Engagement. If the Chair is not acting in accordance with the IRB’s mission, following these policies and procedures, has an undue number of absences, or is not fulfilling the responsibilities of the Chair, a recommendation for removal may be made by the Vice Chancellor for Research and Engagement to the Chancellor.
4.4.2 SUBCOMMITTEES OF THE IRB
The Chair, in consultation with the Director, may designate one or more other IRB members (i.e., a subcommittee) to perform duties as deemed appropriate including reviewing protocols with signature authority, and other IRB functions.
Duties of a subcommittee may include the following:
Serve as designees by the IRB Chair for the expedited review of new or continuing protocols and/or modifications of continuing protocols. The subcommittee must be experienced in terms of seniority on the IRB and must be matched as closely as possible with the field of expertise for the study. This individual is usually the Associate Director to the ORI but at the discretion of the IRB Chair can appoint any IRB member with deemed capable in review of the type of research being conducted.
Review and approve revisions requiring only simple concurrence submitted by investigators for a protocol given provisional approval, i.e. deferred for minor changes, by the convened IRB.
Conduct an inquiry. A subcommittee is appointed consisting of IRB members, and non-members if appropriate, to conduct an inquiry into allegations of IRB non-compliance. Such a subcommittee will be given charges by the IRB, which may include any or all of the following:
Review of the protocol(s) in question;
Review of any relevant documentation, including consent documents and investigational files, etc. as they relate to the investigator’s execution of the relevant research involving human participants;
Interview of appropriate personnel;
Preparation of either a written or oral report of findings to be presented to the full IRB at its next meeting;
Conduct on-site review. Determination of the review interval and the need for additional supervision and/or participation is made by the IRB on a protocol-by-protocol basis. For example, for an investigator who is performing particularly risky research, an investigator who has recently had a protocol suspended by the IRB due to regulatory concerns, or a project/investigator whose initial application or modification application has raised concerns in the eyes of the IRB may be subject to on-site review by an IRB subcommittee. Such a review might occur, or approval might be subject to an audit of study performance, after a few months of enrollment or after enrollment of the first several participants.
4.5 Resources for IRB
The Vice Chancellor for Research and Engagement provides resources to the IRB and the ORI, including adequate meeting and office space and staff for conducting IRB business. Office equipment and supplies including technical support, file cabinets, computers, internet access, and copy machines, will be made available to the IRB and staff. The resources provided for the IRB and the ORI will be reviewed during the annual budget review process.
4.6 Conduct of Quality Assurance/Quality Improvement Activities for IRB Operation
The ORI staff will conduct investigations and audits of ongoing research when the IRB directs an audit be conducted or a complaint or allegation of non-compliance is received. In addition, the staff will conduct “for cause” and “not for cause” audits of research. (See Section 11 for a detailed discussion of investigations and audits.)
Appendix 3: Information for US Visa Applications
5.1 Composition of the IRB
- The IRB will have at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB will not consist of entirely men or entirely women.
- The IRB will be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human participants.
- In addition to possessing the professional competence necessary to review specific research activities, The IRB will be able to ascertain the acceptability of proposed research in terms of institutional policies and regulations, applicable law, and standards of professional conduct and practice. The IRB will therefore include persons knowledgeable in these areas.
- If the IRB regularly reviews research that involves a vulnerable category of participants (e.g., children, prisoners, pregnant women, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons), consideration will be given to the inclusion of one or more individuals on the IRB, who are knowledgeable about and experienced in working with these participants. When protocols involve vulnerable populations, the review process will include one or more individuals who are knowledgeable about or experienced in working with these categories of subjects, either as members of the IRB or as consultants (see Section 5.3).
- The 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.
- 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.
- One member may satisfy more than one membership category.
5.2 Appointment of Members to the IR
The IRB Chair and the Director of the ORI identify needs for new or replacement members, or alternate members. Department Chairs and other UNCG administrators may forward IRB nominations to the Director, the Vice Chancellor for Research and Engagement, the ORI, or the IRB Chairperson.In replacing faculty members on the IRB, the Director will consult with the current IRB members to request a recommendation for replacement. The Director will then contact the nominee to discuss his or her interest and/or qualifications. If there are no nominees, then appropriate Department Chairs or Program Directors will be contacted in writing by the Vice Chancellor for Research and Engagement or the Director concerning the vacancies and nominees will be solicited from the Department Chairs or Program Directors.The final decision in selecting new members is made by the Vice Chancellor for Research and Engagement and the Director.Appointments are made for a renewable three-year period of service. Any change in appointment, including reappointment or removal, requires written notification. Members may resign by written notification to the Chair.On an annual basis, the IRB Chair and the Director review the membership and composition of the IRB to determine if it continues to meet regulatory and institutional requirements.Alternate MembersThe role of the alternate member is to serve as a voting member of the IRB when the regular member is unavailable to attend a convened meeting. The appointment and function of alternate members is the same as that for primary IRB members, and the alternate’s expertise and perspective are comparable to those of the primary member.The IRB roster identifies the primary member for whom each alternate member may substitute. The alternate member will not be counted as a voting member unless the primary member is absent. When an alternate member substitutes for a primary member, the alternate member will receive and review the same materials prior to the IRB meeting that the primary member received or would have received. The IRB minutes will document when an alternate member replaces a primary member. Alternate IRB members should be individuals who have formerly served as regular IRB members or have the appropriate work experience so as to ensure their knowledge, ability and familiarity with UNCG IRB policies and procedures and relevant federal documents governing IRB operations.
5.3 Use of Consultants (Outside Reviewers)
When necessary, the IRB Chair or the Director may solicit individuals from the University or the community with competence in special areas to assist in the review of issues or protocols which require appropriate scientific or scholarly expertise beyond or in addition to that available on the IRB. For full reviews, the need for an outside reviewer will be determined in advance of the IRB meeting in which the review will occur by the Director or the Chair by reviewing the protocols scheduled to be reviewed at the convened meeting. The ORI will ensure that all relevant materials, including the protocol, are provided to the outside reviewer prior to the convened meeting. For expedited or exempt reviews, the need for an outside reviewer will be determined by the Director or the Chair by reviewing the protocol itself. The ORI will ensure that all relevant materials are provided to the outside reviewer as soon as he or she is identified.Prior to committing to review, consultants will be informed of the IRB conflict of interest policy either by telephone or letter from the Director. Consultants must verbally confirm to the Director that they do not have a conflict of interest prior to review. Individuals who have a conflicting interest or whose spouse or family members have a conflicting interest in the sponsor of the research will not be invited to provide consultation.In the case of full reviews, the consultant’s findings may be presented to the IRB for consideration in person. If in attendance, these individuals will provide consultation but will not participate in the vote. The consultant may be asked to participate in the IRB’s deliberations at the IRB’s discretion. In the case of expedited or full reviews, consultants will be asked to provide written documentation concerning their findings. Written statements of consultants will be kept in IRB records. Key information provided by consultants at meetings will be documented in the minutes.Ad hoc or informal consultations requested by individual members (rather than the full board) will be provided in a manner that protects the researcher’s confidentiality and is in compliance with the IRB conflict of interest policy (unless the question raised is generic enough to protect the identity of the particular PI and research protocol).
5.4 Duties of IRB Members
IRB Members have many responsibilities inclusive of initial protocol and modification review, attending committee meetings, assisting in procedure development, and possibly serving on subcommittees.In preparation for convened meetings, IRB members are provided the following information: the agenda and submission materials including protocols, proposed informed consent forms, and other appropriate documents. These are distributed to members prior to the convened meetings at which the research is scheduled to be discussed. Members receive the materials at least one week before each meeting in order to participate fully in the review of each proposed project. IRB members will treat the research proposals, protocols, and supporting data confidentially. All copies of the protocols and supporting material are returned to the IRB staff at the conclusion of the review for document destruction.
5.5 Attendance Requirements
Members should attend all scheduled IRB meetings. Given that IRB meetings are scheduled at a standard time and location, individuals should not be appointed to the IRB unless they have indicated their willingness and ability to attend meetings as scheduled. Members should not miss more than 25% of scheduled meetings. If a member is unable to attend a scheduled meeting, he or she should inform the IRB Chair or an ORI staff member. If the inability to attend will be prolonged, a request for an alternate to be assigned may be submitted to the Chair or the Director. This is vital to ensure that quorum can be met at all meetings.If an IRB member is to be absent for an extended period of time, such as for a sabbatical, he or she must notify the IRB at least 30 days in advance so that an appropriate replacement can be obtained. The replacement can be temporary, for the period of absence, or permanent if the member is not returning to the IRB. If the member has a designated alternate (See Section 7.5.2), the alternate may serve during the primary member’s absence, provided the IRB has been notified in advance.
5.6 Training/Ongoing Education of Chair and IRB Members in Regulations, Procedures
A vital component of a comprehensive human research protection program is an education program for the IRB Chair and the IRB members. UNCG is committed to providing training and an ongoing educational process for IRB members and the staff of the ORI related to ethical concerns and regulatory and institutional requirements for the protection of human participants.OrientationNew IRB members, including alternate members, will meet with the IRB Chair and Director for an informal orientation session. At the session, the new member will be given a copy of the Institutional Review Board Member Handbook, IRB review procedures will be discussed, will be informed that the most current IRB SOPs are on the ORI website, and they will be informed the CITI modules must be completed.New members are required to complete the Initial Education requirement for IRB members before they may serve as Primary Reviewers.Initial EducationIn addition to the orientation meeting described above, IRB members will complete the online CITI IRB Member Training.Continuing EducationTo ensure that oversight of human research is ethically grounded and that decisions made by the IRB are consistent with current regulations and policies, training will be ongoing for IRB members throughout their service on the IRB. Ongoing educational activities will include, but are not limited to:In-service training at IRB meetingsReviewing copies of appropriate publicationsIdentification and dissemination by the Director of new information that might have affected the human research protection program, including laws, regulations, policies, procedures, and emerging ethical and scientific issues distributed to IRB members via email, mail, or during IRB meetingsCompletion of CITIThe Vice Chancellor for Research and Engagement will provide support for the Chair and as many members of the ORI/IRB staff as possible to attend the annual PRIM&R conference on human research protections.
5.7 Liability Coverage for IRB Members
All University employees and authorized volunteers at UNCG are covered by the Defense of State Employees Act and the UNC System excess liability insurance policy in case of a lawsuit claiming that the employee or volunteer injured another’s person or property. In order to qualify for that coverage, the employee or volunteer must have been acting within the course and scope of his or her job or volunteer duties and must not have violated laws, regulations, or University policies. Intentional acts of wrong doing are also excluded. The coverage provides for free legal defense by the Attorney General’s office and, if a judgment is entered against the employee or volunteer, the judgment will be paid up to the limits of coverage (currently $5,000,000). All UNCG IRB members will be covered under the conditions described here. More information can be found at:http://www.uncg.edu/ucn/faq/liability.html
5.8 Performance of IRB Members
The performance of IRB members will be discussed as necessary by the Director, the IRB Chair, and the Vice Chancellor for Research and Engagement. Members who are not acting in accordance with the IRB’s mission, following these policies and procedures, have an undue number of absences (more than 25%), or are not fulfilling the responsibilities of an IRB member may be recommended for removal by the Vice Chancellor for Research and Engagement to the Chancellor.