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IRB functions are
conducted under the auspices of the Office for Research Compliance (ORC) in
the Moore Humanities and 2. Who should be contacted for questions about IRB policy and procedures? Eric Allen, Director Office of Research Compliance and may be contacted by telephone at (336) 256-1482 or by email at: eric_allen@uncg.edu Additional guidance can be sought from the departmental representatives. For forms and other general
questions, please contact Ms. Aicha Davis at (336) 256-1482 or asalston@uncg.edu 3. How can investigators obtain IRB forms? All of the IRB forms are available for download from the ORC website: http://www.uncg.edu/orc/humanres.html 4. What is the IRB? The Institutional
Review Board (IRB) for the Protection of Human Participants in Research is
the body at The University of North Carolina at IRB members are appointed by the Chancellor for staggered three year terms, and may be reappointed for successive periods. In accordance with applicable federal regulations, the Board must have a minimum of five members, including at least one individual who would be considered a non-scientist. Members are selected from faculty, staff, students, and community members. Considerable effort is expended to recruit individuals from the University campus who have expertise in different areas. This diversity helps to ensure that protocols are evaluated fairly by knowledgeable individuals. If necessary, non-voting consultants may be enlisted to review specific protocols for which there is no IRB member with sufficient knowledge of the research method or scientific discipline to conduct a substantive review. 6. Upon what federal regulations is IRB policy based? The primary regulation that pertains to human participant research is Title 45 of the Code of Federal Regulations, Part 46 (45 CFR 46). This statute defines relevant terms and describes all aspects of human participant’s protection, including the composition of review boards, criteria for protocol review, guidelines for informed consent, requirements for record-keeping, special protections for vulnerable populations, types of review, and procedures for dealing with non-compliance. It is based on the ethical principles identified in the Belmont Report. As written, 45 CFR 46 applies only to federally funded research, however, UNCG maintains an agreement with the federal Department of Health and Human Services (DHHS) that extends the protections of 45 CFR 46 to all research conducted by University personnel, regardless of the source of funding, or lack thereof. This agreement is the Federal Wide Assurance (FWA) and is required before the institution may receive federal research funds. 7. How often does the IRB meet? The IRB meets biweekly, except during June and July when the committee meets as necessary. 8. What are the criteria for IRB review of a protocol? When reviewing a protocol, the IRB must make the following determinations: (1) Risks to participants are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk, and (ii) whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes. (2) Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies participants would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of participants is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons. (4) Informed consent will be sought and documented from each prospective subject or the subject's legally authorized representative, in accordance with federal regulations (5) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants. (6) When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data. When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants. The vast majority of researchers plan and conduct their research in accordance with sound ethical principles. When the researcher is affiliated with an academic institution, repercussions for failing to protect participants affect not only the investigator, but the institution as well. For this reason, oversight by an institutional review board is necessary to ensure that projects include the appropriate safeguards to protect human participants. 10. When is IRB review required? IRB review is required whenever an investigator who is affiliated with the institution conducts research with human participants. Research is defined by federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge". Student projects are considered to be research when the intent is to disseminate study results. More information on student projects can be found in the course vs. class assignment document. 11. What are the different types of IRB review, and how do they differ from one another? There are three levels of IRB review: exempt from full review, expedited review, and full review. Exempt from full review: Protocols that present extremely low levels of risk to participants and include only procedures described in six specific categories of research as described in the federal regulations may qualify for exemption. This DOES NOT MEAN EXEMPT FROM REVIEW BY THE IRB. Expedited Review: Protocols that present no more than minimal risk to participants.
Full Review: Protocols that do
not meet the criteria for either exempt from full review or expedited review
must be reviewed by the convened IRB.
The investigator is invited to the convened IRB meeting to lend
support and answer questions that the committee may have in regards to the
protocol. ONLY FULL REVIEW PROTOCOLS MUST BE REVIEWED AT A CONVENED IRB
MEETING. 12. How is minimal risk defined? A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
13. What are minor/significant
modifications to a protocol? Significant Changes
Minor Changes 1. Increasing the sample size for a study 2. Changing the stimuli for an experimental
study (e.g., memory lists of words to memory lists of pictures, as long as the pictures are of the same
caliber or similar response) 3.
Requesting additional contact information (email or fax number) 4.
Changing PI of equal capabilities or adding students to a project 5.
Adding sites to collect data of same caliber (another high school in
the Federal regulations require that all protocols involving human participants be reviewed by the IRB at least annually. Approximately three months prior to the expiration date of a protocol, the investigator or faculty sponsor for student investigators will receive a Request for Continuing Review form by mail, from the ORC office. If the project, including data analysis, collection, or dissemination will not be completed by the expiration date, then the investigator should complete the form and return it by the due date so that there is no interruption in the approval period. Enrollment of new participants cannot occur on a project if it becomes inactive. In addition, research intervention or interaction with already enrolled participants must stop if a project becomes inactive unless the IRB determines that it is in the best interest of individual participants to continue. If a protocol becomes inactive, submission of a new Request for IRB Review and Clearance may be required. An investigator
should not deviate from the processes and procedures approved by the IRB and
needs to submit a request for modification.
To request a modification or addendum to an approved protocol form, send
a completed modification request to your departmental representative. The
departmental representative will conduct the initial review and forward the
document on to the ORC. The ORC will
then forward the document for final review.
After IRB review, a notice of approval will be mailed to the
investigator. Changes to approved
protocols may not be implemented until the change is approved by the IRB. An Adverse/Unexpected Event is defined as: (1) any clinical, psychological or behavioral event that is undesirable and unintended, although not necessarily unexpected; (2) an event in which the outcome is negative, loss of job, hospitalization, imprisonment or public humiliation; (3) an overdose; or (4) a complaint by a research subject or family member of a research subject concerning the research or the protocol. If an adverse or unexpected event occurs on an approved protocol, the investigator is required to submit an Adverse/Unexpected Event Report to the IRB. The form and specific instructions may be downloaded from the ORC website at: http://www.uncg.edu/orc/ADVERSE%20PROBLEM.doc Informed consent is one of the primary ethical requirements underpinning research with human participants; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. The prospective subject should be presented with the information, then given an opportunity to ask questions and have them answered, prior to signing the consent document. 18. Do I need to submit both the short
form and the long form? No, you only need to submit
either the short form with oral presentation or the long form. A short
form with an oral presentation may be used when procedures are rather simple
and when the researcher will have direct contact with the participants. The oral presentation must include the
aspects of informed consent. A witness unaffiliated with the study must sign
the oral presentation. The witness can be a subject or a family member, but
NOT a member of the research team. The
long form must be used when research procedures are complicated or when the
researcher will have no direct contact with the participants. The long form is a good choice when the
researcher cannot be assured that a witness will be available to witness an
oral presentation. 19. What information should be included in a consent document? (a) Basic elements of informed consent: The informed consent document must be written in language that can be understood by the participants. Usually this is in layman’s terms at approximately an eighth grade reading level and technical terms are not advised. If the investigator plans to work with participants that speak languages other than English the informed consent document needs to be translated in that language. Example: If the proposed research is set in a German medical center the translator must be fluent in German and understand medical terminology. (1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) a description of any reasonably foreseeable risks or discomforts to the subject; (3) a description of any benefits to the subject or to others which may reasonably be expected from the research; (4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) for research involving more than minimal risk, an explanation as to whether any compensation will be made and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) an explanation of whom to contact for answers to pertinent questions about the research and research participants' rights (Eric Allen , Director of Office of Research Compliance, 256-1482), and whom to contact in the event of a research-related injury to the subject; and (8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent.
When appropriate, one or more of the following elements of information shall
also be provided to each subject: (1) a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; (2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; (3) any additional costs to the subject that may result from participation in the research; (4) the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and (6) the approximate number of participants involved in the study. 20. Are sample consent/assent forms available for review? Yes. Sample consent forms may be found within the Informed Consent/Assent guidance material online at: http://www.uncg.edu/orc/humanres.html Numerous sample forms are presented, to provide guidance to researchers from various disciplines. Additional forms will be added periodically. 21. What is assent? Assent is defined as, " A child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent. While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research: (1) does not involve interventions likely to be of benefit to the participants; and (2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others. The IRB must determine for each protocol - depending on such factors as the nature of the research and the age, status, and condition of the proposed participants - whether all or some of the children are capable of assenting to participation. In general the IRB requires an assent document for children ages 7-17. However the IRB reviews protocols on a case-by-case basis to determine whether assent should be sought from given individual participants. 22. How do the regulations apply to Oral History projects? The UNCG IRB reserves the right to review all research and determine if it is in fact Oral history or if it needs to go to the IRB for review. If the IRB declares that the research is not Oral History the investigator needs to receive IRB approval before the research project begins. The IRB requires that the researcher make provisions for obtaining informed consent from all participants and document the process. Participants in oral history projects should be allowed to review the material prior to public archive and decide if they wish any or all of the oral history are archived. 23. For collaborative research is IRB approval from both Institutions required? Yes. When working in collaboration with another institution you must provide evidence that the protocol has been approved through the collaborating institutions IRB. Under some circumstances, UNCG’s IRB approval is required prior to obtaining a copy of the collaborating institution’s IRB approval. In this situation researchers must notify their IRB department representative. 24. What are the procedures for working with
medical records at Relative
to a protocol that has been approved by UNCG IRB, and also has received
reciprocal approval by Moses Cone IRB by virtue of the signed agreement; and
the approval requires access to patient records at Moses Cone, please do the
following: The researcher doing the
chart review will inform Eric Allen, ORC Director, (by hard copy or email)
about needing to review records and will give him a hard/electronic copy of
the protocol summary and approval (attached to the packet/email). Eric Allen will forward the summary and
approval to the Moses Cone IRB chair. The
Moses Cone IRB Chair will, in turn, review the summary and forward it to the
Director who is over medical records. When
the researcher visits Medical Records, the Medical Records Director will be
aware of the need to review charts, and permission will be granted. Be
sure the researcher informs the contact person in Medical Records that the
Medical Records Director has been made aware.
Calling ahead will probably save time and it may not be necessary for
Eric Allen to be involved at all. The
researcher can forward the summary and approval directly to the Moses Cone
IRB chair and the chair can facilitate. 25. When is a Certificate of Confidentiality required? A Certificate of Confidentiality is required of all individuals that have access to confidential information for non-research purposes. Examples of such individuals are transcriptionist and student assistants. These certificates are to be maintained by the researcher along with their secured files. 26. What are the CITI and Cornell training modules? The CITI and Cornell training modules are a web-based education programs for all principal investigators and other key personnel who are named on protocols that involve human participants. As a requirement for an assurance of compliance, which allows an institution to receive federal funding for research involving human participants, the federal Office for Human Research Protections (OHRP) has mandated that principal investigators and other key personnel involved in human subject protocols participate in education designed to increase understanding of the regulations, policies, and ethical standards governing the protection of human participants. 27. How are certification of training letters obtained? After successful completion of either tutorial a certificate should be printed and retained by the researcher. A copy of the certificate is required with submission of their IRB application. 28. Who is the contact
person for student research? All communication inclusive
of approval documents, renewal notices, and request for additional information for student
research is directed to the faculty member who is the
PI on the project. 29. How does the IRB
define “Moderate Exercise”? When evaluating subject 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 possessed by the person who is going to engage in a given intensity of exercise. The most important thing to do in keeping people safe is to screen them properly prior to exercise participation. Some people who possess a high level of fitness along with a satisfactory health history and no serious personal risk factors can participate in very high intensity exercise testing or training and are at minimal risk for a serious medical event. Their risk is close to the risk level of participation in normal, everyday activities. This is in comparison to other people 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. The above examples are meant to provide support that the IRB should primarily evaluate research subject risk in relation to certain types of exercise, not just make decisions based on intensity of the exercise, when deciding if an application should be expedited or undergo full review. Nationally, exercise science professionals use the American College of Sports Medicine Guidelines for Exercise Testing and Prescription (currently in the 7th edition) to decide the conditions under which someone should be exercise tested or trained. It is one of the most widely read and referenced texts of its kind in the world. It is a state-of-the-art manual and it is referenced-based. Through tight health history screening and risk factor and symptom evaluation, the Guidelines place people into risk categories and recommend appropriate safeguards for exercise testing or training. We recommend that in the future, IRB applications
with an exercise component, where the research subjects are considered to be
at moderate risk or less during the proposed exercise as per ACSM Guidelines,
should receive an expedited review.
Only those applications, where subjects are at more than moderate
risk, should be full-reviewed. Also, we believe this proposal is acceptable
in conjunction with the opinion sent back to Eric Allen from Kevin A.
Prohasta, D.O. at the Office for Human Research Protections relative to
judging exercise risk. Of course, if a situation arises where the Guidelines
are not clear, a full-review should be completed. This would probably be very seldom—the
Guidelines are comprehensive.
Additionally, researchers outside of the Department of ESS who propose
studies which involve exercise are welcome to check with the ESS-IRB
representative to evaluate risk as per the Guidelines before submitting their
application for review—if they wish to do so. Approved by UNCG IRB August 21, 2006 30. What is UNCG's Federal Wide Assurance
(FWA) number? FWA number: 00000216 |
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