|
|
| Research Services and Sponsored Programs |
| CONTENTS |
 |
|
General information about the IRB What is the IRB? The Institutional Review Board (IRB) is a federally-mandated committee charged with protecting the rights of human subjects used in research. Faculty members from a variety of scientific and non-scientific disciplines and a community representative serve on this university committee to review and approve research projects involving human subjects.The Office of Research Services and Sponsored Programs (ORSSP) is the administrative office that coordinates the activities of the IRB. All research projects involving human subjects must be approved by the IRB. The research and human subjects decision charts available above (see links) can help researchers determine if their projects meet the federal definition of research with human subjects. Sponsored Programs will not accept funding for human subject research from an external agency without documentation of IRB approval.
Why does this concern me? UNCW has assured the U.S. Department of Health and Human Services that it will follow all regulations pertaining to human subjects protection. UNCW also has the highest standards for conducting research and protecting the people we ask to participate in our research. Even if you do not conduct research that involves human subjects, it is important for faculty members to be aware of their institution’s human subjects protection program. Who do I call with questions? Any questions or concerns pertaining to human subjects research should be directed to Leanne Prete (regulatory compliance officer) at 962-7774 or Dr. Candace Gauthier (IRB Chair) at 962-3558.
The IRB is just for medical research, right? The IRB is not just for medical research. There are non-medical risks that can potentially be associated with other types of studies such as surveys, interviews and focus groups. The IRB helps researchers identify less obvious emotional and social risks, and assures that subjects are fully informed about the purpose of the research, how their information will be used and how their confidentiality will be protected. In addition to the Psychology and Nursing departments, the UNCW IRB has approved research protocols from many UNCW departments and offices, including: Health and Applied Human Science, History, Foreign Language and Literature, CROSSROADS, Randall Library, Chemistry, Mathematics & Statistics, Political Science and others. There are well over a hundred active human subject projects being conducted by UNCW faculty and students today. Do undergraduate student projects need IRB approval? Sometimes undergraduate student projects do need IRB approval. IRB approval is not necessary if the students are conducting studies on campus and do not plan to publish or externally present their work. Instead, this type of project should be reviewed by the relevant professor or advisor. If in doubt, you should review the Research Decision Chart to determine if the activity meets the definition of research (also see the next two questions below).
How does the IRB define “research”? The IRB definition of “research” comes from the Code of Federal Regulations (CFR Title 45 Part 46). Research is defined as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” The UNCW IRB has defined “systematic investigation” as a cohesive approach involving data collection (quantitative or qualitative) from one or more individuals and analysis to address a question or test a hypothesis. “Generalizable knowledge” is defined by the UNCW IRB as the results or outcomes gained from systematic investigation that may be published, archived, presented, or viewed in some way as relevant beyond the specific participant population. The Research Decision Chart is helpful to determine if an activity meets the IRB definition of research. How do I know if I am working with “human subjects”? “Human subject” is defined in the federal regulations as “a living individual about whom an investigator conducting research obtains: 1) data through intervention or interaction with the individual; or 2) identifiable private information.” Research with human subjects includes program evaluation, interviews, surveys, and questionnaires, as well as more complex behavioral interventions with human subjects. The Human Subject Decision Chart is helpful to determine if the people you will use in your research meet the IRB definition of human subjects.
Why do IRBs continue to require review of oral history projects when the AHA has obtained guidance from OHRP that oral history activities are never human subjects research? OHRP’s guidance stated that oral history projects, in general, do not involve research as defined by IRB regulations. However, OHRP advised IRBs to handle this determination on a case-by-case basis. The AHA subsequently stated, “Interview projects that meet with the above federal definition should be submitted for IRB review. Those that do not are not subject to review.” The UNCW IRB completely agrees with the AHA’s subsequent statement, which is in keeping with how we handle all projects. First, make a determination as to whether the activity meets the definition of research according to the above federal regulations and UNCW IRB policy. If the project meets the definition of research, determine if human subjects are involved according to the federal definition of human subjects. If both definitions are met, oral history projects must be submitted for IRB review the same as all other projects. The UNCW IRB has tried very hard to redesign our Human Subject Protocol Form so that it is more user-friendly for researchers conducting non-clinical activities. I am planning a research project that will involve human subjects. What am I required to do? First, any member of the research team who is involved in the design or conduct of the research is required to complete an online training course offered by the University of Miami’s Collaborative Institutional Training Initiative (CITI). The link to CITI and instructions on how to properly register for the correct course can be found on the IRB website: http://www.uncw.edu/orssp/conduct-human-training.html. The principal investigator (PI) must indicate the date each research team member completed training on the Human Subject Protocol Form. After completing the protocol form, the PI submits an electronic copy and a signed hard copy with appropriate attachments, including an informed consent form, any surveys to be used, and letters of support from research sites (if applicable) to the regulatory compliance officer in ORSSP. If the PI needs IRB approval by a certain date, the PI must make sure ORSSP has the signed hard copy at least ten (10) days prior to the desired start date to allow time for review and approval. However, if the PI believes the project will require review by the full IRB at a convened meeting, the PI should check to see when the next scheduled IRB meeting is, and when the deadline is for protocol submission. These dates are posted on the IRB home page. I submitted my protocol. What happens next? When a protocol is received, the regulatory compliance officer conducts an initial review and forwards the protocol to the IRB Chair. The IRB Chair determines what type of review will be needed: exempt, expedited, or full IRB review. The IRB Chair conducts exempt and expedited reviews throughout the year. When a protocol requires full IRB review, it is placed on the agenda for the next scheduled meeting. The IRB Chair forwards notice of approval directly to the PI.
How long will it take the IRB to review my protocol? This depends on the type of IRB review required. Certain projects can be reviewed by the IRB Chair when they have very low risk to the study participants (see question below for more information). When the IRB Chair can conduct the review herself, the turnaround time is within two weeks. ORSSP must receive the signed hard copy of the protocol and any supporting documentation at least ten (10) days prior to the researcher's desired start date to allow adequate time for IRB processing, review and approval. When a protocol must be reviewed by the full IRB, the protocol is placed on the agenda for the next scheduled IRB meeting.
What are the different levels of IRB review? There are three types of IRB review depending on the level of risk involved in the project: exempt, expedited and full IRB review. Projects that qualify for exempt review are projects having such a low level of risk to subjects that further IRB oversight is not required with the exception of protocol amendment forms. Amendment forms are required on exempt studies since a change to the study may alter its exempt status. Projects qualifying for expedited review are also minimal risk to subjects, but may involve other apsects that require continuing IRB oversight and annual renewal of protocol approval. A project may require full review for a number of reasons such as the subjects belonging to a potentially vulnerable population or a higher degree of risk to subjects. Researchers may NOT make their own determination as to the appropriate type of review. Only the IRB Chair or designate can determine which type of review is applicable.
What is the difference between exempt, expedited and full IRB review? When a protocol is approved by exempt review, the IRB deems the risk to be so minimal that continuing review of the project by the IRB is not required. A good example of an exempt study is a completely anonymous written or online survey where there is no way to identify the subjects. Protocols that are approved by expedited review are also minimal risk projects such as surveys or interviews. However, ongoing review by the IRB is required because the subjects are identifiable in some way. When subjects are identifiable, PIs must provide documentation of how the subjects’ confidentiality will be protected. Protocols that require full IRB review are projects that utilize a procedure involving more than minimal risk to subjects, or involve subjects who may be particularly susceptible to coercion, such as prisoners or economically disadvantaged people, or subjects who need additional protections, such as mentally or physically disabled people.
What is the difference between anonymous and confidential? When the data are collected in such a way that the subjects cannot be identified, the data are considered to be anonymous. Anonymous data does not have to be kept confidential because there is no way to associate subjects to their responses. When the data are collected so that subject names can be linked to the data, the data are not anonymous and must be kept confidential. The principal investigator (PI) of a study must demonstrate how confidentiality will be maintained to protect human subjects.
Who needs to complete the required online IRB training? Any person involved in the design and/or conduct of a human subject research project must complete the approved online human subject protections training program offered by the University of Miami's Collaborative Institutional Training Initiative (CITI). The IRB will not review a protocol until training documentation is on file at ORSSP. This requirement includes any faculty, staff, students, or collaborators from other institutions. The training page of this website provides instructions on how to properly register for the CITI course.
How often do I need to renew my training? At this time there is no expiration to your completion certificate. However, since the new training course has refresher courses available, this may change in the future. Some institutions require refresher training after 3 years, so if you conduct research at another institution they may consider your training to be expired.
Who do I send my completion certificate to? If you are a research assistant on a project, the principal investigator may ask you to provide him or her with a hard copy of the completion certificate. You are strongly encouraged to keep a hard copy for your own records as well. You are no longer required to submit a hard copy of your completion certificate to ORSSP if you complete the CITI training and identify the University of North Carolina Wilmington as the participating institution. When you complete the course for which you registered, the regulatory compliance officer will receive an email notification directly from CITI. This notification is considered "official" documentation of your training. However, if you completed the CITI training through a participating institution other than the University of North Carolina Wilmington, ORSSP will not be able to access those records. There are several options available for this situation and you should contact the regulatory compliance officer, Leanne Prete, to see what is best for you (962-7774 or pretel@uncw.edu). Also, if you completed training through the National Cancer Institute site you must still provide a hard copy of your completion certificate if it is not already on file with ORSSP, since there is no other way for ORSSP to obtain this documentation. Please send completion certificates to Leanne Prete, Regulatory Compliance Officer, ORSSP, Campus Box 5973.
Are Institutional Review Board members required to complete additional training? Yes. The IRB Member learner group has more modules than any other group. IRB members must complete all of the required modules. If a new IRB member previously completed the Social & Behavioral Research Investigator learner group, the IRB member only needs to complete the additional modules required for IRB members.
What do I do if something unexpected happens with a subject during my project? If there is an unexpected adverse event during your human subjects research, the PI is required to report it to the IRB on an Adverse Event Report form, available on the Forms page of this website. If the problem is very serious, the PI or another responsible person must contact the IRB Chair, Dr. Candace Gauthier (ext. 3558) as soon as possible and file an Adverse Event Report form within five days. If Dr. Gauthier is not available, the PI must contact Leanne Prete in ORSSP (ext. 7774). If the event is less serious, the PI does not have to contact the IRB Chair but must submit an Adverse Event Report within five days. For more information on adverse event reporting, please see the IRB policy posted on the IRB website.
If my subjects provide me with health information, am I a covered entity subject to HIPAA? No. A covered entity is defined under HIPAA as “health plans, health care clearinghouses and health care providers who electronically transmit any health information in connection with transactions for which the Department of Health and Human Services has adopted standards.” UNCW is not a covered entity and researchers are generally not considered covered entities. Health information that is provided to the researcher by the human subject is not considered protected health information under HIPAA. Researchers who are covered entities due to operating a private practice must comply with HIPAA regulations. Information and resources for HIPAA are available on the Resource Materials page of this website.
I need to make a minor change to a survey that was already approved by the IRB. Do I need to notify the IRB? Yes. Any change to an approved protocol, no matter how small (including personnel changes), must be approved by the IRB prior to the PI making the change. Researchers should obtain a Protocol Amendment form from the Forms page of this website. Approved amendments do not change the original approval dates for a project. In other words, if your protocol was approved in April 2008 and will expire in April 2009, an amendment to the protocol approved in October 2008 will not extend the expiration date beyond April 2009. What is informed consent? (Copied from OHRP's Informed Consent FAQs: http://www.hhs.gov/ohrp/informconsfaq.html#q1) The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained. HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 describe the informed consent requirements. The informed consent process is the critical communication link between the prospective human subject and an investigator, beginning with the initial approach of an investigator to the potential subject (e.g., through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study. For the purposes of the HHS regulations at 45 CFR part 46, “investigators” are individuals who conduct human subjects research projects, including individuals directly involved in seeking the voluntary informed consent of potential subjects. Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. The informed consent process should be an active process of sharing information between the investigator and the prospective subject. The exchange of information between the investigator and prospective subjects can occur via one or more of the following modes of communication, among others: face-to-face contact; mail; telephone; video; or fax. Prospective subjects should be provided with ample opportunity to ask questions and seek clarification from the investigator. The prospective subjects should be in a position to freely decide whether to initially enroll in the research, or later, to withdraw or continue participating in the research. The informed consent process should ensure that all critical information about a study is completely disclosed, and that prospective subjects or their legally authorized representatives adequately understand the research so that they can make informed choices.
When is an informed consent form required? An informed consent form is required in most situations. The IRB may consider waiving this requirement for anonymous surveys and other situations, but usually some form of consent is required. Researchers should refer to the UNCW IRB Polocies and Procedures or call the IRB Chair with questions regarding consent requirements.
What do I do if I suspect a colleague is fabricating information on his/her human subjects research? Research misconduct is defined as “a significant departure from accepted practices of the relevant scholarly community, committed intentionally, knowingly, and/or recklessly, including but not limited to…fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” Research misconduct does not include honest error or differences of opinion. Anyone who has information pertaining to a suspected incident of research misconduct should speak to the Dean or Director who supervises the person suspected of the activity, and review UNCW’s Research Misconduct policy at http://www.uncw.edu/policies/.
What is a Certificate of Confidentiality and when is it a good idea to obtain one? A certificate of confidentiality is a document issued by certain U.S Department of Health and Human Service agencies that allows a researcher to refuse to reveal identifiable research information, even if the researcher is subpoenaed to do so in any civil, criminal, administrative, legislative or other proceeding, whether at the federal, state or local level. A certificate of confidentiality may be awarded whether or not the project is federally funded. Researchers may want to consider applying for a certificate of confidentiality if they will be collecting information that may be damaging to subjects if it is revealed, for example, damaging the subject’s financial standing, employability, insurability or reputation within the community. The National Institutes of Health operate an online Certificate of Confidentiality Kiosk that has more detailed information. This kiosk can be found at: http://grants.nih.gov/grants/policy/coc/index.htm There is also a link to this kiosk on the Resource Material page of the UNCW IRB website.
What is a Federalwide Assurance? A Federalwide Assurance is an agreement with the United States Department of Health and Human Services (DHHS) to conduct human subject research in accordance with certain principles.
What does UNCW's Assurance agree to? UNCW's Assurance agrees to comply with the principles outlined in the Belmont Report and the Code of Federal Regulations Title 45, Part 46 Protection of Human Subjects, Subparts A, B, C and D. UNCW has agreed to follow these regulations for all research involving human subjects, regardless of the funding source. See the DHHS website for more information about Assurances.
|
