The information presented here pertains specifically to the Reynolda campus IRB. For more comprehensive information on the IRB and its procedures, see Policies. For eIRB FAQ's, see Getting Started in eIRB?.
IRB stands for Institutional Review Board. The IRB protects the rights and welfare of human participants involved in research conducted under the auspices of Wake Forest University in accordance with its Federalwide Assurance and 45 CFR §46.
Research means a systematic investigation (including research development, testing and evaluation) designed to contribute to generalizable knowledge.
The IRB generally meets the third Monday of the month. Meeting dates are listed under IRB in a Nutshell. Applications requiring full Board review must be submitted one week before the scheduled meeting. Exempt and expedited applications can be submitted at any time.
WFU and WFUHS are two legally separate entities and maintain separate FWAs. However, to accommodate the frequent collaboration among investigators from both campuses, the WFU IRB and the WFUHS IRB have signed a Memorandum of Understanding concerning the reciprocal waiver of IRB oversight by the WFUHS and WFU IRBs for designated cooperative research. Under this agreement, each institution may rely upon the IRB review and continuing oversight of the other institution's IRB.
Research involving medical testing, medical records and treatments is primarily conducted at WFUHS. Investigators select which IRB, WFU or WFUHS, will review the research within the eIRB application based on what the research entails and in some cases, where it is performed.
The approval period for any research is no more than 1 year, less if the proposed research needs more frequent monitoring. Before the end of the approval period, the researcher must submit a request for continuing review.
The most common reasons for delays are:
An additional resource is the Department of Health and Human Services’ Office for Human Research Protections’ IRB Guidebook
Deception can be used if the benefits outweigh the risks to the participants and if there is compelling justification. The subjects must be informed at the end of their participation either in person or via email that the experiment involved some deception and the reason for the deception. They must have the opportunity to ask questions during the debriefing. A debriefing script may be required as part of the application.
Maintaining confidentiality is essential to any research in order to protect the privacy and well-being of participants. Whenever possible, research should use unlinked, truly anonymized data, i.e., data prepared from personal information from which the participant cannot be identified by the recipient of the information. If this is not possible, the amount of personal data stored by researchers should be kept to the minimum necessary to achieve the purpose of the research. Personal data that has been encoded remains personal data as long as the key for decoding remains in existence. If you have destroyed the key or another organization is holding it and will never give you access to it, then you have taken suitable steps to anonymize the data. When planning a project, researchers should always consider giving data to and receiving data from others, and before publishing information whether their research may lead to the identification of individual participants.
If the PI is receiving data from another organization, ideally the organization providing the data should anonymize it before giving it to the investigator. This means the PI will receive unlinked data, reducing the risk that the data will be identifiable. When this is not possible, the research team should anonymize the records rather than use identifiable data.
Coded data are identifiable personal information in which the details that could identify someone are concealed in a code that can be readily decoded by those using the data. Coded data is not anonymized data.
Existing data is data that has been collected prior to the research for a purpose other than the proposed research and includes data collected in research and non-research activities.
Security measures should be appropriate to the degree of risk in the study. The PI should consider: 1) where all personal data recorded on paper, audio or videotaped or computerized will be stored; 2) the security procedures for storing and transporting physical data; 3) the arrangements in place to prevent theft of data; 4) how access to data will be restricted; 5) password protection procedures used to protect electronic data; 6) security arrangements if data are processed off-site; 7) how data will be disposed of at the end of the study.
Researchers must promptly report to the IRB any serious or continuing noncompliance with federal regulations or university policies and any injuries to subjects or unanticipated problems. See Policies for the guidelines on reporting adverse events/unanticipated problems. In eIRB choose New Safety Event under My Activities. For paper studies, you may access the report forms at http://www.wfu.edu/rsp/irb/forms.html.
In eIRB, once the application is submitted, the study team can read but not make any changes until eIRB releases the application for editing by the study team in response to concerns raised by the IRB or IRB Administrator.
Any changes to an original application must be submitted for review and approval to the IRB using the (paper) Amendment Request form at www.wfu.edu/rsp/irb/2007forms.html or the Amendment form on eIRB. .
Researchers are required to keep IRB correspondence and research data (including informed consent/assent forms) in a secured location for as long as the data is scientifically valuable or 3 years after study closure, whichever is longer.
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