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Welcome Ethical Research Practice Institutional Review Board IRB Review Criteria Informed Consent Genetic Testing Types of Review Continuation & Final Reports Serious Adverse Events Frequently Asked Questions Conclusion |
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Frequently Asked QuestionsYou have questions about the Institutional Review Board process and the staff in the IRB office is available to assist you. Please take a moment review the FAQs below, and feel free to call or write to the IRB office with any questions that you may have. IRB Overview
What does the IRB do? Institutional Review Boards are responsible for ensuring that an institution meets the requirements of the federal regulations, and that the rights and welfare of the subjects are adequately protected. If I’m doing a study that is not funded by any outside pharmaceutical or government agency, why do I have to abide by federal regulations? HFHS has filed a Federal Wide Assurance (FWA) with the U.S. Department of Health and Human Services. By doing this, we (HFHS) have agreed to the following: “All of the Institution's human subject activities and all activities of the Institutional Review Boards (IRBs) designated under the Assurance, regardless of funding source, will be guided by the ethical principles in: (a) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, or (b) other appropriate ethical standards recognized by Federal Departments and Agencies that have adopted the Federal Policy for the Protection of Human Subjects.” Once I receive my approval letter, do I need to file regular reports? Yes. The IRB requires you to submit progress reports at least on an annual basis. If your study is high risk you may be asked to provide a progress report more frequently than once a year. You should also know that if you conduct research (i.e. gather data) after your IRB approval has expired, your are in violation of federal regulations and IRB policies. If the IRB disapproves my study, can I bring it to another administrative body within the hospital for approval? If the IRB has denied approval for a proposal, any other administrative or clinical body cannot overturn their decision. In order to insure the safety of human subjects in research, the IRB is a truly independent review board.
Use of Personal Health Information Do I need an authorization to review records in order to prepare for a study? HFHS employees/researchers can access patient medical records for the purposes of preparation of research activities as long as the researcher does not remove such PHI from HFHS. The investigator must sign the HFHS Confidentiality Agreement and agrees to use the PHI solely to prepare a research protocol or determine feasibility for research. What’s the difference between de-identified information and a limited data set? A limited data set allow several of the 18 identifiers to remain. The identifiers that may remain for a limited data set are 1) town/city, state, and zip code, 2) all elements of dates including birth date, admission date, discharge date, and date of death, 3) any other unique identifying number, characteristic, code (i.e., Medical Record Number). Can I call prospective subjects for recruitment purposes without IRB approval? No. Patients cannot be contacted for recruitment until the research protocol has been approved by the IRB. Also, the primary or treating physician must be contacted in writing and told of the researcher’s intention to contact their patients. The primary or treating physician must respond within 2 weeks if they do not want their patient(s) contacted. When do I need to get a Business Associate Agreement? Business Associate Agreements are required when identifiable patient information from HFHS is being given to a recipient outside of HFHS and the information contains Personal Health Information, there is no patient authorization, or written consent was previously waived by the IRB.
How soon do I need to report a serious adverse event to the IRB? Serious adverse events must be reported no later than 10 days after the Principal Investigator is notified of the event. How do I know if the device I’m testing falls into the category of “significant risk”? A significant risk device is defined as a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject, and 1) is an implant; 2) is used in supporting or sustaining human life; 3) is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or 4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. A “non-significant risk” device is one that does not meet the definition of a significant risk device. What is meant by minimal risk? The definition of minimal risk, per Federal guidelines, is “The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves tan those ordinarily encountered in daily like of during the performance of routine physical or psychological examinations or tests”. If I’m doing a chart review, can I get expedited IRB approval? In the context of research with medical records, the risk of the potential consequences associated with a breach of privacy and confidentiality must be considered. The expedited process cannot be used if identification of the subjects would place them at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing.
Is the purpose of the IRB review of informed consent to protect the institution or the subject? The fundamental purpose of IRB review of informed consent is to assure that the rights and welfare of subjects are protected. A signed informed consent document is evidence that the document has been provided to a prospective subject (and presumably, explained) and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution has complied with applicable regulations. Does an IRB or institution have to compensate subjects if injury occurs as a result of participation in a research study? Institutional policy, not FDA or NIH regulations, determines whether compensation and medical treatment(s) will be offered and the conditions that might be placed on subject eligibility for compensation or treatment(s). The federal regulation on compensation (21 CFR 50.25 and 45 CFR 46.116) requires that, for research involving more than minimal risk, the subject must be told whether any compensation and any medical treatment(s) are available if injury occurs and, if so, what they are, or where further information may be obtained. Any statement that compensation is not offered must avoid waiving or appearing to waive any of the subject's rights or releasing or appearing to release the investigator, sponsor, or institution from liability for negligence [21 CFR 50.20]. Are there any regulations that require clinical investigators to report to the IRB when a study has been completed? IRBs are required to function under written procedures. One of these procedural requirements (21 CFR 56.108 and 45 CFR 46.103) requires ensuring "prompt reporting to the IRB of changes in a research activity." The completion of the study is a change in activity and should be reported to the IRB. Although subjects will no longer be "at risk" under the study, a final report/notice to the IRB allows it to close its files as well as providing information that may be used by the IRB in the evaluation and approval of related studies. What is expedited review? Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The Agency's IRB regulations (21 CFR 56.110 and 45 CFR 46.110) permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk. The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval. Under an expedited review procedure, review of research may be carried out by the IRB chairperson or by one or more experienced members of the IRB designated by the chairperson. The reviewer(s) may exercise all the authorities of the IRB, except disapproval. Research may only be disapproved following review by the full committee. The IRB is required to adopt a method of keeping all members advised of research studies that have been approved by expedited review. Must an investigator's brochure be included in the documentation when an IRB reviews an investigational drug study? For studies conducted under an investigational new drug application, an investigator's brochure is usually required by FDA [21 CFR 312.23(a)(5) and 312.55]. Even though 21 CFR part 56 does not mention the investigator's brochure by name, much of the information contained in such brochures is clearly required to be reviewed by the IRB. The regulations do outline the criteria for IRB approval of research. 21 CFR 56.111(a)(1) requires the IRB to assure that risks to the subjects are minimized. 21 CFR 56.111(a)(2) requires the IRB to assure that the risks to subjects are reasonable in relation to the anticipated benefits. The risks cannot be adequately evaluated without review of the results of previous animal and human studies, which are summarized in the investigator's brochure. Is getting the subject to sign a consent document all that is required by the regulations? No. The consent document is a written summary of the information that should be provided to the subject. Many clinical investigators use the consent document as a guide for the verbal explanation of the study. The subject's signature provides documentation of agreement to participate in a study, but is only one part of the consent process. The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subject's questions, ensuring that the subject has comprehended this information, obtaining the subject's voluntary agreement to participate and, continuing to provide information as the subject or situation requires. To be effective, the process should provide ample opportunity for the investigator and the subject to exchange information and ask questions. 21 CFR 50.27(a) requires that a copy of the consent document be given to the person signing the form. Does this copy have to be a photocopy of the form with the subject's signature affixed? No. The regulation does not require the copy of the form given to the subject to be a copy of the document with the subject's signature, although this is encouraged. It must, however, be a copy of the IRB approved document that was given to the subject to obtain consent [21 CFR 50.27(a) or 21 CFR 50.27(b)(2)]. One purpose of providing the person signing the form with a copy of the consent document is to allow the subject to review the information with others, both before and after making a decision to participate in the study, as well as providing a continuing reference for items such as scheduling of procedures and emergency contacts. If an IRB uses a standard "fill-in-the-blank" consent format, does the IRB need to review the filled out form for each study? Yes. A fill-in-the-blank format provides only some standard wording and a framework for organizing the relevant study information. The IRB should review a completed sample form, individualized for each study; to ensure that the consent document, in its entirety, contains all the information required by 21 CFR 50.25 in language the subject can understand. The completed sample form should be typed to enhance its readability by the subjects. The form finally approved by the IRB should be an exact copy of the form that will be presented to the research subjects. The IRB should also review the "process" for conducting the consent interviews, i.e., the circumstances under which consent will be obtained, who will obtain consent, and so forth. When should study subjects be informed of changes in the study? Protocol amendments must receive IRB review and approval before they are implemented, unless an immediate change is necessary to eliminate an apparent hazard to the subjects (21 CFR 56.108). Those subjects who are presently enrolled and actively participating in the study should be informed of the change if it might relate to the subjects' willingness to continue their participation in the study (21 CFR 50.25(b)(5)). FDA does not require reconsenting of subjects that have completed their active participation in the study, or of subjects who are still actively participating when the change will not affect their participation, for example when the change will be implemented only for subsequently enrolled subjects. Is it acceptable for the consent document to say specimens are "donated"? What about a separate donation statement? It would be acceptable for the consent to say that specimens are to be used for research purposes. However, the word "donation" implies abandonment of rights to the "property". 21 CFR 50.20 prohibits requiring subjects to waive or appear to waive any rights as a condition for participation in the study. Whether or not the wording is contained in "the actual consent form" is immaterial. All study-related documents must be submitted to the IRB for review. Any separate "donation" agreement is regarded to be part of the informed consent documentation, and must be in compliance with 21 CFR 50. <<< Back |
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