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Answers to Frequently Asked QuestionsQuestions Related to the Need for IRB Review Questions Related to the Need for IRB Review Q: Does a pilot study have to be reviewed by the IRB? A: Yes. Any study involving human subjects, regardless of the number of subjects to be involved, must be reviewed and approved by the IRB prior to initiation.
Q: If I am just looking at specimen samples (i.e., urine, blood, skin, etc.) that are being collected for a clinical purpose and that are otherwise going to be thrown away, do I have to get IRB review. A: Yes, all procedures that are looking at human samples (that are identifiable directly, or through codes) in the fashion of a systematic investigation outside of clinical care have to be reviewed by the IRB. These studies will most likely qualify for expedited review or be granted IRB exempt status depending on the amount of confidential information accessed by the PI.
A: It depends. IRB review is not needed if the materials do not contain any personal identifiers (PHI). However, if personal identifying information is linked to the materials, then IRB review is required. The review is required because the IRB also acts as the privacy board and the HIPAA privacy regulation extends to deceased individuals.
Q: If I want to make a change to my study after I've received approval, do I need IRB approval again? A: Yes. Any change to a previously approved study must be reviewed and approved by the IRB prior to implementation. This includes changes to any document related to the study (e.g. informed consent form, surveys, advertisements, recruitment letters, etc.) You will need to submit the form to request a modification / addendum to a previously approved study. The only exception to this is that a change can be implemented if it is needed to eliminate immediate harm to subjects or others. Such changes must be reported to the IRB within 5 business day.
Questions Related to IRB Submissions Q: Once I submit my application, how long does the IRB review process take? A: Review of exempt and expedited applications occurs on an on-going basis. Screening of the application will generally occur within 7 to 10 business days of receipt. Any concerns will be communicated to the investigator via e-mail so check your messages. Once all concerns have been addressed the application will be forwarded for official review. Studies requiring full board review must be submitted at least 12 business days prior to the meeting date. This allows sufficient time for the committee to review the application prior to the meeting. After the meeting the minutes must be prepared and approved by the committee before letters are sent to the investigators. Therefore, investigators should not expect an official letter until 7 to 10 business days after the meeting. Note that you may not begin your research until you have received final, unconditional approval from the IRB.
Q: My study was deferred at the IRB meeting held on Monday night. Can I have an extension to the submission deadline so that my study can be reviewed at the next regularly scheduled meeting of that panel? A: Yes, you can have a one week extension on the submission deadline. This is allowed for two reason. First because the IRB recognizes that the turn-around-time without the extension is quite difficult to meet. Second, because the reviewers have already seen the initial version of the protocol and discussed it at the board, allowing the reviewer one week to re-review is sufficient. Note that if you study was deferred it must be reviewed by the same IRB panel that conducted the initial review.
Q: Do I have to submit every single protocol deviation (e.g. instance of non-compliance with the protocol) to the IRB? A: Yes, however the timing of when you report the non-compliance may differ. If the non-compliance was within the control of the research team (e.g. a follow-up appointment was scheduled by the research team outside of the study window) it should be reported within 5 days of becoming aware of it using the problem report form available at http://resadm.uchc.edu/hspo/irb/forms.html. All reports should contain a description of the deviation, why and when it occurred, and corrective action implemented, if any, to prevent future occurrence. If the non-compliance was not within the control of the research team it (e.g. the subject canceled a scheduled appointment and had to be rescheduled outside of the study window) the event can be reported at the time of continuation. However, if the event was not within the control of the research team but has in impact on subject safety or data integrity it should still be reported within 5 days of becoming aware of it. If possible, investigators should allow for "windows" within the protocol design to reduce the instances of non-compliance. For example, rather than stating that a second visit will occur in 2 weeks state that second visits will occur within 10 to 18 days.
Q: How do I know which HIPAA form to submit? A: You must address HIPAA within your application if your study will involve the use of protected health information. Protected health information means individually identifiable health information transmitted or maintained in any form (electronic means, on paper, or through oral communication) that relates to the past, present or future physical or mental health or conditions of an individual. In general,
Q: If the sponsor requires that a safety report be submitted to the IRB, but the adverse event reporting policy requires that it be reported only at the time of continuation (e.g., it is a non-serious event), should I still submit it to the IRB? A: You should inform the sponsor that our reporting policy is that non-serious events will be submitted in summary format at the time of continuation. The IRB will not review individual non-serious reports.
Q: If my project will most likely qualify for exempt status do I still have to submit the entire IRB application, write a protocol, and make sure everyone has completed training in the protection of human subjects? A: Yes. Exempt status only means that your project will be exempt from the requirement of continuing review. The Human Subjects Protection Office holds research that qualifies for exempt status to the same standard as any other research.
Q: I submitted an application for expedited review three days ago. Why haven't I heard from the IRB yet? A: Expedited review does not mean a quicker review. It simply means that only the Chair or an IRB member designated by the Chair has to review the project. All of the same criteria for approval still apply and applications are reviewed with the same level of scrutiny as a full board review.
Q: I will be doing research that will involve individuals who speak a foreign language. If the IRB approved the English version of the consent form do I have to submit a translated version for approval? A: Yes. The IRB must approve all translated documents that will be presented to subject, e.g. the informed consent form and surveys. Investigators may either use a professional translation service or the back translation process. The full details are available in the Human Subjects Protection Office/IRB operating policies. Information on companies that provide translation services is available on the Information for Investigators page.
Questions Related to Continuing Review Q: How do I know when my study is due for continuing review? A: When the IRB grants you final approval the approval letter will include the date by which your study will expire if continuing review is not sought. If your study has an informed consent form, the date will also be stamped on that document. This is referred to as the valid through date. Continuing review will generally occur in the month prior to the valid through date. As a courtesy, the IRB will send one reminder notice to you to request continuing review approximately 8 to 10 weeks before the valid through date. However, the investigator retains the responsibility for seeking continuation of an approved study.
A: A lapse in IRB approval for the study will occur. All research related activity must cease as of the date approval lapses. You will know what that date is from the approval letter sent to you by the IRB or from the the valid through stamp on the informed consent form. If a subject is on active treatment and will be exposed by harm if treatment is withheld during the lapse in approval, you must request in writing approval to continue to treat the subject from Dr. Richard Simon, the Director of the Human Subjects Protection Office. You must also confirm that you are seeking continuation and will meet the next submission deadline.
A: Federal regulations require that continuing review occur at least annually. However, the IRB has the authority to require that review occur more frequently. Example scenarios of when the IRB may exercise this option include studies that pose a high risk to subjects or studies for which the investigator does not have extensive experience in the field.
Q: Why do I have to submit the complete protocol again at the time of continuing review if I haven't changed it since the initial approval? A: Federal guidance states that in order for continuing review to be meaningful and substantive the IRB must review the complete protocol. For studies requiring full board review four copies are required. Each of the two reviewers get a copy, the Chair gets a copy and a copy goes to the IRB file.
Q: What is informed consent? A: Informed consent reflects an individuals voluntary agreement to participate in a research study. In order to make this agreement the individual must have adequate knowledge and understanding of the relevant information (purpose of the study, risks and benefits of the study, methods to be used, etc.). the process of informing a subject about a study is documented using the informed consent form.
Q: Who can provide informed consent? A: Subject who have reached the age of majority and who are competent can provide informed consent to participate in a research study. If the subject is either a minor or lacks the capacity to provide informed consent, a surrogate person must provide consent and the subject will generally be asked to provide assent. The policy to provide surrogate consent for research studies follows the same standards as providing surrogate consent for clinical care. The policy is available in the Investigators Guide for Human Subject Research and in the standard operating policies of the Human Subjects Protection Office.
Q: What does a research subject need to be informed of during the consent process? A: The informed consent checklist outlines the regulatory requirements of the informed consent form and the IRB sample consent forms covers these topics. If these documents are used as a guideline, you should address all required topics within your consent document. However, consent is more than a document. Consent must be a process in which the research subject has the right to read and discuss the form and to ask any questions regarding the study and have them answered in a satisfactory manner.
Q: Is informed consent always required? A: In the majority of studies informed consent is required. However, there are situations in which the requirement to obtain informed consent may be waived or altered. A retrospective chart review study is an example of when the requirement to obtain consent may be waived. The form to request a waiver or alteration of informed consent must be completed and submitted to the IRB for review and approval. The form describes the criteria that must be satisfied in order for the IRB to grant approval to the request. |
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