Questions Related to the Need for IRB Review
Q: Does a case study / case series require IRB review?
A: The DHHS definition of research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. In consistent practice with many other institutions, UConn Health does not consider a write up of a single case, or two or three cases, as constituting research. The retrospective summary of such a few number of cases is not considered to meet the systematic investigation element of the definition of research. A review of four or more cases is considered to meet the definition of research and prospective IRB review is required.
Q: When should I submit a Human Subject Research Determination Form?
A: The Human Subject Research Determination Form can be submitted when an individual is considering a project (e.g. a quality improvement project, student project etc.) that s/he does not think constitutes human subject research, but would like an official determination made by the IRB prior to initiating the project. A representative of the IRB will review the form and make the final determination as to whether the proposed activity meets the definition of human subject research. If the reviewer determines the project does not constitute human subject research the HSPO / IRB will have no further involvement. If the reviewer determines that the project does constitute human subject research a complete IRB application will be required. The IRB will send a copy of the determination to the PI. Determination results are usually available within two weeks of the date the IRB received the request for determination.
Q: Does a Student Project involving humans require IRB review?
A: In accordance with federal regulations, the UConn Health IRB requires that all human subjects research be prospectively reviewed by the IRB. Both the definition of “human subject” and “research” must be met for IRB review to be required. The definition of research is often key in determining if a student project needs IRB review. Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. If a student project is not designed to develop or contribute to generalizable knowledge (e.g. it will be used only to satisfy a curricular requirement), it would not meet the definition of research. Master’s or Doctoral proposals are typically designed to develop or contribute to generalizable knowledge so IRB review for such is typically required. IRB approval cannot be granted retrospectively. Students are therefore encouraged to submit a Human Subject Research Determination Form to the IRB prior to starting any activity for which a question exists as to whether it constitutes human subject research. The IRB can make a determination and instruct the student as to whether a full IRB application will be required.
Q: What type of IRB review is required for a research project using existing specimens?
A: The type of review depends on how the specimens are obtained/received by the investigator. Research that is conducted on existing human specimens that are identifiable or linked to a subject must be submitted for IRB review.
- The IRB may determine that research involving existing specimens qualifies for expedited review if a link is maintained between the specimen and the individual from whom it came.
- The IRB may determine that research involving existing specimens qualifies for exempt status if the investigator records the information in such a manner that there are no link between the subject and the specimens.
- If the original holder of the specimens provides the specimens without any link between the subject and the specimen (i.e., the specimens are anonymous), this does not constitute human subject research and IRB review is not required.
Note, the use of existing specimens means that all specimens needed for the study must already be available at the time of IRB submission and 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.
Q: If I am doing research on cadavers or on samples obtained from cadavers, do I have to get IRB review?
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: Can I e-mail my IRB materials to the IRB office?
A: IRB forms (applications, requests for continuation, requests for modifications, problem reports) and supporting documents should be submitted through the IRIS system. For UConn Health employees and students, your UConn Health network ID and password can be used to access IRIS at https://imedris.uchc.edu
Q: What is my IRB number?
A: After you have submitted your research study application to the IRB for review, the application and its supporting materials are reviewed by one of the three IRB Coordinators. The reviewer of your study will assign an IRB number as follows: e.g., 12-001-1 (the first two digits represent the latter part of fiscal year that the study was submitted which in this example is 2011/2012, the next three digits represent the sequence number which in this example is the first application received, and the last digit represents the panel to which the study was assigned: e.g., 1, 2, or 3). If there is a letter appended after the sequence, the letter indicates that UConn Health is acting as the IRB for another institution as well, e.g. 001C would indicate UConn Health is the IRB for Connecticut Children’s Medical Center, 001H would mean UConn Health is the IRB for Hartford Hospital.
Note that any e-mail written or phone inquiry should make reference to the IRB number of the study. This will enable the IRB to quickly locate any required information.
Q: Why should I have a version number on my protocol and consent form?
A: It should always be possible to quickly determine which version of the protocol was current when the ICF was signed. Investigators should maintain a link between the consent document and current protocol. For example, if you submit a modification that affects the informed consent form, but not version 1.0 of the protocol, the informed consent version reference should be revised, by adding a number after the version reference, e.g., Version 1.1. This indicates that the informed consent form is still linked to version 1 of the protocol.
Example: If there is a proposed change to version 1.0 of the ICF, but no change to version 1 of the protocol: revise the ICF version to 1.1 and maintain version 1 of the protocol.
Revising the version number also helps investigators to differentiate between copies of the protocol that have been modified. For example, if a modification was made to procedures in the protocol but both versions were labeled as version 1 (as opposed to 1 and 2 or 1 and 1.1) it would be easier for the investigator to follow the incorrect version of the protocol.
Q: I am not sure how to answer some questions in the application; can I leave them blank?
A: The IRB expects the investigator to respond to relevant items on the IRB application. Unless instructed on the application to skip certain questions if an entire section is not applicable, if a particular question is not relevant to the study being proposed respond with “not applicable”. A common problem with new applications is that not enough detail is provided for the IRB chair or members to evaluate the study’s purpose and/or procedures. In particular, investigators are encouraged to provide detailed information regarding how potential subjects are initially identified, and how consent is obtained. The more complete the initial description is, the less likely that time will be spent with correspondence back and forth to fill in the details.
Staff members in the HSPO and IRB are available to respond to questions by e-mail or phone. Investigators with unique situations are encouraged to contact the staff in advance of submissions.
Q: Can I submit my application without the Principal investigator signature?
A: No, the application must be signed by the Principal Investigators. With the implementation of the IRIS system, the PI can access the system from any place with internet access in order to sign the submission.
Q: What documents do I need to submit to the IRB for review of my study?
A: Because every study is unique it is not possible to provide directions that will address every situation. Please, review the table “What Documents to Submit” at http://research.uchc.edu/rcs/hspp/resources/expedited-exempt/ . The documents common to all new expedited and exempt submissions are noted in the first row and additional documents that are often associated with specific study designs follow. Some projects may combine characteristics of more than one study type. You should also refer to the IRB application checklist that includes information relevant to studies reviewed by the convened IRB.
Q: Are there any protocol templates in the IRB/HSPO web-site that can guide me in preparing my study protocol?
A: If your study involves surveys/interviews/questionnaires you should use the Survey Protocol Template and Related Documents. If your study involves review of documents, records, medical charts you should use the Review of Documents, Records, Medical Charts protocol template. If your study involves other types of research activities, please use the General Protocol Template for Investigator Initiated Research.
Q: What additional information should I include on the documents and forms submitted to the IRB for review?
- If you have already IRB #, you should include the IRB # for the listed study title on all documents e.g., Protocol, Informed Consent Form, HIPAA Authorization Form, Recruitment materials, Surveys/Questionnaires/Data Collection forms.
- Consent and protocol versions should be noted on documents (e.g., in the footer and/or the face page, and if applicable revise appropriately when modifications are made)
- The title of the study on Consent Form, HIPAA, Protocol, and DSMP/B should be the same.
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 on the Institutional Review Board Meetings, Instructions, Forms and Samples page. 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,
- if you are obtaining informed consent you will also need to obtain a HIPAA Authorization
- if you are not using or recording any identifiable information you will submit a Certification of Using De-Identified data form. On that form you must specify by which of three possible ways you are de-identifying data.
- if you need to keep some identifiable information, and the information will be kept within UConn Health, and you cannot obtain an Authorization, you will apply for a Waiver of HIPAA Authorization. A waiver of informed consent is also typically requested when a Waiver if HIPAA Authorization is requested. If you are collecting PHI during a screening session prior to obtaining an authorization, e.g. telephone screening, you should request a partial waiver of HIPAA for the screening phase.
- if you need to keep some identifiable information, and the information will be shared outside of UConn Health you will use the Data Use Agreement and Limited Data Set forms.
- if you are trying to determine the feasibility of a conducting a study, or or using information of deceased individuals you will submit the Assurance Form for either preparatory to research or on decedants.
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. The IRIS system should send 30, 60 and 90 day reminders to you to request continuing review. However, the investigator retains the responsibility for seeking continuation of an approved study and the IRB encourages you to add reminder notices to your outlook calendar.
Q: What happens if I miss the submission deadline for my continuation that requires full board review?
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 from the IRB Chair to continue to treat the subject. You must also confirm that you are seeking continuation and will meet the next submission deadline.
Q: Why must I request continuation in less than one year when my colleagues’ studies where given approval for a full year?
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. Attaching the protocol at the time of continuing review includes it in a master pdf file that the IRIS system creates for the assigned IRB reviewer. This facilitates the review process for them.
Questions Related to Informed Consent:
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.