{"id":241,"date":"2014-08-13T16:00:00","date_gmt":"2014-08-13T21:00:00","guid":{"rendered":"https:\/\/uwm.edu\/irb\/?page_id=241"},"modified":"2024-02-08T09:33:30","modified_gmt":"2024-02-08T15:33:30","slug":"irb-faqs","status":"publish","type":"page","link":"https:\/\/uwm.edu\/irb\/about-the-uwm-irb\/irb-faqs\/","title":{"rendered":"IRB FAQs"},"content":{"rendered":"

General Information<\/strong><\/h2>\n

1. What is the Institutional Review Board (IRB)?<\/strong><\/span>

\nFederal regulations and UW-Milwaukee policy requires research involving human subjects to be reviewed and approved by the Institutional Review Board (IRB). There is currently one 51ÁÔÆæ IRB registered under a Federalwide Assurance (FWA) with the Department of Health and Human Services. The IRB reviews research conducted by 51ÁÔÆæ faculty, staff, or students. The IRB is comprised of 51ÁÔÆæ faculty, staff, students, and community representatives.<\/p>\n<\/div>\n

2. What is a Federalwide Assurance (FWA)?<\/span>

<\/strong>An FWA is a document that designates the IRB that will review and oversee the research. It also specifies the ethical principles under which the research will be conducted and names the individuals who will be responsible for the proper conduct of the research. 51ÁÔÆæ has its own FWA (FWA00006171) for research conducted at 51ÁÔÆæ. Under the FWA, the IRB is also charged with the responsibility for assuring that human subject research conducted under the auspices of 51ÁÔÆæ (e.g., investigators and facilities) is conducted in compliance with federal law.<\/p>\n<\/div>\n

3. What ethical principles guide the IRB?<\/span>

<\/strong>The IRB is guided by three basic principles set forth in the Belmont Report:1) Respect for Persons: Treating subjects with dignity and autonomy while affording those with diminished autonomy with additional protections. A key part of this is informed consent; 2) Beneficence: An obligation to not harm subjects; to maximize benefits and minimize possible harms; 3) Justice: Fairness in the selection of research subjects; fairness in the distribution of benefits and risks.<\/p>\n<\/div>\n

4. What qualifies for IRB review?<\/span>

<\/strong>The criteria to determine whether a project requires IRB review and approval is based on it being (1) “research<\/span>” defined as: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” and<\/strong> the project involves (2) “human subjects<\/span>” defined as: a living individual about whom an investigator conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.<\/p>\n

Once a project is determined to be “research involving human subjects,” 51ÁÔÆæ must also be engaged in the research in one or more of the following capacity: (1) research conducted by 51ÁÔÆæ faculty (any percent time appointment, including adjunct and non-salary), students, and staff under 51ÁÔÆæ auspices; (2) research conducted by affiliated faculty under 51ÁÔÆæ auspices; or (3) non-51ÁÔÆæ personnel using 51ÁÔÆæ equipment.<\/p>\n

See the page “Do You Need to Submit to the IRB?”<\/a>\u00a0for detailed instructions.<\/p>\n

Determining when a Quality Improvement project requires 51ÁÔÆæ IRB review can be complicated. Please see #9 below for more information.<\/p>\n<\/div>\n

5. Do I need IRB review\/approval if I am not affiliated with 51ÁÔÆæ but would like to conduct research at 51ÁÔÆæ or use 51ÁÔÆæ subjects?<\/span>

<\/strong>If you intend to use certain facilities or equipment (e.g., psychology and exercise physiology lab), or have subjects perform physical activities on 51ÁÔÆæ premises, IRB review\/approval may be needed, please contact the IRB office for details. Certain activities (e.g., interviewing or surveying students in the Union) would not need 51ÁÔÆæ IRB review. See the “Do You Need to Submit to the IRB?”<\/a> page for detailed information and a link to our Determination form.<\/p>\n<\/div>\n

6. I am required to conduct a research project for my class assignment, do I need IRB review?<\/span>

<\/strong>This type of research does not need approval if the data collected from the research project will not go beyond the classroom setting. For instance, if a student is required to design and conduct interviews for her research methods course, IRB review would not be required. However, if they plan to use that data for a larger project (PhD dissertation), that would constitute generalizable knowledge, then IRB review is required. See the “Do You Need to Submit to the IRB?”<\/a> page for detailed information and a link to our Determination form.<\/p>\n<\/div>\n

7. What about anthropological and ethnographic research?<\/span>

<\/strong>These types of research will need to be submitted to the IRB if it involves “a systematic investigation…designed to develop or contribute to generalizable knowledge.” Although these types of studies take place in natural settings, IRB review is necessary to ensure that the human subjects are not harmed. See the American Anthropological Association’s statement on IRB review<\/a>.<\/p>\n<\/div>\n

8.What about oral history projects?<\/span>

<\/strong>Oral History projects may or may not meet the definition of research.\u00a0 Review the “Do You Need to Submit to the IRB?”<\/a> page for detailed information and a link to our Determination form.<\/p>\n<\/div>\n

9. When do Quality Improvement projects require IRB approval?<\/span>

<\/strong>If a quality improvement or quality assurance project meets the definition of research then it would need to be submitted and approved by the IRB.\u00a0\u00a0See the “Do You Need to Submit to the IRB?”<\/a> page for detailed information and a link to our Determination form and feel free to contact the IRB office if further clarification is needed.\u00a0 The IRB staff have also put together a brief explanation<\/a> for guidance.<\/p>\n<\/div>\n

10. What is Exempt, Expedited, and Full Board Review?<\/span>

<\/strong>There are three types of IRB review (Exempt, Expedited, and Full Board). Even though the Principal Investigator identifies the type of review when s\/he completes the New Study Form, the IRB makes the final determination. View OHRP’s Decision Chart<\/a>.<\/p>\n

1. Exempt<\/strong>: Under federal regulations, certain types of research may be exempt from IRB review if the study involves no more than \u201cminimal risk\u201d and falls into one or more of six categories. Click here to see the categories for exempt<\/a>. The New Study Submission Form also identifies the six categories. Exempt status must be determined by the IRB, so a new study submission and approval letter from the IRB are required.
\n2. Expedited:<\/strong> The IRB may use an expedited review procedure when the research involves no more than minimal risk to the subjects and where the only involvement of human subjects will be in one or more of the expedited categories. Click here to see the categories for expedited<\/a>. The New Study Submission Form also identifies the categories.
\n3. Full Board:<\/strong> Submissions that are neither exempt nor expedited are sent to the Full Board for review.<\/p>\n<\/div>\n

11. Who can be a Principal Investigator (PI)?<\/span>

<\/strong>Under current 51ÁÔÆæ guidelines, only faculty and staff are allowed to be the Principal Investigator. Students may be listed as “Student PI.”<\/p>\n<\/div>\n

Training Related to Human Subjects Research<\/strong><\/h2>\n

12. Is training required?<\/span>

<\/strong>Human Subjects Research Training provides information on the rules, regulations, and ethical principles governing research involving human subjects and is required for all Principal Investigators, Student Principal Investigators, and strongly recommended for research personnel interacting (consenting, recruiting, data collecting, etc.) with research participants. The IRB may require non-PIs to complete the training. Visit the Human Subjects Research Training <\/a>page for additional information.<\/p>\n<\/div>\n

13. How do I complete human subjects training?<\/span>

<\/strong>Visit the 51ÁÔÆæ IRB\u2019s human subjects training page<\/a> and follow the detailed instructions for completing the CITI training.<\/p>\n

<\/div>\n

14. Does the IRB track those who complete Human Subjects research training?<\/span>

<\/strong>Yes.\u00a0 If you have completed CITI training and have listed your institution as 51ÁÔÆæ then the IRB will automatically receive an electronic notice once certification is complete. If you list your 51ÁÔÆæ email address in CITI, the training information is also automatically pulled into I-Manager.<\/p>\n

If you have completed the CITI training under a different institution, please email the IRB office (irbinfo@uwm.edu) a copy of your completion certificate that includes the list of modules you completed and quiz scores). If the modules you completed are similar enough to the ones 51ÁÔÆæ requires, we will accept this training instead of requiring you to do the 51ÁÔÆæ-specific training.<\/p>\n

<\/div>\n

15. What if I am not 51ÁÔÆæ faculty, staff, or student but have completed or want to complete the CITI training? <\/span>

<\/strong>Register for and complete the CITI training using your current institution and email the IRB office a copy of your completion certificate.<\/p>\n

<\/div>\n

16. How do I complete or report previous completion of human subjects training if I am not 51ÁÔÆæ faculty, staff, or student?<\/span>

<\/strong>If you have completed the CITI training under a different institution, please email the IRB office (irbinfo@uwm.edu) a copy of your completion certificate that includes the list of modules you completed and quiz scores). If the modules you completed are similar enough to the ones 51ÁÔÆæ requires, we will accept this training instead of requiring you to do the 51ÁÔÆæ-specific training.<\/p>\n

<\/div>\n

Submitting\u00a0a\u00a0Study for\u00a0Review<\/strong><\/h2>\n

17. I've determined that my study requires IRB review, now what?<\/span>

<\/strong> Begin by reviewing the Step-by-Step Submission<\/a> Page. Create an I-Manager account, if you don’t already have one. To create an account, log in with your PantherID. An account will automatically be created. You will ultimately need to complete the IRB Application Form in I-Manager and create study documents (e.g., Consent Forms). Submit all relevant study materials (survey instrument, interview questions, recruitment flyers, consent forms, etc.) to the IRB via I-Manager<\/a>.<\/p>\n<\/div>\n

18. This study is being conducted at multiple sites, is IRB approval needed from them as well?<\/span>

<\/strong>Typically, yes, if the other site has an IRB. See our IRB Reliance (Deferral) Requests<\/a> page for more information about the potential for arranging single IRB review in these cases.<\/p>\n

If the other institution does NOT have an IRB, then we can usually oversee the study on that institution’s behalf. If there is federal funding, an Institutional Authorization Agreement or Individual Investigator Agreement will be required. Contact the IRB office with questions about how to proceed in these situations.<\/p>\n

Please factor in the extra time that may be needed from other IRBs or institutional permissions when planning your project. For example, projects involving the use of ionizing radioactive materials or radiation producing devices (e.g., x-rays) located here on the 51ÁÔÆæ campus require separate review and approval from the Radiation Safety Program<\/a>. Research conducted at Milwaukee Public Schools requires MPS\u00a0 review and approval. Advocate Aurora Health Care and Children’s Wisconsin also have additional institutional requirements that need to be fulfilled in addition to IRB review and approval. All of these take time.<\/p>\n<\/div>\n

19. When is informed consent necessary? <\/span>

<\/strong>All research subjects must give their express consent to participate in a research study. Consent is a necessary element for all research studies, even exempt research. Consent is only considered valid if the subjects are given enough information to allow them to weigh the study’s risks and benefits and if the information is told to them in terms that they can understand. Subjects always have the right to decline or even withdraw from any study.<\/p>\n

Under certain circumstances, informed consent or parts of it may be waived or modified (e.g., information letters). However, the default should be to obtain informed consent, and waivers are permitted only when there is sufficient justification to satisfy the IRB that obtaining consent is not feasible for your project.<\/p>\n

The IRB Staff has put together some helpful hints on the informed consent process and different types of consent. Click here<\/a> to read.<\/p>\n<\/div>\n

20. What do I need to know about data confidentiality?<\/span>

<\/strong>An important risk for many studies reviewed by the IRB is breach of confidentiality.\u00a0 The IRB will ask you to specifically tell us how you are securing the data you will be collecting as part of your study.\u00a0 See the Data Confidentiality Guidance<\/a> document for recommendations on data confidentiality measures you may want to consider.\u00a0 The University IT security department <\/a>is another resource<\/p>\n<\/div>\n

21. What do I need to know if I am doing internet-based research?<\/span>

<\/strong>Internet-based research involves collecting data from internet-based resources. This can involve websites, chat rooms, message forums, Facebook, virtual reality spaces, etc. There are a variety of issues to consider if you are doing internet-based research.\u00a0 The starting point is to determine if your project involves human subjects based on the OHRP’s definition of human subject:\u00a0 “A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information”.\u00a0 To provide some explanation for how the IRB thinks about this in relation to internet research and answers to other questions around internet-based research, please refer to the Guidance on Internet-based Research document.<\/a><\/p>\n<\/div>\n

22. When can I begin my research?<\/span>

<\/strong> Remember, no research-related activities may begin until the IRB has given your research project full approval, meaning that all revisions or conditions are complete and the researcher has received an official approval letter. This includes screening subjects or mailing out questionnaires. Certain research feasibility activities are permissible (e.g., gathering institutional or other appropriate permissions, gauging participant interest), please contact the IRB staff for specific directions.<\/p>\n<\/div>\n

23. What are Revisions\/Conditions requested by the IRB?<\/span>

<\/strong> After the Principal Investigator submits a study and the study has been reviewed, the IRB may ask for revisions or place conditions on the study before final approval is granted. For example, the IRB may request revisions to the consent form after the IRB staff, designated IRB reviewers, or the Full Board reviews the study.<\/p>\n

After you have made the required changes and resubmitted your study, you will be notified by email with a formal letter attached that your protocol is approved.<\/p>\n<\/div>\n

24. Can I begin my study when I receive a Conditional Approval or Revisions Requested letter?<\/span>

<\/strong>No. Study activities (e.g., recruiting, enrolling, etc.) may not begin until final approval is granted.<\/p>\n<\/div>\n

25. After I receive IRB approval, is there anything else I need to know?<\/span>

<\/strong>Once IRB approval is granted, the following require future submissions to the IRB:<\/p>\n

1) Continuing Review: For some Expedited and all Full Board studies, the IRB must conduct continuing review of research on an annual basis. This means that if your research study will not be complete (including data analysis & writing up of results) within that time, the IRB must review your study and give continuing approval.<\/p>\n

2) Modifications \/ Amendments: Modifications to the planned research may affect the treatment of human subjects and therefore must be reviewed and approved by the IRB prior to their implementation. See “Submitting Modifications \/ Amendments” for additional FAQs.<\/p>\n

3) Reportable Event: Principal investigators are responsible for the timely reporting of adverse events or noncompliance to the IRB. See Question #35 below “What is a Reportable Event” for additional FAQs.<\/p>\n<\/div>\n

After Approval: Annual Reports to the IRB<\/strong><\/h2>\n

26. What is Continuing Review?<\/strong><\/span>

\u00a0Once a study receives IRB approval, federal regulations require an annual review of certain research studies no less than once per year. This review must take place on or before the anniversary date of when the research study was last reviewed, regardless of when the research study actually started. If you plan to continue research past the date of IRB expiration, continuing review and approval from the IRB is required. Any data collected, or research activities conducted without IRB approval is in non-compliance with both institutional and federal regulations.<\/p>\n<\/div>\n

27. Who needs continuing approval? <\/span>

<\/strong>Continuing review is required for all Full Board and some Expedited studies. You will receive automated notifications in advance of the expiration date giving you instructions about what to do to keep your study open (either submit a continuing review, if required, or provide an email update of your study status).<\/p>\n<\/div>\n

28. What do I need to do in order to get continuing approval?<\/span>

<\/strong>Continuing review submissions are made by completing and submitting a continuing review x-form in I-Manager. You will receive automated notices beginning 45 days before the date of IRB expiration with instructions for submitting.<\/p>\n<\/div>\n

29. When should I file the submission?<\/span>

<\/strong>\u00a0The recommended timeframe is approximately ~30 days before the date of IRB expiration.\u00a0 Please note that the IRB Staff will review the continuing review documents shortly after they are submitted but that an approval letter will not be sent out until within days of the expiration date so as to keep the approval dates consistent from year to year.<\/p>\n<\/div>\n

30. My study went past the expiration date, what do I do?<\/span>

<\/strong>STOP all research activities immediately! There is no grace period. Only if the IRB determines that the continuation of the subjects in the research activity (i.e., medical or psychological treatment\/intervention) presents a prospect of direct benefit, may individual subjects continue in the research as the investigator seeks IRB re-approval for the study (contact the IRB office). Expiration of IRB approval (unless the offense is repeated) will not be reported to OHRP as a suspension of IRB approval under DHHS regulations.<\/p>\n

If your IRB approval lapses:
\n(a) If you are done with the study, then there is no need to do anything. The IRB automatically closes your study if it has not received a submission by your study’s IRB expiration date.
\n(b) If you plan to continue research, then you must apply for IRB approval by submitting a Continuing Review Form or provide the requested update.<\/p>\n<\/div>\n

After Approval: Making Changes to the Study<\/strong><\/h2>\n
\n

31. What are Modifications or Amendments?<\/span>

<\/strong>Once a study receives IRB approval, any changes to the research project must be approved by the IRB before implementation. For instance, changes to the study title, principal investigator, informed consent document, and study design all require prior authorization from the IRB.<\/p>\n

<\/div>\n

32. What do I need to do in order to get my modification\/amendment approved?<\/span>

<\/strong>See our page Amendment and Continuing Review Submissions<\/a> for instructions. Remember to use track changes to clearly indicate the requested changes in these documents so that the IRB can readily identify the changes.<\/p>\n<\/div>\n<\/div>\n
<\/div>\n
\n

33. Can I submit a Modifications\/Amendment request at the same time as the Continuing Review?<\/span>

<\/strong>Yes, however, you must submit a separate Amendment and Continuing Review x-form. You cannot request changes in the Continuing Review.<\/p>\n<\/div>\n

After Approval: Something Happened to One of My Participants<\/strong><\/h2>\n

34. What is a Reportable Event?<\/span>

<\/strong>The IRB is responsible for on going monitoring of the safety and welfare of human subjects. Part of this monitoring is on-going review and assessment of reportable events related to participation in the research.<\/p>\n

One type of reportable event is an Adverse Event (AE), which are any occurrences that may present itself during the conduct of a research study that ultimately harms the subject. AEs may either be related or unrelated to the research. Remember, some adverse events are required to be reported to the IRB within 10 working days.<\/p>\n

Submit a reportable event to the IRB by completing and submitting a Reportable Event x-form.<\/p>\n<\/div>\n

<\/div>\n

35. What do I do if a subject needs medical care?<\/span>

<\/strong>51ÁÔÆæ generally does not provide research participants with reimbursement for medical expenses incurred as a result of their participation. Thus, participants are responsible for their own medical care. Sometimes, however, medical situations can and do arise.<\/p>\n

For Emergencies: Dial 9-911 (on campus) or 911 (off campus).
\nFor Non-Emergencies: If the individual needs basic First Aid, contact the 51ÁÔÆæ Police Department at x4627. If the individual does not need First Aid but may need some additional care, ask the injured person if he or she would like assistance a health care provider of his or her choice. If the injured person is a student, he or she may be entitled to services at the Norris Health Center. Ask the student if he or she would like assistance contacting Norris at x4716.<\/p>\n

After the incident has occurred: The PI must complete a General Incident Report Form. If you have questions about this requirement, contact the Risk Manager at 229-5079. You must complete this Form whether or not the injured person wants you to do so, even if the injuries are very minor.<\/p>\n

If this event was not an anticipated risk identified in the protocol and consent form, it must be reported to the IRB as a Reportable Event. When in doubt, contact the IRB office for guidance.<\/p>\n

<\/div>\n

36. What if I enrolled more subjects than the IRB approved?<\/span>

<\/strong>Please contact the IRB office to discuss and we can give you guidance on how to report this and what the next steps are.<\/p>\n<\/div>\n

Definitions<\/span>

<\/strong>Research:<\/strong> Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR46.102(d))<\/p>\n

Human Subject:<\/strong> Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:<\/p>\n

(1) Data through intervention<\/strong> or interaction<\/strong> with the individual, or
\n(2) Identifiable private information<\/strong>.<\/p>\n

Intervention<\/strong> includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction<\/strong> includes communication or interpersonal contact between investigator and subject. Private information<\/strong> includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (45CFR46.102(f))<\/p>\n

Minimal Risk:<\/strong> Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45CFR46.102(i))<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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