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Frequently Asked Questions
1. What is the Institutional Review Board (IRB)?
2. What is a Federalwide Assurance (FWA)?
3. What ethical principles guide the IRB?
4. What qualifies for IRB review?
5. Do I need IRB review/approval if I am not affiliated with UWM but would like to conduct research at UWM or use UWM subjects?
6. I am required to conduct a research project for my class assignment, do I need IRB review?
7. What about anthropological and ethnographic research?
8. What is Exempt, Expedited, and Full Board Review?
9. Who can be a Principal Investigator (PI)?
10. So I've determined that my study requires IRB review, now what?
11. This study is being conducted at multiple sites, is IRB approval needed from them as well?
12. When can I begin my research?
13. After I receive IRB approval, is there anything else I need to know?
14. What is "Continuing Review"?
15. Who needs continuing approval?
16. What do I need to in order to get continuing approval?
17. When should I file the submission?
18. Can I submit a Modifications/Amendment request with the Continuing Review?
19. My study went past the IRB expiration date, what do I do?
20. What are "Revisions/Conditions"requested by the IRB?
21. Can I begin my study when I receive a "Conditional Approval" or "Revisions Requested" letter?
22. What are "Modifications or Amendments"?
23. What do I need to do in order to get my modification/amendment approved?
24. What is a "Reportable Event"?
25. What do I do if a subject needs medical care?
26. When is informed consent necessary?
27. Is the Human Subjects Training Tutorial required?
28. Does the IRB track those who complete it?
29. What do I type in the completion form if I am not UWM faculty, staff, or student?
1. What is the Institutional Review Board (IRB)? Federal 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 UWM IRB registered under a Federalwide Assurance (FWA) with the Department of Health and Human Services. The IRB reviews research conducted by UWM faculty, staff, or students. The IRB is comprised of UWM faculty, staff, students, and community representatives.
2. What is a Federalwide Assurance (FWA)? 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. UWM has its own FWA (FWA00006171) for research conducted at UWM. Under the FWA, the IRB is also charged with the responsibility for assuring that human subject research conducted under the auspices of UWM (e.g., investigators and facilities) is conducted in compliance with federal law.
3. What ethical principles guide the IRB? 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. It underlies the importance of 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.
4. What qualifies for IRB review? The criteria to determine whether a project requires IRB review and approval is based on it being (1) "research" defined as: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" and the project involves (2) "human subjects" 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.
Once a project is determined to be "research involving human subjects," UWM must also be engaged in the research in one or more of the following capacity: (1) research conducted by UWM faculty (any percent time appointment, including adjunct and non-salary), students, and staff under UWM auspices; (2) research conducted by affiliated faculty under UWM auspices; or (3) non UWM personnel using UWM equipment. Use the Determination of UWM IRB Submission form located in the Pre-Submission section of the Forms and Templates page for detailed instructions.
Determining when a Quality Improvement project requires UWM IRB review can be complicated. Please see the brief explanation and examples for guidance.
5. Do I need IRB review/approval if I am not affiliated with UWM but would like to conduct research at UWM or use UWM subjects? If you intend to use certain facilities or equipment (e.g., psychology and exercise physiology lab), or have subjects perform physical activities on UWM 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 UWM IRB review. Use the Determination of UWM IRB Submission form located in the Pre-Submission section of the Forms and Templates page for detailed instructions.
6. I am required to conduct a research project for my class assignment, do I need IRB review? 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 she plans to use that data for a larger project (PhD dissertation), that would constitute generalizable knowledge, then IRB review is required. Use the Determination of UWM IRB Submission form located in the Pre-Submission section of the Forms and Templates page for detailed instructions.
7. What about anthropological and ethnographic research? These types of research will need to be submitted to the IRB if it involves "a systematic investigation...designed to develop or contribute to generalizeable 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.
8. What is Exempt, Expedited, and Full Board Review? 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.
1. Exempt: Under federal regulations, certain types of research may be exempt from Full Board IRB review if the study involves no more than “minimal risk” and falls into one or more of six categories. Click here to see the categories for exempt. The New Study Submission Form also identifies the six categories. Studies seeking exempt status may require prior department approval.
2. Expedited: 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. The New Study Submission Form also identifies the categories.
3. Full Board: Submissions that are neither exempt nor expedited are sent to the Full Board for review.
9. Who can be a Principal Investigator (PI)? Under current UWM guidelines, only faculty and staff are allowed to be the Principal Investigator. Students may be listed as "Student PI."
10. So I've determined that my study requires IRB review, now what? Begin by reviewing the Getting Started Page. You will ultimately need to complete the required forms (New Study Form and Protocol Summary Form) and templates (Consent Forms) and submit all relevant materials (survey instrument, interview questions, recruitment flyers, etc.) to the IRB email address.
11. This study is being conducted at multiple sites, is IRB approval needed from them as well? If the PI of the study is (1) UWM faculty, student, or staff; and (2) the secondary institution(s) are “engaged” in research; and (3) the secondary institution(s) has an IRB, then IRB approval should be sought after by the PI from those institutions. If the secondary institution(s) do not have their own IRB, then an IRB Authorization Agreement may be required. Please contact the IRB office.
Remember, other researchers who are collaborating (e.g., you are working with someone who is from another institution) with UWM may need IRB approval from their own institution depending on that institution’s policies.
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 UWM campus require separate review and approval from the Radiation Safety Program. Research conducted at Milwaukee Public Schools requires the review/approval by the Division of Research and Evaluation.
12. When can I begin my research? Remember, no research related activities may begin until the IRB has given your research project full approval. This includes screening subjects or mailing out questionnaires. Certain research feasability activities are permissible (e.g., gathering institutional or other appropriate permissions, gauging participant interest). This means that all revisions or conditions are complete and the researcher has received an official letter.
13. After I receive IRB approval, is there anything else I need to know? Once IRB approval is granted, the following require future submissions to the IRB:
1) Continuing Review: If your study was approved as either Expedited or Full Board, 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.
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.
3) Reportable Event: Principal investigators are responsible for the timely reporting of adverse events to the IRB. See "Submitting a Reportable Event" for additional FAQs.
14. What is "Continuing Review"? Once a study receives IRB approval, federal regulations require an annual review of 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 activies conducted without IRB approval is in non-compliance with both institutional and federal regulations.
15. Who needs continuing approval? If your study was reviewed and approved under Expedited or Full Board status, then continuing review is required. Exempt studies (so long as no changes have been made to the study) are exempt from further IRB review.
16. What do I need to in order to get continuing approval? Visit the Forms and Templates page and complete and submit the appropriate documents to the IRB. The IRB will send out a reminder to the PI by email ~30 days before the date of IRB expiration.
17. When should I file the submission? The recommended timeframe is approximately ~30 days before the date of IRB expiration.
18. Can I submit a Modifications/Amendment request with the Continuing Review? Yes, however, you must also complete the "Modifications/Amendment Form."
19. My study went past the IRB expiration date, what do I do? Stop all research related 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.
If your IRB approval lapses, you can:
(a) do nothing so long as you do not intend to use the data you collected during the time of IRB approval lapse. The IRB automatically terminates your study if it has not received a submission by your studies IRB expiration date.
(b) If you plan to continue research, then you must apply for IRB approval by submitting a Continuing Review Form.
20. What are "Revisions/Conditions"requested by the IRB? After the Principal Investigator submits a study, 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.
Instructions: To fulfill the conditions, (a) re-submit the documents of your protocol which require the revisions (e.g., if the revisions are only to the consent form, submit only the consent form). (b) submit a cover memo referencing the revisions by the corresponding item number in the revisions letter. (e) Highlight, bold, or underline each revision referencing them by the corresponding item number in the revisions letter. Once you have fulfilled the conditions, you will be notified by email with a formal letter attached that your protocol is approved.
21. Can I begin my study when I receive a "Conditional Approval" or "Revisions Requested" letter? Unless specified in the letter, Study activities (e.g., recruiting, enrolling, etc.) may not begin until final approval is granted.
22. What are "Modifications or Amendments"? Once a study receives IRB approval, any changes to the research project must be approved by the IRB before implimentation. For instance, changes to the study title, principal investigator, informed consent document, and study design all require prior authorization from the IRB.
23. What do I need to do in order to get my modification/amendment approved? Visit the Forms and Templates page and complete and submit the appropriate documents to the IRB. Remember to submit copies of the proposed changes clearly identifying (highlight, underline, bold) what they are so the IRB can readily identify the changes. Also submit a clean copy of the proposed changes. For example, if you are adding an additional procedure, submit: (a) marked-up copy of the Protocol Summary Form and marked-up copy of the consent form; and (b) clean copy of the Protocol Summary Form and consent form.
24. What is a "Reportable Event"? 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.
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.
25. What do I do if a subject needs medical care? UWM 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.
For Emergencies: Dial 9-911 (on campus) or 911 (off campus).
For Non-Emergencies: If the individual needs basic First Aid, contact the UWM 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.
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 his or her injuries are very minor.
26. When is informed consent necessary? 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.
Under certain circumstances, informed consent or parts of it, may be waived or modified (e.g., information letters) upon IRB approval. Please see the UWM IRB Guidelines section 7.2.
27. Is the Human Subjects Training Tutorial required? The 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 page for additional information.
28. Does the IRB track those who complete it? Yes. The IRB receives an electronic notice once certification is complete. Names are then entered into a database. View the list of completions here.
29. What do I type in the completion form if I am not UWM faculty, staff, or student? Leave the fields for "College or School" and "Department" blank. Enter a valid email address. Type in the "comment" box how you are associated with the study? For example, "I am a nurse at West Clinic and will be working with Dr. Smith on his project titled "Communication Methods in Preventative Care".
Research: Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45CFR46.102(d))
Human Subject: Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.
Intervention 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 includes communication or interpersonal contact between investigator and subject. Private information 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))
Minimal Risk: 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))