University Safety and Assurances

Frequently Asked Questions


SECTIONS
General Information about the Institutional Review Board and how it works
Training related to Human Subjects research
Submitting a study for review
After Approval- Annual reports to the IRB
After Approval- Making changes to the study
After Approval-Something happened to one of my participants
Contacting the IRB staff

Contents

General Information

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 about oral history projects?

9. When do Quality Improvement projects require IRB approval?

10. What is Exempt, Expedited, and Full Board Review?

11. Who can be a Principal Investigator (PI)?

Training related to Human Subjects research

12. Is Human Subjects Training required?

13. How do I complete human subjects training?

14. Does the IRB track those who complete it?

15. How do I complete or report previous completion of human subjects training if I am not UWM faculty, staff, or student?

Submitting a study for review

16. So I've determined that my study requires IRB review, now what?

17. This study is being conducted at multiple sites, is IRB approval needed from them as well?

18. When is informed consent necessary?

19. What do I need to know about data confidentiality?

20. Which consent form do I use if I am conducting an online survey?

21. What do I need to know if I am doing internet-based research?

22. When can I begin my research?

23. What are "Revisions/Conditions" requested by the IRB?

24. Can I begin my study when I receive a "Conditional Approval" or "Revisions Requested" letter?

25. After I receive IRB approval, is there anything else I need to know?

After Approval-Annualreports to the IRB

26. What is "Continuing Review"?

27. Who needs continuing approval?

28. What do I need to in order to get continuing approval?

29. When should I file the submission?

30. My study went past the IRB expiration date, what do I do?

After Approval- Making changes to the study

31. What are "Modifications or Amendments"?

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

33. Can I submit a Modifications/Amendment request with the Continuing Review?

After Approval-Something happened to one of my participants

34. What is a "Reportable Event"?

35. What do I do if a subject needs medical care?

36. What if I enrolled more subjects than the IRB approved?

 

Contacting the IRB staff

37. Who do I talk to if I have questions?

A list of common terms and definitions


General Information


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 about oral history projects?

Oral History projects may or may not meet the definition of research.  Review and complete the Determination of UWM Submission form to determine if you need to submit to the IRB or not.
 

9. When do Quality Improvement projects require IRB approval?
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.  Please review and complete the Determination of Submission form to help you figure out if you need to submit and contact the IRB office if further clarification is needed.  

The IRB will be issuing a guidance document on this topic in the future.


10. 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.

11. 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."


Training Related to Human Subjects Research

12. 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 Human Subjects research training? Yes.  if you have completed the CITI training and have listed your institution as UWM then the IRB will automatically receive an electronic notice once certification is complete. Names are then entered into a database. View the list of completions here.

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 and you will be added to the list. 29. What if I am not UWM faculty, staff, or student but have completed or want to complete the CITI training? Register for and complete the CITI training using your current institution and email the IRB office a copy of your completion certificate.

13. How do I complete human subjects training?
Visit the UWM IRB’s human subjects training page and follow the detailed instructions for completing the CITI training.

14. Does the IRB track those who complete Human Subjects research training?
Yes.  If you have completed the CITI training and have listed your institution as UWM then the IRB will automatically receive an electronic notice once certification is complete. Names are then entered into a database. View the list of completions
here.

15. How do I complete or report previous completion of human subjects training if I am not UWM faculty, staff, or student?

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 and you will be added to the list.  

Submitting a Study for Review
 
16. So I've determined that my study requires IRB review, now what? Begin by reviewing the Getting Started Page and requesting an IRBManger account. You will ultimately need to complete the required forms (Protocol Form) and templates (Consent Forms) and submit all relevant materials (survey instrument, interview questions, recruitment flyers, etc.) to the IRB via IRBManager.

17. 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. Research projects involving multiple IRBs may qualify for an inter-Institutional Authorization Agreement (IAA).  This will allow one IRB to defer review and oversight to another IRB.  Refer to the Forms and Templates page to view IAA request forms for several local institutions or call the IRB office to explore the possibility of an IAA with another institution.

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.

18. 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.

The IRB Staff has put together some helpful hints on the informed consent process and different types of consent.  Click here to read.

19. What do I need to know about data confidentiality?
An important risk for many studies reviewed by the IRB is breach of confidentiality.  The IRB will ask you to specifically tell us how you are securing the data you will becollecting as part of your study.  Seethe Data Confidentiality Guidance document for recommendations on data confidentiality measures you may want to consider.  The University IT department (link) is another resource

20.  Which consent form do I use if I'm conducting an online survey?
The IRB has created a template specifically forinvestigators who are conducting online surveys.  In order to complete the template you will need to be clear if your survey is anonymous or if you will be collecting identifiers that you intend to keep confidential. Here is a guidance document that will clarify the difference.  If you do plan to use the online consent template and will NOT be collecting the signature of the participant you will also need to submit a request to waive documentation of consent(link).

21.  What do I need to know if I am doing internet-based research?
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.  The starting point is to determine if your project involves human subjects based on the OHRP's definition of human subject:  "A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information".   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-bases Research document.

22 When can I begin my research? 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 feasability activities are permissible (e.g., gathering institutional or other appropriate permissions, gauging participant interest), please contact the IRB staff for specific directions.

23. 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) Highlight, bold or underline each revision referengint hem by the corresponding item number from the revisions letter. (b) Re-attach each revised document to the original new study x-form. (c) Create a cover memo that explains how each requested revision has been addressed and attach the cover memo to the x-form. (d) Resubmit the original new study x-form to the IRB for review.  After you have fulfilled the requested revisions you will be notified by email with a formal letter attached that your protocol is approved.

24. 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.

25. 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.


After Approval- Annual Reports to the IRB

26. 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.

27. 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 although investigators will be required to update the status of their exempt studies every three years.

28. What do I need to do in order to get continuing approval? Continuing review submissions are made by completing and submitting a continuing review x-form in IRBManager. The IRB will send out a reminder to the PI by email ~30 days before the date of IRB expiration.

29. When should I file the submission? The recommended timeframe is approximately ~30 days before the date of IRB expiration.  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.

30.  My study went past the 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.



After Approval- Making Changes to the Study


31. 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.

32. What do I need to do in order to get my modification/amendment approved?
Log in to IRBManager, click on the study number and complete and submit an Amendment x-form. You will need to submit revised versions of the appropriate documents- protocol form, consent form, recruitment materials, etc...  Remember to use track changes to clearly indicate the requested changes in these documents so that the IRB can readily identify the changes.

33. Can I submit a Modifications/Amendment request at the same time as the Continuing Review?
Yes, however, you must submit a separate Amendment x-form and Continuing Review x-form.

After Approval- Something Happened to One of My Participants

34. 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.

Submit a reportable event to the IRB by completing and submitting a Reportable Event x-form.

35. 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.

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.  Please contact the IRB office to determine if this is required.

36. What if I enrolled more subjects than the IRB approved?
Please contact the IRB office to discuss and we can give you guidance on how to report this and what the next steps are.


Contacting the IRB

37. Who do I talk to if I have a question?
Please contact the IRB staff by emailing irbinfo@uwm.edu or calling 414-229-3182 or 414-229-3173




Definitions

Research: Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR46.102(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))