Frequently Asked Questions
Visit the Guidelines and Procedures page for more information
Contents
1. General questions about the IRB
2. What qualifies for IRB review
3.
Submitting a New Study
4. Submitting a study for Continuing Review
5. Submitting revisions requested by the IRB
6. Submitting Modifications/Amendments
7. Submitting a Reportable Event
8. Informed Consent & Assent
9. Human Subjects Training
10. Definitions
1. General question about the IRB
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, and community representatives.
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.
After I receive IRB approval, is there anything else I need to know? Once IRB approval is granted, the following require 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 at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109(b)). The IRB can only give approval for a given research study for a period of no more than one (1) year. 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. See "Submitting a study for Continuing Review" for additional FAQs.
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.
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.
2. What qualifies for IRB review
How do I know if I have to submit my study to the IRB? This is a multi-level answer. Requiring IRB review means you are first doing "research" defined as: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Second, the research involves "human subjects" defined as: 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. Third, UWM is 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) or staff under UWM auspices; (2) research to satisfy a requirement imposed by UWM for the award of a degree or the completion of a course of study;
(3) research conducted by affiliated faculty under UWM auspices.
My study is in the classroom, do I need to submit? This type of research does not need approval if the research is not generalizable outside of the classroom setting. However, if that research will be used later on as part of another research that will be generalizable, IRB submission is required. IRB submission is required if you have any plans on using research in the future.
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.
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 Submission Form, the IRB makes the final determination. View OHRP's Decision Chart.
- 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/decentral approval.
- 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.
- Full Board: Submissions that are neither exempt nor expedited are sent to the Full Board for review.
Who can be a Principal Investigator (PI)? Under current UWM guidelines, faculty, students, and staff can be a PI. However, students (undergraduate & graduate) will require the authorization of their faculty advisor.
3. Submitting a New Study
So I've determined that my study requires IRB review, now what? Begin by reviewing the Getting Started page. Visit the Forms and Templates page and follow the general instructions for New Study Submission.
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 must be in place (contact the IRB office).
Remember, even 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.
When can I begin my research? Remember, no research related activities may begin until IRB has given your research protocol full approval with no revisions or conditions. This includes screening subjects or mailing out questionnaires.
4. Submitting a study for Continuing Review
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 non-compliance with both institutional and federal regulations.
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.
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 approximately 60 days before the date of IRB expiration.
When should I file the submission? The recommended timeframe is approximately 60-30 days before the date of IRB expiration.
Can I submit a Modifications/Amendment request with the Continuing Review? Yes, however, you must complete the "Modifications/Amendment Form" as well and check off the appropriate boxes for both Modifications/Amendment and Continuing Review on the "Standard Face Page".
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 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 reapply for IRB approval as a New Submission. You must also submit a Continuing Review Form with it.
5. Submitting revisions/conditions requested by the IRB
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 after the IRB staff, designated IRB reviewers, or the Full Board reviews the study.
Instructions: To fulfill the conditions, print out and send your revisions to the IRB office (ENG 270). Complete the (a) Standard Face Page, marking the (b) Revisions Requested by the IRB box. (c) Print out and re-submit the pages of your protocol which require the revisions (e.g., if the revisions are only to the consent form, submit only the consent form). (d) submit a cover memo referencing the revisions by the corresponding item number in the attached email letter. (e) Highlight, bold, or underline each revision referencing them by the corresponding item number in the attached email. (f) Include a copy of the emailed letter requesting revisions. Once you have fulfilled the conditions, you will be notified by email with a formal letter attached that your protocol is approved.
Can I begin my study when I receive a "Conditional Approval" or "Revisions Requested" letter? No. Study activities (e.g., recruiting, enrolling, etc.) may not begin until final approval is granted.
6 Submitting Modifications/Amendments
What are "Modifications or Amendments"? Once a study receives IRB approval, any changes to the research study 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.
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.
7. Submitting a Reportable Event
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 Events (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. Remember, some adverse events are required to be reported to the IRB within 10 working days.
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.
8. Informed Consent & Assent
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. (see Guidelines and Procedures)
9. Human Subjects Training
Is it required? The training is required for all individuals who will be Principal Investigators (PI). Upon completion, the last page is a form where the user inputs his or her name, department, email and phone number. The user is encouraged to print a copy of the verification for their own records.
Though non-PIs (e.g., research assistant, other research team members) are not required to complete the training, it is highly encouraged. In some instances, the IRB may require non-PIs to complete the training.
Does the IRB track those who complete it? Yes. The IRB receives electronic notice once the form is submitted. Names are then entered into a database.
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 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))
