Approval Process

All protocols are reviewed on an on-going basis. For a full board review, requests must be submitted at least two weeks prior to an IRB meeting for consideration, so be sure to get your materials in order with enough time for the IRB to review your work.

Meeting & Submissions Deadlines

1Do I need IRB approval?

If you're completing research on human subjects, you'll likely need IRB approval. For the purposes of our review, research is defined as a systematic investigation, including research development, testing and evaluation designed to develop or contribute to knowledge.

Likewise, human subject is 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.

Quality Improvement Projects

The first step in the review process is to determine if a research project needs IRB review and approval. The Quality Improvement Self-Certification Tool was developed by the UW-Madison Health Sciences IRB Office. This short survey tool allows study teams to decide independently whether their project constitutes the definition of "research" or "quality improvement project."

Quality Improvement Self-Certification Tool

A summary of results will be sent to you upon completion of the survey tool. This tool is designed to provide a pre-certification that the project does not constitute research and further IRB review may not be required. Please note that all Quality Improvement Projects (and research), must be evaluated by the IRB. Please submit your survey results to irb@uwgb.edu. If a follow-up is necessary, we will contact you.

Classroom Research Project

If the project and/or experiment that you are doing in the classroom or lab qualify as “research,” then IRB approval is required. Furthermore, If research data or results are intended to be presented to an audience, IRB approval is required.

However, in-class presentations often do not constitute the definition of "research." To be sure, the IRB recommends that instructors and students take the short Self-Certification survey tool and/or contact the IRB Office with any questions or concerns. All course assignments involving human participants that do not fall under the category of research must still be planned and carried out with due consideration of the University's ethical and legal responsibility to protect individuals involved in these activities.

Scholarship of Teaching and Learning (SoTL) Projects

If using human subjects, SoTL projects require the same IRB approval process that any other project would require. Most, but not all, SoTL projects qualify for either exempt or expedited level of review. However, because many SoTL projects utilize the instructors' own students as participants, and given the inherent power differential present in the teacher-student relationship, the potential for coercion is great in this research setting, regardless of the level of review.

Furthermore, students may feel pressured to participate in such projects because they're worried about the impact of not participating on their grade, want to help out an instructor who they like, etc. When possible, some strategies for decreasing the potential for coercion can be integrated into your protocol methodology:  

• Having someone unaffiliated with the class or the data analyses collect the data so that whether or not a student participated will be unknown to the instructor
• Making clear to students that data will not be analyzed until after the semester is completed and course grades have been submitted
• Offering an alternative assignment for students who do not wish to participate in the study (this procedure is required if students receive either class credit or extra credit for participating in the study)

2Complete Training

Every researcher needs to complete training. CITI training is available for all principal investigators and student investigators seeking research compliance training and certification. Courses depend on who you are in the research process.

Principal Investigators

• Select one from the following CITI course titles:
  • Social and Behavioral Research
  • Responsible Conduct of Research
• Optional courses:
  • Conflicts of Interest
  • Research in Educational Setting
  • Research with Children
  • Privacy and Confidentiality

Student Researchers

• Select one from the following CITI course titles:
  • Social and Behavioral Research
  • Responsible Conduct of Research
• Optional Courses:
  • Research in Educational Settings
  • Research with Children
  • Privacy and Confidentiality

IRB Committee Members

• Belmont Report and Its Principles
• History and Ethics of Human Subjects Research
• The IRB Member Module - 'What Every New IRB Member Needs to Know'
• Defining Research with Human Subjects - SBE
• Basic Institutional Review Board (IRB) Regulations and Review Process
• Privacy and Confidentiality - SBE
• Informed Consent
• Populations in Research Requiring Additional Considerations and/or Protections
• Conflicts of Interest in Human Subjects Research
• Hot Topics
• Unanticipated Problems and Reporting Requirements in Social and Behavioral Research
• Assessing Risk - SBE
• Students in Research
• FERPA for Institutional Review Boards (IRBs)

3Prepare a Protocol

The principal investigator (PI) or instructor completes the applicable sections of the proposal form for the proposed research. Please note, the principal investigator must be a faculty member or instructor; students cannot be the PI.

Complete Protocol Submission Form

Supplemental Documents

• Media Release Form: if you're taking photographs or videos of participants, they'll need to sign this form
• Informed Consent Form Sample: provides an overall structure for informed consent forms
• Recruiting Script Sample: need help getting participants? Use this script as a guide

Risk/Review Status

There are three levels of IRB review: full board review, expedited and exempt.

Full Board Review

If your project involves more than minimal risk to participants, you'll need a full board review. Protocols involving any of the following will also require full board review:

• Minor subjects (children 17 years of age or younger)
• Special populations (prisoners, pregnant women, individuals with disabilities)
• The use of video or audio tape to record subjects (including recording via MS Teams or Zoom)
• Asking questions that may be highly embarrassing or compromising (e.g., sexual behavior, illegal drug use, violations of law, etc.)
• Exposing subjects to graphically violent or pornographic materials
• Inflicting physical pain upon, attaching electrodes to or injecting any substance into subjects
• Creating high levels of stress, fear, discomfort or tension
• Threatening subjects in any way
• Causing subjects to violate laws or official university regulations
• Providing some subjects with benefits denied to others (this includes payments or rewards for participation, e.g., offering extra credit to participants, etc.)
• Causing physical or mental exhaustion or engaging subjects in intense exercise
• Placing individuals in confining physical settings or attaching other devices
• Exposing subjects to extreme conditions (e.g., bright lights, loud noise, intense pressure, strong odors, complete darkness, extreme heat or cold, etc.)
• Leaving subjects alone for periods of time longer than 20 minutes
• Taking hair samples or nail clippings from subjects
• Taking human tissue samples, drawing blood or sampling any other bodily fluid

Expedited

Expedited research only needs to be reviewed by the chair or by a qualified member of the IRB that has been designated by the chair. It is, however, subject to annual review. A research project is appropriate for expedited review if it involves only minimal risk, but is not classified as exempt. Minimal risk is defined as risk that is not greater than what someone encounters in ordinary daily life or during the performance of routine physical or psychological examinations or tests.

Exempt

Research that is classified as exempt will not require any further review after the initial approval and only needs to be reviewed by the chair of the IRB. Exempt research:

• Is conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods
• Involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior UNLESS (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and (ii) Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability or reputation
• Uses educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is NOT already exempt under #2 if: (i) The human subjects are elected or appointed public officials or candidates for public office, or (ii) Federal statute(s) require(s) without exception that confidentiality of the personally identifiable information will be maintained throughout the research and thereafter
• Involves the collection or study of existing data, documents, records or pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects
• Conducted by or subject to the approval of [Federal] Department or Agency heads and which are designed to study, evaluate or otherwise examine: (i) Public benefit or service programs, (ii) procedures for obtaining benefits or services under these programs, (iii) possible changes in or alternatives to those programs or procedures or (iv) payment for benefits or services under those programs
• Taste and food quality evaluation and consumer acceptance studies, (i) If wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture

4Submission & Review Process

Initial Review

The initial review of protocols usually take approximately two weeks. Please plan accordingly when submitting your protocol. After initial review, you will either receive a revise and resubmit letter, notification of your full board review time or a final approval.

Revise and Resubmit

You may receive a revise and resubmit letter that describes the corrections needed to receive final approval. You must submit a revised protocol with the changes annotated on the first page prior to beginning your research. You may receive either another revise and resubmit letter or final approval letter after review.

5I have approval. Now what?

One year from your approval date, unless a protocol modification has been filed and approved, a final report form must be submitted. Failure to submit a final report may result in denial of future protocols. If you have any questions about what information needs to be included in the final report, please contact the IRB chair at irb@uwgb.edu.

Protocol Modification/Extension

If you would like to make any changes to your protocol, you must submit a protocol modification/extension form to the Institutional Review Board. This form may be used for:

• Requests for extension
• Requests for minor modification of procedure
• Requests for modification of co-researchers

If the modifications are minor (i.e., title change, agency change, addition of data collection sites, etc.) the IRB chair or designee will review the protocol. If the modifications include more than minimal risk, the protocol will be included on the next IRB agenda for full board review.

Complete Protocol Modification Form

Annual Progress Report

Projects can only be approved for one year and, if the researcher intends to continue the project past one year, they must complete an annual review. The annual review process is as follows:

• The researcher will receive a reminder from the IRB one month before their annual review is required (see chart below for annual review deadlines).
• The researcher submits an annual progress report, outlining any changes or modifications that have been made and/or any adverse events that have occurred.
• Unless there have been substantial modifications made to the original protocol, the Annual Progress Report will be reviewed by the IRB chair.

*Please note that Annual Progress Reports are needed only if the project continues past one year. Annual Progress Reports do not take the place of final reports.*