Research Using Human Subjects

The Institutional Review Board

The IRB is responsible for implementing policies and procedures that protect the rights and welfare of human subjects utilized in any university affiliated research project. Before you can begin to collect data, an application must be filed with and approved by the IRB using BP Logix eForms.

The following is an online guide designed to familiarize readers with the IRB and its policies and application process.

Policies and Procedures for Protection of Human Subjects in Research

IRB Prologue and General Policies

Prologue

The following is an online guide presenting the reasons and processes for the protection of human subjects in research at UW – Eau Claire. This guide is written in the spirit of U.S. Department of Health and Human Services (HHS) Code of Federal Regulations (45 CFR 46), describing our local application of the federal regulations.

These UW-Eau Claire policies and procedures have been established to protect the rights and welfare of human subjects utilized in research projects. Safeguarding human subjects is a critical step in the research process in order to protect not only the subject but also the investigator, the sponsor, and the institution. In accordance with federal, state, and University regulations, these policies and procedures are implemented by the Institutional Review Board for the Protection of Human Subjects (IRB). The IRB follows specific federal definitions for research (a systematic investigation designed to contribute to generalizable knowledge) and human subject (a living individual about whom an investigator obtains identifiable private information or data through interaction) as outlined in 45 CFR 46.102.

General Policies

Any research project that involves human subjects conducted by UW-Eau Claire faculty, staff, or students must be reviewed and approved by the UW-Eau Claire IRB before any data is collected. During the review process, the IRB asks the following questions:

  1. Will the rights and welfare of subjects be adequately protected?
  2. Will subjects be placed at risk? If so, will any risks be outweighed by the benefits to the subject and the knowledge to be gained from the study?
  3. Will legally effective and ethically appropriate informed consent be secured from subjects?
  4. Will the protocol meet all standards established by the federal government and University guidelines, including those pertaining to special populations such as minors, pregnant women, and prisoners?
  5. Is the research scientifically sound such that valid conclusions can be reached?

The above questions are written in the spirit of 45 CFR 46.111.

Types of Review: Exempt, Expedited, and Full Board Review

Depending on risk and subject demographic, a proposal will fall into one of three categories: exempt, expedited, or full board review. Although investigators should request the level of review they feel is appropriate for their project, this should not be a major concern. The IRB Chair, in consultation with committee members if necessary, will determine the correct level of review.

Exempt level of review

"Exempt" means review by one IRB member, sometimes in consultation with others. A research activity may be declared exempt if it is considered low-risk and the only involvement of human subjects will be in the categories outlined in 45 CFR 46.101(b). Briefly described, these categories are: 

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices.
  2. Research using anonymous or no-risk tests, surveys, interviews, or observations.
  3. Most research involving public officials.
  4. Research involving the collection or study of existing data if it is publically available or if subjects cannot be identified.
  5. Research examining public benefit or service programs.
  6. Taste and food quality evaluation and consumer acceptance studies.

Although subject consent is always needed, signed consent forms are typically not recommended if they are the only identifying variable in an otherwise anonymous project. Approval for exempt projects is good for 5 years, unless the researchers decide to change the protocol.

Most exempt level reviews are completed within two weeks after being received by the IRB from the department chair.

Expedited level of review

Projects not eligible for an exempt review may be eligible for an expedited review. "Expedited" means review by the IRB chair and one or more experienced reviewers.

In general, research may qualify for expedited review if it is judged to involve only minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate informed consent procedures. For example, the collection of physical data through non-invasive procedures is eligible for an expedited review, including:

  • Height and weight
  • ECG, MRI, Ultrasound
  • Moderate exercise
  • Blood or other bodily fluids 

The full list of categories of research that may be reviewed as expedited can be found in 45 CFR 46.110.

Most expedited reviews are completed within approximately three weeks after being received by the IRB from the department chair.

Full board review 

A full board review is required for research that is not eligible for exempt or expedited review. In short, research that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review. Individuals intending to conduct research that requires a full board review should allow ample time to complete the review process.

The following categories of research require full IRB approval:

  1. Projects for which the level of risk is determined by the IRB Chair to be greater than minimal.
  2. Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants.
  3. Projects that involve sensitive or protected populations (such as children or cognitively disabled individuals).
  4. Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal).

Tentatively scheduled IRB meetings for 2017-18 AY are as follows:

  • September 15, 2017
  • October 13, 2017
  • November 10, 2017
  • December 8, 2017
  • January 12, 2018
  • February 9, 2018
  • March 9, 2018
  • April 13, 2018
  • May 11, 2018
  • June 8, 2018

Applications requiring a full board review should be received by the IRB at least two weeks before a meeting in order to be reviewed.

Required Training

All human subject researchers are required to complete the online UWEC Online Human Subject Protection Tutorial before starting their IRB application or collecting any data. Our specific tutorial (see How to Submit to the IRB below) is required (regardless of other previous training), typically takes 1-2 hours, and concludes with a short quiz. Groups are encouraged to take the tutorial together in order to exchange ideas relevant to their project.

Before your research proposal application can be reviewed by the IRB, you must:

  1. Complete the online Human Subject Protection Tutorial. The staff/student who plans to initiate an electronic proposal must have received a certificate of completion of the tutorial.
  2. Complete the initial electronic proposal form in BP Logix.
  3. Provide an explanation as to why your proposal may merit exempt review.
  4. Submit your proposal. Your proposal will then go to the department chair if you are faculty or staff. If you are a student, it will first go to your faculty mentor.
  5. Once your department chair approves the application, he/she will forward it to the IRB.

Once the application has been received by the IRB, the Chair of the IRB shall take the following actions:

  1. Review the proposal in accordance with federal, state, and university regulations for the protection of human subjects and determine in which category the proposal best fits.
  2. As soon as practical, take one of the following steps:
    • If the project fits the exempt category, notify the initiator that the proposal has been approved and that the project may begin; that it requires modification; or that it has been disapproved. The Chair will inform the IRB at the next regularly scheduled meeting of the action taken.
    • If the project fits the expedited category, request a second member of the IRB to assist with a review of the proposal, and then take appropriate action.
    • If the proposal fits the full review category, distribute it to the IRB Committee for discussion and vote at the next committee meeting.

For detailed instructions on how and what to submit, see How to Submit to the Institutional Review Board (IRB).

Definitions

  • Anonymity: The investigator(s) cannot associate the identity of a particular subject with any collected data.
  • Confidentiality: The investigator(s) will not make unauthorized disclosure of identifying information and/or data that have been obtained from a respondent.
  • Data collection: Any research procedure that uses instruments, devices, or observations to record the actions, reactions, attitudes, and/or other behavioral manifestations of subjects during a research project.
  • Deception: In research, this means that the subject/respondent is not fully informed of the nature and purpose of the research at the time of the data collection in order to prevent biased behaviors or responses from the subject/respondent.
  • Human subject: a living individual about whom an investigator obtains data through interaction or identifiable private information.
  • Human subject at risk: Any individual who may be exposed to the possibility of economic, legal, physical, psychological, or social injury as a consequence of participating as a subject in a research project or related activity that departs from the application of those established and accepted methods necessary to meet the person’s needs or that increase the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service. Individuals who have received routine and acceptable educational, medical, nursing, psychological, or social services that were in effect prior to the initiation of the research project in question are not considered human subjects at risk.
  • Informed consent: A subject’s voluntary agreement to participate in research based upon the subjects adequate understanding of the research. The researcher must ensure that the person receives enough information to clearly understand any and all implications of participation. There are specific requirements for adequate informed consent.
  • Interaction: Communication or interpersonal contact between investigator and subject.
  • Intervention: Procedure during the experiment in which a treatment or manipulation of the environment occurs to elicit a change in behavior or physiological functioning.
  • Minimal risk: The probability and magnitude of harm or discomfort anticipated in the research is not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.
  • Private information: Any data that can reveal an individual’s identity or describe their behaviors or answers given during an experiment. In most daily situations, an individual expects that their behavior is not being observed or recorded (for example, at a park or in a restroom). Private information also includes information that is provided for a specific purpose (for example, medical care or social services).
  • Research: a systematic investigation designed to contribute to generalizable knowledge.
  • Risk: The probability that harm (including physical, psychological, social, legal, or economic) will occur as a result of participating in a research study.
  • Survey methodology: Includes, but is not limited to, mail and web-based questionnaires, telephone interviews, personal interviews, and group questionnaires that seek to collect data from any population or sample of individuals.
  • Treatment/stimulus: Any agent or technique that directly influences the attitudes, behavior, or physiological processes of the human subject.
  • Sensitive, vulnerable, or protected populations: Includes minors (except as allowed under expedited review), prisoners, fetuses, cognitively disabled, test subjects for new drugs or clinical devices, pregnant women, legally incompetent persons. For more information, see the HHS Vulnerable Populations page.

IRB Guidelines for Using Deception in Research

In studies involving deception, the reasons for the deception must be fully justified to the IRB and the subject must be given a complete explanation of the study upon completing her/his participation.

The use of deception by an investigator for the purpose of securing subject participation and/or to prevent potentially biased reporting of data/information by the subject is permissible provided all of the following conditions exist:

  1. Deception is necessary due to the lack of alternative procedures for data collection not involving deception.
  2. The deceptive procedures will not place subjects at significant financial, physical, psychological, or social risk.
  3. The data collection/experiment will be followed by careful debriefing sessions whereby the subjects are fully informed of the nature and purpose of the deception.
  4. The procedures for deception should meet any available professional code of ethics or guidelines established by the discipline of the investigator.

Note: Research that uses intentional deception is typically not eligible for an exempt or expedited review.

IRB Composition

The IRB operates as a function of the Office of Research and Sponsored Programs which, in turn, is one of the units within Academic Affairs under the direction of the Provost/Vice Chancellor for Academic Affairs.

2017-2018 Membership

An updated list of membership can be found on the Academic Affairs website.

IRB Membership Requirements
  1. The IRB must have at least five voting members with varying backgrounds to complete an adequate review of research activities commonly conducted at UW-Eau Claire. The IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds to safeguard the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB must be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB must, therefore, include or seek input from persons knowledgeable in these areas.
  2. The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas. It must also include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. As part of local policy, UW-Eau Claire includes one student member. In addition, both the Director of Health Services and the Director of the Human Development Center serve as ex officio voting member. The Assistant Vice Chancellor for Research and Sponsored Programs serves as ex officio, but non-voting member.
  3. In reviewing proposals involving children, pregnant women, mentally disabled persons, or other unique populations, the IRB membership shall be expanded, if necessary, to include an appropriate representative who is knowledgeable about and experienced in working with these special subjects. When prisoners are the subject of research, 45 CFR 46.304 requires that at least one member of the Board be a prisoner representative.
  4. Voting members shall serve three-year staggered terms and shall be eligible for reappointment.
  5. The Provost and Vice Chancellor for Academic Affairs will appoint the IRB Chair, and then the Assistant Vice Chancellor for Research, in consultation with the IRB Chair, will appoint the voting members of the IRB.
  6. No IRB member shall participate in the review of any research project in which said member has a conflict of interest, except to provide information upon the request of the IRB.
  7. The IRB committee will meet once per semester and more often as needed.
  8. Minutes of all IRB meetings shall be recorded and distributed through appropriate channels.
  9. The IRB shall comply with the provisions of the Wisconsin Open Meetings Law including the option of going into closed session, as appropriate, to protect the patent and/or publication rights of the investigator(s).
  10. For additional information from the HHS (Health and Human Services) on institutional administration of an IRB, see the Institutional Review Board Guidebook.

IRB Documents, Policy Statements, and Samples

Useful Links

How to Submit to the Institutional Review Board (IRB) - Includes eForm Instructions.

How to Submit to the Institutional Review Board for the Protection of Human Subjects

All IRB forms are processed in the BP Logix eForm system using your university access. If you are not familiar with BP Logix, It is highly recommended you read the Using eForms and BP Logix Tutorial.

  1. A complete application for the IRB review and approval will include the following:Completion of the Human Subjects Protection Tutorial to receive your IRB Certification
  2. IRB Electronic Project Application (IRB Initial Form Submission) including:
    • Cover Letter to prospective participants
    • Informed Consent Documents
    • Description of proposed protocol, including any survey, tests, or other instruments.
Starting Your Application

To start an application, go to eform1.uwec.edu and log in with your UW-Eau Claire username and password. For a detailed explanation on using BP Logix to start a form, please see the see the Using eForms and BP Logix Tutorial.

After selecting ORSP as the department, there are several IRB forms you may use:

  • IRB Initial Form Submission: used to obtain IRB approval for a single research project.
  • IRB - Course Certification Request: used by instructors to take on some of the responsibilities of the IRB for classroom research projects. (See IRB Course Certification below).
  • IRB Certification Only: used to take the UWEC Online Human Subject Protection Tutorial and obtain certification.
  • IRB Project Status Form: used to renew, terminate, or report any changes to a project already approved by the IRB.

If you wish to have a research project approved by the IRB, you will want to select "IRB Initial Form Submission".

Human Subjects Protection Tutorial

In order to submit any project applications to the IRB, a user must have completed the UWEC Human Subjects Protection Tutorial. This required tutorial is independent of any previous certifications and will only need to be completed once. For subsequent proposals, you will not be prompted to repeat certification. Once you have initiated the tutorial by starting an "IRB Initial Form Submission", and until you complete it, the tutorial will be available under My Tasks. The tutorial will take approximately 1-2 hours to complete. Groups are encouraged to complete the tutorial together in order to discuss topics specific to their project. For easy access, the complete tutorial is available as a Human Subjects Protection Tutorial PDF.

Navigating the Tutorial

  • When finished with a given page, click at the top of the page to move to the next page.
  • To close and save the form for later review, click at the bottom of the page.
  • To delete the form entirely, click at the bottom of the page.
  • In order to fully complete the tutorial and receive a certification, you must answer the three questions correctly at the end of the tutorial (you will have multiple chances). When you have answered all questions correctly, click on to finish the process. You will then receive an email with your certification and an attached PDF of the tutorial.
IRB Initial Form Submission

Once the certification has been completed, you may start the IRB Initial Form Submission. If the form does not already appear on your My Tasks screen, but you are still in BP Logix, click at the top right of the screen to refresh the page. If you still do not see the IRB Initial Form Submission, you may need to initiate a new form. Under Start New Form, select ORSP, and select IRB Initial Form Submission. This should add the form to your My Tasks screen.

Filling out the IRB Initial Form

For any sections that require a narrative, you may type or paste in text or attach documents near the end of the form. The following documents, if applicable, as well as any other supporting documentation, should be included upon submission:

  • Cover Letter to prospective participants
  • Informed Consent Documents
  • Description of proposed protocol, including any survey, tests, or other instruments.

If you need to pause before finishing the form, click "Save to Edit Later." The form will remain accessible in BP Logix under My Tasks. Once you submit the form, it may be viewed, but NOT changed, under View Forms in Process while it is being used by others.

Upon submission, you will receive an email with a PDF of your form attached. If you do not receive the email with the attached PDF after submission or have any questions about this, please contact ORSP at orsp@uwec.edu or 715-836-3405. After submission, you can view and track the progress of your form under the View Forms In Process tab.

Sharing forms with co-investigators

The eForm system only allows one person to edit a form at a time. Therefore, if co-investigators need to contribute to the application, the person who is currently assigned the form (i.e. it appears in their My Tasks tab) will need to make any and all changes to the application. It is recommended that the initiator distribute PDF versions of the application to any co-contributors. The form may be converted to PDF at any time by selecting "Print" at the bottom of the form and saving it as a PDF (by using software such as CutePDF). This PDF, then, can be distributed outside of BP Logix.

Research in Elementary, Middle, or Secondary Schools

Proposals involving research in elementary, middle, or secondary schools must also be submitted to the UWEC Associate Dean of the College of Education and Human Sciences and the respective school district administrative offices. Because researchers must comply with any district policies, it is recommended to allow ample time.

Still need help?

If you have questions about the BP Logix process, it is highly recommended you read the Using eForms and BP Logix Tutorial. If you are still having problems, please call ORSP at 715-836-3405, or email orsp@uwec.edu.

If you have further questions about the IRB process, please contact Michael Axelrod at 715-836-2373 or axelromi@uwec.edu. If you have questions about using the eForm system, please contact ORSP at 715-836-3405 or orsp@uwec.edu.

IRB Cover Letter Preparation and Samples

Sample Cover Letters that you may edit for your own application are available along with this detailed list of items typically needed in a cover letter. Depending on your specific project, your cover letter will need to address many of the following items:

  • Stationery for cover letter. All cover letters should appear on appropriate letterhead (University/Institutional or other Agency affiliation).
  • Purpose of research. A statement of the purpose for the research project must be included in the introductory paragraph of the cover letter.
  • Invitation for subject to participate. By giving an invitation, the subject will be assisted in understanding that a choice is to be made regarding her/his participation in the research project.
  • Benefits, if any, for subject. The benefits, if any, that the subject can reasonably be expected to receive must be indicated. Since any suggestion of a benefit can be a strong inducement to participation in a research project, any such suggestions should be limited to substantial and likely benefits.
  • Explanation as to why subject was selected for participation. This information will assist the subject in assessing the nature and importance of her/his participation.
  • Size of intended sample. The total number of subjects to be included in the eligibility pool/sample should be provided for the potential respondent.
  • Description of research protocol. A description of the procedures to be followed by the subject must be stated clearly and with sufficient information to allow the reader to determine the  risks and/or benefits of the study.
  • Consideration of time allocation. The approximate length of time required to complete the research activity/survey instrument should be clearly stated.
  • Voluntary nature of participation. State that participation in the research project is voluntary and:
    • Not a part of any job or instructional requirements
    • Not a condition for being the recipient of benefits or services from UW-Eau Claire
    • Subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
  • Description of any risks to subject. A description of any risks (see definition) and/or inconveniences that might reasonably be anticipated to occur for the subjects must be provided (Wherever appropriate, a statement should appear that the given procedure(s) may involve unforeseeable risks.
  • Description of any provisions made for harmful or negative physical or psychological effects Subjects should be informed of any provisions made for handling negative physical or psychological effects that may occur from participation. If appropriate, the name of a specific person, office, or clinic should be indicated in the cover letter, e.g., Ms. Janice Jones or your social worker.
  • Protocol to address concerns about treatment of human subjects. The name, address, and telephone number of the Chair of the Institutional Review Board for the Protection of Human Subjects must appear as the contact person for any questions or concerns regarding the treatment of human subjects in the research project.

                    Dr. Michael Axelrod, Chair IRB
                    Schofield 17
                    UW-Eau Claire
                    Eau Claire, WI 54702-4004
                    715-836-2373

  • Protocol to address questions. The name, address, and telephone number of the investigator(s) must appear so as to provide a contact person(s) for any questions about the nature or procedures of the research project.
  • Confidentiality of data. Confidentiality, as herein used, means that the investigator(s) will not make unauthorized disclosure of identifying information and/or data that have been obtained from a participant. An investigator needs to tell to what extent the subjects identity and personal data will be protected in any publication or presentation resulting from the study. Likewise, an investigator must disclose any individuals or agencies with which the information will be shared.
  • Anonymity of data. Anonymity, as herein used, means that the investigator(s) cannot associate the identity of a particular subject with her/his data. If anonymity will be maintained by the investigator, that process should be clearly explained.. .
  • Question of compensation and/or cost reductions. If subjects will receive payment for participation in the research project, the amount must be stated. If subjects will receive services at a lower cost than would ordinarily be charged to non-subjects, said services constitute subject compensation and should be explained. If the investigator intends to use some type of prorated payment system for partial participation, this procedure also must be described.
  • Decline of or discontinuance of participation. The subject must understand that she/he is free to decide not to participate or to later withdraw consent and discontinue participation in the research project without prejudice. It is not permissible to utilize any exculpatory language (e.g., "before you withdraw, you must inform the investigator") in providing the option to discontinue. If appropriate, the conditions under which the investigator would terminate a subject's participation in the research project also must be described. In addition, the subject must be informed if withdrawal could lead to any undesirable consequences, and otherwise be informed that withdrawal does not jeopardize the subject in any way. If the potential subject declines participation in a questionnaire-type research project, she/he should be instructed as to the appropriate disposition of the questionnaire.

Change or Renewal Form

Changing or Renewing an approved Project 

All principal investigators must notify the IRB prior to any protocol changes of an approved application using a Project Status Form (Change). In addition, if your project was approved as an expedited or full-board review, you  must complete a Project Status Form (Renewal) at least once per year. Projects in the exempt category are approved for five years.

To access the change or renewal form, select ORSP as the department and select the IRB Project Status Form (see the BP Logix tip sheet for more information). Be sure to select Change, Renewal or Termination from the menu at the top left of the form. In order to complete the form, you will need the initial IRB approval number and date.

IRB Course Certification Form

The UW-EC Course Certification policy allows instructors the choice of assuming the responsibility of the IRB for low risk projects conducted as part of a course. The instructor will certify to the IRB that she/he will exercise reasonable and customary instructional supervision to ensure that all student research projects are conducted in compliance with IRB policies. This policy facilitates direct and continuous feedback during a student's first research exposure. 

Faculty and academic staff requesting course certification must:

  1. Complete the online Human Subject Protection Tutorial.
  2. Review the IRB policies detailed in the IRB Prologue and General Policies with all students enrolled in the course being requested for certification prior to the initiation of data collection from human subjects. Instructors are encouraged (not required) to use the tutorial as part of the educational process, often as a group or classroom undertaking. You may wish to have a member of the IRB review the University policies with your students.
  3. Submit the IRB – course certification request form prior to the initiation of any data collection by students in the course. See the BP Logix Tip Sheet on how to start this form.
  4. Exercise reasonable and customary instructional supervision in an attempt to ensure student compliance with the policies detailed in the IRB Prologue and General Policies.

Since student projects will not be individually reviewed by the IRB, cover letters and/or consent forms must include the following statement:

This survey (project, etc.) is being conducted in partial fulfillment of the course requirements for (COURSE TITLE), taught by (INSTRUCTOR'S NAME), at the University of Wisconsin-Eau Claire. This course is in compliance with the course certification requirements of the University Institutional Review Board for the Protection of Human Subjects.

All students also must be advised that if they are planning to conduct their research in elementary, middle, or secondary schools, their research proposal must be submitted to the Associate Dean of the School of Education and Human Sciences prior to its initiation in accordance with University policies. Those projects to be conducted in the Eau Claire Area School District must also be approved through their administrative offices.

eForms (BP Logix)

The current IRB Committee Chair is Michael Axelrod, axelromi@uwec.edu, 715-836-5020. Please contact him with any questions relating to the IRB. 

Institutional Review Board Committee Meeting

For the 2017-18 academic year, the IRB committee is tentatively scheduled to meet from 2:00 - 3:30 pm on the following dates: 

  • September 15, 2017
  • October 13, 2017
  • November 10, 2017
  • December 8, 2017
  • January 12, 2018
  • February 9, 2018
  • March 9, 2018
  • April 13, 2018
  • May 11, 2018June 8, 2018

 Please note that meetings will be held only as needed.

We want to hear from you

Please enter your name

Please enter a valid email address

Please enter a valid phone number

Please enter a message