Institutional Review Board (IRB)-Research Using Human Subjects

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 for a 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 subject recruitment occurs. 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.

Useful Links

• HHS Code of Federal Regulations.

The term principal investigator (PI) is used to identify a researcher with primary responsibility for a research project. In various contexts, the specific purpose, eligibility criteria, and responsibility of PI status may vary.

Principal investigators must have appropriate standing at UW-Eau Claire and be performing the relevant research within the scope of that standing. Individuals classified as having university principal investigator status include:

1. Tenured and tenure-track faculty with at least a .5 FTE position at UW-Eau Claire.
2. Instructional Academic Staff with at least a .5 FTE position at UW-Eau Claire and an employment contract that spans the duration of the research project.
3. Other UW-Eau Claire staff with at least a .5 FTE position, an employment contract that spans the duration of the research project, and appropriate experience and training conducting related research.
4. Undergraduate and graduate students conducting student-faculty collaborative research or research for a specific degree program. Student serving as PIs on research studies must have a faculty/staff mentor who meets criteria in 1 through 3 above.

Ultimately, the IRB and university administration (e.g., department chair, unit director, college dean, associate vice chancellor, vice chancellor) determine if a UW-Eau Claire faculty, staff, or student is eligible to serve as a PI on a research study.

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 publicly 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 one month 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 one month after being received by the IRB from the department chair. Approval for expedited projects is good for 1 year, unless the researchers decide to change the protocol.

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 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 the current academic year can be found at the bottom of the page.

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

Approval for full board review projects is good for 1 year, unless the researchers decide to change the protocol, or the IRB decides they need to review more frequently.

The IRB reviews study recruitment methods (including advertisements and payments) to evaluate the equitable selection of subjects and to ensure that the proposed recruitment methods adequately protect the rights and welfare of subjects.

The IRB Initial Proposal must include a description of the following:

1. The source of prospective subjects for all study groups;
2. When, where, how, and by whom these prospective subjects will be recruited;
3. The methods employed to identify prospective subjects; and
4. The materials used to recruit subjects, including the use of email, social media posts, and flyers.

These guidelines apply to all research studies that will identify and recruit subjects.

1. Advertising and recruiting procedures must protect potential subjects’ confidentiality. Names and contact information for prospective subjects must be collected and maintained in a confidential manner.
2. When obtaining names or prospective subjects from third parties (including units and departments within UWEC), researchers must consider whether any breach of confidentiality or privacy laws has occurred. For example, doctors must contact their patients for written permission before releasing names to a third party.
3. Researchers are responsible for ensuring that approved procedures are followed by any third parties (e.g., doctors, teachers, community contacts, UWEC administrators) who may be aiding in the recruitment and/or advertising process. Payment to professionals in exchange for referral of prospective subjects (“finder’s fees”) and payment tied to the rate or timing of enrollment is prohibited.
4. If a researcher plans to use snowball sampling to recruit subjects, the subject population should be considered. For example, for certain populations, just providing a name or contact information to the researcher could present a risk to the prospective subjects. In these situations, the researcher could instead provide a business card to a subject with the directive, “I am looking for others who may be willing to talk with me. If you know anyone, please ask them to contact me using this information.”
5. Researchers may not share names of previous research subjects with other researchers without permission from the subjects.
6. The number of times a research team can contact subjects is study dependent and will be assessed by the IRB.
7. Email and text messaging, while convenient methods for contacting subjects, are not considered secure methods for communicating sensitive or health related information. Both communication methods and the protections in place to minimize security risks must be described to the IRB in the proposal.

Email Recruitment Guidelines

• Only university-issued or approved email accounts should be used (e.g., @uwec.edu). Personal email accounts (e.g., @gmail.com) may not be used.
• IRB proposals must describe how email will be used, including the source of email lists, targeted populations, frequency of emails, and methods for prospective subjects to remove themselves from the email list.
• Researchers must provide recruitment emails for IRB review. The subject line and content of these emails should not contain any references to health information or request health information from the subject through email.
• UWEC allows researchers to use email to send its faculty, staff, and students information about research opportunities. Researchers should consult with Academic Affairs, the UWEC Data Management, Analytics, and Reporting Department, and the Registrar’s Office about specific policies and procedures for accessing and using email distribution lists.
• Recruitment emails should not be used as informed consent forms. Informed consent forms should be separate documents that provide prospective subjects with all the necessary information needed to make an informed decision about participating in the research.

Required Elements

• The word “research” is required. Please make it clear to prospective subjects that they are being asked to consider participating in a research study.
• The institution’s name - “UW-Eau Claire”
• The PIs name and contact information (e.g., email, phone number)
• How prospective subjects’ email addresses were obtained
• Primary inclusion and exclusion criteria
• What is expected of subjects consenting to participate in the research
• Targeted population for the research – “You are receiving this email because you are a student in the English Department.”
• Information on how prospective subjects should proceed, if interested in participating in the research study.
• A statement about UWEC allowing researchers to use email to recruit subjects to support its research mission.
• For UWEC faculty, staff, and students, a statement that the use of these email addresses has been approved by the appropriate campus data custodian.
• Statements indicating the content of the email message was approved by the IRB, describing the IRB’s function, and providing the IRB chair’s name and contact information.

Elements to Consider

• Purpose of the study
• The time commitment
• A statement about compensation – the amount subjects will be paid, although this should not be the most prominent element on the page

Recruitment Email Template

Essential in the protection of human subjects is that potential participants first understand and then freely consent to the proposed research project.

A full explanation of the procedures to be followed—including time, benefits and risks—helps to safeguard the subject's well-being and permits the subject to make fully informed decisions. Although informed consent is often in the form of a signed and archived document, in situations where such a document might become the only identifying data, alternatives are encouraged.

Informed consent typically:

1. Informs participants of all factors that might influence their choice to participate. (including purpose, procedures, possible benefits/risks, and the identity of the investigators)
2. Presents that information in a comprehensible way. Important considerations include ethnicity, language, education, and socio-economic status.
3. Assesses a potential participant's comprehension of the aforementioned information.
4. Obtains consent without coercion or pressure.
5. Continues to provide information if requested.

Specific guidelines on informed consent can be found at UW-Eau Claire's IRB Consent Form preparation page, the 45 CFR 46.116(b), and the Federal Government's Health and Human Services Informed Consent FAQ.

Students as Subjects

Recruitment of any research subjects who may be in a status relationship with the investigators raises unique ethical concerns. At UW-Eau Claire this especially pertains to students but could also include employees and family members. The concern is that individuals may feel they cannot decline participation in a research study because they believe that would lead to adverse consequences for their student careers or employment. Therefore, the IRB has issued the following Policy Statement – The use as research subjects of students or others who have a status relationship with the investigator(s).

Financial Incentives Policy

The Institutional Review Board (IRB) is charged with the responsibility to review and approve both the amounts and methods of incentivizing to ensure that they are not coercive and do not present undue influence to participate or to continue participation. View the Policy on Research Participant Incentives for more information.

UW-Eau Claire's implementation of HHS guidelines

1. Confidentiality is of utmost importance. No respondent should be identified in any way with the information/data provided to the researcher without prior consent. Subjects will be advised at the beginning of the data collection procedure that all information/data will be kept confidential, that is, not identified with the subject unless she/he approves, in writing, of any disclosure.
2. At the outset of the data collection procedure, the subject will be advised in a general way about the purpose of the research as well as its sponsorship if a non-university organization is involved.
3. For survey research projects, informed consent starts by providing a detailed explanation of the purpose and protocol for the research project to the potential subject/respondent. The completion of the survey instrument (i.e., questionnaire/interview schedule) often constitutes informed consent.
4. If questionnaires or interview schedules are used, the maximum number of follow-ups that can be reasonably employed to improve the return rate in a given research project is subject to approval, on a case-by-case basis, by the IRB. This limitation of follow-ups is to avoid feelings of harassment or coercion on the part of the subjects.
5. All research projects that involve human subjects must obtain informed consent. This includes projects in the fields of education and the humanities that utilize research techniques such as oral history and evaluation of performance.

Health Insurance Portability and Accountability Act (HIPAA)

If the project will be collecting protected health information, you must include information about that in the Informed Consent form. 

1. The release of information should clearly state the purposes of acquiring the private health information (PHI).
2. The informed consent form and HIPAA authorizations can be provided to prospective subjects on the same form.
3. HIPAA authorizations expire, so that needs to be stated clearly on both the release of information form and the consent/HIPAA authorization form.
4. HIPAA has what’s called a security rule. More information can be found at HSS.gov.
5. CITI has a great module on research and HIPAA privacy protections. I don’t believe it’s a required module for our Social-Behavioral-Educational Researchers course, so PI's should review that module, if they haven’t already done so.

Below is an example of an approved statement you can tailor to your project.

• If you choose to participate in this study, there are some additional rules that we will follow to protect your private health information (PHI). Your PHI is protected by a law called the Health Insurance Portability and Accountability Act (HIPAA), which is a federal law passed to protect the privacy of your Protected Health Information. By signing this document, you are agreeing to participate in this research study. You are also authorizing the research team to use and disclose your Protected Health Information for this research study. This includes [insert PHI being collected for this study]. You understand that your participation is voluntary, and you may withdraw at any time without penalty.

Principal Investigators, co-investigators, faculty mentors of student-initiated research studies, and any study team member interacting directly or indirectly with subjects are required to complete training in the ethical conduct of human subjects research before submitting a protocol to the IRB. Researchers are also expected to keep current their training in the ethical conduct of human subjects research. Instructions for accessing trainings are at IRB CITI Training. 

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

1. Research team members must successfully complete the appropriate CITI course before submitting a protocol to the IRB. Instructions for Accessing trainings are at IRB CITI Training.
2. Complete the initial electronic proposal form in BP Logix.
3. Provide an explanation as to why your proposal may merit exempt review, if applicable.
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, they will forward it to the Research Compliance Specialist for review.
6. After the compliance review, the protocol will be sent 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) below.

• 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.
• Generalizable knowledge is interpreted as knowledge that is expressed in theories, principles, or statements of relationships that can be generally applied to our experiences. Activities designed to contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program. The information is collected to share with others in a discipline and is created to make broad statements or conclusions about a group of people, procedures, and programs.
• 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.
• 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.
• 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.
• Systematic investigation is interpreted as protocols are developed before the investigator has contact with the target population and those protocols use commonly accepted research methods.

• Treatment/stimulus: Any agent or technique that directly influences the attitudes, behavior, or physiological processes of the human subject.

   

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 their 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.

Background:

The WI Department of Health Services (DHS) requires special approval, called DHS Variance for research involving devices that expose subjects to radiation, in any amount. The DHS allows for variances for the research use of X-rays, but the process has specific requirements. This is because X-ray use for human research, particularly outside of standard medical care, is subject to strict safety regulations outlined in the Wisconsin Administrative Code, Chapter DHS 157.

Procedure:

1. UWEC requires a faculty or staff member to be the PI on these projects.
2. The PI must obtain IRB approval for the project.
3. The PI submits an application for the DHS Variance.
4. The PI forwards the approval letter to Research Compliance Specialist, Patrick Stafford (staffopr@uwec.edu), or IRB Chair, Nick Beltz (IRBUWEC@uwec.edu).

All 3 steps must be completed prior to beginning the project.

How to apply for a variance

1. Contact the DHS Radiation Protection Section. This is the first step for any specific questions. You can email dhsxray@dhs.wisconsin.gov or call 608-267-4782 for guidance.
2. Demonstrate safety equivalency. As with other DHS variances, you must provide information to demonstrate that your proposed research methods will achieve an equivalent degree of safety to the standard regulations.
3. Address the research aspects. If your research involves human subjects, ensure your application addresses how you will meet the requirements of an IRB-approved radiation safety review.

• DHS 157.74 - Wisconsin Legislative Documents

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.

Membership

An updated list of membership can be found below.

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, a staff member affiliated with a department or unit from Student Affairs and the Director of the Human Development Center serve as ex officio voting members. The Executive Director of the Office of 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. Non-student voting members shall serve three-year staggered terms and shall be eligible for reappointment. Student members typically serve one- or two-year terms.
5. The Provost and Vice Chancellor for Academic Affairs will appoint the IRB Chair, and then the Executive Director of the Office of Research and Sponsored Programs, 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).

All IRB forms are processed in the BP Logix eForm system using your university access.

Starting Your Application

To start an application, go to eform1.uwec.edu and log in with your UW-Eau Claire username and password.

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 section below).
• 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 new research project approved by the IRB, you will want to select "IRB Initial Form Submission".

IRB Initial Form Submission

Once the your CITI training 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 Research Compliance Specialist, Patrick Stafford at staffopr@uwec.edu or 715-835-3575.. 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 for review outside of BP Logix.

Still need help?

If you are having problems, please call Research Compliance Specialist, Patrick Stafford at 715-836-3575, or email staffopr@uwec.edu.

If you have further questions about the IRB process, please contact IRB Chair Nicholas Beltz, at715-836-5475, or email at IRBUWEC@uwec.edu.

Ethically and legally, consent is not considered to be informed unless the investigator(s) discloses all the facts, risks, and discomforts that might be expected to influence an individual's decision to willingly participate as a volunteer in a research project.

Sample Informed Consent Forms that you may edit for your own application are available below, along with this detailed list of items typically needed in an informed consent form. Sample Informed Consent forms are also available. Informed consent will need to fulfill the following requirements:

• Stationery for consent form. All consent forms should appear on appropriate letterhead (University/Institutional or other agency affiliation).
• Purpose of research. A statement of purpose for the research project must be included in the introductory paragraph of the consent form. If deception is necessary for successful conduct of the research project, the following statement may be used: “Because the outcome of the study could be affected if the purpose of the study is fully divulged prior to my participation, I understand that the purpose of the study cannot be revealed at this time. Further, I understand that I will have an opportunity to receive a complete explanation of the purpose of the study following my participation.” This statement may be omitted if the IRB determines that its inclusion will harm a research project otherwise acceptable to the Board.
• 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.
• Description of any risks to subject. A description of any risks and/or inconveniences that might reasonably be anticipated to occur for the subjects must be provided.  For a definition of risk, see Definitions. 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.
• Benefits, if any, for subject. The benefits 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.
• Alternative procedures or situations where standard treatment has been withheld. If any standard treatment has been withheld, this information must be disclosed. In addition, if other appropriate alternative procedures that might be more advantageous to the subject are available, the subject must be so informed.
• Confidentiality of data. The issue of confidentiality must be addressed if the data are to be available to anyone other than the subject, any investigators, or investigators’ staff. Any individuals or agencies to whom the information will be furnished must be indicated along with the purpose of the disclosure and the type of information to be provided.  If data are to be in the form of tape recordings, photographs, movies, or videotapes, these procedures should be described. Furthermore, the intended use of such data for other purposes must be disclosed and permission obtained by using a special portion of the standard consent form. Also, the final deposition of any tape recordings, photographs, movies, or videotapes should be specified.
• Anonymity of data. Anonymity, as herein used, means that the investigator(s) cannot associate the identity of a particular subject with their data. If anonymity will be maintained by the investigator, that process should be clearly explained.
• Protocol for treatment of physical injury resulting from research project. It is essential that all subjects be informed that in the event of physical or psychological injury resulting from participation in a research project, financial compensation is not available and that neither medical nor psychological treatment is provided free of charge by the University. Further, subjects must be informed as to the appropriate person to contact in the event of physical or psychological injury in research involving more than minimal risk. If no medical, physical, or psychological risks exist, this section may be omitted.
• Protocol to answer 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.
• 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. Nicholas Beltz
    • Committee Chair, Institutional Review Board for the Protection of Human Subjects
    • University of Wisconsin – Eau Claire
    • 715-836-5475 IRBUWEC@uwec.edu 
• 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.
• 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
• Decline of or discontinuance of participation. The subject must understand that they are 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, they should be instructed as to the appropriate disposition of the questionnaire.
• Subject to be given copy of consent form. If a signed, written consent form is being utilized in the research project, the investigator must give each subject or their representative a copy of the consent form. The reasons for this procedure are these:
  • The subject receives assistance in maintaining a continuing understanding of their involvement in the research project and can help avoid problems should the subject ever forget that they have been previously informed of a risk or discomfort.
  • By giving the subject a copy of the consent form, the subject will be able to recognize differences between their actual experience and what was expected; and
  • The procedure helps to preserve a good relationship between the investigator(s) and the subject.
  • The signature of the investigator also should be utilized so that it can be established who discussed the nature of the research project with the subject. Furthermore, whenever appropriate (i.e., language barrier, functional illiteracy, etc.), there should be space available for the signature of a witness.
• Agreement to participate in research project. The key elements of agreement to participate in a research project are these:
  • The signature indicates that, having read the information provided above, the subject decided to participate and understands that they have the right to withdraw from participation at any time without prejudice.
  • If someone other than the subject is giving consent, such as the parent or guardian if subject is a minor, the signature of only one parent is ordinarily required. (Example: “Your signature indicates that you have read the above information, and you have decided to permit SUBJECT’S NAME to participate.”)
  • Children who are capable of some understanding should be given an opportunity to refuse to participate in a research project. Therefore, informed assent of children includes:
  • If a subject has diminished capacity, the guardian’s consent and subject’s assent is required.
  • In the case of pregnant women, the mother and father must give informed consent and only after having been fully informed regarding the possible impact on the fetus, except that the father’s informed consent is not required if:
    • The purpose of the research activity is to meet the health needs of the mother
    • The father’s identity or whereabouts cannot reasonably be ascertained
    • The father is not reasonably available;
    • The pregnancy resulted from rape.
• Format. Please see example forms linked below.
  • Consent for Participation in a Research Study
  • Informed Consent on Letterhead
  • Survey Informed Consent
  • Encopresis Consent Form
  • vCR Consent Form

Changing, Renewing or Terminating 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, you must complete a Project Status Form (Renewal) by the date designated by the IRB as the end date of approval. Projects in the exempt category are approved for five years.

Study protocols are technically terminated when PIs leave the university, whether that be for retirement, taking another job, or, in the case of student PIs, graduation. For studies that wish to continue, the PI should submit a Project Status Form requesting approval to change the PI from them to someone else (e.g., another faculty member, another student). 

To access the change or renewal form, under New Forms, select ORSP as the department and select the IRB Project Status Form. 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.

The UW-Eau Claire 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 they 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 IRB CITI Training.
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. Presentations are available by contacting ORSP at 715-836-3405.
3. Submit the IRB – course certification request form prior to the initiation of any data collection by students in the course.
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.