Purpose: After the atrocities of the Nazi experiments of the 1930s and 40s, many nations began to develop legislation to establish the rights of human subjects involved in the research. In 1974, the U.S. Department of Health Education and Welfare established the Institutional Review Board (IRB) as one mechanism whereby human subjects would be protected from potential physical or psychological harm. Federal policy now requires review and approval by an IRB of ALL research activities involving living subjects (human and animal). The IRB has the authority to approve, require modifications for, or disapprove all research activities that fall within its jurisdiction. This mandate applies to all faculty, staff and student research, including that to satisfy baccalaureate and master's degrees.

Approval by the IRB of Lakeland University must be obtained PRIOR to the involvement of subjects in research, including pilot studies. The IRB cannot review protocols for projects for which data collection has already begun.

Federal Regulations: The Public Health Service Act (P.L. 93-348) as implemented by the Health and Human Services Federal Regulations (Code of Federal Regulation, Chapter 45, Section 46.11 6- Protection of Human Subjects) sets forth a common federal policy for the protection of human subjects. The regulations stipulate the composition and duties of an IRB, establish standards for informed consent, provide for sanctions against institutions and individuals who violate the regulations and require more intensive scrutiny of research involving vulnerable populations (in vitro fetuses, prisoners, children and minors, persons with mental disorders, etc.). These regulations do not supersede other state and federal laws; they create additional duties for individuals involved in conducting research with human subjects.

Three human rights must be safeguarded by researchers in order to obtain informed consent: freedom from harm, respect for privacy, and voluntary participation.

• Participants have the right not to be harmed by participating in research. Thus, they have the right not to be exposed to physical, emotional, or psychological dangers without very strong justification, and even then only after agreeing to participate with fully informed consent.
• Human participants have the right to privacy, i.e., to determine how information obtained from them is used, whether it is publicly shared, etc. They therefore have a right to anonymity or confidentiality and a right to full disclosure (i.e., informed consent) regarding the study they participate in.
• Human subjects have the right to freely choose to participate or not participate in studies, to know what it is they are volunteering to participate in, and even to withdraw their participation in a study after it has begun. Again, they should be informed of such rights.

In sum, a researcher must take measures to guarantee that subjects have given their informed consent to participate. Informed consent consists of three vital elements:

1. Disclosure: The purpose, procedures, risks and benefits of the study and the invitation to ask questions and/or withdraw at any time from the research must be given to the subjects to enable them to decide whether or not to participate.
2. Comprehension: Subjects must be able to comprehend the information that is given to them, or consent must be obtained from third persons.
3. Voluntariness: Consent must be voluntarily given and free from coercion and undue influence

The Lakeland University Institutional Review Board (IRB) must review and approve all "research" involving "human subjects" that is carried out by members of the college community, their research collaborators, and other "guest" researchers seeking to conduct research on human subjects at Lakeland University. The following definitions and guidelines are provided to help you determine if your work requires IRB review and approval.

Definitions

ResearchFederal regulations define research as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge". This definition excludes instructional activities which are not designed to contribute in any way (e.g., through presentation or publication) to generalizable knowledge. Also excluded are activities related to routine course or program development/evaluation.Human SubjectFederal regulations define a human subject as "a living individual about whom an investigator (whether a professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."

In making a determination about whether an activity constitutes research involving human subjects, ask yourself the following questions:

1. Will the data collected be publicly presented or published?
AND
2. Do my research methods involve a) direct and/or indirect interaction with participants via interviews, assessments, surveys, or observations, or b) access to identifiable private information about individuals, e.g. information that is not in the public domain?

If the answer to both these questions is "yes", a project is considered research with human subjects and is subject to federal regulations. It thus requires review by the Lakeland University Institutional Review Board. The type of review required depends on the nature of the research project.

Activities That May Not Require Review by the IRB

The following activities do not typically require review because they do not satisfy the definition of "research" (i.e., the investigator answers "no" to the first question above). Most often the following activities are thought of as learning experiences only, since the information gathered will not be used as actual "data" for publication or presentation. However, information obtained via any of these activities would be considered research if it were incorporated into a publication or presentation that would be used to contribute to generalizable knowledge.

Classroom Projects

In many academic programs, knowledge of research methods/methodology is vital to a well-rounded education. Instructors may encourage their students to design small projects simply to teach them how to properly conduct research. In most cases, the data will not be used to contribute to generalizable knowledge and may not require IRB review.

Program Evaluations

Investigators may gather data from human subjects through direct or indirect interaction for purposes of program evaluation. The information they collect will not be used to contribute to generalizable knowledge, rather the results will be used to improve or develop an internal program.

Recommendations

Investigators are strongly cautioned to consider whether or not the information collected for a classroom project or program evaluation will be used to contribute to generalizable knowledge. If an investigator is unsure about how the data will be used, it is better to err on the side of caution and submit an application for review.

Even when projects do not qualify as "research", as defined by federal regulations, they must be conducted with the utmost regard for University policies, ethical standards, and the welfare of human participants.

Some projects require more scrutiny than others. To facilitate the timely review of submissions, Lakeland University reviews projects according to a three-tiered system.

1. Tier I or Expedited Review pertains to proposals being submitted to the IRB in which the methodology undeniably poses no discernible threat to the wellbeing of any subjects. Potential researchers submit a brief application (Form A). Expedited Review requires review by only 1-2 IRB members and a board decision will be made within 1-2 weeks of the submission.
2. Tier II or Intermediate Review, encompasses research projects that have at least some discernable potential for harm to a human participant. Potential researchers submit a more detailed research application (Form B). The proposal is reviewed by 3-4 board members, with a board decision within 3-4 weeks of the submission.
3. Lastly, research projects that include vulnerable populations, the use of deception or pose risks to subjects beyond those encountered in daily living, necessitate the highest level of scrutiny or Full Review (Tier III). Potential researchers submit Form B but may be required to provide additional materials/information upon request. The full review requires that all IRB members meet to review the proposal and additionally internal or external faculty and professionals may be invited to provide topical expertise as needed in the review process. Potential researchers should anticipate a board decision within 6-8 weeks of the submission.

The level of review is determined through a series of screening questions, answered by the primary research investigator and submitted to the IRB. Ultimately, the IRB will categorize the level of review as Expedited, Intermediate or Full Review, based on screening question responses and application materials.

1. If your project involves research and human subjects (see "Does My Project Require Review?"), begin by downloading and completing the Lakeland University IRB forms on this site.
   Begin with the Screening Questionnaire. The end of the questionnaire provides instructions for further form downloads.
2. Download either Proposal Application Form A or Proposal Application Form B (contingent upon your responses in the screening questionnaire). Included in your application are the following: Project Cover Sheet, Proposal Form, Required Elements of Informed Consent & Cover Letters, and an IRB Application Checklist.
   Complete the Cover Sheet and Proposal Form in their entirety. Be sure to follow all instructions and provide attached documentation where indicated.
3. Submit completed materials (Screening Questionnaire; Project Cover Sheet; Completed Application Proposal Form A or B; and a copy of instruments, surveys, informed consent documents, etc. per instructions) to: Lakeland University Institutional Review Board Committee Chairperson, Aimee Burns, Lakeland University, W3718 South Drive Plymouth, WI 53073; Phone: 920-565-1000 ext. 2362; E-mail: burnsa1@lakeland.edu. You may submit your proposal in hardcopy format through campus mail, or hand delivery to Aimee Burns. You may also submit your proposal electronically (preferred) to burnsa1@lakeland.edu. Be sure that you have included all required documents and have named your files by project title (i.e. Mental Health Court Clients_Application Form).
4. You will receive an email indicating receipt of the submission. Researchers may be asked to provide more information/clarification.
5. Following review, each proposal will either be approved as is or returned to the researcher with a written statement of concerns and recommendations.

For student researchers: In most cases, the faculty member supervising your research can answer your questions or direct them to the appropriate resource.

For faculty and staff researchers: Contact the IRB Chairperson, Aimee Burns, Lakeland University, W3718 South Drive Plymouth, WI 53073; Phone: 920-565-1000 ext. 2362; E-mail: burnsa1@lakeland.edu. Cases that pose new policy issues will require a meeting of the full IRB. In all cases, an effort will be made to answer a researcher's question(s) as quickly as possible.