As mandated by federal regulations, Lakeland University has established a procedure and committee to review in advance proposals for research that will involve human subjects. The purpose of the review is to assure that the rights of human participants will be protected.
The Institutional Review Board at Lakeland University consists of seven members: A social science faculty representative; natural science faculty representative; non-science discipline representative; non-Lakeland representative; two faculty-at-large representatives; and a Lakeland institutional representative appointed by the President.
Questions concerning research and review may be addressed to the Committee Chairperson, Aimee Burns, Lakeland University, W3718 South Drive Plymouth, WI 53073-4878; Phone: 920-565-1000 ext. 2362; E-mail: email@example.com
Why is an IRB Necessary
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.
Which rights need protection?
Three human rights must be safeguarded by researchers in order to obtain informed consent: freedom from harm, respect for privacy, and voluntary participation.
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:
Does my project need to be reviewed?
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.
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:
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.
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.
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.
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.
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.
Levels of Review
Some projects require more scrutiny than others. To facilitate the timely review of submissions, Lakeland University reviews projects according to a three-tiered system.
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.
How do I get started
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: firstname.lastname@example.org. 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.