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in labGetting Started with Alverno IRB Approval (Researchers External to Alverno)

After receiving Alverno Institutional Approval, external researchers then need to officially submit a request for Alverno IRB approval for human subjects research. The Alverno IRB has jurisdiction as the local IRB for all human subjects research conducted on Alverno premises or on an identified population of Alverno faculty, students, and/or staff.

Many of the terms used in this guide to getting started have specialized meanings that are grounded in federal policy regulations. These terms carry significant weight. When technical terms are in red, their definition pops up when you hover over them, as well as being accessible in the Glossary. A principal investigator needs to make sure he or she has a firm grasp of the meaning of these terms.

  • "Research" is defined in federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [45 CFR 46.102(d)].
  • There is an additional caveat. When an inquiry is denoted as “research” in a publication, it is presumptively research according to federal regulation guidelines.
  • Decision Chart 1 summarizes—as a flow diagram—what is and is not federally regulated human subjects research.

The Alverno IRB encourages principal investigators to contact the Alverno IRB Administrator in a preliminary discussion before making an official submission to the Alverno IRB.

Required Approval by Alverno IRB

Before a principal investigator who is external to Alverno can begin any human subjects research on Alverno College’s premises or on a population affiliated with Alverno College, the research must be approved in writing by the Alverno IRB. This includes research already approved (or determined to be exempt) by another IRB at another institution, as well as research that has gained required Alverno institutional approval.

Selecting the Right IRB Form(s)

Whether requesting a determination of exemption from an Alverno IRB review or making an application for an IRB review, an external principal investigator should complete and submit the Research Protocolform along with the other appropriate form(s).

Exempt Research:

For research to be exempt, it must meet specific defined categories for exempt research and be no more than minimal risk. The General Request for Exemption Determinationform supports the Alverno IRB’s determination of whether or not the research fits one or more exemption categories. For researchers external to Alverno, a request for exemption determination always goes directly to the Alverno IRB. Although Alverno institutional approval is required before the Alverno IRB will formally review and make a determination on your submission, you are encouraged to contact the Alverno IRB about your intent to make a submission. The Alverno IRB encourages a collaborative submission process.

Non-Exempt Research: Some research that is no more than minimal risk may fall outside of the categories for exempt research or may legitimately entail greater risks to participants than the minimal risk standard.

New Study Application: When newly proposed research is not exempt, the principal investigator must complete and submit the following forms directly to the Alverno College IRB Administrator:

These forms cover requests for either expedited or full IRB review. In this regard, the researcher would specifically request an expedited review in Section VIII of the New Study Application for IRB Review form. The researcher may request, by not completing this section, a full board review. The IRB Chair may also determine that a full review is required. A full board review would generally be expected to take somewhat longer to complete because it involves preparation for and convening of a meeting of the full Institutional Review Board. Timing of a submission in relation to an already scheduled meeting could be a consideration. Again, we encourage researchers to first consult with the Alverno IRB prior to completing a formal submission no matter what kind of review or determination is requested.

Continuing Review: All non-exempt research undergoes continuing review after it is approved. In continuing review, the principal investigator is obligated to formally request another Alverno IRB review after the initial (or last continuing) Alverno IRB approval. This review must be completed within no more than a year of the previous Alverno IRB approval. Written approval that the principal investigator receives from the Alverno IRB may specify a shorter interval and may specify other required monitoring processes. Continuing review includes determining and documenting the closure of a research project.

Specialized Forms

Federal regulations detail specific requirements for informed consent in human subjects research. Following these regulations, Appendix A in both the General Request for Exemption Determination and the New Study Application forms articulate required components of informed consent. There are relatively few exceptions to obtaining written informed consent because one of the primary ways researchers distinctly fulfill the principle of respect for persons is by giving potential participants an informed opportunity to voluntarily choose to participate or not participate in their research.

A common example where full written informed consent would not generally be appropriate is in an anonymous survey.  In this case, requiring documentation of written consent might link a participant's responses with their identity, and so, incur risks that might otherwise be avoidable. At the same time, note that participants completing an anonymous survey should often still be informed about the study in a way that they can make an appropriate decision about whether or not to participate, even if they are not required to sign a consent form that both verifies and focuses a consent process.

Bulleted below is the form to use when the principal investigator believes informed consent or its documentation should be waived or altered. This information and the determinations collected through this form are required by federal regulations for any research requiring IRB review and is also required by the Alverno IRB in the context of the General Request for Exemption Determination.



REVIEW (OF RESEARCH): The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis. [Federal Policy 45 CFR 46.108(e)]
SURVEYS: Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
RISK: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk."
PARTICIPANTS: An alternate and equivalent term for "human subjects" used to express respect for the voluntary nature of their participation in research. In context, use of the term is locally understood at Alverno to mean the same thing as "human subjects," but is not a term used in federal regulation and so is less precise when not supported sufficiently by context.
ANONYMITY: A research condition in which no one, including the researcher, knows the identities of research participants.
VOLUNTARY: Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.
PARTICIPANTS: An alternate and equivalent term for "human subjects" used to express respect for the voluntary nature of their participation in research. In context, use of the term is locally understood at Alverno to mean the same thing as "human subjects," but is not a term used in federal regulation and so is less precise when not supported sufficiently by context.
RESPECT FOR PERSONS: An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
INFORMED CONSENT: A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy 116; 21 CFR 50.20 and 50.25].
CONTINUING REVIEW: An IRB review of a study that occurs within no more than a year of the previous or initial RB approval. May also include explicitly specified continuous monitoring procedures. All research, except for exempt research, is necessarily subject to continuing review. Continuing review address, among other things, risks, potential benefits, informed consent, and safeguards for human subjects. In particular, the review addresses whether any new information has emerged that could alter the IRB’s previous determinations, especially with respect to risk to subjects. [adapted from OHRP guidance 1/17/09 on continuing review]
FULL BOARD REVIEW: Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting. [Federal Policy 45 CFR 46.108]
EXPEDITED REVIEW: Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. [Federal Policy 45 CFR 46.110]
MINIMAL RISK: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [Federal Policy 45 CFR 46.102(i)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
RISK: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk."
MINIMAL RISK: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [Federal Policy 45 CFR 46.102(i)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
EXEMPT RESEARCH: Research determined through an IRB sanctioned request for exemption to fit within specific categories of minimal risk research that are articulated in federal regulations. Once a research study is determined to be exempt, data collection may begin, which is why it is said to be exempt from IRB review.
EXEMPT RESEARCH: Research determined through an IRB sanctioned request for exemption to fit within specific categories of minimal risk research that are articulated in federal regulations. Once a research study is determined to be exempt, data collection may begin, which is why it is said to be exempt from IRB review.
EXEMPT RESEARCH: Research determined through an IRB sanctioned request for exemption to fit within specific categories of minimal risk research that are articulated in federal regulations. Once a research study is determined to be exempt, data collection may begin, which is why it is said to be exempt from IRB review.
IRB (INSTITUTIONAL REVIEW BOARD): A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. [Federal Policy 45 CFR 46.102(g), &.108, &.109]
RESEARCH: A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [Federal Policy 45 CFR 46.102(d)]. Note: the IRB only holds jurisdiction over Human Subjects Research.
HUMAN SUBJECTS: Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. [Federal Policy 45 CFR 46.102(f)]
PRINCIPAL INVESTIGATOR: The scientist or scholar with primary responsibility for the design and conduct of a research project.
PRINCIPAL INVESTIGATOR: The scientist or scholar with primary responsibility for the design and conduct of a research project.
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