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Getting Started (Alverno Educator Researchers)

Some terms used in this guide to getting started have specialized meanings that are grounded in federal 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.

An Alverno ethical review is a collaborative process and the IRB encourages you to contact an Alverno IRB member or Alverno certified IRB reviewer in your preliminary deliberations. This person can save you time by guiding you toward the most fruitful process, including assisting you in determining whether your inquiry falls under the federal definition of research or in selecting and completing appropriate IRB forms.

Required Approval by Alverno IRB

Prior to collecting research data, Principal Investigators must (1) submit their proposal to conduct research on human subjects to an ethical review process approved by the Alverno College IRB and (2) receive written approval in that process. This extends to research beyond Alverno, though documentation of another IRB's approval suffices under some circumstances. Also, all human subjects research located on Alverno premises must be approved either directly by the Alverno IRB or by a process of decentralized review it has explicitly sanctioned. In this context, it is important to understand what does and does not fall under the federal policy definition of research on human subjects. Alverno faculty and staff frequently have an even more specific need to determine what is or is not research in relation to their work as educators.

But is my Educational Study Defined as Regulated Research?

Most educationally-related inquiry conducted by educators at Alverno fall outside the federally regulated formal definition of research on human subjects. The Alverno IRB categorically does not require either an IRB review or a request for exemption for review before an educator proceeds with the following kinds of inquiries:

  • inquiry primarily intended to benefit the very individuals who are the focus of the inquiry
  • activities confined to the classroom that teach research methods or simulate research activities

The Alverno IRB also generally does not require either an IRB review or a request for exemption for review before an Alverno educator proceeds with the following kinds of inquiries:

  • improvement-oriented or accountability-oriented inquiry in the college
  • collection of data to support improvement of one’s own classroom instruction
  • collection of data to merely illustrate, as an educational consultant to other institutions, Alverno specific educational practices and outcomes

However, when there is intent to publish in an academic journal or present at an academic meeting, then additional questions are generally warranted to determine whether the three kinds of educational inquiries noted immediately above are research:

  • First, was this project conducted as a systematic investigation?
  • Second, was the primary goal to develop or contribute to generalizable knowledge? (For example, generalizing specific findings beyond the college.)

If the answer to both of the questions immediately above is "yes," then the educational project, or any other inquiry involving human subjects, is likely to be research according to the relevant federal policy. Moreover, there is another caveat. If an inquiry is denoted as "research" in a publication, it is by federal regulation presumptively research.

Although less often relevant to educational research, what counts as research is further limited by the federal policy definition of human subjects. Decision Chart 1 summarizes—as a flow diagram—what is and is not federally regulated human subjects research.

But, isn’t my "Educational Research" Integral to My Role as an Educator? Is that Federally Regulated?

The Alverno IRB acknowledges and accommodates to the expansive role of the Alverno College educator. The college’s commitment to encouraging a scholarship of teaching, learning, and assessment makes it especially likely that educational research will be integral to a faculty member’s role as curriculum developer and reflective teacher. Moreover, others in the college also have parallel educational roles. Instructors, administrators, and student services/academic staff often fulfill individual or collective educational purposes where research may be integral to their role as an educator in the college.

These considerations about Alverno’s practice guide the Alverno IRB’s policy. On the one hand, federal regulations require that any activity that includes a research component must be reviewed. On the other, for research that meets specific federally-defined exempt requirements, the Alverno IRB is allowed by federal regulations to develop a decentralized review process in accordance with the broad framework of the Belmont Report rather than following the otherwise more specifically detailed federal constraints for non-exempt research. One federal exemption from a direct and centralized IRB review applies to educational research.

In this context, the Alverno IRB has created a streamlined decentralized review process for exempt educational research. This provides the Alverno educator with a process that is flexibly geared to how educational research often emerges out of teaching, assessment, and curriculum development. Although much of the educational inquiry at Alverno might not meet the formal definition of research, as more specifically described above, it may nonetheless be advisable for an Alverno educator to complete an IRB process when there is a chance that an inquiry might later become research.

Selecting the Right IRB Form(s)

Path 1, Distinctly Alverno Educational Research: Alverno educators will often be able to complete the:

This form is designed to enable you to clarify whether your study is exempt educational research that can be afforded allowances available within the collaborative culture of care and respect that underlies Alverno’s educational mission. It is important to emphasize that determining exemption from IRB review is itself a decentralized ethical review rather than lack of a review. Determination of exemption is a status that either is approved or is not approved in writing before research begins.

The following six criteria determine whether the form can be used:

  • The principal investigator is a member of the Alverno College faculty or academic staff
  • All investigators are affiliated with Alverno College
  • All collected data are from members of the Alverno College community
  • No approval beyond Alverno is required (for example by another institution’s IRB)
  • The research is not federally funded
  • The research is educational research, free of deception, and entails no more than minimal risk
  • Any private information recorded would fit one or more of the following exceptions:
    • be already available to the investigator in his or her educational, administrative, or internal evaluation role outside of the research context
    • be collected anonymously (see Appendix B)
    • be without significant potential for embarrassment or sensitivity if disclosed more widely (e.g., political affiliation or perceptions of family members might be sensitive for some)

As part of the streamlined review, an Alverno IRB certified reviewer may require that you also complete the Research Protocol form that describes the purposes and methods of inquiry or may allow an alternative oral description of the research protocol, which is more appropriate when the research poses no additional risks to participants beyond those inherent in their Alverno affiliated roles.  

Path 2, Other Exempt Research: Another set of forms you might use would be:

The General Request for Exemption Determination form supports a determination of meeting one or more exemption categories, including an exemption for educational research that is not eligible for the streamlined review described above. Pursuing the path of an exemption from IRB review is not always the best or even the easiest path: even when a legitimate case can be made that an exemption applies to your research. If an exemption is likely, however, the researcher gains one potential pragmatic advantage. If you receive an exemption determination, it is then very likely that the study will not need to undergo a continuing review by the IRB. The General Request for Exemption Determination, like all of the forms, is intended to enable you to independently think through the relevant concerns and to understand why the questions are being asked. However, you may also avail yourself of a collaborative approach encouraged by the Alverno IRB so that you can more quickly gain insight into charting a likely path through the regulatory language and requirements of the exemption categories. Completion of the Research Protocol is a required accompanying document for an Alverno educator’s General Request for Exemption Determination. In some instances, you may be able to submit your request for an exemption determination to the chair of an appropriate Alverno Research Review Committee (RRC) for decentralized review.

Path 3, Non-Exempt Research: For research to be exempt—as in Paths 1 and 2 above—it must meet specific defined categories of research that are also no more than minimal risk. However, some research that is no more than minimal risk may fall outside of these categories, and so not be exempt. Other research may not be exempt because it legitimately entails 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. It is quite possible that the researcher would find it easier to pursue an expedited review even when there is a reasonable chance that his or her research might fit one of the exempt categories covered by General Request for Exemption Determination form. The researcher may request a full board review or the IRB Chair may 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, but also because of the type of research that has been generally conducted at Alverno, full board reviews are expected to be relatively infrequent. Again, we encourage researchers to collaboratively consult with the Alverno IRB prior to completing a submission no matter what kind of review is requested.

Continuing Review: All non-exempt research undergoes continuing review after it is approved. Continuing review includes formal documentation of the closure of research activities. In continuing review, you complete another review later. By Federal Policy, this additional review must be completed within no more than a year subsequent to the last IRB approval.

Specialized Forms

Federal regulations detail specific requirements for informed consent in human subjects research. Whether you are using Paths 1, 2, or 3 above, you need to attend to the specific requirements for informed consent that are detailed in Appendix A of each form. 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 your research. The Streamlined Alverno Educator Request for Educational Research Exemption, however, is able to offer some greater flexibility in how this principle of respect for persons may be met within the specialized context of educational research that is integral to teaching, learning, and assessment here at Alverno. The Student Handbook (PDF) describes related college policies on "Student Participation in Educational Research and Privacy" and on "Student Records and the Family Right, and Privacy Act (FERPA)."

Although exceptions to full written informed consent are more limited in Paths 2 and 3 above, federal regulations make specific provisions for special circumstances where provision of informed consent may be inherently impractical or where its written documentation may create additional risks. A common example where full written informed consent would not generally be appropriate is in an anonymous survey. Requiring documentation of written consent might create a potential linkage to the participants responses and so entail risks that might otherwise be avoided. At the same time, note that participants completing an anonymous survey should 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 the consent process.

Bulleted below is the form to use when you believe informed consent or its documentation should be waived or altered. This information and 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. We note that extending these federal regulations to the general exempt review serves to create a more uniform regulatory environment, particularly as this is the standard approach taken by IRBs and other research review bodies at other institutions.


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)]
INSTITUTION: (1) Any public or private entity or agency (including federal, state, and local agencies). [Federal Policy 45 CFR 46.102(b)]
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 biomedicalor behavioral research. [Federal Policy 45 CFR 46.102(g), &.108, &.109]
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]
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.
ANONYMITY: A research condition in which no one, including the researcher, knows the identities of research participants.
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.
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]
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." (See also: 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.

The definition of minimal risk for research involving prisoners differs somewhat from that given for non institutionalized adults. [See: 45 CFR 46.303(d)]
RESEARCH REVIEW COMMITTEE: A standing committee at Alverno delegated by the Alverno IRB to conduct determinations of exemption of research from IRB review. When located within a School at Alverno (e.g., School of Nursing), the Committee also ensures that student research conforms to the School’s educational policy for protecting human subjects. {Alverno}
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.
PROTOCOL: The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
ANONYMITY: A research condition in which no one, including the researcher, knows the identities of research participants.
PRIVATE INFORMATION: Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Also includes information provided for specific purposes by an individual and which the individual can reasonably expect will not be made public [Federal Policy 45 CFR 46.102(f)(2)].
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.

The definition of minimal risk for research involving prisoners differs somewhat from that given for non institutionalized adults. [See: 45 CFR 46.303(d)]

DECEPTION: Intentionally leading participants to have false beliefs about the study’s purpose and/or the situational context in which they are responding. Deception would only be used when the researcher believes that participant knowledge about the study would alter participants’ behavior or responses in the study in such a way as to undermine the goals of the research. Thus, deception creates conditions that can lead to invasion of privacy. Intentionally withholding information about a study’s purpose is closely related to deception in that both generally limit the capacity of the participant to give full informed consent. Any use of deception or withholding of information would be both explicitly justified and determined necessary in the context of an IRB review process. Participants would be debriefed as soon as it is feasible.

PRINCIPAL INVESTIGATOR: The scientist or scholar with primary responsibility for the design and conduct of a research project.
DECENTRALIZED REVIEW: A formal process for determination of exemption from IRB review that the Alverno IRB has explicitly delegated to a particular individual or Research Review Committee.
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)]
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.
DECENTRALIZED REVIEW: A formal process for determination of exemption from IRB review that the Alverno IRB has explicitly delegated to a particular individual or Research Review Committee.
BELMONT REPORT: A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.
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.
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)]. {as OHRP} Note: the IRB only holds jurisdiction over Human Subjects Research.
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.
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)]
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)]. {as OHRP} Note: the IRB only holds jurisdiction over Human Subjects Research.
FEDERAL POLICY (THE): The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Currently, sixteen federal agencies have adopted the Federal Policy. (Also known as the "Common Rule")
DECENTRALIZED REVIEW: A formal process for determination of exemption from IRB review that the Alverno IRB has explicitly delegated to a particular individual or Research Review Committee.
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]
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)]
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)]. {as OHRP} Note: the IRB only holds jurisdiction over Human Subjects Research.
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