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Alverno Educator Researchers

Getting Started

Some terms used in this guide to getting started have specialized meanings that are grounded in federal regulations. These terms carry significant weight and an asterisk indicates that their definitions appear at the bottom of the page. Definitions are also found 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.

Which Forms do I use and to Whom do I Submit These?

You are encouraged to contact the IRB Administrator for guidance on which of the three paths below would work best for your proposed research.

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

    • Submit to an IRB Direct-Certified Reviewer

This form is designed to enable you to clarify whether your study is exempt educational research that can be afforded those allowances that 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 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
  • 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 minimal risk exemption categories, which includes an exemption for educational research that is not otherwise eligible for the streamlined review described above. 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.

In some instances, which do not include a request to waive or alter informed consent, Nursing faculty may be able to submit your request for an exemption determination to the chair of the School of Nursing Research Review Committee (SON-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. 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 usually take longer to complete because it involves preparation for and convening of a meeting of the full Institutional Review Board.

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. 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.

 

*Definitions

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. Continuing review addresses, among other things, risks, potential benefits, informed consent, and safeguards for human subjects.

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.

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.

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.

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

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.

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. (Also see Decision Chart)

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