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class Getting Started (Alverno Student 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.

Required Supervision

Students who wish to conduct research on human subjects may do so only under faculty supervision. Students may serve as principal investigator on a research project provided that a faculty member supervises both the development of the research proposal and the completion of the research project itself.

  • If you are a graduate student or a student completing research as a course or program requirement, a supervising faculty member will be identified in that context.
  • If you are a student who would like to complete a research project as an independent study, then your first step should be to contact faculty members in your area of interest to get mentoring.

Approval Requirement

Prior to collecting research data, students affiliated with Alverno 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 as a result of that process.

Minimal Risk Standard 

All research on which students serve as principal investigator must have no more than minimal risk. This means that you will need to understand and consider sources of risk to participants even at the earliest stages of selecting a research topic. Like all researchers, you take on two key related responsibilities that you will be required to address in writing on an IRB form that accompanies your research proposal.

  • You must articulate the sources of risks that participants may encounter as a result of participation in your research project.
  • You must design your research project to appropriately minimize risks.

Again, note that these responsibilities have immediate implications for you at the earliest moments in selecting and designing your research project.

Identifying the Appropriate Review Committee

Research Review Committees (RRCs) conduct decentralized reviews of student research that is exempt from IRB review. Each RRC represents one of the academic schools at Alverno and the corresponding disciplinary majors within that school. The decentralized reviews that the RRCs carry out are tailored to a particular educational program and its approach to developing student research skills. 

  • If you are a student conducting research in the context of the School of Nursing or School of Education, you would begin with that particular school’s RRC and it decentralized review process
  • Other requests for IRB review or for exemption from review should be submitted directly to the Alverno College IRB Administrator.

Preparing for Review

Before you request an ethical review, you will need to gain approval from your research supervisor, who often is your course instructor. In this context, you will have:

  • prepared your research proposal (including copies of any instruments and specific questions used to collect data)
  • crafted informed consent forms for participants to complete
  • developed letters that ask for any needed permission from an organization where you are collecting data. (for example, a school or hospital.)

Each of these written products is part of your initial IRB review process and you submit them along with your responses on the appropriate IRB form(s).

Selecting the Right IRB Form(s)

There are more forms than you will probably need to use. The following overview of the forms and their use should help you choose where to start, but you will also benefit from talking with the faculty member supervising your research.

Exempt Research: Student researchers will most often request an exempt review. A student researcher’s request for exemption is usually made through a decentralized review process organized by an RRC. Exemption from IRB review is either approved or not approved in this process. You will receive any approval in writing. For research to be exempt it must be both no more than minimal risk and readily fall into one or more specific categories of exempt research. In these instances, the only IRB form you will likely need to complete is the following.

This form is designed to enable you to clarify whether or not—and, more specifically, how—your study is exempt from IRB review. In this context, it is important to emphasize that determining exemption from IRB review is itself an ethical review rather than lack of review. The review process almost always includes thinking about how to minimize any risks the research has for participants. Depending on your RRC, this might also mean your selecting or revising your planned research project so that it meets the criteria for one of the exempt categories. You may want in advance to ask your faculty supervisor for some strategic assistance here as well, but you can also on your own look directly at Section IV of the General Request for Exemption Determination. Hint: categories 1, 2, and 4 are most frequently used.

Your RRC may document more specific requirements and supports in your particular educational program and major. In particular, each RRC is likely to support one or more course-based processes for writing your research proposal, which would specify the format of your proposal. If not, you would also need to complete the Alverno IRB’s Research Protocol form. In all cases, your research proposal would describe in some detail the research you plan on doing.  

Non-Exempt Research: Less frequently, student researchers may seek an Alverno IRB review for research that does not meet a specific exempt research category. Some research may be no more than minimal risk, and yet, fall outside the exemption categories, even when you consider combinations of categories that might apply to different parts of your research. Each particular RRC will have its own policy on whether or not it allows an alternative application that would cover such non-exempt research. Depending upon the RRC, a student may be eligible to complete and submit the following forms that cover non-exempt research. This alternative submission would be directly to the Alverno College IRB Administrator, but also note that Faculty supervision continues.

Continuing Review: All non-exempt research undergoes continuing review after it is approved. Continuing Review includes formal documentation of the closure of research activities on your project. In continuing review, you complete another review later. This additional review would be required after a specified period of time that could be no more than a year from the last IRB approval. The Alverno IRB may specify a shorter interval and may specify other required monitoring processes. Requirements are specified in writing. If you do not seek and receive required approval, you will be asked to cease research activities until such approval is received.

Exceptions to Full-Written Informed Consent. In some cases, for example, an anonymous survey, it may not be feasible to complete a full wrtten informed consent process where the participants sign their consent to participate in your research. You will find that these exceptions are very few and also that the extent of the exception is often limited. In the case of an anonymous survey for example, participants should still be informed in a way that they can make a decision to participate or not participate, even if you do not ask for their signature to both verify and focus the consent process. Why is there such a strong emphasis on informed consent and its documentation? The Informed consent process is the primary way you as a researcher show respect for persons. Through it, you give potential participants an informed opportunity to voluntarily choose to participate or not participate in your research. Here is the form to use to request an exception.

Making a Successful Submission

Once you have selected the right basic form, which is either the General Request for Exemption Determination or the New Study Application for Review, you will find it provides information that organizes your submission process. Here is some general advice:

  • When you download a form, review the Common Mistakes statement next to it.
  • Answer the questions in the order they are given.
  • Read the full text of the form as you complete it.
  • Put extra attention to the drafting of your consent form.
  • Check to see that all components of your submission are included. These are specified in the instructions for the form and are a substantial part of your preparation to do research.
  • Follow any additional procedures specified by your RRC and your faculty supervisor.
  • Finish your submission as early as possible so you have time to make adjustments based on feedback.

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.
ANONYMOUS: A research condition in which no one, including the researcher, knows the identities of research participants.
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.
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].
ANONYMOUS: A research condition in which no one, including the researcher, knows the identities of research participants.
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.
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)]
RRC (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}.
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.
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]
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.
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}
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)]
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]
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)]
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)]
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.
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