Guidelines for classifying research proposals to the Institutional Review Board at Colgate University.
1. Determine if Project Is Defined as “Research”
“But who is to determine whether a planned project will be 'research' by this definition?”
- Many student projects that bear a superficial resemblance to research and that might even go by the name “research” at Colgate do not qualify as research projects by the federal definition. For example, students in an introductory sociology course might be asked to administer questionnaires or conduct brief interviews using other students as participants, not with the intention of contributing to generalizable knowledge but to teach the student interviewers about how to conduct sociological research.
In such cases, course instructors (but not students) may decide on their own that the planned activities do not constitute research under the federal definition and need not submit applications. Alternatively, they may have their students submit applications to the IRB on an expedited basis, provided that the participants will be legal adults capable of giving informed consent and that the experiments present no more than minimal risk to the participants. In New York, a legal adult is a person at least 18 years of age. Minimal risk means that “the probability and magnitude of harm or discomfort anticipated in the 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.” [45 CFR 46.102(i)]
In general, an instructor at Colgate should consider a project to be research if the instructor or the student intends to publish the results in some way (in a public presentation or a paper submitted to a journal, on the web, etc). If the instructor or the student decides while conducting the investigation that it would be a good idea to make the results known to a wider audience, he or she should at that point seek IRB review.
If an instructor is not certain whether a planned activity constitutes research, they should contact the IRB chair to discuss this question.
- Course projects that will involve persons under age 18 as participants must be submitted in advance to the IRB. Instructors should give especially careful scrutiny to student projects that will involve participants who may be particularly susceptible to coercion, e.g., prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. In these cases, it may be advisable to submit the project in advance to the IRB.
- Even if a planned student project is clearly not research by the federal definition, it is always OK for the instructor to require that students submit IRB applications in order to teach them about the ethical treatment of human participants and the workings of a review committee such as the IRB. Under such circumstances, the instructor should consult with the IRB chair in advance so as to not swamp the committee with proposals unexpectedly.
The federal regulations define research as “a systematic investigation… designed to develop or contribute to generalizable knowledge” Course assignments that mimic research but are intended to teach students the basics of systematic investigation (e.g., an assignment that each student interview another student on campus or administer a short questionnaire) do not ordinarily count as research. However, many student independent research projects probably do count as research. Administrative data-gathering (e.g., a survey of student use of the library to aid in library planning) is not research if the information will be used by the university but is not intended to contribute to generalizable knowledge. Most faculty research involving human participants and some administrative research qualify as research under the above definition.
2. Determine if Project Is Defined as ExemptFederal and state policy allow the Institutional Review Board to exempt certain projects from review. The description of exempt research is given below. It is taken from the Code of Federal Regulations Title 45, Part 46.
Research conducted in established or commonly accepted education settings, involving normal educational practices, such as:
- research on regular and special education strategies, or;
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- information obtained is recorded in such a manner that human participants can be identified, and;
- any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation.
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.
Request an Exemption
If you think the Review Board might decide your project is exempt from review, please submit your request to firstname.lastname@example.org.
The request should include:
- a project title
- a description of the research
- the methodology to be used
- the participant population
- the data to be collected
- the name of your faculty supervisor (if applicable)
- explicitly state which of the three exemptions above apply to your research
3. Determine if Project Should Be Submitted for Expedited or Full Review
Expedited reviews are conducted on a rolling basis by one or several board members and are typically processed quickly. Proposals may be submitted for expedited review if they pose no more than minimal risk to participants, or involve only minor changes from previously approved research. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the 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.
The following is a list of the four most common (of 10) that are defined as minimal risk by the Department of Health and Human Services (HHS). Note that some of these descriptions might also pertain to exempt research.
- Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate participants’ behavior and the research will not involve stress to the participants.
- The study of existing data, documents, records, pathological specimens or diagnostic specimens.
- Voice recordings made for research purposes such as investigations of speech defects.
- Moderate exercise by healthy volunteers.
If a project does not qualify as exempt or expedited, then it requires a full review. If you are uncertain about the appropriate category, please contact the IRB chair for guidance.
Full reviews occur once per semester when the IRB convenes. All new proposals that involve deception or greater than minimal risk are required to undergo full review.