Guidelines for Using Human Subjects in Research
Do I Need To Submit A Form To The Institutional Review Board (IRB)?
The IRB reviews research with human participants.
Not all activities that gather information from humans are considered research—such activities are excluded from IRB review. In addition, some types of research may be exempt from review. So some activities that gather information from human participants do not require IRB review, and you do not need to submit any forms (although you may always choose to do so if you wish, to make sure your work meets the usual standards for research with human participants). While the IRB and the institution think that most activities that gather information from people should be guided by similar principles, not all such activities come under IRB purview.
In making an initial decision about whether the activity you are pursuing is research with human participants that falls under IRB purview, you might begin by using the following guideline:
Consider the following two questions:
1. Is the activity you are planning a systematic investigation that gathers information about/from living human participants?
(This means that the activity is not informal, but uses procedures commonly recognized as research techniques by one’s discipline.)
2. Is the activity you are planning intended or designed to develop or contribute to generalizable knowledge?
(This means that the activity is intended to provide data and/or conclusions that generalize beyond a particular place, person, or setting. That is, the activity does not simply document a specific person’s life, or an event, as in most instances of oral history or journalism.)
|If the answer to one or both of the above questions is NO:||If the answer to both of the above questions is YES:|
|then your activity is not research with human participants, and is thus not subject to IRB review, UNLESS:
It is a class-linked activity that models or employs research techniques (systematic and formal methods normally considered research in a discipline) in the collection of data from participants not enrolled in the course, which in other circumstances could contribute to generalizable knowledge. Examples of this type of activity might be projects or exercises in research methods or laboratory courses in departments such as Sociology and Anthropology, Education, Psychology, etc. If you are planning such activities, you should proceed to the information on Category I, II, and III research to decide which type of proposal to submit. You may also find further discussion of this issue in the ‘Class Research and Laboratory Projects that Gather Data from Participants Outside of the Course’ section.
If your activity is not research by the above criteria, then you do not need to submit a proposal to the IRB. We describe some examples commonly encountered here at DePauw that do not constitute research and do not require review in the section ‘Specific Examples of Activities Not Requiring IRB Review’.
|then your activity is research with human participants, and generally requires IRB review. The exception at DePauw concerns research on the effectiveness of educational techniques. Even if your planned activity is research with human participants, it may be exempt from IRB review if it falls under the following:
RESEARCH ON EDUCATIONAL PRACTICES AND PROGRAMS
If the research you plan to conduct examines the effectiveness of educational practices, techniques, or programs, even in settings that include minors as ‘participants,’ it does not require IRB review, as long as the research examines educational practices or strategies that take place in commonly accepted educational settings and involve normal educational practices (regular or special education). Thus research on the effectiveness of instructional programs or techniques (e.g., strategies, assignments, computer exercises, content units, etc.) does not require IRB review.
Otherwise, the research requires IRB review, and you should proceed to the information on Category I, II, and III reviews to decide which type of proposal to submit.
SPECIFIC EXAMPLES OF ACTIVITIES NOT REQUIRING IRB REVIEW
Some categories of activities that do not require IRB review occur frequently enough that it is possible to identify and list them. We provide such a listing below. You should recognize, however, that the general guidelines above can always be used to establish whether your planned activity requires review. In addition, you should recognize that there are many ambiguous situations, and you should feel free to contact the IRB to discuss whether you should submit a proposal.
The following categories of activities are not research that falls under IRB purview, and do not require IRB review.
Information gathered during the normal course of student teaching, supervised teaching experiences, supervised volunteer reading/teaching work, etc., and activities that assess teaching/or educational program effectiveness (e.g., student evaluations) are exempt, even when such activities involve participants under 18 years of age.
CLINICAL/EDUCATIONAL INTERNSHIPS AND PRACTICE
Activities that gather information from human participants during the normal course of supervised clinical/educational practice or training are exempt, even when the work involves protected categories of participants, if the activity is part of a standard, recognized therapeutic/educational program. If the work involves experimental procedures, or is part of an ongoing research program, then such activity requires IRB review, either from DePauw or the sponsoring organization/institution.
Gathering data for purposes of institutional assessment does not generally require IRB review or approval, because such activities generally serve to assess and document matters specific to the university, rather than contributing to generalizable knowledge. As such, institutional assessment is usually not research of the type that requires IRB review.
JOURNALS AND INFORMAL REFLECTIONS
Activities that gather information from people through informal means (e.g., non-systematic conversations, encounters) that may be documented in a personal journal, written reflection, small group discussions, or that might provide information used in works of fiction, are not research and do not require IRB review. For example, many course or Winter Term activities may require students to maintain a journal in which they may describe information gathered from people they encounter. Such activities will not ordinarily fall under the purview of the IRB. These activities do require IRB review if they are systematic and intended to contribute to generalizable knowledge.
CLASS DEMONSTRATIONS AND LABORATORY EXERCISES (Using students enrolled in a class)
In-class demonstrations, lab exercises, or other non-invasive (i.e., not involving collection of physiological samples beyond pin-prick methods) collection of information from students who are enrolled in the DePauw University class for which the activity is a part, pose only minimal risk as defined by the federal guidelines, and that are conducted for demonstration purposes, rather than for the purpose of developing or contributing to a knowledge base, are exempt from IRB review. That is, an activity is exempt if it simply demonstrates a phenomenon, and is not a systematic investigation intended or designed to contribute to generalizable knowledge. So any class activity using techniques normally considered research, or that models research, gathers information from students enrolled in the course and does not pose more than minimal risk, does not require IRB review, unless it is a project (or part of a larger project or research program) intended to produce generalizable knowledge.
CLASS DEMONSTRATIONS (using participants not enrolled in the course)
Educational activities that gather information from participants who are not students in the class, even from children below 18 years of age (or other protected groups) for demonstration purposes and/or educational training of teachers are exempt from IRB review if they involve only standard educational/developmental demonstrations or assessments (e.g., Piagetian stages, infant behavior, etc.) that do not provide information that might be used to categorize and/or diagnose children or other participants in a way that might adversely impact them (e.g., IQ tests, measures of behavior problems, measures of social functioning). An example of such an activity might be having a toddler visit class and demonstrating a Piagetian conservation task, or having an adult attend a class session to be asked questions by students, or otherwise provide information. These kinds of class activities are not research that requires IRB review unless they are designed or intended to gather information that contributes to generalizable knowledge.
INFORMATION GATHERED INFORMALLY FOR CLASS DISCUSSION
Class-linked activities that gather information from people outside of a class purely for the purposes of providing material for class discussion, reflection, demonstration, or illustration, or as background information for creative writing, theater, or other projects, are not research and do not require IRB review, even if the activity gathers information from people under 18 years of age (or other protected category) so long as the work meets the federal definition of minimal risk. This type of activity (e.g., informal questioning of students, parents, asking other faculty for views, etc.) is not research so long as it does not systematically gather information that is intended to contribute to generalizable knowledge.
Most activities considered journalism (e.g., investigations and interviews that focus on specific events, views, etc., and that lead to newspaper/news publication, documentary production, or are part of training that is explicitly linked to journalism) are not research, and do not require IRB review. When journalists conduct activities normally considered scientific research intended to produce generalizable knowledge (e.g., systematic research, surveys, and/or interviews that are intended to test theories or develop models), some of these activities may be subject to IRB review. In such cases investigators should consult with the IRB.
Oral histories that describe or document particular lives or historical events are exempt from IRB review. Oral histories and similar investigations that are intended to produce generalizable conclusions (e.g., that serve as data collection intended to test economic, sociological, or anthropological models/theories) do require IRB review.
IRB POLICY ON CLASS RESEARCH AND LABORATORY PROJECTS THAT GATHER DATA FROM PARTICIPANTS OUTSIDE OF THE COURSE
In some courses, students conduct activities that are explicitly intended or designed to contribute to generalizable knowledge. These activities are, of course, research and require IRB review and approval.
In many Research Methods or laboratory courses, however, students routinely conduct projects not intended to contribute to generalizable knowledge, but that employ research techniques (systematic and formal methods normally considered research in a discipline) in the collection of data from participants not enrolled in the course, which in other circumstances could contribute to generalizable knowledge. Because such participants have not enrolled in a course where there is a reasonable (or explicit) expectation that they will participate in research, DePauw University views research with such participants as it would any other type of human research. These research activities thus require IRB review and approval.
The IRB also wishes to recognize the value of such pedagogical techniques, and does not wish to impose unnecessary impediments to their use. We wish to facilitate the use of these active learning experiences that involve research training, while balancing the need to protect participants. We also note that that in a small campus and a small local community, it is important to future researchers that we help ensure positive experiences between DePauw student and faculty researchers and participants in order to maintain a participant pool that is not averse to taking part in studies.
To balance these concerns, we have tried to streamline a procedure for faculty to minimize unnecessary effort while safeguarding participants’ experiences. To this end, in courses that gather information from human participants not enrolled in the class in a way that models or teaches research, a professor may submit individual IRB proposals for projects in courses, or a single proposal describing multiple projects that will occur in a semester, along with the names of students enrolled in the course. Once these activities have been reviewed and received approval, in future semesters the professor may simply submit a brief memo to the IRB that the (unchanged) projects will be performed in the current semester, along with the names of current students. Unless the projects have been changed in a substantive way (changes that substantially modify the nature of the project and/or the experience of participants; that is, changes beyond modifying the order of items in a questionnaire, omitting items, switching from computer to paper-based presentation, changing the device used to record observed behavior, etc.), the projects do not require further review.
Which Form Should I Submit?
The IRB has two forms. One is for Category I Research, and the other form is for both Categories II and III (Expedited and Full Review Research, respectively). To decide which form to submit to you should first decide whether your proposal falls under Category I, II, or III.
Category I research involves no more than everyday stress, minimal risk, most field observations, and the study of existing data. [If participants can be identified, the research must receive an expedited review or full review as described below.] You should use the Category I form if all of the following are true. Your research:
Does not involve a special or protected population (e.g., participants under 18 years of age, prisoners, in/outpatients, mentally/physically disabled, pregnant women)
Does not involve deception (beyond not informing subjects about every aspect of this study and hypotheses)
Poses no reasonably foreseeable physical risks to participants
Poses no reasonably foreseeable stress or discomforts to participants (beyond everyday levels)
Does not involve private records (e.g., medical and/educational data linked to names)
Does not probe for sensitive personal information (including disease/disorder/disability status)
Obtains informed consent from participants (if all other conditions are met there may be cases-field studies, for example-when informed consent is not required; the Category I form asks for an explanation/justification in such cases)
Does not present offensive, threatening, or degrading material
Preserves confidentiality of participants
Debriefs participants (there may be exceptional circumstances--field studies--where debriefing is not feasible; the Category I form will asks for an explanation/justification in such cases)
Faculty and students whose research meets the above criteria should fill out the Category I Research Form here. Please note that once the form has been submitted it will be sent to the academic supervisor who must review it and endorse it before the Committee will review it. One or more members of the IRB will review the proposal and respond, generally within 10 working days.
Category I research requires approval, so you may not begin data collection until you have received notification of approval from the IRB reviewer(s).
Category II (Expedited Review Research) and Category III (Full Review Research)
If your research does not fall under Category I, it falls under either Category II or Category III. Both categories require the Category II/III Form here. On the Category II/III form you will need to designate into which category your research falls.
The primary difference between Categories II and III is the level of stress, discomfort, deception, etc., involved, and the characteristics of your participants. Check the Category II space on the online form if your research:
Does not involve special or protected populations (e.g., participants under 18 years of age, prisoners, in/outpatients, mentally/physically disabled, pregnant women), and
Involves only minimal risk, minimal discomfort, moderate stress, etc.
Complete the online form and include any additional information that is required or requested. Please note that once the form has been submitted it will be sent to the academic supervisor who must review it and endorse it before the Committee will review it. Two or more members of the IRB will review the proposal and respond, generally within two (working) weeks.
Because Category II research requires approval you may not begin data collection until you have received notification of approval from the IRB reviewers.
If your proposed research involves:
More than minimal risk, minimal discomfort, moderate stress, etc., or
Involves special or protected populations (participants under 18 years of age, prisoners, in/outpatients, mentally/physically disabled, pregnant women)
then the research falls under Category III, and you should check that space on the form. Complete the online form and attach any required or requested information. The full committee will review the proposal and respond, generally within three (working) weeks. Because Category III research requires approval, you may not begin to collect data until you have received formal approval from the IRB.