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Determinations about whether an activity constitutes research involving human subjects are made by the IRB Director. Individuals seeking advice about whether their proposed activities constitute research should contact the IRB Director. Investigators should provide sufficient information about the activity in writing to determine whether it represents human subjects research.
Following review, the IRB Director may make one of the following determinations:
Completion of the review may require up to one week. Investigators will be notified electronically or in writing of the determination.
Generally speaking, and unless the requirement has been waived by the IRB as outlined in ”Waiver of Requirement for IRB Approval,” or a class-related project is exempt from IRB review, the following individuals (or groups) who propose to conduct research that involves human subjects are required to obtain approval from Union Institute & University’s IRB prior to beginning their research:
All researchers are expected to abide by IRB guidelines that describe the ethical conduct of research and protection of human subjects. Any researcher who is unclear whether his or her study needs IRB approval should contact the IRB Director. All requests for waiver will be considered by the full IRB.
The IRB will not consider waiving the requirement for IRB review and approval for any research project that began after March 1, 2004.
Research involving interactions with other humans designed to collect personally identifiable information from, about, or by them and research that involves analysis of existing personal data about other humans typically require IRB review and approval. The IRB will consider an application only after the proposed study has been approved through all applicable academic and/or administrative processes—faculty advisor, dissertation chair, or dean’s approval. In addition, each application to the IRB must be reviewed and approved by a faculty advisor, dissertation chair, or supervisor, as applicable.
Title 45, Code of Federal Regulations, Part 46, “Protection of Human Subjects,” defines human subjects (sometimes referred to as participants) as follows:
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Intervention encompasses physical procedures by which data are gathered and manipulations of a subject or of a subject’s environment are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
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, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or be associated with the information) in order for obtaining the information to constitute research involving human subjects.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
The need for IRB approval for some research, such as psychological studies, surveys, interviews, etc., is clear. IRB approval for other types of studies, such as those in which no direct interactions occur between the researcher and a subject, may be less clear. These studies must be handled individually. As a general rule, however, the following activities do not require IRB approval:
See “Class-Related and Other Research Activities” and “Research vs. Practice” for more information.
Students are not required to obtain IRB approval for teaching a course or for student teaching, unless the activity will combine research with practice, such as using teaching to investigate the efficacy of a new or experimental teaching method. See “Research vs. Practice,” “Students Used as Research Participants,” and “Class-Related and Other Research Activities.”
Pilot studies or tests conducted prior to engaging in a full study require separate IRB approval. Because the purpose of a pilot study is to test an instrument or other methodological component, any direct benefits to participants are unlikely. In the informed consent process, prospective subjects must be informed that they are being asked to participate in a pilot study and what participation means in terms of potential risks and possible benefits. Once the pilot study / test is completed, the researcher will need to submit a second application for the full study; the proposal should include findings from the pilot test.
Oral history interviewing projects in general do not involve the type of research defined by the Office of Human Research Protections (OHRP) in that oral histories do not involve systematic research development and data collection procedures designed to produce generalizable knowledge as defined by the OHRP. However, some oral history projects are considered research and do require IRB review and approval. The IRB Director will conduct an evaluation to determine whether an oral history or open-ended interview activity constitutes human subjects research. This evaluation involves the following steps:
If a project meets the following criteria, it is considered to be an oral history project and does not require IRB review and approval:
If a project meets the following criteria, it is not considered to be an oral history project and requires IRB review and approval:
Class projects are generally conducted for educational purposes and not as research. Although some class projects require submission of an IRB application or a determination that IRB approval is not required, many class projects require neither. Instructors are required to complete human subject research training (CITI Course) when class projects involving human subject interactions are part of the course syllabus. The IRB Director can provide suggestions related to managing risks of deductive disclosure (discerning an individual participant’s identity through the use of known characteristics), coercion-free recruiting, informed consent, and special considerations for projects that include potentially vulnerable individuals.
Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge; (i.e., results or conclusions are intended to extend beyond one person (participant) or an internal program). (45CFR46.102(d); (21 CFR 50.3(c))
A human subject (or human participant) is a living individual about whom an investigator (professional or student) conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information. (45CFR46.102(f); (21CFR50.3(g))
Class projects may not involve minors (Exception: Projects conducted in established or commonly accepted educational settings, involving normal educational practices such as work on regular and special education instructional strategies, or work on the effectiveness of, or the comparison among instructional techniques, curricula, or classroom management methods.), videotaping of subjects, no more than minimal risk, no deception, and no distribution/ publication beyond the class environment.
Research versus Course Assignment
Student projects conducted within an academic course may be categorized as either a course assignment or disseminated research. Disseminated research includes data that are formally presented to any audience beyond the course (e.g., poster, oral or written paper, seminar, thesis, dissertation, journal article, professional presentation). Disseminated research must be reviewed by the IRB.
If data collection and interpretation are for pedagogical purposes only and are contained wholly within the course environment, the student project should be categorized as a course assignment. Data for these projects are gathered without the intention of dissemination beyond the instructor and students of the course.
Typical purposes of class-related learning activities that will not be published and do not require IRB approval include the following:
Such learning activities do not constitute research because their purpose is not to develop or contribute to generalizeable knowledge (i.e., the results will not be published or otherwise disseminated beyond the learning environment).
A faculty member planning a course, seminar, independent study, or workshop during which students will engage in exercises involving human subjects should consult with the IRB well in advance of the proposed start date to determine whether IRB approval is required. If the proposed activity will occur within the learning environment (such as students interviewing one another), faculty are expected to include information about the activity in the course syllabus or course description so that students will be informed prior to course registration. Instructors and students who are unsure whether an activity needs IRB approval may contact the IRB Director.
Class projectsinvolving secondary data analyses that are assigned and conducted as educational exercises, using data that are either publicly available, de-identified, or otherwise impossible to be linked to personal identities, and results will not be disseminated beyond the instructor and students of the course. No IRB action required (neither approval nor determination of human research status).
Class projects involving secondary data analyses that are assigned and conducted as educational exercises and that use datasets that include private information and codes that link to identifiers, but students do not have access to the identifiers, and results will not be disseminated beyond the instructor and students of the course. No IRB action required (neither approval nor determination of human research status).
Class projects or practicathat involve direct interaction (e.g., in person, via physical mail, e-mail, web surveys, or telephone), but the purpose is training, an educational exercise, or professional development and not research. The project of practicum is not “research” even if students ask people questions as part of learning how to conduct interviews or surveys, take histories, administer assessments, or perform “in-house” evaluations as requested by the practicum site. Students and instructors must complete the CITI Course. No IRB action required (neither approval nor determination of human research status), but IRB action may be requested if the instructor or students are unsure, or if documentation is required by gatekeepers (e.g., schools, businesses) for access to participants.
If a student decides after completing the practicum activity to pursue additional activities with the same information/ data for a final document, thesis, dissertation, article, or presentation, an IRB application describing research use of secondary data should be submitted for review and approval.
Class projects that will be distributed beyond the class environment for theses, presentations, articles, dissertations, or other final documents require IRB review and approval before the research may begin.
Class projects or practica that involve direct interaction or secondary analysis of private identifiable data and are undertaken as both an educational experience and as research (e.g., results of these activities will be presented publicly or otherwise disseminated/ published, or the data will be stored and used by the students or others as research data). IRB approval is required. When several students in a class are doing similar projects, the instructor may submit a single class project IRB application with the instructor as the PI. All students involved in these projects should be listed on the application. If projects vary greatly, students need to submit individual IRB applications.
Each student may interview one or more persons or conduct telephone surveys, but all in the class follow the same general script or guidelines. If class projects follow different protocols, a table or chart can describe these more individualized activities, under the umbrella of a single IRB application submitted by the instructor.
The intent of the research and publication is to develop or contribute to generalizable knowledge. Instructors submit the Instructor Application for Class-Related Research Projects and a model Comprehensive Informed Consent Form to the IRB for review and approval.
Students who wish to use the data in their dissertations, theses, final documents, or culminating projects are required to submit an IRB Application and Research Proposal and the Comprehensive Informed Consent Form to the IRB for review and approval after submitting them to the instructor for review and approval. The consent form must include a statement indicating that the results of the study may be published in a [dissertation, thesis, final document, or culminating study], in a future journal article, or used in a future professional presentation. Instructors will review the applications, consent forms, interview questions, surveys, and other instruments before they are submitted to the IRB for approval. These projects must involve no more than minimal risk to participants.
Instructors will review consent forms, interview questions, surveys, and questionnaires prior to submitting them to the IRB for these class projects. Students are not required to submit separate IRB applications when the instructor obtains blanket approval for class research activities.
Research that involves direct interaction with individuals (e.g., in person, or via postal mail, e-mail, web survey, or telephone) or data from human subjects for which the researchers will have access to identifiers. IRB approval is required. Submit an IRB Application and Research Proposal. Student researcher, co-investigators, and faculty advisor, are required to complete the CITI Course.
Research limited to secondary analysis of data, records, or documents that are publicly available, de-identified, or otherwise impossible to be linked to personal identities. Submit the Exempt Research Study Checklist – Application for IRB review and approval.
Research-like activities using degree program student subject pools (e.g., clinical psychology, public policy & social change, higher education) even when the activity is conducted for educational purposes as a class requirement. IRB approval is required. Submit an IRB Application and Research Proposal for each activity by an individual or small group. Student researchers, co-investigators (if a group), and faculty advisor should have completed the CITI Course.
Instructors are specifically responsible for the following:
The Class Research Project Consent form is for use only in class projects that will not be published or used beyond the class environment. This form does not meet the minimum necessary federal standards for disseminated research. Consent forms used in research projects that will be published must include the necessary elements of consent, components found in the Comprehensive Informed Consent Form, and a statement about possible future publications and other uses beyond the class environment.
Research studies involving human subjects conducted during internships may not be assigned as class projects. Researchers are required to submit an IRB Application and Research Proposal and the Comprehensive Informed Consent Form to the IRB for review and approval before an internship research involving human subjects project may begin. Research to be conducted at a hospital or an educational institution must be submitted to the IRB at those institutions and be approved by the student’s faculty advisor as well as approved by UI&U’s IRB. Copies of other IRB and/or location approval letters must be submitted to the IRB before a study may begin.
Ethical guidelines for research studies in which interactions with subjects occur via the Internet or e-mail are the same as for studies involving other modes of interaction. Internet-based studies must incorporate the principles of The Belmont Report and Title 45 CFR 46. Subjects’ identities must be protected to the extent the researcher is able such as using a secure, password protected study Web site and installing security software on the researcher’s computer. Studies must include an informed consent process. With appropriate preparation of the informed consent form, obtaining electronic agreement to voluntarily participate is possible. Research involving minors requires obtaining consent from parents, a legal guardian, or legal representative. Written consent (signatures) may be obtained by mailing or faxing an informed consent form or consent statement to the researcher. Telephone consent may be obtained for low risk studies. A face-to-face interview should be conducted to obtain parental consent for studies with minors that involve more than minimal risk.
When reviewing a proposed Internet-based study, the IRB will want to know how the researcher will
Researchers may, for example, insert an online informed consent form with buttons for selecting “I Agree” and “I Do Not Agree,” followed by a “Submit” button. (See Template – Consent Statement and Debriefing for Online Study.) Potential participants who click “I Agree” and “Submit” should be directed to the survey, questionnaire, focus group, or interview questions. If a potential participant clicks “I Do Not Agree,” he/she should be returned to the study’s home page or directed to a “Thank you for considering participation in my study” page. Other methods for obtaining consent may also be used. A link to “Exit This Study” should be provided to allow participants to withdraw at any point in the study.
The CITI program offers an optional module addressing Internet research. Anyone submitting an application to the IRB for an Internet-based study is required to complete this module.
Research Conducted in Online Communities
Conducting research in online communities, such as chat rooms, blogs, social sites, and gaming sites, requires researchers to respect members of the communities, their privacy, and their right to grant permission to conduct research within their communities. Researchers should take care to conduct research in online communities in such a way as to avoid damaging the reputation of researchers that would result in fewer opportunities for conducting research in online communities. Joining an online community for the purpose of lurking in the background while collecting information and quotes for a research study would be unethical and would not be approved by the IRB. Researchers need to be aware of whether a blog or other social site is public (no login required) or private (login required) and to respect private sites. Research should also determine whether a blog is searchable through various search engines.
A researcher may set up his/her own chat room, for example, for a research study. Each person who joins the chat room may be greeted with a statement about the research study. For a low risk study, the statement may be sufficient. For higher risk studies, obtaining informed consent from participants is needed.
Conducting Internet research involving sensitive topics requires extreme caution to avoid the loss of confidentiality and release of a participant’s personally identifiable information. The use of pseudonyms and other coding methods may be used and employed with protection of the link between the real names and the pseudonyms or codes.
Researchers need to determine from whom to obtain consent in online communities—the site owner, a group’s gatekeeper, an online personality, and/or individual participants. Sometimes consent is necessary from more than one party.
Documenting Online Sources
Many articles and reports are available on the Internet and provide good sources for literature reviews and bibliographies for culminating research projects—theses, dissertations, final documents, and culminating studies as well as for class-related research projects. Quotes and excerpts from online articles and reports must be properly cited, using the recommended style guide. Total duplication of a portion or of an entire online article or report is considered plagiarism, and it will not be tolerated. Using direct quotes from an online article or report without proper acknowledgment of the source is also considered plagiarism.
Research studies conducted in countries other than the United States must abide by all IRB criteria for approval. The same considerations associated with research involving minor children apply as well. Researchers should adhere to the age of majority in the study location country when conducting research involving children.Obtaining permission/ approval from local, state, and or national officials may be necessary, and another IRB may be associated with the facility where the research study will be conducted. Consequently, researchers need to recognize that the amount of time required to obtain all relevant approvals may be lengthy and plan accordingly. A link to an International Compilation of Human Subject Research Protections on the OHRP Web site is accessible on the IRB Web site.
An optional international research module is available in the CITI course and is required for anyone planning to conduct a research study involving human subjects in a country other than the United States.
Animal research is not conducted at Union Institute & University.
Studies for which review by another IRB is required must meet the criteria of both Union Institute & Universityand the other organization or institution. If the requirements for approval of the two IRBs are in conflict, the researcher should be prepared to negotiate a compromise. Studies for which multiple IRB approvals may be required include:
Researchers should seek approval from the external IRB before submitting the proposal to Union Institute & University’s IRB and attach the external IRB’s approval to the application. If approval from the other IRB is not possible prior to submitting the application, UI&U’s IRB may consider and approve the study. However, it will withhold an approved start date until documentation of the other IRB’s approval is provided.
Anyone associated with Union Institute & University(faculty, students, staff) proposing to conduct research with human subjects is responsible for reading the IRB guidelines; completing all required modules of the CITI course, and becoming familiar with The Belmont Report, federal regulations on the protection of human subjects, and the standards for research and ethical practices for the researcher’s discipline or profession. Researchers are also responsible for:
A researcher seeking IRB approval is responsible for:
Completing IRB training requirements (i.e., reading the IRB Handbook, completing the CITI Course in the Protection of Human Research Subjects)
A researcher conducting a study involving human subjects is responsible for:
Faculty members who advise students and supervisors of university employees, which include faculty and staff employees, proposing to conduct research involving human subjects are responsible for:
Although federal and Union Institute & University policies are clear that all research projects involving human subjects are to be submitted and approved prior to engaging in research activity, in rare cases the IRB will agree to conduct a post-hoc review when research is in progress without prior IRB review and approval. The IRB Director will first determine that the research is, in fact, either in progress or has been completed without prior IRB review and approval. Once this confirmation is secured, the following procedures will be followed:
See International Research Laws.
When the researcher is a consultant to the university, IRB approval is required only if, at the conclusion of the research, the university becomes the owner of the data collected.
See 45 CFR 46.102.
Also see: Oral History Association