If researchers plan to utilize human participants when conducting studies, they must obtain approval from an Institutional Review Board (IRB) prior to the onset of data collection. IRB permission to conduct research is contingent upon the nature and design of submitted proposals. While there are a number of key issues that must be addressed in an IRB request form, including assurances that participation is informed and voluntary, the central goal of the IRB is to ensure that researchers treat human participants with respect and dignity.
Several of our courses examine the role of the IRB and the primary components of a successful IRB proposal. Information provided in those classes is linked to broader ethical concerns that arise when conducting research with human participants. The Ethical Dilemmas in the Behavioral Sciences course represents our most focused attempt to ensure that students understand IRB requirements, their origins, and their relationship to theories of ethics. The course explores studies across the full range of disciplines that typically use human participants in research in order to help students better understand the value of institutional review.
Please review the following checklist to be sure that your application is complete prior to submission. This will insure a more timely review of your proposal.
If you have any questions regarding these requirements, please contact the chair of the Drury University Human Subjects Research Council.
Please read the following Guidelines for Research Involving Human Participants before completing this form.
The U.S. Department of Health and Human Services requires that all research projects involving human participants be screened to confirm that the participant’s rights, privacy, welfare, and civil liberties are protected. The IRB is responsible for reviewing all research projects involving human participants
conducted by individuals affiliated with Drury University.
(Taken from the Code of Federal Regulations, Title 45, Part 46, Subpart A)
Research means a systematic investigation, including research development, testing, and evaluation,
designed to develop or contribute to generalizable knowledge. Activities that meet this definition
constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human participant means a living individual about whom an investigator (whether professional or
student) conducting research obtains data through intervention or interaction with the individual or
identifiable private information.
IRB approval means the determination of the IRB that the research has been reviewed and may be
conducted at an institution within the constraints set forth by the IRB and by other institutional and
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.
Vulnerable populations are groups of individuals who require additional measures to ensure that rights, privacy, welfare, and civil liberties are protected. These groups include children, prisoners, pregnant women, and people with mental, physical, and/or intellectual disability. People with intellectual disability are not officially considered a vulnerable population in the current code of federal regulations as there is no subpart devoted to this group. They are included here as their inclusion appears to be consistent with the spirit of the regulations. Refer to the current code of federal regulations for additional information concerning vulnerable populations.
No. All research involving human participants must be reviewed by the IRB. However, the IRB may
determine that a project qualifies for exempt status.
The following criteria for a project to be considered exempt were taken directly from the Code of Federal Regulations, Title 45, Part 46, Subpart A. You will be allowed to explain on the application form why you believe your project fits the exempt status criteria; however, the final determination for exempt status is made by the IRB.
The Department of Health and Human Services has established that the IRB may use an expedited review procedure to review either research involving no more than minimal risk or for minor changes in approved research. Taken from the Notice in the Federal Register, research involving no more than minimal risk includes research on individual or group characteristics or behavior (including, but not
limited to, research on perception, cognition, motivation, identity, language, communication, cultural
beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus
group, program evaluation, human factors evaluation, or quality assurance methodologies. See the code of regulations for a list of other types of research involving only minimal risk.
Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviews designated by the chairperson from among the members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the
reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in the code of regulations. Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure.
To help ensure a favorable review, our records suggest that the IRB evaluates research protocols with an eye toward certain elements. These elements are presented to aid in the development of the research
protocol and application.
In addition, to the general items provided in 8 a-h, the Informed Consent Form must include the following paragraphs verbatim:
When preparing the research protocol and application, please note that the IRB must review and
approve all cover letters, informed consent forms, scripts, instructions to the participants, introductory remarks, survey materials, etc.
Research Utilizing Electrical or Psychophysiological Equipment
All electrical/psychophysiological equipment connected to a participant (such as EEG, EKG, or
polygraph equipment) or that the participants come in contact with should be checked by a qualified technician within one month prior to testing and on a regular basis during testing (i.e., normally one
month intervals). Assurance of this should be included on the application form.