Institutional Review Board (IRB)

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
federal requirements.

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.

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and (b) 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.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
   survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if: (a) the human participants are elected or appointed public officials or candidates for public office; or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. 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.
5. Research and demonstration projects which are conducted by or subject to the approval of
   department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures, or (d) possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods
   without additives are consumed or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. 

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.

1. All data are recorded anonymously or identifying information deleted at the end of the study. The coding system to protect participants’ identity does not use participant initials, ID numbers (such as social security numbers or student ID numbers), mailing addresses, etc., in place of the participant’s name. Instead, assignment of unique or random numbers to participants is recommended. In cases where follow-up is important, a master key could be maintained with the participant’s name and contact information. However, only the number is placed on test materials. When final analyses are completed and no follow-up is planned, this key is destroyed.
2. When required, participant/parental permission must always be provided in a written format that is returned to the researcher.
3. When conducting research with vulnerable populations, additional protections are delineated and aligned with the code of regulations for that population.
4. If a control group is used as part of the treatment-type study, the advantages derived from the research should be made available to the control group or the control group told of the advantages.
5. Results are generally given to the participant in aggregate or group form; individual results are
   generally not reported back to the participants.
6. Services are not to be terminated or negatively affected if an individual refuses to participate or
   withdraws from the study.
7. A cover letter is provided to all research participants. The following information should be included in the cover letter:
   1. The researcher’s affiliation with Drury University.
   2. An overview of the project that includes a description of what the participants will be asked to do. The description should be written in terms laypersons can easily understand and should avoid the use of jargon, technical terms, or medical terms or phrases.
   3. A statement of the voluntary nature of the project.
   4. A statement of anonymity/confidentiality of the participant’s data.
   5. The contact information for the researcher so that participants can request details of the research study, ask follow-up questions, or express concerns.
8. All research participants are asked to read and sign an informed consent form. The informed consent form must include the following elements stated in language the participant can easily understand.
   1. An explanation of:

• 1. • the purpose of the research and the expected duration of the individual’s participation,
     • a description of the procedures to be followed,
     • and identification of any procedures that are experimental.
  2.  A description of any reasonably foreseeable risks or discomforts to the participant.
  3.  A description of any benefits to the participants or to others which may reasonably be expected from the research.
  4.  A disclosure of appropriate alternative procedures or courses of treatment (if any) that might be advantageous to the participant.
  5.  A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
  6.  An explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
  7.  An explanation of whom to contact for answers to pertinent questions about the research and research participant’s rights, and whom to contact in the event of a research-related injury to the participant.
  8.  A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled and that participation may be discontinued at any time without penalty or loss of benefits to which the participant is otherwise entitled.
  9. For phone surveys or interviews, participants should be informed of items 8a-h.

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.