Types of Reviews, Submission Deadlines & Time Requirements

Exempt Status Review

Exemptions from IRB Review pertain to research where the subjects are at no more than minimal risk, the subjects' confidentiality is maintained, and the research meets at least one of the eight criteria for exemption. Research proposals that meet the criteria for exempt status must still be processed through the IRB, either directly or through a departmental review committee. An exempt review may be conducted by the IRB Chair or by a member of the IRB committee. Care will be taken in the selection of expedited reviewers to avoid a conflict of interest. The IRB exempt reviewer will make one of five recommendations:

1. Proposal is approved as submitted,
2. Proposal is approved with required revisions,
3. Proposal should be revised and resubmitted,
4. Proposal should receive expedited review, and
5. Proposal should receive full review.

Although a research project may meet the criteria for exempt status, it does not mean the study is exempt from meeting federal regulations regarding informed consent and storage of confidential materials. Proposals approved for Exempt Status are not required to submit a Continuing Review or Project Completion form. In the case of minors, only research conducted in established or commonly accepted educational settings may be considered for exempt status. In this situation, the research must be conducted in the minor's classroom or school by his/her teacher, instructor, or therapist. This does not apply to student teachers in locations outside of the MSUM campus. Proposals requesting exempt status must include:

1. Human Research Approval Form;
2. Request for Exempt Status form;
3. letter of permission from institution(s) other than MSUM (if applicable);
4. copy of Informed Consent form or implied consent letter for surveys; and (5) 100-150 word abstract or summary of the proposed study.
   The abstract should contain information about the purpose and mechanics of the study, to include information about the subjects, the procedures and methods, data collection, etc.

The following types of research are exempt from the required review (45 CFR 46.101b):

1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
      1. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
      2. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
   1. The identifiable private information or identifiable biospecimens are publicly available;
   2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
   3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
   4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
   1. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
6. Taste and food quality evaluation and consumer acceptance studies:
   1. If wholesome foods without additives are consumed, or
   2. 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.
7. Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
8. Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
   1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
   2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
   3. An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
   4. The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

*Project reviews are conducted each year from the last week in August through the first week in May.

Expedited Review

An expedited review by the IRB will be conducted for research that involves no more than minimal risk or to review minor changes in previously approved research. An expedited review may be conducted by the IRB Chair or by a member of the IRB committee. Care will be taken in the selection of expedited reviewers to avoid a conflict of interest. The IRB expedited reviewer will make one of five recommendations:

1. proposal qualifies for exempt status,
2. proposal is approved as submitted,
3. proposal is approved with required revisions,
4. proposal should be revised and resubmitted, and
5. proposal should receive full review.

The Chair of the IRB will make the final decision regarding approval of proposals that were revised and resubmitted for Expedited Review.

*Project reviews are conducted each year from the last week in August through the first week in May.

Full Review

A full review by the IRB will be conducted for research that involves greater than minimal risk. A full review must be conducted at a meeting of the IRB. In order to approve research under a full review the IRB will consider the following:

1. risks are reasonable in relation to expected benefits and minimized by the use of the safest procedures consistent with standard research practices;
2. selection of subjects is equitable, taking into account the purposes of the research;
3. privacy of the subjects and confidentiality of data are protected; and
4. informed consent is obtained and documented.

Proposals for full review must include:

1. Completion of the Human Research Approval Form.
2. Completion of the Ethical Compliance Questionnaire.
   • Attach a complete statement of the research methods, including copies of the instrument(s) being used to collect data. Do not include literature review chapters or proposals.
   • Attach an Informed Consent Form
   • Attach signed letter(s) of permission from an institutional representative, if research is to be conducted in an institution such as a school, hospital, etc.
   • Attach a debriefing statement when applicable
3. A 100-150 word abstract or summary of the proposed study.
4. Submit the original and ten copies of the entire proposal.

Full Reviews are convened on demand during the academic year.

*Project reviews are conducted each year from the last week in August through the first week in May.