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  • Types of Reviews

Institutional Review Board

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  • Types of Reviews

    There are three types of research proposals:

    1. Those that require Full Review by the IRB
    2. Research that meets specific criteria for an Expedited Review
    3. Proposals that are Exempt from IRB review

    A description of each type of research proposal and instructions for completing the application process is presented below. Please refer to the Research Proposal Checklist prior to completing any of the IRB forms. The checklist is provided for your convenience in order to ensure that you submit all the necessary materials.

    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 under the procedures established below. 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.
    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 take place once a month during the academic year. A current meeting schedule is available at:

    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 and by one or more reviewers designated by the Chair from among IRB members. In order to insure that all members have involvement in the expedited review process, the Chair will designate reviewers on a rotating basis. 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. When an expedited review procedure is used, all IRB members will be advised of research proposals that have been approved under the procedure. If issues of concern arise in the process of full or expedited review, the investigator will be provided the opportunity to respond to those concerns prior to any action on that review. Proposals for expedited review must include the same materials required for full review. The only difference is in the number of copies to be submitted to the IRB. Expedited reviews require the original and one copy of the entire proposal.

    Exemptions from IRB 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 six 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. The Chair of the IRB will make the decision regarding exemption approval when proposals contain a Request for Exempt Status. Proposals may be returned to the principal investigator if it does not provide sufficient information to make a determination about exemption. In this case, the PI may be asked to submit the proposal for expedited 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. [See samples of abstracts by following this link.]

    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, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. This type of research is an area of exemption that may apply to minors, whereby the researcher is the minor's teacher, instructor, therapist, etc.
    2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifies linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' 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 (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) 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 subjects cannot be identified, directly or through identifiers linked to the subjects. This type of research is an area of exemption that may apply to minors.
    5. Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefits or services programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) 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, (1) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use founds to be safe, or agricultural chemical or environment 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.