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  • Procedures

Institutional Review Board

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  • Procedures

    Summary of the Review Process

    1. The researcher identifies a research project. If the researcher is a student he or she discusses the project with his or her faculty advisor. In order to protect subjects and student investigators, the IRB requires that the principal investigator must be a MSUM faculty member. Graduate or undergraduate students cannot be the sole or principal investigator on an IRB proposal.
    2. The required forms must be completed following the guidelines available on the IRB Website. A Research Proposal Checklist is available to assist in this process.
    3. The completed approval form is signed by the principal investigator, co-investigators and submitted to the Graduate Studies Office with any required supporting documentation, such as the 100-150 word abstract of the proposed study, copies of cover letters, informed consent forms, surveys or questionnaires, letters of agreement from cooperating institutions, debriefing statements, etc. If the proposal is incomplete it may be returned to the applicants without being reviewed. Proposals may be submitted at any time.
    4. The research proposal is either routed to a member of the IRB for Expedited Review or a Full Review meeting is called by the Chair of the IRB. Requests for Exempt Status will not be exposed to the complete review process. However, the reasons for seeking Exempt Status must be consistent with at least one of the six criteria for exemption.
    5. A formal letter of approval or disapproval is sent by the Chair of the IRB to the principal investigator. In the case of suggested minor modifications, the principal investigator may be asked to "Revise and submit" the proposal.
    6. If the proposal is disapproved, the researcher may appeal the decision.
    7. All researchers will complete and submit a Project Completion /Continuing Review Form at the end of each academic year.

    Assent

    Research involving minors may require their assent, i.e., the minor's agreement or willingness to participate in the study. This is in addition to parental or guardian permission. Assent may only come from children capable of making this decision. Parental permission may suffice when a child is not capable of making this decision. Regardless of the situation, investigators are required to provide a method of assent with their IRB proposals involving minors. This may include, but not limited to the following: 1) letter of assent signed by the minor; 2) statement of assent read or communicated to the minor; 3) a procedure whereby assent is implied by the child's active participation; and 4) a statement explaining why assent is not necessary. In the latter case, a minor's assent may not be required, e.g., minors involved in classroom activities that are part of their required curriculum and instruction.

    Regardless of the method of assent used by the investigator, minors may not be coerced, actively or passively, into participating in a study. Furthermore, any statement, written or expressed verbally, must be communicated in ways that the minor will understand.

    Investigators may request exception to or waiver of assent procedures in their particular study. However, their request must come before the entire IRB for approval, and may not be handled through exempt status or expedited review proposals. In order to do this, investigators must submit to the IRB 10 copies of a written proposal along with any supporting documentation explaining their reasons for exception or waiver. Federal regulations provides for exceptions and waivers.

    Answers to Frequently Asked Questions (FAQ) regarding the treatment of minors by the U.S. Department of Health and Human Services, Office of Human Research Projections may be found at the following link: http://www.hhs.gov/ohrp/researchfaq.html.

    Informed Consent

    In order to involve a human subject in research, a researcher must obtain the legally effective informed consent of the subject or the subject's legally authorized representative. Special care should be exercised when the subjects are legal minors or adults legally incapable of giving consent. Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. By federal law, researchers are to keep signed informed consent forms for three years. 45 CFR 46.116

    Information conveyed in the informed consent procedure shall:

    1. Be expressed in understandable language.
    2. Exclude language waiving legal rights.
    3. Be stated in language that minimizes the possibility of coercion or undue influence.
    4. Contain an explanation of the purpose(s), procedure(s), and duration of research.
    5. Describe any benefits.
    6. State conditions of participation and circumstances for termination of subject's participation by the investigator.
    7. Include a statement concerning the subject's right to withdraw from participation at any time without prejudice to the subject, at which point any data pertaining to said subject will be destroyed.
    8. Include a statement, when appropriate, that the procedure(s) may involve unforeseeable risks and/or possible additional costs.
    9. Include an explanation, when appropriate, of compensation and treatment availability if injury occurs.
    10. Describe the extent to which confidentiality of records and anonymity of subjects will be maintained.
    11. Provide assurance that any new information developed during the course of the research which may relate to a subject's willingness to continue will be disclosed.
    12. Provide the opportunity for acceptable response to a subject's pertinent inquiries (concerning procedures).
    13. State, when appropriate, the approximate number of subjects in a study.

    Types of Review

    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. 

    IRB Training Requirement for Principal and Co-Investigators

    Office for Human Research Protections (OHRP) approved on-line training is required of principal investigators (PI) and co-investigators (CI) prior to submitting proposals for full review and expedited review. Only the PI is required to complete IRB training prior to submitting proposals for exempt status reviews, except when children are involved in the study. In this case, both the PI and CI are required to complete basic IRB training.

    The on-line training program is available at NIH Office of Extramural Research.

    A copy of the training certificate is to be submitted to the IRB Chair prior to completing an initial proposal. This should be accompanied by the person's Dragon ID number and name of their department. A record of the training will be kept on file, as well as in a database for future reference. Investigators may obtain IRB forms upon completion of their training.

    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 purpose 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 on the IRB website.

    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 ofabstracts 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 reserch 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 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.

    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. 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.  

    Department Reviews

    Department Review Committees (DRCs) may be formed to handle the review of class projects and faculty or student research proposals within the department. Applications for the formation of a departmental review committee should be sent to the IRB c/o the Graduate Studies Office (Owens 215). The applications should include a letter of intent to form a committee along with the names of the DRC chair and members. DRCs are required to meet the following conditions:

    1. Types of Reviews
      • Department Review Committees (DRCs) will only evaluate proposals from department students and faculty submitted for expedited and exempt status reviews.
      • DRCs may not evaluate proposals for:
        • research conducted by faculty, other than in course related activities
        • research funded by external grants
        • research involving minors and other vulnerable populations
         
       
    2. Membership
      • There will be a minimum of three (3) members (including the committee chair).
      • Department Review Committees (DRCs) must provide the IRB list of their committee members each academic year.
      • DRC Chairs (or a DRC representative) will serve as non-voting, ex officio members to the IRB.
       
    3. Policies and Procedures
      • Department Review Committees (DRCs) must adhere to all IRB policies and procedures.
      • The IRB Chair will familiarize department committee members with IRB policies and procedures before committees begin reviewing departmental research proposals.
      • DRC members will be invited to attend IRB meetings whenever the agenda deals with issues pertinent to IRB procedures and training.
      • DRCs will maintain all records from reviews for three (3) years.
      • The IRB will review files each fall semester in order to insure compliance with policies and procedures
      • DRCs will be designated "inactive" if they do not process any proposals during an academic year. Active status may be reinstated upon a renewal training orientation with the IRB chair, and current NIH training certificates from the DRC members.
      • Inactive DRCs cannot become active again until all of its members complete the NIH on-line training program and meet with the IRB chair for a renewal orientation meeting. Current on-line training certificates must be submitted to the IRB chair prior to scheduling the renewal orientation meeting.
      • Departmental Review Committee (DRC) members are required to complete an OHRP approved on-line training course and submit their certificate of training to the IRB chair within thirty-days of being appointed to the committee. The training program is available at: NIH Office of Extramural Research.  
      • DRC members are encouraged to pursue additional training through videotape and IRB sponsored workshops.
      • The DRC chair will submit to the IRB all training certificates for the investigators of proposals they process.
       
    4. Forms
      • All appropriate IRB forms must be used by department committees.
      • Other forms may be used for routing and reviewing proposals.
       
    5. Proposals
      • Department Review Committees (DRCs) must submit to the IRB a list of all of the proposals they processed for each academic year.
      • The list must be submitted by the completion of the spring semester.
      • The spreadsheet format for this list is available through the Graduate Studies Office.
       
    6. Project Completion and Continuing Reviews
      • Department Review Committees (DRCs) must submit to the IRB a list of all of the project completion and continuing reviews for each academic year.
      • The list must be submitted electronically in spreadsheet format to the Graduate Studies Office at the end of each semester.
      • The spreadsheet format for this list is available through the Graduate Studies Office.
       

    Student Research

    All research conducted by students involving human subjects must be reviewed by the IRB or Departmental Review Committee (see Department Review Committees for details regarding their responsibilities). Students are expected to submit their research proposals through their faculty advisor who will serve as the principal investigator (PI) of the study. Students are to be listed as co-investigators (CI). Refer to Summary of Review Process for details. PIs and CIs must complete an on-line training program before proposals will be processed by the IRB or DRC. Refer to Training Requirements for details.

    Research Using Electronic Methods

    Researchers must take added precautions to protect the identities of their research participants when using electronic methods for obtaining and/or storing information and data. A MSUM (mnstate) account designated as a secure site must be used for any research:

    • conducted on the internet (e.g., survey research)
    • that uses email addresses
    • using email as a method of communication

    Violations

    Violations to the policies and procedures that are brought to the attention of the IRB will be handled on a case-by-case basis. As a general rule, the principal investigator of the alleged violation will be asked to meet with the IRB to discuss the situation. the IRB will make every effort to assist the principal investigator in finding a remedy to the violation. Failure on behalf of the principal investigator to comply with the decision of the IRB may result in one of the following:

    1. Sanction from future IRB reviews for a period of time.
    2. Referral to the MSUM administration for appropriate action.

    Appeals

    In the instance of IRB disapproval of a project, or of a contingency approval, a project director/researcher may request an appeal hearing before the IRB in full. Records and notice of action will be provided.

    No other University approval may be provided in opposition to IRB disapproval. However, IRB approved projects may be disapproved by other offices of the University. 

    Project Completion and Continuing Review

    All researchers must complete a Project Completion or Continuing Review Form at the end of each academic year. Forms will be sent by the Graduate Studies Office to the Principal Investigator. Once a research project is determined to be complete, all associated documents will be sent to the Office of Academic Affairs to hold for three years. It is the principal investigator's responsibility to provide secure storage of the Informed Consent forms and any audio/video tapes or photographs. These items must also be maintained for three years.