Review Procedures - Policy Statement Part Three

Research Review Procedures

Exempt Review
Research projects that the principal researcher (and faculty research supervisor in the case of a student research) believes meet the qualifications for exempt status must be reviewed by a member of a Departmental Review Panel (not the faculty research supervisor) before the researcher begins contacting participants or collecting data. The researcher should send the application and associated documents to the Departmental Review Panel. If the researcher is not in a department that has a Departmental Review Panel, the researcher will send the Human Subjects Review Application and associated documents to the IRB manager, who will select a review panel member and forward the application and materials. If the reviewer confirms that the research is exempt, the reviewer will sign the application form and send the Human Subjects Review Application and associated documents to the IRB manager. The IRB manager will assign a number, inform the researcher or research supervisor in writing that the project is approved, and file the application. If the reviewer determines that the project does not meet the exempt criteria, the reviewer will notify the researcher with a recommendation for modification or resubmission for expedited or full review. Researchers should allow three days in their planning for the review process. The researcher must not begin collecting data until the written IRB approval is received.
  
Expedited Review
Research projects that the principal researcher (and faculty research supervisor in the case of a student research) believes meet the expedited review criteria must be reviewed by a member of the researcher’s Departmental Review Panel (not the faculty research supervisor) and an IRB  reviewer outside of the researcher’s department. The researcher should submit the Human Subjects Review Application and associated documents to the Departmental Review Panel and to the IRB manager, who will assign a number and send the materials to an IRB reviewer outside of the researcher’s department.  If the researcher is not in a department that has a Departmental Review Panel the researcher should send the Human Subjects Review Application and associated documents with a request for two reviewers to the IRB manager, who will send the application and materials to two reviewers in separate departments. Each reviewer will send the completed signed application to the IRB manager. The IRB manager will inform the researcher or research supervisor in writing if the project is approved, or revision or full review is recommended and file the application. Researchers should allow one week in their planning for the review process. The researcher must not begin collecting data until the written IRB approval is received.

Full Review
If a research project requires a full review, the researcher must submit the Human Subjects Review Application and associated documents to the IRB manager requesting a full review. The IRB manager will send the application and materials to the IRB members for consideration at their next meeting. Proposals should be submitted at least three working days prior to a scheduled meeting. The IRB will meet the second and the sixth week of the fall and spring semesters. A majority of the IRB members must be present for research to be reviewed. Approval of a proposal by the IRB requires a majority vote of the members present at the meeting. The IRB manager will inform the researcher or research supervisor in writing of the IRB decision.

Continuation or Renewal
Approval of research is good for a one year period. If the research is to continue beyond the approved time the researcher must request an extension. The request for extension must be reviewed at the same level of review as the original proposal. The researcher’s request must include the following information.

1. The name of principal investigator and title of the research project.
2. The number of participants that have been tested to date and the number of additional participants needed.
3. A description of any modifications that will be made to the procedures.
4. Any changes in anticipated risks or benefits.
5. A description of any adverse effect or participant complaints to date.
6. A brief summary of the findings to date.

External Researcher
Individuals from other institutions who wish to conduct research using MSSU students or personnel as participants must send proof of the approval of their research by their home institution’s Institutional Review Board to IRB c/o Dr. Delores Honey, 3950 Newman Road, Joplin, MO 64801-1595 or honey-d@mssu.edu. If the home institution does not have a procedure for approving human research procedures, the individuals must submit the appropriate information to the MSSU IRB for review.

Informed Consent Requirements

The participant should have sufficient knowledge and understanding of the elements of informed consent. To the extent possible, the participant should make an informed decision about whether or not to participate in the research. As a part of the process of obtaining informed consent, the following elements of consent should be considered.

Elements of Informed Consent
Informed Consent Forms should include the following elements.

1. A statement that the study involves research.
2. An explanation of the purposes of the research.
3. The expected duration of the subject's participation.
4. A description of the procedures to be followed.
5. Identification of any procedures which are experimental.
6. A description of any reasonably foreseeable risks or discomforts to the subject.
7. A description of any benefits to the subject or to others which may reasonably be expected from the research.
8. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
9. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
10. For research involving more than minimal risk, 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.
11. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
12. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled.

Documenting or Waiving Documentation of Informed Consent
When research presents a greater than minimal risk to the participants, a signed written Informed Consent Form must be retained with the research records for three years. A copy of the form must be given to the participant.

Signed documentation of informed consent can be waived if 1) the research presents no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context or 2) the consent document would be the only record linking the subject and the research and the principal risk would come from a breach of confidentiality. The researcher still needs to provide the subject with the elements of consent so an informed decision is assured. This process is recommended for projects that require less than a full review because it preserves anonymity and eliminates the need to store the consent forms.

Informed consent may be waived or altered if the research meets all of the following conditions: 1) The research involves no greater than minimal risk. 2) It is not practicable to conduct the research without the waiver or alteration. 3) Waiving or altering the informed consent will not adversely affect the subjects’ rights and welfare.  4)  Pertinent information will be provided to the subjects later, if appropriate. This category of waiver includes cases in which the investigator needs to withhold some information about the research, which if known by the participant would bias the result of the study. Ordinarily, the researcher will plan a debriefing session after completion of the individual’s participation to provide the missing information.

Debriefing

When the informed consent procedures withhold information from the participants of the research or the research design involves deception, researchers should provide the participants additional information and correct any misperceptions that have been created. This information should be provided as early as possible, preferably at the end of participation, but at least by the conclusion of the research. When appropriate the researcher should provide the participants the opportunity to learn about the nature of the results and conclusions of the research.
 
Research with Children

Research involving children must be undertaken with care and meet strict ethical standards. Research with children is never considered exempt from IRB review, even if the same research procedures would be exempt with adult participants. It is anticipated that most research conducted with children will present minimal or less-than-minimal risk. Research involving more than minimal risk to children should be conducted only if sufficient potential benefits are anticipated. If research involving more than minimal risks with children is proposed, it must meet the special considerations specified in 45 CFR §46.405, or §46.406 to be approved by the IRB. For the purpose of these rules a “child” is a person under the age of 18 or legally emancipated.

When engaging in research with children the researcher may need to seek permission of the school district and parents or guardians as well as assent of the child. Permission of the school (superintendent or principal) is required for any research that takes place in a school setting or involves school records. Parental permission and child assent may be waved, if the research does not involve direct intervention with children or include personally identifiable information. Examples of such research include observations of public or classroom behavior and analysis of educational test or existing data recorded without personal identifiers. Projects that involve direct intervention with children require permission from the parent or guardian. In addition, assent from the child is required when appropriate.