1. Foundational Policy Statement
In compliance with NDUS Board Policy 611.8 ("Employee Responsibility and Activities: Research on Human Subjects") and out of concern for the welfare and protection of human subjects of research, it is the policy of Valley City State University that all research involving human subjects conducted under its auspices shall be in accordance with federal regulations including, but not limited to, the "Guidelines for Protection of Human Research Subjects" 45 Code of Federal Regulations (CFR) 46 established by the National Institutes of Health, and regulations to protect human subjects, 21 CFR 50, 312, 812 as established by the Food and Drug Administration. To this end, this document establishes rules for the creation and operation of an Institutional Review Board at Valley City State University.
The information found in this document is not a set of recommendations, but firm policies that will be enforced. These policies are not intended to infringe on the academic freedom of researchers. It is specifically intended to reaffirm that freedom while focusing on protection of human subjects and to comply with federal regulations. Safeguarding the rights and welfare of all those individuals involved as subjects in research, development, or related activities carried out or supervised by members of the faculty and staff of Valley City State University is not only the responsibility of the individual members of the faculty or staff involved, but is ultimately and directly the responsibility of the University.
To ensure adequate safeguards and to discharge the responsibility of the institution, no research (including grant applications), development, or related activity involving human subjects may be undertaken unless the University Committee appointed for the purpose has reviewed and approved such proposed activity.
2. Institutional Review Board: Composition and Structure
- The President of the University shall establish an Institutional Review Board (IRB) of not fewer than five members and, with advice from appropriate committees, boards, councils, Chairs or Deans of the University, appoint its members to terms of not more than three years. In constituting the first IRB, member terms shall be staggered to allow for overlapping terms of membership in subsequent years. Membership on this committee is not restricted to members of the faculty of the University but shall also include individuals drawn from various sectors of the community at large who are interested in and knowledgeable about the problems of protecting the rights and welfare of individuals involved in research, development, or related activities including problems relating to securing consent. The President, in consultation with the Vice President for Academic Affairs and the Administrator, shall annually designate a Chairperson of the IRB.
- Structure of the IRB: The following representatives shall be assigned to the committee.
- One representative from each Division or School and one representative elected at large by the Faculty Association.
- One representative of the Administration appointed by the President in consultation with the Vice President for Academic Affairs.
- One lay representative from the community or surrounding area.
- One representative of the medical profession not associated with the University, ordinarily holding an M.D. or D.O. degree.
- Alternate members officially permitted to attend and vote on IRB matters in cases of the absence of one of the Board's regular members.
- Additional members are allowed as determined by university leadership in consultation with faculty.
- No member of the Committee shall be involved in either the initial or continuing review of an activity in which that member has a conflicting interest, except to provide information requested by the Committee.
- The full IRB shall meet three times during the year, and may hold additional meetings as the need for review of proposals requires. The board may also meet for special purposes as called by the Chairperson. A simple majority of the members shall constitute a quorum of the IRB for conducting its business. In the absence of the Chairperson, the members present shall elect a Chairperson pro tempore to conduct the business of the meeting.
- A subcommittee of the IRB consisting of the Chair and at least two other members shall meet monthly, or less frequently if appropriate, to perform expedited reviews. The IRB Chair in consultation with the IRB membership shall appoint the subcommittee.
- The IRB will have a secretary assigned by university administration.
- Definition of Research on Human Subjects: Any systematic investigation designed to develop or contribute to generalizable knowledge based on data obtained from human subjects. This includes both original studies and replications of existing studies performed by faculty, students, or others. The phrase "considered to involve human subjects" as used in these Policies is considered to involve a full range of activities described in this section, and include activities that make use of such things as:
It is important to note that specifically excluded from this definition are activities whose primary focus is on benefiting the individual(s) involved in the procedure. (See item e., below.)
- Bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials
- Residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research
- Private information, such as medical information, which can be readily identified with individuals, even if the information was not specifically collected for the study in question. Psychological or social research, or research on cell lines or DNA samples that can be associated with individuals fall into this category.
- Activities Included as Research
- Physical, chemical, electrical or psychological stimulation of responses with the human body as well as interview, observation of behavior, administration of tests or other techniques of measurement, examination, or evaluation of individual humans.
- Observation of the performance of activities; or of physical or psychological reactions of individual humans or groups of human beings to stimuli which are either controlled by the investigator or are present in a normal non-manipulated environment.
- Observation or evaluation of the products of individual performance of tasks or reactions to stimuli in which human beings are directly involved through their active conduct or through giving consent to have procedures performed upon them.
- Activities Specifically Excluded: These activities are distinguished from research as understood under the auspices of the IRB, and include activities that may be classified as beneficial services. Activities under "Excluded" do not need IRB approval. These activities include:
- Teaching/training of individuals.
- Performance of diagnostic evaluation of individuals which will directly benefit the individual, or the relation of an individual to whom the human participant has agreed to assist, or the mass screening of disease.
- Performance of therapeutic procedures for the direct benefit of the individual participating or for the relation of an individual participating as in the interviewing relative to counseling services.
- Clinical Training and Research: Clinical training covers those procedures and activities that are used to teach students to engage in professional activities with human beings other than the teacher or student involved in the procedure. Clinical training is excluded from the scope of this policy. Research training is intended to train the student in the methodology and the procedures for conducting research involving human subjects and is involved in the scope of this policy.
- There may be cases where the original procedure is performed as Clinical training or as Diagnosis or as Therapy and at some later date the case record, or product of such service, would be the subject of study. In this case, it is the subsequent use of records or products that will constitute research involving human subjects and is subject to this policy.
- If Research training utilizes research designs, methodology, procedures, and/or techniques that are frequently used and does not violate minimal risk or confidentiality, then the original design must be approved by the IRB with periodic review every five years.
- Categories of Human Research: It is expected that any research involving human subjects will be reported to the IRB Chair. Even if it is determined that a research activity is exempted from review, the researcher pursuing this activity must obtain a permission form from the IRB approving the work under the exempt classification.
- Research funded by external agencies requiring review, e.g., DDHS. Such research will be reviewed by the IRB in accord with the appropriate agency guidelines.
- Research not funded by agencies requiring review but employing human subjects in a manner not explicitly exempted. Such research shall be subject to either an expedited or a full review by the IRB and must conform to the principles outlined in this document.
- Explicitly exempted research Involved are projects of no or low risk as defined by the American Association of University Professors (AAUP). These guidelines are principally based upon those established by the U.S. Department of Health and Human Services (DHHS). Specifically exempt from full IRB review are:
- Research on normal educational practices that are conducted in schools. (Examples of normal educational practices include research or comparison of instructional strategies and techniques, curricula, and classroom management methods.)
- Research which involves the use of educational tests (cognitive, diagnostic, aptitude, achievement) if the investigator will record the information so obtained in a manner that makes identification of the subjects impossible.
- Research involving survey or interview procedures where the subjects are legally competent, and where the investigator identifies himself/herself, and states that he/she is conducting a research survey interview.
- Research involving the observation (including observation by participants) of public behavior in places where there is a recognized expectation of privacy, except where both of the following conditions exist:
- Observations are recorded in such a manner that the human subjects can be identified directly or through identifiers linked to the subjects, and
- the observations recorded about the subjects, if they became known outside of the research, could reasonably place the subjects at risk of criminal or civil liability, be damaging to their social standing, or be damaging to the subjects' financial standing, employability or reputation.
- Research involving the collection or study of the existing data, if either the data are publicly available, or the investigator will record them in a manner that makes identification of the subjects impossible.
- Participant Information Statement, Informed Consent Form, and Informed Consent: In many research activities an informed consent must be obtained by the investigator from each of the participants; or, in the case of those not able to give consent (e.g., children, mentally handicapped), consent must be obtained from their guardians or legal representatives.
4. The Review Process
- Basic Expectations: It is expected that research design will satisfy the following the following two criteria:
- Risk: Research procedures should be designed so as to ensure that subjects are not exposed to physical, psychological, or social risks significantly in excess of that normally encountered in daily life. Any possible risks imposed must be weighed against the scientific importance and the potential benefits of the research. Specifically, risks of harm to human subjects must be (1) of no greater probability or magnitude than those encountered in daily life or during performance in routine physical or psychological examination or tests; or (2) reasonable in relation to expected benefits of the research, and minimized by the use of the safest procedures. The review process is dependent on the amount of risk involved in regard to the human subjects.
- Confidentiality: Research procedures shall not disclose confidential information, including names and/or salient identifying characteristics, to other than the investigator(s) and their research staff. Further adequate provisions must be made to protect the confidentiality of information that is to be retained over an extended period.
- Types of Review and When Reviews are Required
- Exemptions from IRB Consideration: For projects associated with university courses, if the identity of a research subject is sufficiently protected and the subject is at minimal risk, an exception may be granted. All submissions for exempt status will receive special attention by the Chair if a protected population is included in the study.
- Expedited Review: An expedited review is a review by a subcommittee of the IRB consisting of the chair of the IRB and two other members of the IRB for research that involves no more than minimal risk, protected populations, or to review minor revisions in previously approved research, or review revisions for proposals that were approved but require revision. The subcommittee meets monthly to perform expedited reviews. An initial discussion of a project proposal with the IRB chair will determine whether an expedited or full review is necessary.
- Full Review: A full review is a review of a project proposal by the entire IRB. This will be conducted for research that involves greater than minimal risk, or when the research is of a psychological nature.
5. Monitoring of Ongoing Research
The IRB shall maintain ongoing review of nonexempt human research with respect to subjects' rights. Monitoring procedures shall be arranged at the time of the review on a case-by-case basis.
Anyone who believes that the rights of any human subject involved in a VCSU related research project are being violated is encouraged to inform the IRB of their concern. The IRB will investigate the complaint to determine if, in the committee's majority opinion, it is valid. If so, the IRB shall require either (1) the problem be remedied or (2) the research be discontinued. Notification of such action will be forwarded to the investigators and any appropriate agencies and/or university personnel (e.g., president, VPAA, dean, department or division chair, etc.)
Sponsor: Vice President for Academic
Approved and Effective: February 2010