Human and Animal Participants
Institutional Review Board

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Human Participant Research Background Information and Policies

Chadron State College Institutional Review Board (IRB)

Statement of Policy regarding Research with Human Participants:

Chadron State College is committed to the standards of quality of research involving human participants, and the ethical principles therefore appropriate. The College subscribes to the principles set forth in the Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the “Belmont Report ”). The Belmont Report provides for respect for the dignity and integrity of the persons being studied, including their right not to be the subjected to potentially harmful research http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

Chadron State College believes that full compliance with the Code of Federal Regulations Title 45, Part 46 is fundamental to our self-imposed commitment to maintain and uphold the highest standards of ethical research are maintained and upheld. Potential research participants should be provided the opportunity to decide freely and without coercion whether to participate in a study and research procedures should minimize the risk of harm and maximize the possible benefits to the participant and to society. Researchers who promise confidentiality are responsible for maintaining it, and for informing participants of the limits of their capacity to meet that responsibility. Researchers must exercise special care when the research participants are especially vulnerable to harm because they cannot understand the risks or because they are not in a position to refuse their participation. (Federal Regulation Title 45 Part 46 can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html )

1. the risks to the participants are minimized by using procedures that are consistent with sound research design and do not unnecessarily expose the research participants to risk;
2. the participant risks are reasonable relative to the anticipated benefit and importance of the knowledge expected to be gained;
3. the participants are selected through a process as equitable as possible;
4. participants are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research;
5. informed consent is obtained from each prospective participant or his/her legally authorized representative, as appropriate and is obtained in advance of research participation;
6. informed consent will be appropriately documented;
7. the research plan makes adequate provisions for monitoring the data collected to ensure the safety of participants;
8. adequate provisions for protection of privacy and confidentiality of the participants is provided, and the exact procedures for confidentiality will be clearly explained to potential participants; and
9. the researcher has provided sufficient attention to the special problems that may arise when the participant is from a population likely to be vulnerable to coercion or undue influence.

The IRB has the authority to approve, require modifications in, or disapprove all research activities that involve either human or animal subjects, as specified by both federal regulations and Chadron State College policy. Further, the IRB must annually review continuing research covered by IRB review to ensure accordance with the Policies and to evaluate the participants’ potential benefit and harm.
Research approved by the IRB may be subject to further appropriate review and approval or disapproval by the College President. The President may not approve research unless the IRB also approves the research as being in compliance with federal standards.

Institutional Review Board Responsibilities:

Chadron State College Institutional Review Board (IRB) reviews all proposed research involving human participants (subjects) to ensure that the rights and welfare of the participants are protected. By law, the IRB has the authority to approve, require modifications in, or disapprove all research activities that involve human participants.

Investigative activities covered by the IRB include:

1. research sponsored by Chadron State College, or
2. research conducted by or under the direction of any employee, agent, or student of Chadron State College in connection with his or her institutional responsibilities, or
3. research interventions or actions are performed at or on a Chadron State College facility or property and/or the research involves the use of this institution’s non-public information, or
4. research involving the use of College personnel or students as participants.

Approval of research involving human participants is required prior to research initiation, regardless of funding status or sponsorship. The review procedures proscribed below are not intended to be a barrier to research, but rather are intended to facilitate ethical study and to ensure compliance with federal regulation and community standards.

Student research projects must be sponsored by a CSC faculty or professional staff member, who shall serve as the principal investigator of the project. The sponsor must be familiar with the student and the proposal protocol, and accept responsibility to oversee the research within IRB standards.