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IRB

The Institutional Review Board (IRB) performs critical oversight functions for research conducted on human subjects.

The committee is formally designated to review and monitor research protocols involving varying degrees of humans as research subjects.

It is charged with the responsibility and authority of approving, requiring modification in, halting unapproved or non-compliant research, periodically monitoring the progress of long-term records, or disapproving all research activities involving human subjects that fall within its jurisdiction.

The IRB at Nebraska Methodist College is an appropriately constituted administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities.

The Nebraska Methodist College Institutional Review Board (IRB) is organized and operates under the authority of the Chief Executive Officer. The  IRB's  purpose  and  role  is  to  review  and  approve  (or  disapprove) proposed studies to ensure that:

         • Risks to subjects are minimized;

         • Risks to subjects are reasonable in relation to anticipated benefits;

         • Selection of subjects is equitable;

         • Proper informed consent will be obtained

Other appropriate safeguards are maintained as necessary to assure the safety of subjects, protect privacy and protect the rights of any subjects who are likely vulnerable to coercion and undue influence due to physical or mental illness.

 

Ethical Principles

 

NMC and its IRB are guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," a.k.a., the "Belmont Report." See Guidebook. In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (the "Common Rule") will be met for all applicable HHS-supported research

 

Institutional Policy

  1. Appropriate measures will be taken to protect the rights and welfare of human subjects of research. Before human subjects are involved in research, proper consideration will be given to, without limitation, the following:

    1. The risks and burdens to the subjects;

    2. The anticipated benefits to the subjects and others;

    3. The importance of the knowledge that may reasonably be expected to result;

    4. The informed consent procedures and documents to be employed and

    5. The existence or non-existence of possible conflicts of interest or financial incentives adversely affecting the research process.

  2. NMC, through its Institutional Review Board, will be responsible for the review of all research involving human subjects within the scope of the IRB's authority, including continuing review of the research.

  3. NMC and all persons involved in human research will comply with federal, state or local laws governing such research.

  4. NMC encourages and promotes constructive communication among the department heads, research Investigators, human subjects, institutional officials and others involved in research as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of human subjects.

  5. NMC, acting through the IRB, will exercise appropriate administrative overview carried out at least annually to ensure that its practices and procedures designed for the protection of the rights and welfare of human subjects are being effectively applied.

  6. The IRB shall consider additional safeguards in research when that research involves prisoners, pregnant women, children, individuals who are mentally disabled, other potentially vulnerable groups and human in vitro fertilization.

  7. NMC shall  provide  each  individual  at  the  institution  conducting  or reviewing human subject research (e.g., research Investigators, department heads, research reviewers) with a copy of this statement.

  8. NMC and the IRB will encourage and support continuing education for IRB members and Investigators.