IRB: Protocol Initial Submission and Screening Process

IRB: Protocol Initial Submission and Screening Process

Screening Checklist:

  • Most current application form on website included?
  • Approved & signed by Chair and Advisor, if applicable?
  • Dissertation or Thesis proposal accepted by committee?
  • Project description included (not full dissertation or thesis proposal)?
  • Abstract of project included?
  • Consent Forms, Survey Instruments, and Other Instruments (or waiver request with justification) included?
  • Assent Form (or script) included, if subjects under 18?

3.14 - Information Needed When Using Human Blood or Tissue

Under certain circumstances, additional paperwork is required when conducting human subject research. If you are using human blood, other fluids, or tissue in your research, you must, in addition to the IRB application, contact the Institutional Biosafety Committee(IBC), Dr. Mike Mossing, Chair, at 915-5339, email: mmossing@olemiss.edu, for review and approval of the research protocol. Final IRB approval is contingent upon IBC approval.

Submitted by Linda on May 9, 2008 - 12:51pm.

5.4 - Reports of the President’s Commission

U.S. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

Compensating for Research Injuries: The Ethical and Legal Implications for Programs to Redress Injured Subjects. Washington, D.C.: U.S. Government Printing Office, 1982. G.P.O. Stock Number 040-000-00455-6.

Deciding to Forego Life-Sustaining Treatment: A Report on the Ethical, Medical, and Legal Issues in Treatment Decisions. Washington, D.C.: U.S. Government Printing Office, 1983.

Submitted by Errol on April 3, 2008 - 2:50pm.

5.3 - Reports and Recommendations of the National Commission

U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Reports and Recommendations

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: U.S. Government Printing Office, 1978. DHEW Publication No. (OS) 78-0012. Reprinted in Federal Register 44 (April 18, 1979): 23192.

Submitted by Errol on April 3, 2008 - 2:49pm.

5.2 - Journals

Clinical Research

Evaluation Research

Hastings Center Report

IRB: A Review of Human Subjects Research

Journal of Philosophy and Medicine

Journal of the American Medical Association

Kennedy Institute of Ethics Journal

Law, Medicine and Health Care

New England Journal of Medicine

Submitted by Errol on April 3, 2008 - 2:49pm.

5.1 - Books and Articles

Annas, George; Glantz, Leonard; and Katz, Barbara. Informed Consent to Human Experimentation: The Subject's Dilemma. Cambridge, MA: Ballinger Publishing Company, 1977.

Appelbaum, Paul S., and Rosenbaum, Alan. "Tarasoff and the Researcher: Does the Duty to Protect Apply in the Research Setting" American Psychologist 44 (No. 6, June 1989): 885-894.

Beauchamp, Tom L.; Faden, Ruth R.; Wallace, R. Jay, Jr.; and Walters, LeRoy, eds. Ethical Issues in Social Science Research. Baltimore, MD: Johns Hopkins University Press, 1982.

Submitted by Errol on April 3, 2008 - 2:48pm.

Chapter 5 - General Bibliography

45 CFR 46, Code of Federal Regulations, Final Regulations for the Protection of Human Research Subjects (revised June 18, 1991, as the Federal Policy for the Protection of Human Subjects; Notices and Rules) (Appendix 6.1)

The Belmont Report - Ethical Considerations and Principles for the Protection of Human Subjects of Research.

Submitted by Errol on April 3, 2008 - 2:48pm.
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