Delta State University maintains a federally certified Institutional Review Board which has been established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University and other affiliated entities in the region. DSU IRB policies are extensions of the Belmont Report (1979) and the Code of Federal Regulations, Title 45, Part 46, also known as 45CFR46. Both of these documents can be found and downloaded from the Health and Human Services (HHS) Office of Human Research Protections (OHRP). The federal regulations apply to “all research involving humans subjects conducted, supported, or otherwise subject to regulation by any federal department or agency.” However, DSU has adopted the federal regulations as its institutional policy and all human subject research, regardless of funding support, is subject to these regulations.
- Historical Incidents Related to Human Subjects Protections
- The Nuremburg Code
- Procedure Policy
- IRB Process and Forms
The Nuremburg Code
Following the atrocities in medical research during the Holocaust of WWII, this code was developed to provide specific rules intended to prevent future abuse of research subjects. The Nuremburg Code differs from the later Belmont Report in that the later developed general principles and provided far more depth of understanding for research ethics.
- The voluntary consent of the human subject is absolutely essential.
- The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
- The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
- The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
- No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
- The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
- Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
- The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
- During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seemed to him to be impossible.
- During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
University Procedure Policy
DSU has adopted definitions of “research” and “human subjects” in accordance with the Code of Federal Regulations, Title 45, Part 46 (45CFR46): Protection of Human Subjects. These definitions are as followed:
Research – a systemic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
Human Subjects – living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Select to view the full University Procedure Policy.
IRB Process and Forms
Faculty, student, and other persons conducting research in collaboration with Delta State must fill out the one page Request for IRB Clearance Form A. Required attachments include letters of Informed Consent and Assent, and copies of all surveys and questionnaires. For more information, see Criteria for Informed Consent and Assent Appendix A.
If an application is judged to have ‘minimal risk’ it will be classified as EXEMPT from further IRB review. For details, see Criteria for Exempt Status Appendix B.
If risks are considered greater than minimal, research may still be eligible for EXPEDITED REVIEW by three IRB members. For details, see the Expedited Review section of the IRB Policy.
If any phase of externally funded research, including the write-up, extends beyond one year, researcher will submit a Request for Continuing IRB Review Form B.
Research which does not qualify for EXEMPT status or Expedited Review must have a FULL IRB REVIEW. See Request for Full IRB Review Form C.
IRB clearance must be obtained prior to the beginning of any research involving human subjects. Every researcher must have a current NIH certificate, which can be obtained by completing the certification process on the NIH Office of Extramural Research website at http://phrp.nihtraining.com/users/login.php. For more information, send an email to firstname.lastname@example.org or call 662 to reach the IRB Chair.
Delta State University Federalwide Assurance (FWA) approval number:
Delta State University Institutional Review Board Organizations (IORG) approval number:
For Research Participants
One of the purposes of Delta State University’s Institutional Review Board is to ensure research participants’ rights and safety. If you wish to make a complaint or report an issue concerning a study you have participated in or have been asked to participate in, send an email to email@example.com or call 662 to reach the IRB Chair.
For more information, contact:
Dr. Beverly M. Moon, IRB Chair
Kent Wyatt Hall Room 239
Delta State University
Cleveland, MS 38733