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 Appendix A: Criteria for Informed Consent and Assent.
Appendix A: Criteria for Informed Consent and Assent
Additional information may be included at your discretion:
- a statement identifying the researchers and their affiliations.
- an invitation to participate in the study as part of a research project.
- an explanation of the purpose of the research, the expected length of time of the subject’s involvement, a description of the procedures to be followed, and identification of any procedures which are experimental in nature.
- a description of any benefits to the subject or others which may reasonably be expected from the research.
- a description of compensation (if any) for participation (money, extra course credit, etc.).
- a statement describing the subject’s anonymity or the extent to which confidentiality of records identifying the subject will be maintained.
- the names, addresses, and phone numbers of the people to contact for answers to questions about the research, and the office to contact for questions about the rights of research subjects.
- an assurance that participation is voluntary and that the subject may withdraw from participation at any time.
- for subjects under 18 years of age (or custodial adult) parental consent is required for any research in the expedited or full review categories. The IRB may waive that requirement under special circumstances. Written consent of a school administrator is required for all research, whether exempt or not.
- for subjects under 18 years of age, a statement of informed “Assent” is required. “Assent” refers to the willingness of the research subject to participate. Thus, if the research subject is a minor (under 18 years of age) both parental (custodial) consent and “Assent” are required.
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.
Appendix B: Criteria for Exempt Status
The criteria stated below must be met in order to qualify for the exempt status. However, research described in category 2 below that is supported by federal funds and which involves subjects under the age of 18 may not be certified as exempt. An exception may be made if the research subject is enrolled in college. If the project otherwise meets the above criteria for exempt status, it may be reviewed by expedited procedures. Questions regarding the protection of human subjects should be submitted to the Chair of the IRB.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies; or (b) research on effectiveness of or comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures or observation of public behavior, unless a research subject will be under 18 years of age*. However, such research is NOT EXEMPT if a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; or (b) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under category 2, may be considered EXEMPT if (a) the human subjects are elected or appointed public officials or candidates for public office; or (B) confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection and study of existing data, documents, records, pathological specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads, and which are designed to study, evaluate, or otherwise examine (a) public benefit or service programs; (b) procedures for obtaining benefits or services under these programs; (c) possible changes in methods or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed: or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be Safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
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 662-846-4700 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 662-846-4700 to reach the IRB Chair.
For more information, contact:
Dr. James A. Gerald, IRB Chair
Kent Wyatt Hall Room 239
Delta State University
Cleveland, MS 38733