Human Subjects Research
The University of the South Institutional Review Board
IRB Review Guidelines
 Why do we need an IRB?
The University of the
South IRB is required by federal policy for human subjects protection -- this federal policy is known as “The Common Rule”. The Common Rule requires an institution that is conducting research to assure the federal government that it will provide and enforce protections for human subjects of research conducted under its auspices. The Common Rule was first promulgated by the U.S. Department of Health and Human Services (then known as DHEW) in 1974, and extended to 16 governmental agencies in 1991.
The Common Rule is based on the ethical principles articulated in The Belmont Report (issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). The three basic principles are:
[a] Respect for persons:  individuals should be treated as autonomous agents, capable of making autonomous choices;  persons with diminished autonomy, such as children and prisoners, are entitled to protection -- the extent of protection (ranging from ensuring that activities are undertaken freely and with an awareness of possible adverse consequences to “extensive protection”) depends on the risk of harm and likelihood of benefit, as well as the capacity for self-determination of the individual.
[b] Beneficence:  do no harm -- when there is a risk of harm, this is only justifiable when the benefits are considered to outweigh the harm;  maximize possible benefits and minimize possible harms.
[c] Justice: the benefits and burdens of research should be justly and fairly distributed.
 What is the purpose of the University of the
South IRB ?
The goal of the University of the South IRB is to assist Principal Investigators at the University of the South in their efforts to protect the rights and welfare of individuals who participate in research conducted at or under the auspices of the University, and to ensure the University of the South’s compliance with federal regulations regarding the protection of human subjects. To meet these goals, the IRB will provide Principal Investigators with information about ways to design their research projects in a manner to minimize potential harm to human subjects, review all planned research involving human subjects prior to initiation of the research, approve research that meets established criteria for protection of human subjects, and monitor approved research to ensure ongoing protection of human subjects. The IRB does not review the scientific merit of research studies; however, the IRB does evaluate the risks to subjects in light of the potential benefits of the study, which requires a consideration of the scientific merit of the study.
 Does my project or proposal need IRB Review?
Federal regulations require that any project or proposal that involves research (“a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”) with living individuals 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 must be reviewed either by the University of the South IRB or by individual departments of the University. The University of the South IRB reviews all federally- and state-funded research proposals and projects, all proposals that require human subjects assurance for other outside funding sources, as well as research conducted by investigators external to the University of the South that uses data from University of the South students. Individual departments are responsible for human subjects protection for all other research conducted at, or under the auspices of, the University of the South, including pilot studies and students’ studies.
Exemption from Review
Federal regulations stipulate that you do not need a review if you are using existing data that is publicly available, or if you are using existing data from which the investigator records data in such a way that subjects cannot be identified. You also do not need a review if you are conducting research using educational tests, survey procedures, interview procedures or observation of public behavior, UNLESS (I) subjects are identified in, or identifiable from, the data collected; AND (ii) any disclosure of subjects’ responses could place subjects at risk of criminal or civil liability or be damaging to subjects’ financial standing, employability or reputation. If you are not sure if your research is exempt, consult Requesting “Exemption from IRB Review” guideline, or the IRB chair. Note: Protocols that have been granted exemption from the University of the South IRB Review may still be subjected to review mandated by study sites, schools, or collaborating institutions.
Because certain categories of individuals, such as children, are viewed as more vulnerable to harm by research, and less able to give fully-informed consent, extra safeguards are included for children. Federal regulations require that all research with children, including adolescents, must be reviewed, except: observations of children’s public behavior with no interaction with the children; research conducted in education settings of normal educational practices (e.g., on instructional strategies or curricula); research using existing records or data, if these sources are publicly available or if the information is recorded in such a way that the child cannot be identified. When in doubt, consult the IRB chair.
Research that involves only minimal risk to the subject may receive “expedited review” by the IRB chair. “Risk” is defined as the probability of physical, psychological, social or economic harm or injury as a result of participation in a research study. “Minimal risks” are those where the probability of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily experienced in daily life or during the performance of routine psychological or physical examinations or tests. If a Principal Investigator wishes to apply for an expedited review, please read the guideline on Requesting an “Expedited Review” on Appendix C and follow IRB submission instructions.
Training Certification for NIH Proposals
Since October 1, 2000, the National Institutes of Health (NIH) has required all key personnel on funded NIH proposals involving human subjects to complete an educational course on the protection of human subjects. At the University of the South, our training program has two parts:
1) Reviewing the written IRB guidelines (which you are now reading)
2) A web-based training course, at http://phrp.nihtraining.com/users/login.php This training was originally designed for NIH employees. When you are taking the course, you will find that certain parts do not apply to you. Where appropriate, (this should be obvious as you go through the training) declare yourself as an individual required to take the training, but who is not at NIH. In addition, the section on who to contact/who's who does not apply to the University of the South. See our IRB guidelines (below) for this information.
3) Be sure to print out the certificate at the end of the web based course and send it to the IRB Chair. Faculty should also send a copy to Leigh Lentile, Sponsored Research Officer.
Once funded, all key personnel must complete this training. You can not receive IRB approval until the certificate is on file. The time to complete the web-based training is approximately one hour.
 What do I submit to the IRB?
The IRB needs enough information about your study to review it for human subjects protection, and to offer you advice, as needed, on ways to improve human subjects protection. See Appendix A for these guidelines, which outlines ways to protect the rights and welfare of individuals participating in the project.
When you submit your proposal to the IRB, please include the following documents:
*For a full review, please submit 8 copies of each, for expedited review please submit 1 copy.
1. A completed University of the South IRB Cover Sheet
2. A 1-2 page description of the project (this does not need to follow this format -- if the proposal already includes this information, simply submit the appropriate pages from the proposal). Be sure to include:
[a] Description of informed consent procedures (attach informed consent forms). Include a description of plans for the recruitment of research participants and the consent procedures to be followed - the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective participants, and the method of documenting consent.
[b] Information about who will be the subjects of the research -- who are you studying? Outline the characteristics of the study population, including their anticipated number, age range, and health status. Identify the criteria for inclusion or exclusion of any group (e.g., on the basis of gender, race/ethnicity, poverty-status, etc.). Explain the rationale for the inclusion of any “special classes” of research participants, such as children, institutionalized individuals, or others who are likely to be vulnerable.
[c] Information about the data you will collect on these subjects -- what information will you collect, how will you collect it, from whom or from what source will you collect it (interviews with the study participants, questionnaires completed by teachers, doctors’ records, observations, etc.), will the information collected include identifiable private information, or involve intervention or interaction with the subject of the study? Indicate whether the material or data will be obtained specifically for research purposes, or not, and whether you will be using existing records or data.
[d] If the measures being used are not ones commonly known to members of the IRB, attach copies of the measures, so that the IRB can make an informed review of the risks involved in the study, and the adequacy of the procedures for protecting human subjects.
[e] A discussion of the risks of the study, and their likelihood and potential seriousness. If the study involves more than minimal risk, explain why the benefits justify the risk. Include a discussion of what will be done to minimize the risks, including risks to confidentiality, and what provisions have been made in the event that the participants are harmed by the research.
[f] A discussion of the benefits of the research, and analysis of the risks to the participants relative to the anticipated benefits to the participants and to the importance of the knowledge that may reasonably be expected to result.
[g] If applying to NIH: NIH requires that all PIs complete training on the protection of human subjects (see above). Please attach a copy of NIH Training Certificate, if not already on file.
3. If applying for an exemption from review, please attach a completed ‘Requesting Exemption from IRB Review’ form.
4. If applying for an expedited review, please attach a completed ‘Requesting an Expedited Review’ form.
If you have any questions when preparing these materials, feel free to consult with the IRB chair.
Helen V. Bateman
Associate Professor and Chair
Sewanee: The University of the South
735 University Avenue
Sewanee, TN 37383-1000
 Annual Reviews
The IRB is required by 45 CFR 46.109(e) to conduct a continuing review of every "minimal risk or deception" IRB approved protocol. After a proposal is approved by the IRB, PIs are required to submit an Annual Progress Report form to the IRB for continued review – your approval letter will tell you the review date, and the IRB chair will send you an Annual Progress Report form each year, until your study is completed.
APPENDIX A - Protecting the Rights and Welfare of Individuals Participating in Research Studies
Based on the three basic principles of The Belmont Report, there are three core elements to human subjects protection:
 ensuring that individuals can make informed choices about their participation in research, and protecting those individuals with diminished autonomy;
 ensuring that the potential risks of a study are minimal, or are justified by the potential benefits;
 ensuring that the selection of research participants is fair, and not based simply on their easy availability, their willingness to participate, or other considerations not directly related to the problem being studied.
The key elements of a study that meet these goals are:
 The informed consent process. Informed consent is not just a signed form, but a process of communication between researchers and participants that conveys respect for the individual.
For adults able to exercise full autonomy in making choices about participating in a research study, the informed consent process should include the following:
- a statement that the study involves research, an explanation of the purposes of the research, and a description of what participation in the study will involve;
- a description of any reasonably foreseeable risks and benefits to the participant;
- if the study involves health treatments, the participant must be informed of alternative procedures or courses of treatment;
- a statement describing the extent to which confidentiality of records or data identifying the subject will, or will not, be maintained;
- for research involving more than minimal risk (see below), an explanation of the treatment or resources available if any harm occurs;
- identification of whom to contact for further information about the study (e.g., the Principal Investigator), and about participants’ rights in the event of research-related harm (usually the Committee for the Protection of Human Subjects [IRB]);
- a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant in otherwise entitled, and that the participant may discontinue participation at any time.
Informed consent should usually be obtained in writing. However, verbal consent is sometimes acceptable (e.g., under conditions of minimal risk, or where written consent would jeopardize the benefits of the study).
For individuals with “diminished autonomy” (for example, children), informed consent procedures typically involve obtaining consent from an individual who has the legal authority to make decisions about the individual’s participation in research. In the case of children, The Ethical Standards for Research with Children of the Society for Research in Child Development suggest that informed consent should be obtained from parents, legal guardians or those who act in loco parentis (e.g., teachers, school superintendents). Where feasible, children should also be given the opportunity to assent to participate, even if they do not fully comprehend the full significance of such assent, as well as the opportunity to refuse to participate.
 Identification of the risks and benefits of the study. “Risk” is defined as the probability of physical, psychological, social or economic harm or injury as a result of participation in a research study. “Minimal risks” are those where the probability of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily experienced in daily life or during the performance of routine psychological or physical examinations or tests. The investigator has three responsibilities: one is to reduce the risks (and maximize the benefits); the second is to explain the risks to potential participants so that participants can decide for themselves whether or not they want to take the risk; the third is to provide appropriate remedies or treatments for individuals who are harmed by the research. Where the risks are more than minimal, the investigator must provide evidence to the IRB that the benefits justify the risk.
 Sample selection. Sample selection is important because it addresses the third ethical principle of The Belmont Report: justice. Much of the research that has been done to date can be criticized on two different grounds. First, when research involves only white, middle-class males, the benefits of that research are only available to white, middle-class males (both to those who participate in the study, and to those whose health care, employment or other benefits are improved as a result of the study). A related problem associated with samples limited to white, middle-class males is that the results of those studies have been presumed, often inaccurately, to apply to men of color, women, and working class or poor individuals -- such an assumption potentially deprives these groups of the benefits of research. Second, when research uses readily-available subjects, such as soldiers, prisoners, or institutionalized individuals, or uses subjects who are disenfranchised in other ways, such as the poor, the risks of those studies fall disproportionately on the disenfranchised. Therefore, investigators are encouraged to use sampling designs that allow the benefits and risks to be fairly shared among those populations appropriate for inclusion in the study on scientific grounds.
Exemption from IRB.pdf
Click above for information on exemptions to IRB requirements and how to apply for an exemption.