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Review Process

The following description of the IRB review process reflects the various ethical principles and regulatory requirements that each investigator should consider during the design phase of their project. In order to approve a research project involving human subjects, the IRB must assure itself that (1) the prospective subject population is appropriate in terms of characteristics and number, (2) the recruitment of subjects is free of coercion, (3) the experimental design of the study is sound, (4) any risks associated with the research project are minimized to the greatest extent possible, (5) the potential benefits are maximized to the greatest extent possible, (6) the risks to the subject are outweighed or balanced by the potential benefits, (7) the level of subject compensation (if any) is fair and non-coercive, (8) the degree to which confidentiality is maintained is acceptable, (9) the method used to obtain informed consent is ethically and legally acceptable, and (10) the investigator has the appropriate qualifications, experience and facilities to conduct the research.

The IRB review process is not particularly concerned with the nature of a research topic. Providing the rights and welfare of the subjects are adequately protected and the protocol will be conducted in full compliance with HHS regulations, it does not matter what the research topic is or how controversial it is perceived to be. However, after IRB review and approval is obtained, it is possible that a research project could require an additional level of review. As per 45 CFR 46:112, research that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. Those officials cannot, however, approve any research project unless it is first approved by the IRB.

  1. Review of the Prospective Subject Population 
    The prospective subject population must be appropriate with respect to the nature and goals of the research. In addition, the investigator should be guided by the principles which lead to an equitable selection of subjects with regard to the potential risks and benefits of the research. The IRB, therefore, will examine carefully the characteristics of the subject population. Factors such as the required number of subjects, age range, sex, ethnic background, and health status will be considered. The utilization of any vulnerable classes of subjects such as sick persons, pregnant women, fetuses, prisoners, children, elderly persons, mentally disabled persons, and persons who are educationally or economically disadvantaged must be clearly justified. Although the use of vulnerable persons as subjects is not prohibited by any regulations or ethic codes, justification for involving vulnerable persons in research generally becomes more difficult as the degree of risk and vulnerability increases. 

    Naturally, there are exceptions to the principle of "equitable selection of subjects." For instance, research involving the social consequences of a disease to which only one ethnic or racial group is susceptible would not require the application of this principle. Two examples are sickle cell anemia in the black population and Tay-Sachs Disease, which affects Jewish people. (In cases of unequal access, a full explanation is required.)
  2. Review of Method(s) of Subject Recruitment
    The IRB will review the method of prospective subject identification and recruitment in order to be assured it is ethically and legally acceptable. Advertisements used to recruit subjects are considered an extension of the recruitment and informed consent processes and, therefore, must be reviewed by the IRB.
  3. Review of Research Methods and Procedures 
    The IRB will review the experimental design in order to be assured that the potential risks to the subjects are minimized and the potential benefits maximized by using procedures consistent with sound research design. The IRB accepts the need for certain types of behavioral and social science studies to employ strategies that include either deception and/or the withholding of information. Employment of such strategies must, however, be fully justified. In general deception is not acceptable if, in the judgment of the IRB, the subject would have declined to participate had she/he been informed of the true purpose of the research. Studies which use deception and/or the withholding of information as part of their experimental design must include a post-study debriefing unless a waiver is granted by the IRB.
  4. Review of Potential Risks
    A risk is a potential harm (injury) associated with the research that a reasonable person would be likely to consider significant in deciding whether or not to participate in the research. The concept of risk includes, but is not limited to, discomfort, burden, or inconvenience a subject may experience as a result of the research procedures. Underlying the consideration of risk, is the implicit moral guideline that all investigators have a duty not to harm their subjects and must minimize potential risk to the greatest extent possible.

    The five major types of risks are:
    • physical risk (e.g., pain, bruising, and infection associated with venipuncture, muscle soreness and pain as a consequence of exercise testing, heart attack induced by maximal exercise test);
    • psychological risk (e.g., stress associated with psychological testing, stimulation of painful memories, feelings of guilt or discomfort precipitated by a sensitive survey);
    • social risk (e.g., invasion of privacy, loss of community standing);
    • legal risk (e.g., criminal prosecution or revocation of parole); and
    • economic risk (e.g., loss of employment, loss of potential monetary gain).

      Both immediate and delayed risks of any procedure involving human subjects will be reviewed by the IRB.  In addition, the estimated probability, severity, average duration, and reversibility of any potential harm will be considered according to available empirical data.  Furthermore, since certain populations of vulnerable subjects may be at greater risk than others, the IRB will take into consideration the potential risk characterization of the subjects.  Victims of child abuse or assault, for example, may be at increased risk in sociological or psychological studies.  Children, the elderly, prisoners, the mentally disabled, and various ethnic groups may incur an increased level of risk in certain kinds of research projects.

      Risk can also be classified as less than minimal, minimal, and greater than minimal. Federal regulations (45 CFR 46.102(i)) define minimal risk as, "The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." The term "minimal risk" is used as a base or standard by which the risk associated with research is judged.

      Examples of "less than minimal risk" procedures include collection of urine, collection of sweat, weighing, pulse measurement, blood pressure measurement, voice recordings, skin fold body composition measurements, and any standard psychological testing with no stress. In actuality, most "less than minimal risk" procedures are interventions that usually (but not always) have no known associated risk. For example, if an investigator were to take one blood pressure measurement using a sphygmometer, this would clearly be a "no known risk" procedure. If, however, the investigator's protocol requires monitoring of the subject's blood pressure every thirty minutes during a five-hour written exam given for board certification, the associated risk would be at least "less than minimal" as opposed to "no known risk." This is because of the inconvenience and discomfort associated with multiple interventions. Since risk is such a relative concept, the IRB classification system does not distinguish between "no known risk" and "less than minimal risk" research except for the purpose of risk disclosure on the consent form.

      Examples of "minimal risk" procedures include electrocardiography, collection of blood by venipuncture from healthy adults who are not pregnant, moderate exercise testing, administration of standard psychological tests with only a minor level of associated stress, and magnetic resonance imaging. Examples of "greater than minimal risk" procedures include radiology exams (x-ray, CT scan), maximal exercise testing, and stressful psychological testing, including asking sensitive or personal questions on a survey.

      The IRB will review carefully the risk classification of the research which determines the type of IRB review and consent form format. Under certain circumstances, application of the minimal risk classification will be based upon a consideration of the risks inherent in each subject's life, thereby resulting in a relative standard of minimal risk. Thus, for example, the standard of minimal risk may be different when applied to a person with cancer or mental retardation versus a healthy person.
  5. Review of Potential Benefits 
    A benefit is a valued or desired outcome. Benefits associated with participation in research can be classified generally as those that accrue to the subject directly (e.g., acquisition by the subject of knowledge considered of value) and those that accrue to society (e.g., additions to the knowledge base). The IRB will review the anticipated benefits to both the subject and to others. In addition, the IRB will consider whether the benefits are maximized to the greatest extent possible through proper protocol design. Therefore, an underlying moral notion of "beneficence" should guide the investigator.

    Financial or other forms of compensation are not considered a benefit to be derived from research participation. Although the subject may consider financial compensation a desirable outcome, this fact will not be used in the risk/benefit analysis.
  6. Risk/Benefit Analysis 
    Once the potential risks and benefits are identified, an ethical review of research requires an examination of the relationship of the risks to the benefits. Risks and benefits cannot be considered parallel constructs and, therefore, no formula is applicable. The various ethical codes and regulations, however, require a favorable balance between harm and benefit. To assist the investigator and the IRB in assessing the risk/benefit relationship the following principles are provided.

    In non-therapeutic research the potential risk to the subject must be outweighed or balanced by the potential benefit to the subject and/or by the potential benefit to society.

    In research where a standard therapy (not part of the research protocol) is employed solely for the benefit of the subject along with additional procedures performed solely for research purposes, the anticipated benefits of the therapy must not be used to justify exposing subjects to the risks associated with the research procedures. Such risks can only be justified in light of the potential benefits of the research procedures. Therefore, only the risks associated with the research procedures should be used in determining the risk/benefit ratio.
  7. Review of Subject Compensation 
    The IRB will review the amount of compensation (monetary as well as other forms) in order to be assured that it is not coercive and is equitable in distribution.
  8. Review of Confidentiality
    The IRB will review the methods to be used to preserve confidentiality. If research data with subject identifiers will be made available to persons other than the listed investigators, sponsor or federal agency, the IRB will review the justification for sharing these data and determine acceptability.
  9. Review of Informed Consent 
    Although there are federal regulations requiring the subject or the subject's legally authorized representative to give consent prior to the subject's participation in an experiment, the principal reason for informing subjects about an experiment is that they have a moral right to know what is to be done to them and what risk this entails before they give their consent. Human beings are considered autonomous, and the requirement of informed consent is designed to uphold the ethical principal of "respect for persons." The use of human subjects is a privilege--a favor--granted to the researcher, rather than a right. An experiment is something that is done to the subject either primarily or solely for the purpose of advancing knowledge. Indeed, in non-therapeutic research the subject seldom receives any benefit. In order for consent to be ethically and legally valid, it must meet the requirements stated in Principle I of the Federal Regulations (45 CFR 46:116) which is based, in part, upon the Nuremberg Code. Principle I of the Nuremberg Code states, "The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision." The legal documentation of informed consent is the consent form signed by both the subject and the investigator. The ethical and, indeed, legal validity of consent is, however, dependent upon the process of informed consent which requires the investigator to engage in dialogue or negotiation with the prospective subject. The consent form, therefore, should be used by the investigator as an instrument to guide the negotiations with the prospective subject. The informed consent form must embody the elements of informed consent contained in the HHS regulations as reflected in the IRB Guidelines. The IRB will review both the consent form and the process of informed consent to ensure its acceptability.
  10. Review of Investigator Qualifications 
    The IRB will review investigator qualifications and must be assured that a) the investigator has the appropriate qualifications and licensure to carry out the procedures involving human subjects with an acceptable degree of risk, and b) the investigator has adequate facilities and equipment to conduct the research with an acceptable degree of risk.
  11. Review of Monitoring Requirements 
    The IRB will determine whether or not a research project requires review more often than annually and will establish an appropriate monitoring procedure which may include observation of the consent process, observation of on-going research, and review of research records.
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