Western Kentucky University

Levels of Review

Levels of Review

Human Subjects Regulations Decision Charts

The IRB certifies human subject research at the three following review levels:

  • Exempt Review
  • Expedited Review
  • Full Board Review

Exempt Review

Although the category is called "exempt," this type of research does require IRB review and registration. The exempt registration process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into one of six federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. The following are examples of Exempt Research:

  • Projects that use existing data, documents, records, or specimens properly obtained and either:

* subjects cannot be identified in the research data directly or statistically, and no one can track subjects' identities

* the sources are publicly available.

  • For research not involving vulnerable subjects the intent is to observe public behavior, or conduct interviews or surveys or educational tests and either:

* the subjects cannot be identified, directly or statistically; or

* the responses/observations could not harm the subjects if made public; or

* federal statute completely protects all subjects' confidentiality;

* all respondents are candidates or elected or appointed public officials.

  • In educational settings, research or evaluation of normal educational practices.
  • To be catagorized as Exempt Review the research project must also meet the following criteria:

* If potentially exempt because subjects cannot be identified, the research must protect anonymity; and

* If subjects give information about others, inadvertent disclosure presents no more than minimal risk to those others.

Expedited Review

Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers among members of the IRB to evaluate and approve specific types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a subcommittee cannot approve the research under expedited review, the study is referred to the full Committee for review.

 

To qualify for an expedited review, research must fall into one of nine federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of expedited research are:

  • collection of existing data, documents, records, or specimens that was originally approved at the expedited level
  • moderate exercise by healthy volunteers
  • drugs or devices not needing investigational new drug or device exemptions
  • individual/group behavior or characteristics without manipulation or stress, recording data from adults by non-invasive clinical procedures, e.g., weight, height, eye-color
  • collection of blood samples from ambulatory non-pregnant adults (Not more than 2x/wk, less than 550ml in 8 wks)
  • collection of hair, nail clippings, deciduous or permanent teeth needing extraction
  • collection of supra-/sub-gingival dental plaque/calculus by prophylactic scaling
  • non-invasive collection of excreta - e.g., sweat, saliva, placenta, amniotic fluid
  • voice recordings for research - e.g., investigation of speech defects

Full Board Review

All projects that do not fall into either the Exempt or Expedited Review categories, or deal with special concerns or vulnerable populations go to the full IRB for review. This is the most rigorous level of review. Full Board Review Research involves the following:

  • Research projects that have special concerns or involves vulnerable populations.

* Children: Both assent of child and permission of parents is required. Research with more than minimal risk but no direct benefit to the child is restricted.

* Pregnant women or fetuses: Research is severely restricted; the IRB must assure appropriate process to select, inform, and obtain consent of subjects.

* Subject selection is from individuals considered to be representative of an ethnic minority group or are unable to speak English.

* Prisoners: Severely restricted research.

* People with mental impairment: No regulations apply, but because informed consent is problematic, and the subjects are vulnerable, this type of research should be limited.

  • Projects that involve possible coercion or undue influence that induces or entices consent, e.g., excessive compensation, inequitable relationship, etc.
  • Sensitive information is being gathered, e.g., child abuse, violence, sexual conduct/misconduct, mental health/status information, AIDS, alcohol, compulsive disorders, etc.
  • Does the research present more than "minimal risk?" "Risk" means both magnitude of harm, and the probability of incurring harm. "Minimal risks" means risks a non-vulnerable person ordinarily encounters in daily life in routine medical, dental, or psychological exams. For research with greater than minimal risk, the IRB should ensure that the researcher's benefits are maximized and risks minimized and compare its scientific merit to its risks.
  • For genetic research, and research using blood and other body tissues: the protocol must:

a. discard the blood/tissue without doing tests beyond the protocol, or have no personal identifiers; and

b. either promise not to grow perpetual cell lines, or mention that possibility in the consent process.

  • Major deception, e.g., intentionally misleading subjects about their status, giving false information about the researchers or the research purpose.
  • Minor deception, e.g., incompletely disclosing the full purpose of the study, to avoid biasing the results.

Other IRB Issues and Concerns: Items to be considered.

  • In situations when there is more than minimal risk, the IRB determines if the scientific merit outweigh risk, and if the benefits are maximized and the risks are minimized?
  • Should the IRB require reports from the principal investigator and review this project at shorter intervals than annually?
 Last Modified 7/22/13