Which Form to Use
Decide which form to use based on the level of potential risk to the research subjects.
Greater than minimal risk
Full IRB review
If your research project involves greater than minimal risk, it must be go through full IRB review for approval.
Examples of full IRB review research:
- Research with children and other vulnerable populations
- Research that involves experimental drugs or devices, invasive procedures
- Research involving deception
- Survey research that involves sensitive questions or information about sexual practice or illegal behavior
- Any survey or interview that is likely to be stressful for the subject
To qualify for expedited review, an activity must:
- Involve no more than minimal risk, and
- Be found on the list of Expedited Review Categories of Research
Minimal risk: 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 test.
Examples of minimal risk research:
- Non-invasive recording of data from subjects
- Minimal blood draw amounts
- Voice recordings
- Non-stressful research on individual or group behavior
- Moderate exercise by healthy volunteers
When making a decision about minimal risk of research, consider both magnitude and likelihood of risk. A more serious risk may be permissible if its probability is extremely low. For example, airplane flight carries a risk of death, but it occurs only once in some millions of passenger miles.
Risks of ordinary, non-invasive diagnostic tests such as routine blood draws in adults, general physical exams, pen-and-paper tests, and ultrasound exams (at accepted levels) are okay; however, minimal risk may be age- or context-dependent: blood draws may be minimal risk for someone old enough to give consent, but not for a needle-shy child. And the context-dependent “ordinary” risk of a sick patient experiencing numerous invasive procedures differs from that of a healthy individual.
Remember that risks need not be “physical” to be “greater than minimal.” For example: a privacy/confidentiality risk, informational risk, or risk of embarrassment may qualify the research as “greater than minimal risk,” requiring full IRB review.
Screening for IRB review exemption
DHHS Guidelines (45 CFR Part 46.101(b) and (c)) define research as exempt from further IRB review when the research involves no risk to the subject. Research that is considered exempt from full IRB review must still be submitted to the IRB and screened for exempt status. The final determination of level of review will be made by the IRB upon receipt of the application form.
Examples of exempt research: survey interview research with adult subjects; the use of nonidentifiable laboratory specimens; review of nonidentified existing records; observation of the public behavior of subjects where there is no manipulation of the subject; and some educational testing and classroom activity.
Use the Exempt Review Categories of Research to decide which exemption category might apply to your research and which form to then use. If you don’t see a category for your research, expedited or full IRB review is probably required.
Exempt review categories of research
Research conducted in educational settings, involving normal educational practices.
Instructional Research in Educational Settings
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- Research on regular and special education instructional strategies, or
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
This category may be applied to research involving children.
Examples of Research in Category 1:
- Evaluating the use of accepted or revised standardized tests
- Testing or comparing a curriculum or lesson
- A program evaluation of pharmacy continuing education
Category 1 Form:
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior.
Surveys/Interviews; Standardized Education Tests; Observation of Public Behavior
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior unless:
- Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- Any disclosure of the human subjects’ responses outside the research could reasonably place employability, or reputation.
Surveys on sensitive or personal topics that may cause stress to study participants are not exempt from IRB review.
This section pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity. This section is not applicable to survey or interview research involving children.
Examples of Research in Category 2:
- Surveying teachers, nurses, or doctors about a technique or an outcome
- Interviewing managers about a management style or best practice
- Conducting a focus group about an experience or an opinion of a community program
Category 2 Form:
Research involving the activities in category 2 and the human subjects are elected or appointed public officials or candidates for public office.
Public Officials; Surveys/Interviews; Educational Tests; Observation of Public Behavior
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior not exempt under category 2 if:
- The human subjects are elected or appointed public officials or candidates for public office, or
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Examples of Research in Category 3:
- Interviewing public officials about a local or global issue
Category 3 Form:
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens.
Existing Data; Records Review; Pathological Specimens
Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
To qualify for this exemption ALL of the data, documents, records, or specimens must be in existence before the project begins.
Records considered private based on federal and state statute, including medical records and education records, require written release by the study subject or by the custodian of the record. Researchers are cautioned that review of private records involving access to and/or recording of identifiable information is not exempt from IRB Review and requires written consent of the study subject. Review of existing public records do not require prior consent of subjects.
Pathological or diagnostic specimens that are considered waste and are destined to be destroyed can be used in research and are considered exempt from IRB review if there are no patient identifiers linked to the specimen and if the data is not intended to be used in the diagnosis or treatment of a patient. (If either of these conditions apply, consent of the research subject and IRB review is required.) Specimens retrieved as extra during a clinical procedure require IRB review and written consent from the subject.
Inclusion of fetal tissue in the pathological specimens category of exempt research is prohibited by regulation.
Examples of Research in Category 4:
- Analyzing de-identified tissue samples or data set
- Analyzing de-identified national test scores
- Analyzing census data about aging or housing
Category 4 Form:
Reserved for Federal Government Research. Not available for local IRB exemptions.
Public Service Programs; Demonstration Projects
Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
- Public benefit or service programs
- Procedures of obtaining benefits or services under those programs
- Possible changes in or alternatives to those programs or procedures; or
- Possible changes in methods or levels of payment for benefits or services under those programs
Taste and food quality evaluation and consumer acceptance studies.
Taste Testing and Food Quality Evaluation
Taste and food quality evaluation and consumer acceptance studies:
- If wholesome foods without additives are consumed, or
- 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.
This category may be applied to children; however, university policy requires written parental consent to include children in taste testing studies.
Examples of Research in Category 6:
- Taste testing whole grain food products
- Comparing taste or smell of molasses, cheese or milk
- Sampling texture of ice cream
Category 6 Form:
What if more than one category applies to the research?
Complete the exempt application form where the majority of the research clearly matches. Include description of the additional exempt category research in this application as well.