If you plan to conduct research involving human subjects, you must submit an application for IRB review or request an exemption from IRB review. You must receive IRB approval of your application prior to the initiation of the research. Additionally, you must submit an application for continuing review before the IRB approval expiration date. Approval will not be given for more than one year.

If there are changes in the protocols, sponsor, investigatorship, or informed consent procedures at any time during the course of the research, you must submit those changes to the IRB for approval.

Federal regulations require the IRB to ensure that investigators promptly report “any unanticipated problems involving risk to subjects or others” (UPIRTSO). The IRB defines UPIRTSO as any problem or event which in the opinion of the local investigator was unanticipated, serious, AND at least possibly related to the research procedures.

• UPIRTSO policy
• UPIRTSO form
  

IRB APPLICATION FORMS

***ALL forms must be typed -- Handwritten forms will NOT be accepted***

Clinical Research Sample Consent Form
Social Sciences Research Sample Consent Form

Full and Expedited IRB Review Forms:
Initial Review of Clinical Research
Initial Review of Social Science Research
Continuing Review of IRB-Approved Clinical Research
Continuing Review of IRB-Approved Social Science Research

Request for IRB Review Exemption Forms:
Category 1 Form: Investigational Strategies in Educational Setting
Category 2 Form: Surveys/Interviews, Standard Educational Tests, Observation of Public Behavior
Category 3 Form: Public Officials, Surveys/Interviews, Educational Tests, Observation of Public Behavior
Category 4 Form: Existing Data: Records Review, Pathological Specimens
Category 6 Form: Food Quality and Consumer Acceptance Studies

APPENDICES
(As you complete your IRB application, you may be prompted to include one or more appendices.)

Appendix A: Sponsored Projects
Appendix C: Prisoners as Subjects
Appendix E: Drugs and/or Biological Products
Appendix F: Use of Devices in Research
Appendix H: Use of Protected Health Information (HIPAA)
Appendix I: Targeting/Inclusion of Vulnerable Populations
Appendix J: Student as PI
Appendix K: International Research
Appendix L: Field Work
Appendix M: Research in Schools
Appendix N: Debriefing for Research Involving the Use of Deception
Appendix P: Research Methods Class Protocol
Appendix R: Use of Radiation
>>FORM: Ionizing Radiation in Human Subjects Research
Appendix T: Tissue and Sample Storage
Appendix W: Informed Consent Waivers

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

Minimal risk
Expedited Review
To qualify for expedited review (see 45 CFR 46.110), 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 tests" (from 45 CFR 46.102(i)).

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 embarassment may qualify the research as "greater than minimal risk," requiring full IRB review.

No risk
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
Category 1. Research conducted in educational settings, involving normal educational practices.

Federal Definition
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:
Investigational Strategies in Educational Setting

Category 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior.

Federal Definition
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:
Surveys/Interviews, Standard Educational Tests, Observation of Public Behavior

Examples of Research in Category 3:

• Interviewing public officials about a local or global issue

Category 3 Form:
Public Officials, Surveys/Interviews, Educational Tests, Observation of Public Behavior

Category 4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens.

Federal Definition
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:
Existing Data: Records Review, Pathological Specimens

Category 5. Reserved for Federal Government Research. Not available for local IRB exemptions.

Federal Definition

Category 6. Taste and food quality evaluation and consumer acceptance studies.

Federal Definition
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:
Food Quality and Consumer Acceptance Studies

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.