GUIDELINES FOR APPLICATION FOR APPROVAL OF RESEARCH

INVOLVING HUMAN SUBJECTS

WHEN IS REVIEW REQUIRED?  All research and research-related activities involving human subjects must be reviewed and approved by the IRB in writing prior to initiation of a project.  Review by the IRB is required whether a project is conducted by faculty members, graduate students, undergraduate students, or staff.  It is required whether the project receives external funding, internal funding, or no funding.

WHO SHOULD COMPLETE THE APPLICATION?  This application should be completed by the principal investigator.  If that is a student, the application must list the student's faculty sponsor as principal investigator and the student as co-principal investigator, and should be approved and signed by the named faculty sponsor.

WHAT TO SUBMIT?  One original of the completed, signed application and all supporting materials must be forwarded to the Office of Research Administration, Room 319 National institute of Aviation Research Building, campus box #7.  Supporting materials include, but are not limited to, informed consent forms, questionnaires, survey instruments, letters of approval from cooperating institutions, etc.

WHAT ARE THE LEVELS OF REVIEW?

Full IRB review is required for all research posing greater than minimal risk to subjects.  In addition, full review is required for all research activities involving vulnerable subject populations, including, but not limited to, pregnant women, prisoners, and psychiatric patients.

Expedited IRB review is provided for research that presents no more than minimal risk to subjects, and involves

only procedures listed in one or more of the following categories:

•  research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis);

• collection of data from voice, video, digital, or image recordings made for research purposes;

•  research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies;

•  clinical studies of drugs and medical devices only when a new drug application (21 CFR Part 312) is not required;

•  clinical studies on medical devices for which an investigational device exemption application is not required or the medical device is cleared/approved for marketing;

•  collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, nonpregnant adults who weigh at least 110 pounds;

•  collection of biological specimens for research purposes by noninvasive means, such as hair and nail clippings, teeth, excreta, and external secretions (including sweat and saliva);

•  collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in cilinical practice, excluding procedures involving x-rays or microwaves, and

• continuing review of research previously approved by the convened IRB.

The expedited review procedu res may not be used where identification of the subjects or their responses would place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing.