See also: Human Subjects Inclusion Codes.
Scientific review group concerns of unacceptable risk or inadequate protection can result in a bar or restriction to award—see the Bars and Restrictions to Grant Awards—Human Subjects SOP. If you see a code on your summary statement, read Know What a Summary Statement Means.
These codes reflect the status of human subjects involvement on summary statements of grant applications and on the grants management and program officer worksheets in IMPAC II:
- Code 10—Award can be processed, no human subjects involved.
- Codes X1-X8—Award can be processed, human subjects involved, designates an exemption.
- Code X1—Exemption category 1—research is conducted in an educational setting using normal educational practices.*
- Code X2—Exemption category 2—research uses educational tests, surveys, interviews, or observations of public behavior, unless subjects are identifiable and disclosure could place them at risk.
- Code X3—Exemption category 3—research uses benign behavioral interventions.
- Code X4—Exemption category 4—secondary research involves the collection or study of identifiable private information or biospecimens, if the sources are publicly available, the information is recorded so subjects cannot be identified, the information collection and analysis is regulated under HIPAA, or the research is conducted by or on behalf of a federal department or agency, using data obtained for non-research purposes and subject to federal privacy standards.
- Code X5—Exemption category 5—research involves public service program or demonstration project.
- Code X6—Exemption category 6—research evaluates taste and food quality.
- Code X7—Exemption category 7—research involves storage of identifiable information or biospecimens for secondary research use. Broad consent and limited institutional review board (IRB) are required.
- Code X8—Exemption category 8—secondary research uses identifiable information or biospecimens. Broad consent and limited IRB are required.
- Code 20—Award cannot be processed, human subjects involved and no appropriate exemption designated.
- Code 30—Award can be processed, human subjects involved, no scientific review group (SRG) human subjects concerns.
- Code 35—For institutional training grant trainees working on mentored projects that involve human subjects, Federalwide Assurance required just-in-time.
- Code 48—At time of award, restrictions will apply.
*Cannot include any other procedures, such as collecting clinical data or biospecimens.