Who makes the determination that the research is exempt?
At CHOP, the IRB's SOPs place the responsibility on the IRB for making the determination. At other institutions, others may be responsible or share the responsibility with the IRB.
Is a protocol needed to submit for a determination of exemption?
No. The CHOP IRB does not require a full protocol. A description of the study should be entered into eIRB Question 3.01 (1.0). The question reads "Provide a summary of the proposed study including: 1) the age range of subjects; 2) projected enrollment at CHOP and total enrollment study-wide; and 3) description of study procedures. If the study will enroll children, provide the justification for involving children in this research."The information should include enough information so that the IRB can determine that the research qualifies as exempt.
Does Category 2 apply to research involving children?
Surveys and observations of behavior require IRB approval this is usually through expedited review. The lone exceptions are observations of public behavior where the investigator has no interactions with the subjects, for example, watching children play on a playground.
When research is not federally funded, the CHOP IRB's SOPs permit an expansion of Category 2 to include adolescents for whom the IRB would otherwise waive the requirement for parental permission.
Does the IRB approve the consent form for exempt research?
When the research is exempt, that means that none of the requirements of 45 CFR 46 apply. This means that the IRB has no role in the review and approval of the consent documents. The eIRB application Question 3.02 (3.0) requests that the investigator provide a description of the plan for obtaining the informed consent of the participants (if applicable). A copy of the consent form is not required. This request is not due to the regulatory requirements of 45 CFR 46 but rather is due to the additional standards set by CHOP's Human Subjects Protection program. As a service to investigators, the IRB provides an consent form template (on the Consent Form Templates page) that can be used/modified for exempt research.
When is an amendment necessary for research determined to be exempt?
When the IRB determines that the research qualifies for exemption from the federal regulations it means that the IRB has no oversight over the ongoing research. Changes to the exempt research do not need to be submitted to the IRB for approval unless the changes affect the original determination of exemption. For example, if research was originally limited to review of existing records will now involve prospective medical records, that research is no longer exempt and would require IRB approval.