Policy Title / Exempt Determination

Policy

Research projects that meet the criteria set forth by the federal regulation 45 CFR 46.101(b) may be exempt from IRB review. The PI must submit a Request for Exemption Determination Form (located on website) with all supporting documents to the IRB for consideration.

All requests for exempt determination for a study being conducted at a Providence Health Care ministry or by a Providence Health Care/Providence Medical Group investigator, must be accompanied by a signed Facility Approval Form (located on the IRB website).

The IRB makes the final determinationwhether a research activity is exempt from review.

Procedure

  1. Research in which the only involvement of human participants is in one or more of the following categories may be exempt:

Category 1 - Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

  1. Research on regular and special education instructional strategies; or
  2. Research on the effectiveness of the comparison among instructional techniques, curricula, or classroom management methods.

Category 2 - Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior unless:

  1. Information is recorded is such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
  2. Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability; or be damaging to the subjects’ financial standing, employability, or reputation.

Note: This category does not apply to research involving children, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.

Category 3 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under Category 2 (above) if;

  1. The human subjects are elected or appointed public officials or candidates for public office; or
  2. Federal statue(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Category 4- 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 by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Note: This category applies only to data that is already existing “on the shelf” at the time of exempt determination request. This exemption may not be applied to activities involving prospective collection of such materials.

Category 5 - 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

  1. Procedures for obtaining benefits or services under those programs
  2. Possible changes in or alternatives to those programs or procedures; or
  3. Possible changes in methods or levels of payment for benefits or services under those programs.

Note: This applies only if the program under study delivers a public benefit, such as a medical or financial benefit provided under the Social Security Act, or provide a public service, such as nutritional or social services, provided under the Older Americans Act; the research or demonstration project must be conducted pursuant to federal statutory authority; there is no statutory requirement that the project be reviewed by an IRB; and, the project may not involve significant physical invasions or invasions into the privacy of participants.

Category 6 -Taste and food quality evaluations and consumer acceptance studies:

  1. If wholesome foods without additives are consumed, or
  2. 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, approved by the Environmental Protection Agency or the Food Safety and Inspection Services of U.S. Department of Agriculture.
  1. The PI will be notified in writing if the research is determined to be exempt. The letter will include the specific category for exemption, under the federal regulations, that applies.
  1. If an exempt determination is unable to be made from the information submitted, or the activity does not qualify for exempt determination, the PI will be notified in writing with a request to submit an application to the IRB for full or expedited review.
  1. Exempt determinations are assigned an IRB numberfor tracking purposes.

Exempt determinations prior to revision date 6-11 were not assigned an IRB number and are filed alphabetically under the Principal Investigator’s last name in an Exempt Review file.

Version date 4-21-2008 Page 1 of 2

Revised 6-11, 11-15