Determination of Applicability of Human Subjects Regulations, Request to Classify Project

Institutional Review Board Determination of Applicability of Human Subject Regulations "Request to Classify Project as Not Involving Research or Research Not Involving Human Subjects" This form should be used to submit to the Institutional Review Board (IRB) information and documentation for projects that the person directing the project believes are not dependent on human subjects regulations. Projects are eligible for this classification either as “non-research" projects (primary intent is not to generate generalizable knowledge) or as research projects that do not involve identifiable human subjects. Such projects do not require oversight by the IRB.

This form cannot be used to document "IRB Exempt Research," which must be submitted to the IRB with a Claim of Exemption form.

1. Protocol Title:

2. Principal Investigator: Address or BCHO Department:

Phone: ( ) - Fax: ( ) - E-mail:

CATEGORIES OF DATA COLLECTION THAT DO NOT CONSTITUTE HUMAN SUBJECT RESEARCH ARE LISTED BELOW. PLEASE CHECK THE APPROPRIATE CATEGORY.

1. Activity is not research. Primary intent is a public health practice disease control activity, program evaluation or surveillance activity. A. Epidemic/endemic disease control activity; collected data directly related to disease control needs, e.g., mandated submission of data to a national or state registry/database. B. Routine disease surveillance activity; data used for disease control program or policy purposes. C. Program evaluation activity; data are used primarily for that purpose. D. Post-marketing surveillance of efficacy and/or adverse effects of a new regimen, drug or device if the sponsor has no intention of improving generalizable knowledge and never intends to report the outcomes to the FDA. 2. Activity is not research. Primary intent is to protect patients/clients, decrease

Determination of Applicability of Human Subjects Regulations – 03-16 Page 1 of 3 cost, increase patient/client satisfaction, and introduce new validated practices. A. Activity is quality assurance (QA) or quality improvement (QI): a. Activities, or presentation/publication of results thereof, designed to determine or measure if aspects of practice or procedures within BCHO only, are being performed in line with established standards of care or benchmark (e.g., JCAHO) (QA)…or… b. Activities specifically initiated with a goal of developing a standard of care or benchmark for use within BCHO only, or improving performance in relation to an established standard (QI)…or… c. Outcome analysis. Descriptive analyses of outcomes. Comparison of results to an established standard is not a defining feature as it is with QA. B. Activity is medical or behavioral practice: a. Innovative therapy, designed solely to benefit individual patient(s). The desired outcome is unproven, but there is an expectation of success. This class of activity could be termed "non-validated practice"…or… b. Medical or behavioral practice to benefit people other than those directly affected by the intervention. The goal of this activity is to benefit a well-defined group of people in a predictable way. C. Activity is resource utilization review. Medical record or other data review is conducted to evaluate the use of resources in a specific activity. D. Case Report. Data concerning one individual, their family, and/or environment, including medical history and any other information, collected for the purposes of analyzing and diagnosing the individual’s condition or for instructional purposes or publication. It does not involve a testable hypothesis.

3. Activity is research but does NOT involve identifiable human subjects. A. Activity is research involving collection/analysis of data about health facilities or other organizations or units, which are not individual persons. B. Activity is research but does not constitute research involving human subjects pursuant to 45 CFR §46.102(f) because data or biological specimens are not individually identifiable and are not coded to enable identification of a specific individual. C. Activity is research involving coded private information or biological specimens, the data and/or specimens were not collected specifically for the currently proposed research project, and the investigator(s) cannot readily ascertain the identity of the individuals to whom the data or specimens pertain. *● [see following paragraph, next page]

Determination of Applicability of Human Subjects Regulations – 03-16 Page 2 of 3 *● The following two conditions for coded data or specimens must be met:

 The data or specimens were not collected specifically for the currently proposed research project; and

 The investigator(s) cannot readily ascertain the identity of the individuals because: (Please check the appropriate box below)

a. The key to decipher the code will be destroyed before the research begins.

b. The investigators and the holder of the key have entered into an agreement prohibiting the release of the key to the investigator(s) under any circumstances, until the individuals are deceased.

c. There are IRB-approved written policies and operating procedures for a repository or data management center that prohibit release of the key to the investigator(s) under any circumstances, until the individuals are deceased.

d. There are other legal requirements prohibiting the release of the key to the investigator(s) until the individuals are deceased.

D. Activity is research involving deceased persons, and the data and/or specimens from them are unidentified.

Although IRB review may not be required, investigators are expected to adhere to ethical principles and standards by respecting and protecting to the maximum extent possible the privacy, confidentiality and autonomy of participants. As Principal Investigator, I assure that all applicable State and Federal privacy laws will be followed and that the project meets the criteria for the category or categories checked above.

Principal Investigator’s Signature Date

If this project is classified by the IRB as not applicable to human subject regulations, informed consent may nevertheless be appropriate. Information disclosed in the consent process should address the eight standard consent elements of 45 CFR 46.116 .

Attach project description in enough detail to clarify the “non-human subject research” nature. Also submit other documentation such as project contracts, if available, to support this request for classification.

Determination of Applicability of Human Subjects Regulations – 03-16 Page 3 of 3