Determination of Applicability of Human Subjects Regulations

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					                                   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 CHRCO 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.


Determination of Applicability of Human Subjects Regulations – 08-10               Page 1 of 3
       2. Activity is not research. Primary intent is to protect patients/clients, decrease
          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 CHRCO 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 CHRCO 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 – 08-10              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 – 08-10                Page 3 of 3

				
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