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Exempt Human Research

By Warren Riley,2014-05-02 09:22
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Exempt Human Research

    Definitions:

    Research: As defined by DHHS any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

    Clinical Investigation: Any experiment that involves a test article and one or more human subjects, and that is subject to the FDA regulations. FDA regulations consider the terms “clinical investigation” and “research” to be synonymous. The following are considered experiments subject to FDA regulations:

    ; Any use of a drug, other than the use of an approved drug in the course of medical

    practice.

    ; Any use of a medical device to evaluate safety or efficacy of that device. ; Any activity where data are being collection to submit to FDA or to be held for

    inspection by FDA.

    Test article: Any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA regulation.

    Human Subject: A defined by DHHS: a human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains either data through intervention or interaction with the individual, or identifiable private information. As defined by FDA: An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A subject is also an individual on whose specimen a medical device is used.

    Intervention: Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subjects’ environment that are performed for research purposes.

    Interaction: Includes communication or interpersonal contact between an Investigator or his/her research staff and the research participant or their private identifiable information.

    Private Information: Includes information about behavior that occurs in a setting in which an individual can reasonably expect that no observation or recording is taking place. It includes information, which has been provided for specific purposes by an individual, and the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the UHCMC IRB Policies and Procedures

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    information) in order to be considered information to constitute research involving human participants.

Research Activities Involving Human Subjects: Activities that either (1) meet the

    DHHS definition of “research” and involve “human subjects” as defined by DHHS OR

    (2) meet the FDA definition of “research” and involve “human subjects” as defined by FDA.

    Policy:

    All research activities involving human subjects under the jurisdiction of the UHCMC IRB will be reviewed to determine (i) whether the research meets one or more of the exemption categories described in the federal regulations and (ii) whether it complies with UHCMC’s ethical standards. Research conducted under exempt review is also

    subject to all applicable institutional and IRB polices and procedures. A) Exempt Eligibility:

    The Federal regulations allow certain research activities involving human subjects to be exempt from IRB full or expedited review [see 45 CFR 46.101(b)(1-6); 45 CFR

    46.401(b); and 21 CFR 56.104(d)]. There are however restrictions for research involving children (see 45 CFR 46, Subpart D); and research involving prisoners does not qualify

    for exempt research (see 45 CFR 46, Subpart C).

     In addition, FDA-regulated research does not qualify for IRB exemption unless it falls

    under the FDA’s emergency use provision for the use of a test article [21 CFR 56.104(c)]

    or Taste and Food Quality Evaluations and Consumer Acceptance studies [21 CFR

    56.104(d)].

    The following are a list of categories as noted in the Federal Regulations 45 CFR 46.101 (b) that are permitted to be classified as research that is “exempt” from IRB full or

    expedited review:

    (1) Research conducted in established or commonly accepted educational settings,

    involving normal educational practices, such as (i) research on regular and special

    education instructional strategies, or (ii) research on the effectiveness of or the

    comparison among instructional techniques, curricula, or classroom management

    methods.

    (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude,

    achievement), survey procedures, interview procedures or observation of public

    behavior, unless:

    (i) information obtained is recorded in such a manner that human subjects can be

    identified, directly or through identifiers linked to the subjects; and (ii) any

    disclosure of the human subjects' responses outside the research could reasonably UHCMC IRB Policies and Procedures

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    place the subjects at risk of criminal or civil liability or be damaging to the subjects'

    financial standing, employability, or reputation.

    (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 paragraph (b)(2) of this section, if:

    (i) the human subjects are elected or appointed public officials or candidates for

    public office; or (ii) federal statute(s) require(s) without exception that the

    confidentiality of the personally identifiable information will be maintained

    throughout the research and thereafter.

    (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.

    (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:

    (i) Public benefit or service programs; (ii) procedures for obtaining benefits or

    services under those programs; (iii) possible changes in or alternatives to those

    programs or procedures; or (iv) possible changes in methods or levels of payment

    for benefits or services under those programs.

    (6) Taste and food quality evaluation and consumer acceptance studies, (i) if

    wholesome foods without additives are consumed or (ii) 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 or approved by the Environmental

    Protection Agency or the Food Safety and Inspection Service of the U.S.

    Department of Agriculture.

    Only one category of will apply to the project. Only the IRB may determine what human subject research activities qualify as “exempt” under the Federal regulations.

    Investigators do not have the authority to make an independent determination that research involving human subjects is exempt. IRB approval of exempt status is required prior to initiation of the research.

    A request for determination as to whether or not a human research protocol may be considered “exempt” may be submitted electronically through the iRIS system by adding

    a new study. In order to receive the questions related to exemption, you must answer yes to the question Are you requesting determination as to whether your project qualifies for exemption as described in 45 CFR 46 / 21 CFR 56.104?

    UHCMC IRB Policies and Procedures

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    The IRB will review the proposed changes to determine if the project still qualifies for Exempt status. If the project is still considered Exempt, changes proposed may be implemented once the investigator receives an approval for the amendment through the iRIS system. Approved amendments do not change the current Exemption IRB number or current expiration date. If the IRB determines that the project no longer qualifies for Exemption, the investigator will be notified accordingly. The investigator may then choose to forego the proposed changes and continue with the study as currently approved or to close out the current exemption and resubmit for full or expedited IRB review and approval.

    E) Use and Disclosure of PHI (applicability of the HIPAA Privacy Rule):

    If the proposed research involves utilization of Protected Health Information (PHI), HIPAA regulations still apply, even if the IRB has determined that the research qualifies for IRB Exemption. Investigators must indicate applicability of HIPAA Privacy Rule as part of the IRB application process. Investigators must also submit the appropriate supporting documentation for review.

F) Certification in Human Subjects Protections:

    Investigators requesting a determination of exemption are required to be certified in Human Subjects Protections through the Case CREC (Continuing Research Education

    Credit) Program.

References and/or Regulatory Citations:

    45 CFR 46.101(b)(1-6)

    45 CFR 46.401(b)

    21 CFR 56.104(c)

    21 CFR 56.104(d)

    Related Policies:

    IRB Policy, Protocol Submission Requirements

    IRB Policy, Certification in Human Subjects’ Protections

    IRB Policy, Assent from Children in Research Studies

    IRB Policy, Use and Disclosure of Protected Health information (PHI) for Research

    Purposes HIPAA and the Privacy Rule

UHCMC IRB Policies and Procedures

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