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Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

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Latest Update: May 15, 2022

Table of Contents

INTRODUCTION DOMAIN I: ORGANIZATION DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE DOMAIN III: RESEARCHER AND RESEARCH STAFF TABLES

TABLE II.2.C.1.

table ii.2.c.1.: REQUIRED DETERMINATIONS FOR LIMITED IRB OR EC REVIEW
When following DHHS regulations, written materials should include the following exemption categories.
  • See Element II.2.A. and Table II.2.A.1. for a complete listing of exemption categories and required determinations.
  • This table lists only the exemption categories where limited IRB review is required.

Required written materials

CATEGORY 2

  • Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) where:
    • The information obtained is recorded by the researcher in such a manner that the identity of human participants can be readily ascertained, directly or through identifiers linked to the participants. (§___.104(2)(iii))
    • Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
    • Research does not involve children.
    • The IRB or EC must determine there are adequate provisions to protect the privacy interests of research participants and the confidentiality of identifiable date. (See Elements II.3.D. and II.3.E.) 
    • The research is not regulated by the US FDA.
    • For organizations located outside the US, the laws of that country do not prohibit an exemption. (See AAHRPP Addenda for discussion of country-specific laws)

(See AAHRPP Addenda for discussion of country-specific laws)

CATEGORY 3

  • Research involving benign behavioral interventions in conjunction with the collection of information from adult participants through verbal or written responses (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention and where:
    • The information obtained is recorded by the researcher in such a manner that the identity of human participants can be readily ascertained, directly or through identifiers linked to the participants. (§___.104(3)(i)(C))
    • Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
    • The IRB or EC must determine there are adequate provisions to protect the privacy interests of research participants and the confidentiality of identifiable date. (See Elements II.3.D. and II.3.E.)
    • The research is not regulated by the US FDA.
    • For organizations located outside the US, the laws of that country do not prohibit an exemption. (See AAHRPP Addenda for discussion of country-specific laws)

(See AAHRPP Addenda for discussion of country-specific laws)

CATEGORY 7

  • Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary 
  • research use. (§___.104(7)) 
    • The researcher plans to obtain broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens, including all required disclosures. (See Table II.2.C.2.)
    • Documentation of consent or waiver of consent was obtained. (See Elements II.3.F. and II.3.G.)
    • If there is a change made for research purposes in the way identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy interests of participants and the confidentiality of data. (See Elements II.3.D. and II.3.E.)
    • When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants, when appropriate.
    • Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
    • The IRB or EC must determine the requirements for broad consent are met, but does not need to determine that other criteria for approval (See Standard II-3) are met.
    • The research is not regulated by the US FDA.
    • For organizations located outside the US, the laws of that country do not prohibit an exemption.
(See AAHRPP Addenda for discussion of country-specific laws)

CATEGORY 8

  • Research involving the use of identifiable private information or identifiable biospecimens for secondary research use. (§___.104(8))
    • There are adequate plans to protect the privacy of participants and the confidentiality of participants’ data.
    • Broad consent (See Table II.2.C.2.) was obtained for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens, including the required disclosures. (See Table II.2.C.2.)
    • Documentation of consent or a waiver of documentation of consent was obtained. (See Elements II.3.F. and II.3.G.)
    • If there is a change made for research purposes in the way identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy interests of participants and the confidentiality of data. (See Element II.3.E.)
    • When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants, when appropriate.
    • Research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
    • The IRB or EC must determine the requirements for broad consent are met, but does not need to determine that other criteria for approval (see Standard II-3) are met.
    • The research is not regulated by the US FDA.
    • For organizations located outside the US, the laws of the country do not prohibit an exemption. (See AAHRPP Addenda for discussion of country-specific laws)

Proceed To: TABLE II.2.F.1.