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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.A.1.

table ii.2.a.1.: CRITERIA ALLOWING EXEMPTION FROM US FEDERAL REGULATIONS

CATEGORY 1

  • The research is conducted in established or commonly accepted educational settings.
  • The research involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction, such as:
    • Research on regular and special education instructional strategies.
    • Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  • The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
  • 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 2

See Element II.2.C. and Table II.2.C.1. regarding requirements for limited IRB or EC review.

  • The research only involves interactions involving one or more of the following:
    • Educational tests (cognitive, diagnostic, aptitude, achievement).
    • Survey procedures.
    • Interview procedures.
    • Observation of public behavior (including visual or auditory recording).
  • One of the following conditions are met:
    • The information obtained is recorded in such a manner that participants cannot be identified, directly or indirectly through identifiers linked to the participants.
      • When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed.
    • Any disclosure of the participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.
      • When the research involves children, this exemption only applies to educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed.
    • The information obtained is recorded by the investigator in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, and an IRB or EC conducts a limited IRB or EC review of the research, and determines whether there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data. (See Element II.2.C.)
      • This condition cannot be applied when research is subject to Subpart D. 
  • If the research is regulated by the Department of Veterans Affairs:
    • If any disclosure of the participants’ responses outside the research could reasonably place the participants at risk of loss of insurability.
    • Information obtained is not recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants.
  • The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
  • 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 3

See Element II.2.C. and Table II.2.C.1. regarding requirements for limited IRB or EC review.

  • Research involving benign behavioral interventions in conjunction with the collection of information from an adult participant through verbal or written responses (including data entry) or audiovisual recording if the participant prospectively agrees to the intervention and information collection. 
    • Benign behavioral interventions are:
    • Brief in duration.
    • Harmless.
    • Painless.
    • Not physically invasive.
    • Not likely to have a significant adverse lasting impact on the participants.
  • The researcher has no reason to think the participants will find the interventions offensive or embarrassing.
  • At least one of the following criteria is met:
    • The information obtained is recorded by the investigator in such a manner that the identity of the human participants cannot readily be ascertained, directly or through identifiers linked to the participant; or
    • Any disclosure of the human participants’ responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement, or reputation; or
    • If the information obtained is recorded by the investigator in such a manner that the identity of the human participants can readily be ascertained, directly or through identifiers linked to the participants, an IRB conducts a limited IRB review  and determines, when appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
  • If the research involves deception of participants regarding the nature or purposes of the research:
    • The participant authorizes the deception through a prospective agreement to participate in research in circumstances in which the participant is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
  • The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
  • 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 4

  • Secondary research for which consent is not required, that uses of identifiable private or identifiable biospecimens, if at least one of the following criteria are met:
    • The identifiable private information or identifiable biospecimens are publicly available.
    • Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects.
    • The research involves only information collection and analysis involving the researcher's use of identifiable health information regulated under HIPAA for the purposes of "health care operations" or "research" or "public health activities and purposes" as defined in HIPAA.
    • The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable 
    • private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 or Privacy Act of 1974, 5 U.S.C. 552a., and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
    • The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
    • 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 5

  • The project is a research or demonstration project.
  • The research is conducted by or subject to the approval of a US federal government Department or Agency head (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects).
  • The research is designed to study, evaluate, improve, or otherwise examine a program that delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act) and includes one or more of the following:
    • Procedures for obtaining benefits or services under those programs.
    • Possible changes in or alternatives to those programs or procedures.
    • Possible changes in methods or levels of payment for benefits or services under those programs.
  • The research is conducted pursuant to specific statutory authority of the US federal government.
  • There is no statutory requirement that an IRB or EC review the research.
  • For US government agencies, the agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site a list of research and a list of the research and demonstration projects prior to commencing the research involving human subjects.
  • The research does not involve significant physical invasions or intrusions upon the privacy of participants.
  • The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
  • 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 6

  • The research involves taste and food quality evaluation or is a consumer acceptance study.
  • Either of the following is true:
    • Wholesome foods without additives are consumed.
    • If a food is consumed that contains a food ingredient or an agricultural chemical or environmental contaminant, the food ingredient or agricultural chemical or environmental contaminant is at or below the level and for a use found to be safe by one of the following:
      • The Food and Drug Administration.
      • The Environmental Protection Agency.
      • The Food Safety and Inspection Service of the U.S. Department of Agriculture.
  • The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
  • 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 7

  • See Element II.2.C. and Table II.2.C.1. regarding requirements for limited IRB or EC review.
  • Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use, if the research has undergone limited IRB or EC review. For purposes of conducting the limited IRB or EC review, the IRB or EC must determine:

    • Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained:
      • The researcher obtains the legally effective broad consent of the participant or the participant's legally authorized representative.
      • The researcher must provide the prospective participant or legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
      • The information that is given to the participant or the legally authorized representative must be in language understandable to the participant or the legally authorized representative.
      • The prospective participant or legally authorized representative must be provided with the information a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
      • No broad consent may include any exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the researcher, the sponsor, the organization, or its agents from liability for negligence.
      • Broad consent must include the following information:
        • A description of any reasonably foreseeable risks or discomforts to the participant.
        • A description of any benefits to the participant or to others that may reasonably be expected from the research.
        • A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
        • A statement that participation is voluntary.
        • A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is 
        • otherwise entitled.
        • A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
        • When appropriate, a statement that the participant's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.
        • When appropriate, for research involving biospecimens, a statement indicating whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
        • A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted.
        • A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens.
        • A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which could be indefinite).
        • Unless the participant or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies.
        • Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the participant in all circumstances, a statement that such results may not be disclosed to the participant.
        • An explanation of whom to contact for answers to questions about the participant’s rights and about storage and use of the participant's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.
        • For organizations located outside the US, the laws of that country do not prohibit an exemption.
  • Documentation of broad consent or waiver of documentation of consent is 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.
  • The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
  • 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

See Element II.2.C. and Table II.2.C.1. regarding requirements for limited IRB or EC review.

  • Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use if the following criteria are met:
  • Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained.
  • Documentation of consent or waiver of documentation of consent was obtained. (See Elements II.3.F. and II.3.G.)
  • The research has undergone limited IRB review by an IRB or EC member, who determines:
    • There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
    • The research to be conducted is within the scope of the broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens
  • 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.
  • The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.
  • 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)




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