Association for the Accreditation
of Human Research Protection Programs, Inc. ®

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Download as PDF
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.3.F.1.

table ii.3.f.1.: ELEMENTS OF CONSENT DISCLOSURE

Required written materials

BASIC ELEMENTS OF CONSENT DISCLOSURE FOR LONG FORM AND SHORT FORM CONSENT DOCUMENTS

  • A statement that the study involves research. 
  • An explanation of the purposes of the research. 
  • An explanation of the expected duration of the participant’s participation. 
  • A description of the procedures to be followed.
  • Identification of any procedures that are experimental. (May be omitted if there are none.)
  • A description of any reasonably foreseeable risks or discomforts to the participant. (May be omitted if there are none.)
  • A description of any benefits to the participant or to others, which may reasonably be expected from the research. (May be omitted if there are none.)
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant. (May be omitted if there are none.)
  • A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not be maintained.)
  • An explanation as to whether compensation is available if injury occurs. (May be omitted if the research involves no more than minimal risk.)
  • If compensation is available when injury occurs, an explanation as to what it consists of or where further information may be obtained. (May be omitted if the research involves no more than minimal risk.)
  • An explanation as to whether any medical treatments are available if injury occurs. (May be omitted if the research involves no more than minimal risk.)
  • If medical treatments are available when injury occurs, an explanation as to what it consists of or where further information may be obtained. (May be omitted if the research involves no more than minimal risk.)
  • An explanation of whom to contact for answers to pertinent questions about the research. 
  • An explanation of whom to contact for answers to pertinent questions about the research participants’ rights. 
  • An explanation of whom to contact in the event of a research-related injury to the participant. (May not be omitted just because the research involves no more 
  • than minimal risk.)
  • Contact information for the research team for questions, concerns, or complaints. (Element III.1.G.)
  • Contact information for someone independent of the research team for problems, concerns, questions, information, or input. (Element I.4.A.)
  • 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. 
  • If research involves the collection of identifiable information or identifiable biospecimens, an explanation of potential future use. (May be omitted if the research does not involve collection of identifiable information or identifiable biospecimens)
    • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or legally authorized representative, if this might be possible; or
    • A statement that the participant’s information or specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

ADDITIONAL ELEMENTS OF DISCLOSURE

  • A statement that the particular treatment or procedure may involve risks to the participant, which are currently unforeseeable. 
  • A statement that if the participant is or becomes pregnant, the particular treatment or procedure may involve risks to the embryo or fetus, which are currently unforeseeable. 
  • Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent. 
  • Any additional costs to the participant that may result from participation in the research. 
  • A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant.
  • The approximate number of participants involved in the study.
  • 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.
  • The amount and schedule of all payments.
  • The consequences of a participant’s decision to withdraw from the research. 
  • Procedures for orderly termination of participation by the participant. 
  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to the participant, and if so, under what conditions.
  • For research involving biospecimens, a statement specifying whether the research will (if known) or might include whole genome sequencing.

ADDITIONAL REQUIREMENTS FOR FDA-REGULATED RESEARCH

  • A statement that the results of the research will be posted on clinicaltrials.gov.
  • A statement that notes the possibility that the Food and Drug Administration may inspect the records.

ADDITIONAL REQUIREMENTS WHEN FOLLOWING THE ICH-GCP (E6) GUIDELINE

  • The approval or favorable opinion by the IRB.
  • The probability for random assignment to each treatment.
  • The participant's responsibilities.
  • When applicable, the reasonably foreseeable risks or inconveniences to an embryo, fetus, or nursing infant.
  • The important potential benefits and risks of the alternative procedures or courses of treatment that may be available to the participant.
  • When there is no intended clinical benefit to the participant, the participant should be made aware of this.
  • A statement that the monitors, the auditors, the IRB, and the regulatory authorities will be granted direct access to the participant's original medical records for verification of clinical trial procedures and data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the participant or the participant's legally authorized representative is authorizing such access.
  • If the results of the trial are published, the participant’s identity will remain confidential.

ADDITIONAL REQUIREMENTS FOR DOD RESEARCH

  • A statement that the DoD or a DoD organization is funding the study.
  • A statement that representatives of the DoD are authorized to review research records

ADDITIONAL REQUIREMENTS FOR DOE RESEARCH

  • The identity of the sponsoring agency, unless the sponsor requests that it not be done, because doing so could compromise intelligence sources or methods; the research involves no more than minimal risk to participants; and the IRB determines that by not disclosing the identity, the investigators will not adversely affect the participants.
  • When research is classified, consent documents must state the project is classified, and what it means for the purposes of the research project.

ADDITIONAL REQUIREMENTS FOR DOJ RESEARCH

  • When research is funded by the National Institutes of Justice, the consent document must disclose:
  • The name(s) of the funding agency(ies).
  • When research is sponsored by the Bureau of Prisoners, consent documents must disclose: 
  • The identity of the researchers.
  • Anticipated uses of the results of the research.
  • The extent to which confidentiality of records identifying the participant will be maintained. For studies sponsored by NIJ the participant should be informed that private, identifiable information will be kept confidential and will only be used for research and statistical purposes. If, due to sample size or some unique feature, the identity of the individual cannot be maintained, the participants need to be explicitly notified. If the researcher intends to disclose any information, the participant needs to be explicitly informed what information would be disclosed, under what circumstances, and to whom. The participant must be informed of any risks that might result from this disclosure and must explicitly provide written consent prior to participating in the research.
  • A statement that participation is completely voluntary and that the participant may withdraw consent and end participation in the project at any time without penalty or prejudice (the inmate will be returned to regular assignment or activity by staff as soon as practicable).
  • A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law. For example, a researcher may not guarantee confidentiality when the participant indicates intent to commit future criminal 
  • conduct or harm himself or herself or someone else, or, if the participant is an inmate, indicates intent to leave the facility without authorization.
  • A statement that participation in the research project will have no effect on the inmate participant's release date or parole eligibility.

ADDITIONAL REQUIREMENTS FOR VA RESEARCH

  • A statement that in the event of a research-related injury the VA has to provide necessary medical treatment to a participant injured by participation.
  • Any payments the participant is to receive for participating in the study.
  • Any real or apparent conflict of interest by the researchers where the research will be performed.
  • A statement that VA will provide treatment for research-related injury in accordance with applicable federal regulations.
  • A statement that informs VA research participants that they or their insurance will not be charged for any costs related to the research.
  • A statement that a veteran-participant will not be required to pay for care received as a participant in a VA research project except in accordance with federal law and that certain veterans were required to pay co-payments for medical care and services provided by VA.
  • Consent for research must describe any photographs, video, or audio recordings obtained for research purposes; how they will be used, and whether they will be disclosed outside the VA.
  • For studies with a certificate of confidentiality, the informed consent document approved by the IRB must include a statement that the study has a certificate of confidentiality.

BROAD CONSENT FOR THE STORAGE, MAINTENANCE, AND SECONDARY USE OF IDENTIFIABLE PRIVATE INFORMATION AND IDENTIFIABLE BIOSPECIMENS

When following DHHS regulations, written materials should include the following requirements for broad consent.

  • A statement that the study involves research.
  • A description of any reasonably foreseeable risks or discomforts to the participant. (May be omitted if there are none.)
  • A description of any benefits to the participant or to 
  • others which may reasonably be expected from the research. (May be omitted if there are none.)
  • The types of organizations or researchers that might conduct research with the identifiable private information or identifiable biospecimens.
  • The period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite).
  • The time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period could be indefinite).
  • A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not 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.
  • 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.
  • Information about future use of private identifiable information or identifiable biospecimens:
    • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or legally authorized representative, if this might be possible; or
    • A statement that the participant’s information or specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
  • A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens, such that a reasonable person would expect 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 the research.
  • Whether sharing of identifiable private information or identifiable biospecimens might occur.
  • Unless the participant or legally authorized representative will be provided details about the 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 not have chosen 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 might not be disclosed to the participant.
  • For research involving biospecimens, a statement specifying whether the research will (if known) or might include whole genome sequencing.
  • An explanation of whom to contact for answers to pertinent questions about the research participant’s rights.
  • An explanation of whom to contact for answers to questions about storage and use of the participant’s identifiable information or biospecimens.
  • An explanation of whom to contact in the event of a research-related injury to the participant. (May not be omitted just because the research involves no more than minimal risk.)
  • Contact information for the research team for questions, concerns, or complaints. (Element III.1.G.)
  • Contact information for someone independent of the research team for problems, concerns, questions, 
  • information, or input. (Element I.4.A.)

 


Proceed To: TABLE II.3.G.1