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Evaluation Instrument for Accreditation
Jan 19, 2022, 16:59 PM
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INTERNATIONAL ADDENDA
Feb 20, 2023, 23:40 PM -
INTRODUCTION
Mar 20, 2022, 20:45 PM -
TABLES
Feb 17, 2022, 11:24 AM -
DOMAIN III: RESEARCHER AND RESEARCH STAFF
Feb 9, 2022, 14:15 PM -
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
Jan 20, 2022, 11:37 AM -
DOMAIN I: ORGANIZATION
Jan 19, 2022, 17:01 PM
Resources: For Accreditation - Evaluation Instrument
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Table of Contents
INTRODUCTION
USE OF THE EVALUATION INSTRUMENT FOR ACCREDITATION
THE FIVE SECTIONS OF ELEMENTS AND STANDARDS
GLOSSARY OF TERMS
LIST OF STANDARDS AND ELEMENTS
SUMMARY OF REVISIONS
DOMAIN I: ORGANIZATION
STANDARD I-1
STANDARD I-3
STANDARD I-4
STANDARD I-5
STANDARD I-6
STANDARD I-7
STANDARD I-8
STANDARD I-9
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
ELEMENT I.1.A.
ELEMENT I.1.B.
ELEMENT I.1.C.
ELEMENT I.1.D.
ELEMENT I.1.E.
ELEMENT I.1.F.
ELEMENT I.1.G.
ELEMENT I.1.H.
STANDARD I-2
STANDARD II-1
STANDARD II-2
DOMAIN III: RESEARCHER AND RESEARCH STAFF
ELEMENT II.2.A.
ELEMENT II.2.B.
ELEMENT II.2.C.
Element II.2.D.
Element II.2.E.
Element II.2.F.
Element II.2.G.
Element II.2.H.
Element II.2.I.
STANDARD II-3
ELEMENT II.3.A.
ELEMENT II.3.B.
ELEMENT II.3.C.
ELEMENT II.3.D.
ELEMENT II.3.E.
ELEMENT II.3.F.
ELEMENT II.3.G.
STANDARD II-4
STANDARD II-5
STANDARD III-1
TABLES
INTERNATIONAL ADDENDA
ELEMENT III.1.A.
ELEMENT III.1.B.
ELEMENT III.1.C.
ELEMENT III.1.D.
ELEMENT III.1.E.
ELEMENT III.1.F.
ELEMENT III.1.G.
STANDARD III-2
LIST OF STANDARDS AND ELEMENTS
list of standards and elements:
What follows is an overview of all of the Domains, Standards, and Elements with links to more detailed information.
- STANDARD I-1: The organization has a systematic and comprehensive Human Research Protection Program that affords protections for all research participants. Individuals within the organization are knowledgeable about and follow the policies and procedures of the Human Research Protection Program.
- ELEMENT I.1.A.: The organization has and follows written policies and procedures for determining when activities are overseen by the Human Research Protection Program.
- ELEMENT I.1.B.: The organization delegates responsibility for the Human Research Protection Program to an official with sufficient standing, authority, and independence to ensure implementation and maintenance of the program.
- ELEMENT I.1.C.: The organization has and follows written policies and procedures that allow the Institutional Review Board or Ethics Committee to function independently of other organizational entities in protecting research participants.
- ELEMENT I.1.D.: The organization has and follows written policies and procedures setting forth the ethical standards and practices of the Human Research Protection Program. Relevant policies and procedures are made available to sponsors, researchers, research Staff, research participants, and the Institutional Review Board or Ethics Committee, as appropriate.
- ELEMENT I.1.E.: The organization has an education program that contributes to the improvement of the qualifications and expertise of individuals responsible for protecting the rights and welfare of research participants.
- ELEMENT I.1.F.: The organization has and follows written policies and procedures for reviewing the scientific or scholarly validity of a proposed research study. Such procedures are coordinated with the ethics review process.
- ELEMENT I.1.G.: The organization has and follows written policies and procedures that identify applicable laws in the localities where it conducts human research, takes them into account in the review and conduct of research, and resolves differences between federal or national law and local laws.
- ELEMENT I.1.H.: The organization has and follows written policies and procedures specifically designed to protect the rights and welfare of research participants during an emergency.
- STANDARD I-2: The organization ensures that the Human Research Protection Program has resources sufficient to protect the rights and welfare of research participants for the research activities that the organization conducts or oversees.
- STANDARD I-3: The organization’s transnational research activities are consistent with the ethical principles set forth in its Human Research Protection Program and meet equivalent levels of participant protection as research conducted in the organization’s principal location while complying with local laws and taking into account cultural context.
- STANDARD I-4: The organization responds to the concerns of research participants.
- ELEMENT I.4.A.: The organization has and follows written policies and procedures that establish a safe, confidential, and reliable channel for current, prospective, or past research participants or their designated representatives that permits them to discuss problems, concerns, and questions; obtain information; or offer input with an informed individual who is unaffiliated with the specific research protocol or plan.
- ELEMENT I.4.B.: The organization conducts activities designed to enhance understanding of human research by participants, prospective participants, or their communities, when appropriate. These activities are evaluated on a regular basis for improvement.
- ELEMENT I.4.C.: The organization promotes the involvement of community members, when appropriate, in the design and implementation of research and the dissemination of results.
- STANDARD I-5: The organization measures and improves, when necessary, compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The organization also measures and improves, when necessary, the quality, effectiveness, and efficiency of the Human Research Protection Program.
- ELEMENT I.5.A.: The organization conducts audits or surveys or uses other methods to assess compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The organization makes improvements to increase compliance, when necessary.
- ELEMENT I.5.B.: The organization conducts audits or surveys or uses other methods to assess the quality, efficiency, and effectiveness of the Human Research Protection Program. The organization identifies strengths and weaknesses of the Human Research Protection Program and makes improvements, when necessary, to increase the quality, efficiency, and effectiveness of the program.
- ELEMENT I.5.C.: The organization has and follows written policies and procedures so that researchers and research staff may bring forward to the organization concerns or suggestions regarding the Human Research Protection Program, including the ethics review process.
- ELEMENT I.5.D.: The organization has and follows written policies and procedures for addressing allegations and findings of non-compliance with Human Research Protection Program requirements. The organization works with the Institutional Review Board or Ethics Committee, when appropriate, to ensure that participants are protected when non-compliance occurs. Such policies and procedures include reporting these actions, when appropriate.
- STANDARD I-6: The organization has and follows written policies and procedures to ensure that research is conducted so that financial conflicts of interest are identified, managed, and minimized or eliminated.
- ELEMENT I.6.A.: The organization has and follows written policies and procedures to identify, manage, and minimize or eliminate financial conflicts of interest of the organization that could influence the conduct of the research or the integrity of the Human Research Protection Program.
- ELEMENT I.6.B.: The organization has and follows written policies and procedures to identify, manage, and minimize or eliminate individual financial conflicts of interest of Researchers and research staff that could influence the conduct of the research or the integrity of the Human Research Protection Program. The organization works with the Institutional Review Board or Ethics Committee in ensuring that financial conflicts of interest are managed and minimized or eliminated, when appropriate.
- STANDARD I-7: The organization has and follows written policies and procedures to ensure that the use of any investigational or unlicensed test article complies with all applicable legal and regulatory requirements.
- ELEMENT I.7.A.: When research involves investigational or unlicensed test articles, the organization confirms that the test articles have appropriate regulatory approval or meet exemptions for such approval.
- ELEMENT I.7.B.: The organization has and follows written policies and procedures to ensure that the handling of investigational or unlicensed test articles conforms to legal and regulatory requirements.
- ELEMENT I.7.C.: The organization has and follows written policies and procedures for compliance with legal and regulatory requirements governing emergency use of an investigational or unlicensed test article.
- STANDARD I-8: The organization works with public, industry, and private sponsors to apply the requirements of the Human Research Protection Program to all participants.
- ELEMENT I.8.A.: The organization has a written agreement with the sponsor that addresses medical care for research participants with a research-related injury, when appropriate.
- ELEMENT I.8.B.: In studies where sponsors conduct research site monitoring visits or conduct monitoring activities remotely, the organization has a written agreement with the sponsor that the sponsor promptly reports to the organization findings that could affect the safety of participants or influence the conduct of the study.
- ELEMENT I.8.C.: When the sponsor has the responsibility to conduct data and safety monitoring, the organization has a written agreement with the sponsor that addresses provisions for monitoring the data to ensure the safety of participants and for providing data and safety monitoring reports to the organization.
- ELEMENT I.8.D.: Before initiating research, the organization has a written agreement with the sponsor about plans for disseminating findings from the research and the roles that researchers and sponsors will play in the publication or disclosure of results.
- ELEMENT I.8.E.: When participant safety could be directly affected by study results after the study has ended, the organization has a written agreement with the sponsor that the researcher or organization will be notified of the results in order to consider informing participants.
- STANDARD I-9: The organization has written policies and procedures to ensure that, when sharing oversight of research with another organization, the rights and welfare of research participants are protected.
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
- STANDARD II-1: The structure and composition of the IRB or EC are appropriate to the amount and nature of the research reviewed and in accordance with requirements of applicable laws, regulations, codes, and guidance.
- ELEMENT II.1.A.: The IRB or EC membership permits appropriate representation at the meeting for the types of research under review, and this is reflected on the IRB or EC roster. The IRB or EC has one or more unaffiliated members; one or more members who represent the general perspective of participants; one or more members who do not have scientific expertise; one or more members who have scientific or scholarly expertise; and, when the IRB or EC regularly reviews research that involves vulnerable participants, one or more members who are knowledgeable about or experienced in working with such participants.
- ELEMENT II.1.B.: The IRB or EC has qualified leadership (e.g., chair and vice chair) and qualified members and staff. Membership and composition of the IRB or EC are periodically reviewed and adjusted as appropriate.
- ELEMENT II.1.C.: The organization has and follows written policies and procedures to separate competing business interests from ethics review functions.
- ELEMENT II.1.D.: The IRB or EC has and follows written policies and procedures so that members and consultants do not participate in the review of research protocols or plans in which they have a conflict of interest, except to provide information requested by the IRB or EC.
- ELEMENT II.1.E.: The IRB or EC has and follows written policies and procedures requiring research protocols or plans to be reviewed by individuals with appropriate scientific or scholarly expertise and other expertise or knowledge as required to review the research protocol or plan.
- STANDARD II-2: The IRB or EC evaluates each research protocol or plan to ensure the protection of participants.
- ELEMENT II.2.A.: The IRB or EC has and follows written policies and procedures for determining when activities are exempt from applicable laws and regulations, when permitted by law or regulation and exercised by the IRB or EC. Such policies and procedures indicate that exemption determinations are not to be made by researchers or others who might have a conflict of interest regarding the studies.
- ELEMENT II.2.B.: The IRB or EC has and follows written policies and procedures for addressing protection of participants in research that is exempt from applicable laws and regulations. These functions may be delegated to an entity other than the IRB or EC.
- ELEMENT II.2.C.: The IRB or EC has and follows written policies and procedures to conduct limited IRB or EC review, if such procedure is used.
- ELEMENT II.2.D.: The IRB or EC has and follows written policies and procedures to conduct meetings by the convened IRB or EC.
- ELEMENT II.2.E.: The IRB or EC has and follows written policies and procedures to conduct reviews by the convened IRB or EC.
- ELEMENT II.2.F.: The IRB or EC has and follows written policies and procedures to conduct reviews by an expedited procedure, if such procedure is used.
- ELEMENT II.2.G.: The IRB or EC has and follows written policies and procedures for addressing unanticipated problems involving risks to participants or others, and for reporting these actions, when appropriate.
- ELEMENT II.2.H.: The IRB or EC has and follows written policies and procedures for suspending or terminating IRB or EC approval of research, if warranted, and for reporting these actions, when appropriate.
- ELEMENT II.2.I.: The IRB or EC has and follows policies and procedures for managing multi-site research by defining the responsibilities of participating sites that are relevant to the protection of research participants, such as reporting of unanticipated problems or interim results.
- STANDARD II-3: The IRB or EC approves each research protocol or plan according to criteria based on applicable laws, regulations, codes, and guidance.
- ELEMENT II.3.A.: The IRB or EC has and follows written policies and procedures for identifying and analyzing risks and identifying measures to minimize such risks. The analysis of risk includes a determination that the risks to participants are reasonable in relation to the potential benefits to participants and to society.
- ELEMENT II.3.B.: The IRB or EC has and follows written policies and procedures for reviewing the plans for data and safety monitoring, when applicable, and determines that the data and safety monitoring plan provides adequate protection for participants.
- ELEMENT II.3.C.: The IRB or EC has and follows written policies and procedures to evaluate the equitable selection of participants.
- ELEMENT II.3.D.: The IRB or EC has and follows written policies and procedures to evaluate the proposed arrangements for protecting the privacy interests of research participants, when appropriate, during their involvement in the research.
- ELEMENT II.3.E.: The IRB or EC has and follows written policies and procedures to evaluate proposed arrangements for maintaining the confidentiality of identifiable data, when appropriate, preliminary to the research, during the research, and after the conclusion of the research.
- ELEMENT II.3.F.: The IRB or EC has and follows written policies and procedures to evaluate the consent process and to require that the researcher appropriately document the consent process.
- ELEMENT II.3.G.: The IRB or EC has and follows written policies and procedures for approving waivers or alterations of the consent process and waivers of consent documentation.
- STANDARD II-4: The IRB or EC provides additional protections for individuals who are vulnerable to coercion or undue influence and participate in research.
- ELEMENT II.4.A.: The IRB or EC has and follows written policies and procedures for determining the risks to prospective participants who are vulnerable to coercion or undue influence and ensuring that additional protections are provided as required by applicable laws, regulations, codes, and guidance.
- ELEMENT II.4.B.: The IRB or EC has and follows written policies and procedures requiring appropriate protections for prospective participants who cannot give consent or whose decision-making capacity is in question.
- ELEMENT II.4.C.: The IRB or EC has and follows written policies and procedures for making exceptions to consent requirements for planned emergency research and reviews such exceptions according to applicable laws, regulations, codes, and guidance.
- STANDARD II-5: The IRB or EC maintains documentation of its activities.
- ELEMENT II.5.A.: The IRB or EC maintains a complete set of materials relevant to the review of the research protocol or plan for a period of time sufficient to comply with legal and regulatory requirements, sponsor requirements, and organizational policies and procedures.
- ELEMENT II.5.B.: The IRB or EC documents discussions and decisions on research studies and activities in accordance with legal and regulatory requirements, sponsor requirements (if any), and organizational policies and procedures.
DOMAIN III: RESEARCHER AND RESEARCH STAFF
- STANDARD III-1: In addition to following applicable laws and regulations, researchers and research staff adhere to ethical principles and standards appropriate for their discipline. In designing and conducting research studies, researchers and research staff have the protection of the rights and welfare of research participants as a primary concern.
- ELEMENT III.1.A.: Researchers and research staff know which of the activities they conduct are overseen by the Human Research Protection Program, and they seek guidance when appropriate.
- ELEMENT III.1.B.: Researchers and research staff identify and disclose financial interests according to organizational policies and regulatory requirements and, with the organization, manage, minimize, or eliminate financial conflicts of interest.
- ELEMENT III.1.C.: Researchers employ sound study design in accordance with the standards of the discipline. Researchers design studies in a manner that minimizes risks to participants.
- ELEMENT III.1.D.: Researchers determine that the resources necessary to protect participants are present before conducting each research study.
- ELEMENT III.1.E.: Researchers and research staff recruit participants in a fair and equitable manner.
- ELEMENT III.1.F.: Researchers employ consent processes and methods of documentation appropriate to the type of research and the study population, emphasizing the importance of comprehension and voluntary participation to foster informed decision-making by participants.
- ELEMENT III.1.G.: Researchers and research staff have a process to address participants’ concerns, complaints, or requests for information.
- STANDARD III-2: Researchers meet requirements for conducting research with participants and comply with all applicable laws, regulations, codes, and guidance; the organization’s policies and procedures for protecting research participants; and the IRB’s or EC’s determinations.
- ELEMENT III.2.A.: Researchers and research staff are qualified by training and experience for their research roles, including knowledge of applicable laws, regulations, codes, and guidance; relevant professional standards; and the organization’s policies and procedures regarding the protection of research participants.
- ELEMENT III.2.B.: Researchers maintain appropriate oversight of each research study, as well as research staff and trainees, and appropriately delegate research responsibilities and functions.
- ELEMENT III.2.C.: Researchers and research staff follow the requirements of the research protocol or plan and adhere to the policies and procedures of the organization and to the requirements or determinations of the IRB or EC.
- ELEMENT III.2.D.: Researchers and research staff follow reporting requirements during a research study in accordance with applicable laws, regulations, codes, and guidance; the organization’s policies and procedures; and the IRB’s or EC’s requirements.
- TABLE II.2.A.1.: CRITERIA ALLOWING EXEMPTION FROM US FEDERAL REGULATIONS
- TABLE II.2.C.1.: REQUIRED DETERMINATIONS FOR LIMITED IRB OR EC REVIEW
- TABLE II.2.F.1.: EXPEDITED REVIEW CRITERIA
- TABLE II.3.F.1.: ELEMENTS OF CONSENT DISCLOSURE
- TABLE II.3.G.1: WAIVERS AND ALTERATIONS OF CONSENT - US DHHS REGULATIONS
- TABLE II.3.G.2.: WAIVERS AND ALTERATIONS OF CONSENT - US FDA REGULATIONS
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SUMMARY OF REVISIONS