VA Human Research Protection Accreditation Program Accreditation Standards

August 16, 2001

2000 L Street
Suite 500
Washington, DC 20036

Introduction

Definitions

Institutional Responsibilities (INR)

Individual IRB Structure and Operations (IRB)

Consideration of Risks and Benefits (CRB)

Recruitment and Subject Selection (RSS)

Privacy and Confidentiality (PCF)

Informed Consent (ICS)

Introduction

Purpose and organization of Introduction

The purpose of this introduction is to provide background and context for the VA Human Research Protection Accreditation Program and the standards that will be used to assess human research protection at the VA Medical Centers. The introduction is organized as follows:

Overview of accreditation program

The Department of Veterans Affairs contracted with NCQA to develop and implement an accreditation program for Veterans Affairs Medical Center (VAMC) Human Research Protection Programs (HRPPs). While Federal regulations for the protection of human research subjects have been in place for three decades, this program is the first to routinely and independently, assess human research protections.

Purpose of Accreditation program

The purpose of the accreditation program is to strengthen the protections afforded human subjects of research at VAMCs through an ongoing program of independent, external review. Accreditation of VAMC HRPPs, can assure the public that research is performed that meets standards for the protection of study volunteers. Such assurance can be expected to strengthen public support for, and participation in, the VAMCs' research programs. The VA Office of Research and Development promulgates policy for VAMCs that conduct research. The VA Office of Research Compliance and Assurance provides education and assistance to VAMCs in implementing policy and works to assure regulatory compliance in VAMC research programs. The purpose of accreditation is to provide independent, external validation that HRPPs are in place, functioning properly and effectively protecting human subjects.

Purpose, scope and effective date of accreditation standards

The purpose of these accreditation standards is to specify minimum performance expectations for VAMC HRPPs and to enable surveyors to make valid and reliable assessments of HRPP performance. These standards are intended to apply to all VAMCs that conduct human research including those that operate their own IRBs, those that operate an IRB jointly with another VAMC or affiliated university, and those that delegate IRB functions to another VAMC's or affiliated university's IRB. This version of the standards, dated August 16, 2001, will be in effect until July 31, 2002. Further development of the standards will occur through annual review and revision cycles.

Principles and concepts of human subject protection

There is a large international body of literature concerning the ethics of experimentation on humans. Formal ethical principles for protecting subjects began to develop with the Nuremberg Code, written in response to the horror of experiments conducted in Nazi Germany on concentration camp inmates. These principles have continued to develop through the Declaration of Helsinki as it has been periodically updated. In the United States, the Belmont Report codifies the ethical principles that underlie modern concepts of human subject protection.

Principles of human subject protection

The Belmont Report outlines three key principles for protecting human subjects of research: respect for persons, beneficence and justice. These principles form the basis for the current regulations and structures established to protect human subjects in research. The institutional review board (IRB) has as its essential function, to ensure that research benefits outweigh their risks (beneficence). The IRB's focus on assuring fully informed consent addresses the principle of respect for persons. Finally, the IRB's consideration of the equitable distribution of the risks and potential benefits of research addresses the principle of justice.

Concept of Human Research Protection Program

Regulations detail the various responsibilities of IRBs, investigators and research sponsors for protecting human research subjects. Federalwide Assurances and their predecessors, the Multiple Project Assurances and VA MPA Contracts Single Project Assurances, outline the responsibilities for human research protection of institutions engaged in research. This accreditation program, aimed at the HRPP within the VAMC, is built on the assumption that the VAMC as an institution is accountable for the protection of human research subjects who engage in its research enterprise. Each VAMC that conducts human research holds an assurance with the Federal Office of Human Research Protections or the VA Central Office, Office of Research Compliance and Assurance, and each VAMC is responsible for assuring compliance with human research protection regulations. The VAMC has the authority to hire or appoint, train, supervise and discipline investigators. It is responsible to assure the scientific merit of the research conducted within the institution and to assure that human research subjects are protected. The VAMC must have, or make arrangements for, IRB review of research, and it must assure that both the review and conduct of research protects human subjects and meets regulatory requirements. The VAMC, as part of this assurance function, must conduct compliance assurance and continuous quality improvement of its HRPP functions. In short, the VAMC must operate a comprehensive and organized system to protect those who would volunteer to participate as subjects in its research.
This comprehensive system is what we have referred to as the human research protection program (HRPP). In the VAMCs the HRPP consists of a variety of individuals and committees. These include institutional officials; the Research and Development (R&D) Committee, one or more IRBs, which may be subcommittees of the R&D Committee or may be constituted by affiliated VAMCs or university medical or dental schools; IRB staff; investigators; research staff; research pharmacists and others. Except for the specific requirements established in regulation or VA policy, the standards for accrediting HRPPs are flexible with respect to how HRPPs are organized and how human subject protections are carried out. The VAMC need not establish all new committees or departments to carry out human research protection functions. Indeed, many of these functions may already be housed within existing structures, committees, and jobs.

Development of accreditation program and standards

Development of accreditation program

This program is being implemented using a phased approach with the intention of improving human research protections over time. In the introductory year of the program, standards largely mirror regulatory requirements, and they apply to the one year period preceding the survey. In the future, accreditation requirements will become more rigorous, increasingly focusing on performance results, demonstrated by the VAMC's internal quality improvement efforts. Renewal surveys will cover the three-year period between the initial survey and the renewal survey. This phased approach allows rapid implementation of the accreditation program, and it stimulates VAMCs to improve their HRPPs while being held accountable for requirements that are well established. As requirements for accreditation develop and increasingly emphasize results, their advance publication will be important to enable the VAMCs to come into compliance with those requirements.

Development of standards

The principal sources used to develop and inform this initial set of requirements were:

NCQA started work on the standards by obtaining agreement from the VA on the sources to be consulted for current requirements for human subject protections in VA Medical Centers. NCQA then convened a Program Standards Committee, comprised of experts in human research and human research protections, to review and comment on various drafts of the standards. The Committee commented on the organization, content and emphasis of the standards, various approaches to scoring, and performance thresholds. NCQA provided draft standards to the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects and received significant feedback in its report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. An Advisory Group, more broadly constituted than the Standards Committee, spent a day debating a variety of issues and concerns that had direct bearing on the standards. NCQA issued the draft standards for public comment, and received approximately 200 comments from 14 sources. Finally, NCQA conducted a series of test site visits and pilot accreditation surveys to VAMCs. NCQA used comments from the Standards Committee, Advisory Group, IOM committee and the public, along with findings from the pilot surveys, to guide revisions to the standards.

Organization of standards

The standards are organized into the following six domains:

Within each domain, the standards are organized to indicate a chain of activity, from plans, policy and procedure (suggesting intent), through results (demonstration that the intent is being met and the desired outcome achieved). Standards pertain to the following functions:
Plans, policies and procedures
Performance of required activities
Evaluation and improvement (quality assurance and quality improvement)
Results.
In this document unless otherwise specified, the term "standards" encompasses the entire set of performance expectations. These expectations are expressed in increasing detail, in the following ways. Each domain includes a statement of rationale. Within the domain there is one or more over-arching standards, used to organize or group a set of more specific requirements. Each requirement is further defined by one or more elements, and each element contains one or more factors. The survey is designed to assess compliance with each factor.

Use of standards to assess VAMC HRP programs

Trained and certified surveyors, who have been screened for conflict of interest with the VAMC, will conduct the assessment of VAMC HRPPs. VAMCs will submit materials documenting compliance with the standards in advance of the scheduled survey. NCQA staff will evaluate these documents and make compliance assessments, where possible, prior to the site visit. Surveyors will start with the NCQA staff findings, and through interviews, observation and review of a random sample of protocol files, verify the staff findings and complete the assessment. Surveyors will document all findings and make compliance designations with each element; however, they will not decide the accreditation outcome for the VAMC. Surveyors will prepare a report for NCQA. The draft survey report will be submitted to the VAMC first, for review and, if necessary, correction before it is finalized. The Program Accreditation Committee, a committee of experienced surveyors, will review the final report and make the accreditation determination.

Scoring

There are a total of 100 points possible under this accreditation program. The 100 points are distributed across 130 elements, according to the strength of the relationship of the element to protecting human subjects and to underlying regulation. Those elements that have the strongest direct relationship to protecting subjects and are derived directly from regulation are scored most heavily. For example, elements that address IRB consideration of risks to privacy are scored more heavily than elements that address IRB documentation of consideration of risks to privacy because the documentation requirement is an interpretation and not a literal requirement specified in regulation.
Each element includes a scoring guideline, which details the requirements for full, partial, or no score on that element. Each element also has an associated maximum accreditation achievable (MAA), when the score for that element is 0%.

Accreditation outcomes

An accreditation survey will result in one of three possible outcomes: "Accredited," "Accredited with Conditions" or "Not Accredited." A VAMC need not get all 100 points to receive an outcome of "Accredited." However, it must receive at least partial score on every element with an MAA of "Accredited with Conditions." A VAMC that gets no credit on numerous elements with an MAA of "Accredited with Conditions" may have its accreditation outcome downgraded to "Not Accredited" by the Program Accreditation Committee if deficiencies are numerous and serious.

Continuous quality improvement

This accreditation program is itself, subject to continuous quality improvement. Surveyors, VAMCs, VA Central Office staff, committee members and the public are all potential sources of improvement suggestions. Standards will be updated on an annual cycle, taking into account changes in regulation and policy, as well as suggestions for improvement. Suggestions for operational improvement will be continuously logged and evaluated periodically. Operational changes will be implemented as needed. Suggestions for improvements to policy and regulation will be communicated to the relevant government agency. The accreditation program is subject to the same expectations for continuous quality improvement, as the HRPPs that it is designed to assess.

Definitions

ADVERSE EVENT (AE) – Any untoward event associated with a research study. The event does not necessarily have a causal relationship with treatment or study intervention. An AE can be any unfavorable and unintended sign, symptom or disease.
AFFILIATE'S HUMAN RESEARCH PROTECTION PROGRAM – The HRPP of a VAMC's academic affiliate. See HRPP.

CERTIFICATE OF CONFIDENTIALITY – Where data are being collected from subjects about sensitive issues (such as illegal behavior, alcohol or drug use, or sexual practices or preferences), researchers can obtain an advance grant of confidentiality from the Public Health Service that will provide protection against involuntary disclosure of the research subjects identity and the subject's participation in the study, even against a subpoena for research data.

FDA FORM 3454 – The financial disclosure form required by the FDA to reveal/identify any potential financial conflict of interest that an investigator(s), sub-investigator(s) or their spouse and children may have that is applicable to the submission of marketing applications for human drug, biological product, or device for each covered study.
FEDERALWIDE ASSURANCE (FWA) – An agreement or contract between the institution and OHRP, on behalf of the Secretary, DHHS, stipulating the method(s) by which the organization will protect the welfare of research subjects in accordance with the regulations. The Assurance, approval of which is a condition of receipt of DHHS support for research involving human subjects, spells out the organization's responsibilities for meeting the requirements of 45 CFR 46. The FWA replaces all other previous forms of assurance (i.e., MPA, SPA, VA MPA, etc.). All VA facilities conducting human research will be required to maintain an FWA.
FOOD AND DRUG ADMINISTRATION (FDA) – The Federal agency responsible for the regulation of food, drugs and cosmetics, including the human subject research performed for FDA-regulated articles.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) – The systematic and comprehensive approach by an organization to ensure human subject protection in all research. The implementation of any part of the program may be delegated to specific committees, individuals or entities (i.e., academic affiliate or another VAMC) by the organization.
HUMAN SUBJECT – A living individual about whom a research investigator (whether professional or student conducting research) obtains data through intervention or interaction with the individual or identifiable information.
HUMAN SUBJECT SUBCOMMITTEE (of the R&D Committee) – The VAMC's IRB is constituted as a subcommittee to the R&D Committee.
INSTITUTION – Refers to an individual VAMC/HCS. The institution retains ultimate responsibility for human subject protection in research conducted at their facility and/or by their staff.
INSTITUTIONAL REVIEW BOARD (IRB) – An independent committee comprised of scientific and non-scientific members established according to the requirements outlined in Title 38, part 16 (same as Title 45, part 46 and Title 21, part 56) of the U. S. Code of Federal Regulations. The IRB may also be referred to as the HUMAN STUDIES SUBCOMMITTEE of the R&D Committee. Other committees with the same or similar functions are also considered to be IRBs.
INVESTIGATIONAL DEVICE EXEMPTION (IDE) – The process by which the FDA permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.
INVESTIGATIONAL NEW DRUG APPLICATION (IND) – The process by which new drugs or biologics, including the new use of an approved drug, are registered with the FDA for administration to human subjects. An IND number is assigned by the FDA to the drug or biologic for use in tracking.
INVESTIGATOR (Principal investigator) – An individual who conducts an investigation, i.e., under whose immediate direction research is conducted, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
INVESTIGATOR/SPONSOR – A term defined in the FDA regulations as an individual with responsibility for initiating and conducting a research study.

LEGALLY AUTHORIZED REPRESENTATIVE – An individual, judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in research.
MEDWATCH - The FDA Medical Products Reporting Program, is an initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems to FDA and/or the manufacturer and to ensure that new safety information is rapidly communicated to the medical community, thereby improving patient care. The purpose of the MedWatch program is to enhance the effectiveness of postmarketing surveillance of medical products as they are used in clinical practice and to rapidly identify significant health hazards associated with these products.

MEMORANDUM OF UNDERSTANDING (MOU) – A written agreement outlining the details of the relationship between organizations, including the responsibilities of each. Such an agreement is used by the VAMC to delineate the terms and conditions under which it may utilize another entity's IRB.
MINIMAL RISK – The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
MULTIPLE PROJECT ASSURANCE (MPA) – An agreement or contract between the institution and OPRR, on behalf of the Secretary, DHHS, stipulating the method(s) by which the organization will protect the welfare of research subjects in accordance with the regulations. The Assurance, approval of which is a condition of receipt of DHHS support for research involving human subjects, spells out the organization's responsibilities for meeting the requirements of 45 CFR 46. MPAs will be replaced by FWAs.

POLICY – A written principle or rule to guide decision-making.
PRACTICE – An activity that is actually routinely performed, regardless of whether it is required in POLICY or specified in PROCEDURE.
PROCEDURE – See Standard Operating Procedure (SOP).
PROTOCOL – A plan that includes, at minimum, the objectives, rationale, design, methods and other conditions for the conduct of a research study.
PROTOCOL FILE – The documents maintained by the IRB administration containing the protocol, investigator's brochure, IRB/investigator communications and all other supporting materials.
QUALITY IMPROVEMENT (QI) – The effort to assess and improve the level of performance of a program or institution. QI includes quality assessment and implementation of corrective actions to address any deficiencies identified.

RESEARCH - A systematic investigation, including development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
SAFETY REPORTS (IND/IDE) – Written reports from sponsors notifying the FDA and all participating investigators of any adverse experience associated with the use of a drug that is both serious and unexpected.
SERIOUS ADVERSE EVENT (SAE) – Any event that results in death, a life threatening situation, hospitalization or prolonged hospitalization, persistent or significant disability/incapacity or a congenital anomaly/birth defect. SAEs require reporting to the sponsor and the IRB.
SPONSOR – Any person or entity who takes responsibility for and initiates a clinical study. The sponsor may be an individual, pharmaceutical company, device manufacturer, governmental agency, academic institution, private organization, or other organization.

STANDARD OPERATING PROCEDURE (SOP) – A written set of methods or steps to be followed for the uniform performance of a function or activity.
UNEXPECTED ADVERSE EVENT – Any adverse event that has not previously been observed (e. g., included in the investigator brochure).

VULNERABLE SUBJECTS – Individuals whose willingness to volunteer in a research study may be unduly influenced or coerced and individuals with limited autonomy. These individuals may include, but are not limited to, children, prisoners, pregnant women, mentally disabled, or economically or educationally disadvantaged persons.


Topic Area

Institutional Responsibilities (INR)
Rationale

Each VA Medical Center (VAMC) engaged in research involving human subjects is responsible for ensuring the rights, safety and well-being of those recruited to participate in research activities. As a research institution, it is also responsible for assuring that investigators and their staffs understand and comply with standards for the ethical conduct of research. These broad responsibilities can be met through three institutional actions: developing a systematic and comprehensive approach, a Human Research Protections Program (HRPP), to monitor, evaluate and improve the protection of human research subjects; establishing and/or designating an Institutional Review Board (IRB) to review research following Federal and institutional requirements; and educating staff involved in research about their ethical responsibility to protect research subjects. This standard outlines the responsibilities of institutions that conduct human subjects research.

INRI

The institution has a systematic and comprehensive program, a Human Research Protection Program (HRPP), with dedicated resources to ensure the rights, safety and well being of human research subjects in relation to their participation in research activities.

Requirement INR1

The institution has a written description of (or plan for) its HRPP appropriate for the research involving human subjects conducted at the institution.

Element INR1A

The HRPP description includes the following:

  • Statement of principles concerning protection of human research subjects.
  • Identification of the institutional officer accountable for the HRPP.
  • The organizational structure, process, roles and responsibilities for making policy to protect human research subjects.
  • Roles and responsibilities of the R&D Committee in protecting human subjects.
  • One or more of the following arrangements for an IRB: the institution has a Human Subjects Subcommittee to R&D Committee and registers it with OHRP; the institution has a written arrangement with a regional VA IRB or another VA IRB that is registered with OHRP; the institution has a written arrangement with an affiliated medical or dental school or university for the use of its registered IRB.

Scoring Guidelines

100%

75%

50%

0%

HRPP description includes five factors.

NA

NA

HRPP description includes less than five factors.

Scope of Review

NCQA evaluates this element once for the institution.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

38CFR16.103(b)(1), 38CFR16.103(c), M-3, Part I, 2.02b, M-3, Part I, 3.01b, M-3, Part I, 9.07, 45CFR46.103(b)(1), 45CFR46.103(c), IRB Guidebook (1), MPA

Data Source

Documented process

Notes

Examples of documents that may demonstrate compliance with this element include: MPA, institutional organizational charts, job descriptions, policies and procedures (IRB and institution), budget/time allocation, formal IRB agreement, R&D Committee charter.

Element INR1B

The institution's Research and Development (R&D) Committee conforms to VA policy regarding Human Subjects Research. Responsibilities include the following:

  • The R&D Committee is responsible for the scientific quality and appropriateness of all research involving human subjects.
  • The R&D Committee re-evaluates at least annually, the scientific quality of all research studies involving human subjects to assure protection of human subjects.
  • The R&D Committee membership, supplemented as needed by advisors or consultants, possesses the expertise required to perform the scientific review.
  • The R&D Committee cannot alter an adverse report or recommendation, e.g., disapproval for ethical or legal reasons made by the Subcommittee on Human Studies.

Scoring Guidelines

100%

75%

50%

0%

R&D Committee meets all four factors.

NA

NA

R&D Committee meets less than four factors.

Scope of Review

NCQA evaluates this element once for the institution.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

M-3, Part I, 2.02b(1), M-3, Part I, 2.02b(2), M-3, Part I, 3.01a(4), M-3, Part I, 3.01b(1), M-3, Part I, b3(a-b), M-3, Part I, 3.01d(5)(e)

Data Source

Documented process, reports

Notes

Examples of documents that may demonstrate compliance with this element include: R&D Committee charter, R&D or institutional policies and procedures, R&D membership list, R&D minutes.

Element INR1C

A designated committee or individual (e.g., R&D Committee or ACOS for R&D) ensures that the HRPP is operational. The following specific responsibilities are outlined in job descriptions, committee charters or other documents:

  • Implementation of the institution's HRPP policy.
  • Review and evaluation of the reports and results of compliance assessment and quality improvement activities.
  • Implementation of needed improvements and follow-up on actions, as appropriate.
  • Monitoring changes in VA and other Federal regulations and policies that relate to human research protections.

Scoring Guidelines

100%

75%

50%

0%

All four responsibilities are identified.

Three responsibilities are identified.

Two responsibilities are identified.

Less than two responsibilities are identified.

Scope of Review

NCQA evaluates this element once for the institution.

Accreditation

0% Þ Accreditation no greater than Accredited

Regulatory Support

38CFR16.103(c), IRB Guidebook I

Data Sources

Documented process

Notes

Examples of documents that may demonstrate compliance with this element include: R&D or institutional policies and procedures, job descriptions, committee charters.

Element INR1D

The institution maintains and supports a current and approved Federalwide Assurance (FWA) and/or an assurance in accordance with current VA regulations that includes its principles and guidelines for protecting research subjects. The institution demonstrates its maintenance and support of its assurance by the following:

  • The institution is operating under a current approved assurance.
  • The institution identifies the responsible official for the assurance (Note: In VA facilities, the Medical Center Director/CEO is the responsible official).
  • If the assurance is an FWA, it is approved by the VA Office of Research Compliance and Assurance (ORCA).

Scoring Guidelines

100%

75%

50%

0%

The institution maintains and supports an assurance as required.

NA

NA

The institution does not maintain an assurance.

Scope of Review

NCQA evaluates this element once for the institution.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

38CFR16.103(a), M-3, Part I, 9.03c, 45CFR46.103(a), FWA, ORCA Directive 2c-201-5, VA MPA

Data Sources

Documented process

Notes

Examples of documents that may demonstrate compliance with this element include: FWA, VA Letter of Assurance with any of the following - MPA with OHRP, VA MPA Contract, IIA with MPA/ FWA institution.

Element INR1E

For each commitment of the institution's assurance, the institution has corresponding documented processes for implementation. The documented processes:

  • Address commitments made in the assurance.
  • Do not contradict commitments made in the assurance.

Scoring Guidelines

100%

75%

50%

0%

Each commitment has a corresponding documented process.

75% of the commitments have a documented process.

50% of the commitments have a documented process.

Less than 50% of the commitments have a documented process.

Scope of Review

NCQA reviews this element once for the institution.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

IRB Guidebook I, MPA

Data Sources

Documented process

Notes

Examples of documents that may demonstrate compliance with this element include: institutional, IRB and R&D Committee policies and procedures.


Requirement INR2

The institution provides sufficient resources for the HRPP, R&D Committee and its IRB(s)

Element INR2A

The institution engages in a systematic budgeting process for the HRPP including the R&D Committee and if applicable, its Human Subjects Subcommittee (IRB) at least annually. Budgeting includes consideration of the following factors:

  • Analysis of the volume of research to be reviewed.
  • Feedback from IRB members and staff.

Scoring Guidelines

100%

75%

50%

0%

Budgeting includes consideration of two factors.

NA

Budgeting includes consideration of one factor.

Budgeting includes consideration of less than one factor.

Scope of Review

NCQA evaluates this element once for the institution.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

M-3, Part I, 3.01b(1), M-3, Part I, 3.02g(1), IRB Guidebook, MPA

Data Sources

Reports

Notes

Examples of documents that may demonstrate compliance with this element include: budget records, institutional policy regarding budget, IRB forms.

Element INR2B

During the budgeting process, resources reviewed include but are not limited to:

  • Personnel.
  • Materials and supplies.
  • Space.
  • Capital Equipment.
  • Training and education.

Scoring Guidelines

100%

75%

50%

0%

Budget review includes all five factors.

Budget review includes three factors.

Budget review includes two factors.

Budget review includes less than two factors.

Scope of Review

NCQA evaluates this element once for the institution.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

M-3, Part I, 3.01(b)(1), M-3, Part I, 3.02(g)(1), IRB Guidebook, MPA

Data Sources

Reports

Notes

Examples of documents that may demonstrate compliance with this element include: budget records, institutional policy regarding budget, budget analysis forms, reports.

Element INR2C

The institution must be able to ascertain the following for each active research proposal:

  • Date originally approved and if applicable, date of most recent approval.
  • Date of expiration of approval.

Scoring Guidelines

100%

75%

50%

0%

The institution tracks two factors.

NA

The institution tracks one factor.

The institution tracks less than two factors.

Scope of Review

NCQA evaluates this element once for the institution and once for each external IRB used.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

38CFR16.115(a), 45CFR46.115(a), 21CFR56.115(a), FDA Information Sheets – Self Evaluation Checklist for IRB's, IRB Guidebook I, III

Data Sources

Reports

Notes

Examples of documents or methods that may demonstrate compliance with this element include: database reports, IRB files, log sheets, reports, live system queries.


Requirement INR3

The institution provides proper oversight to its IRB(s).

Element INR3A

If the institution uses the IRB(s) of a VA regional system, affiliated university or another VA facility, there is a legal document, e.g. Memorandum of Understanding (MOU), contract or letter of agreement (Formal IRB Agreement). This document, includes, at a minimum:

  • Specific requirements for the membership and operation of the IRB to review VA research in compliance with VA regulations.
  • The respective responsibilities of the institution and the designated IRB for human subject protection.
  • The scope of activities delegated to the IRB.
  • The method, frequency and nature of reporting to the R&D Committee.
  • The process by which the institution evaluates the IRB's performance.
  • The remedies, including revocation of the Formal IRB Agreement, available to the institution if the designated IRB does not fulfill its obligations.

Scoring Guidelines

100%

75%

50%

0%

NA

Formal IRB Agreement includes all six factors.

Formal IRB Agreement includes five factors.

Formal IRB Agreement includes four factors.

There is no Formal IRB Agreement or it includes less than four factors.

The institution has its own IRB.

Scope of Review

NCQA evaluates this element for each external IRB used.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

M-3, Part I, 3.01e, M-3, Part I, 9.07a, M-3, Part I, 9.16

Data Sources

Documented Process

Notes

The only documents that may be used to demonstrate compliance with this element are Formal IRB Agreements that may be contained within other broader inter-institutional agreements or legal documents.

Element INR3B

If the institution has used the IRB(s) of a VA regional system, affiliated university or another facility for one year or longer, the institution conducts oversight of the designated IRB(s) including the following:

  • Regularly evaluating reports as required in the Formal IRB Agreement.
  • Annually reviewing designated IRB's charter, policies and procedures.
  • Annually evaluating whether the designated IRB is in compliance with current VA, Federal and other regulations and guidance.

Scoring Guidelines

100%

75%

50%

0%

NA

Oversight includes all three factors.

Oversight includes two factors.

Oversight includes one factor.

Oversight is not performed, or does not include any factor.

Institution has used the external IRB for less than 1 year.

Scope of Review

NCQA evaluates this element for each external IRB used.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

M-3, Part I, 3.01e(1)(c)

Data Sources

Reports

Notes

Examples of documents that may demonstrate compliance with this element include: R&D Committee minutes, IRB performance reports, correspondence with IRB regarding performance findings.

Element INR3C

If the institution has used the IRB(s) of a VA regional system, affiliated university or another VA facility for less than one year, the institution conducts oversight of the designated IRB(s) including the following:

  • Prior to designation, evaluates designated IRB's capacity to perform the designated activities.
  • Regularly evaluates reports as required in the Formal IRB Agreement.

Scoring Guidelines

100%

75%

50%

0%

NA

Oversight includes both factors.

NA

Oversight includes one factor.

Oversight is not performed or includes less then one factor.

The institution has used the IRB for 1 year or longer.

Scope of Review

NCQA evaluates this element for each external IRB used.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

M-3, Part I, 3.01e(1)(c)

Data Sources

Reports

Notes

Examples of documents that may demonstrate compliance with this element include: R&D Committee minutes, IRB performance reports, correspondence with IRB regarding performance findings.

Element INR3D

Whether the IRB is internal or external to the institution, the institution at least annually reviews and documents consideration of the following:

  • The IRB(s) and the membership of the IRB(s) are appropriate given the research being reviewed.
  • The IRB(s) includes representatives with an interest in or experience with vulnerable populations involved in research, either as members or ad hoc consultants.

Scoring Guidelines

100%

75%

50%

0%

The institution annually reviews two factors.

NA

The institution annually reviews one factor.

The institution does not annually review either factor.

Scope of Review

NCQA evaluates this element for each IRB (internal or external).

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

38CFR16.107(a), M-3, Part I, 3.01(b)(1), 45CFR46.107(a), 21CFR56.107(a), VA MPA

Data Sources

Reports

Notes

Examples of documents that may demonstrate compliance with this element include: R&D Committee minutes, IRB performance reports, correspondence with IRB regarding performance findings.

Element INR3E

The R&D Committee assesses the qualifications and experience of the IRB Chair prior to appointment.

Scoring Guidelines

100%

75%

50%

0%

NA

The R&D Committee assesses the qualifications and experience of the chair.

NA

NA

The R&D Committee does not assess the qualifications and experience of the chair.

No change in IRB Chair in the last year.

Scope of Review

NCQA evaluates this element for each IRB used.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

Data Sources

Reports

Notes

Examples of documents that may demonstrate compliance with this element include: R&D Committee minutes, R&D Committee communications

Element INR3F

The institution evaluates the performance of the IRB(s). Evaluation includes the following areas:

  • Content and accuracy of informed consent forms.
  • IRB analysis of risks and benefits including designation of minimal risk.
  • Special considerations and protections for vulnerable or potentially vulnerable populations.
  • Privacy and confidentiality protections.
  • Continuing review of approved research.
  • Ongoing review of previously approved research (i.e. amendments, adverse events).
  • Use of expedited review or other procedures requiring review of less than the full IRB.
  • Granting exemption from Federal requirements for IRB review.
  • Granting waivers for documentation of informed consent.
  • Granting waivers of any elements of informed consent.

Scoring Guidelines

100%

75%

50%

0%

Evaluation includes all ten factors.

Evaluation includes eight factors.

Evaluation includes six factors.

Evaluation is not performed or includes less than six factors.

Scope of Review

NCQA evaluates this element for each IRB used.

Accreditation

0% Þ Accreditation no greater than Accredited

Regulatory Support

M-3, Part I, 3.01e(1)(c)

Data Sources

Reports

Notes

Examples of documents that may demonstrate compliance with this element include: R&D Committee minutes, IRB performance reports, correspondence with IRB regarding performance findings.


Requirement INR4

The institution has policies and procedures to identify and manage institutional, IRB member and investigator conflicts of interest with research conducted at the institution.

Element INR4A

The institution has policies and procedures for the identification and management of conflict of interest of IRB members.

Scoring Guidelines

100%

75%

50%

0%

The institution has policies and procedures addressing the element.

NA

NA

The institution does not have policies and procedures addressing the element.

Scope of Review

NCQA evaluates this element for each IRB used.

Accreditation

0% Þ Accreditation no greater than Accredited with Conditions

Regulatory Support

38CFR16.107(e), M-3, Part I, 9.08(e), 45CFR46.107(e), 21CFR56.107(e)

Data Sources

Documented process

Notes

Examples of documents that may demonstrate compliance with this element include: IRB, institutional, or R&D policies and procedures, IRB and R&D Committee minutes.

Element INR4B

The institution has policies and procedures for the identification and management of conflicts of interest of the following parties