Professional Documents
Culture Documents
FINAL
JOINTCOMMISSIONINTERNATIONAL
ACCREDITATIONSTANDARDSFOR
HOSPITALS
Supplementto4thEdition
StandardsforAcademicMedicalCenterHospitals:
MedicalEducationPrograms
ClinicalResearchPrograms
2012JointCommissionInternational
Introduction
These standards for academic medical center hospitals* were developed to recognize the unique
resource such centers represent for health professional education and human subject research in
their community and country. These standards were also developed to present a framework for
including medical education and human subject research into the quality and patient safety activities
of academic medical center hospitals. Unless deliberately included in the quality framework,
education and research activities often are the unnoticed partners in patient care quality monitoring
and improvement.
The standards are divided into two chapters, as medical education and clinical research are most
frequently organized and administered separately within academic medical centers. For all hospitals
meeting the eligibility criteria below, these two chapters will be a required addition to the Joint
Commission International Accreditation Standards for Hospitals, 4th Edition. The evaluation of these
standards will be integrated into the evaluation process for the accreditation of hospitals. For
example, when the on-site evaluators are reviewing patient care in a clinical unit, they will also
evaluate the contribution of medical trainees to care processes in that unit, and the integration of
clinical research protocols into the care provided on the unit and the quality monitoring processes.
To recognize that an academic medical center hospital has been surveyed under these standards, the
Certificate of Accreditation will note that the hospital is accredited under the Joint Commission
International Standards for Academic Medical Center Hospitals. These hospitals will also be
recognized separately on the JCI website listing of all accredited organizations.
Eligibility Criteria
The following three eligibility criteria must be met:
1. The applicant hospital is organizationally or administratively integrated with a medical school.
2. The applicant hospital is the principal site for the education of both medical students and medical
specialty residents from the medical school noted in criterion #1.
3. The applicant hospital conducts academic and/or commercial human subject research involving
patients of the hospital.
* Academic medical center hospitals may also be referred to as university hospitals when they are present
with a medical school in the same university setting.
Standard MPE.1
Those responsible for governance and leadership of the organization approve and monitor the
participation of the organization in providing medical education.
Intent of MPE.1
Integrating medical education into a hospitals operations requires a significant commitment of
time, energy and resources. Thus, these decisions are best made at the highest decision-making level
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of the organization. When the decision to provide medical education involves a network or
consortia of organizations, governance is fully informed as to all the relationships and
accountabilities. As the governance level also is responsible for decisions related to the
organizations mission, strategic plans, resource allocation, and quality program (see GLD.1.1
through GLD.1.6), it is necessary to make this an integrated decision. For example, is the
commitment to educate medical students and medical residents consistent with the organizations
mission, and how will this commitment be portrayed to the public and the organizations patients?
The governance and leadership of the organization are also responsible for obtaining, reviewing,
and agreeing to the education program parameters of the sponsoring academic program.
A set of metrics, relevant to the education programs within the organization, are selected and
reported to governance and leadership on an annual basis for review and use in an annual review of
the scope and activities of the program, achievement of program goals, any relevant regulatory
compliance issues, and the satisfaction of patients and staff with the program.
Standard MPE.2
The organizations professional staff, patient population, technology, and facility are consistent with
the goals and objectives of the education program.
Intent of MPE.2
Providing a rich and meaningful learning experience for medical students and medical residents
requires many factors, in addition to governance and leadership commitment. The professional staff
of the organization must be adequate in number and in expertise to advance student education. For
example, nursing staff numbers support the educational program and nursing staff understand their
relationship to the educational program. The organizations patient population is sufficient in
number and needs to support the education and clinical learning experience. There must also be
adequate classroom space, off-duty study and rest facilities, as well as print and online resources to
support an effective learning environment. In addition, adequate opportunities and time for
student/clinical staff interaction and learning must be provided. Contemporary technology needs to
be available so that evidence-based health care practices can be taught.
members, it is clear if tiles are earned or honorary, how those titles are to be used, and what the
titles mean to the public. The organization has a complete listing of clinical teaching staff with their
medical and academic titles. Any requirements for the renewal or redesignation of academic titles
are monitored for compliance (also see SQE.9 through SQE.11)
Measurable Elements of MPE.3
1. Clinical teaching staff are identified to hospital staff and there is a complete list of clinical
teaching staff, including both professional and academic titles.
2. Staff are educated about these individuals, their accountabilities, and their authority.
3. The hospital has a process in place to monitor academic titles and requirements for renewal or
redesignation and to keep such titles up-to-date.
Standard MPE.4
The organization understands and provides the required frequency and intensity of medical
supervision for each type and level of medical student and resident trainee.
Intent of MPE.4
Supervision is required to ensure safe patient care and ensure that the training program is a learning
experience for the medical student and resident trainee. The required level of supervision is
consistent with the level of training and level of competence of the medical student and resident
trainee. The organization understands that medical student and resident trainee competence cannot
be assumed and must be demonstrated early in the training program.
Each medical student and resident trainee understands the clinical supervision process, including
who is to provide the supervision and the frequency of the supervision. For example, a medical
school student understands if supervision is provided by a resident or by the patients primary
physician or by a medical school faculty member. Students and residents also understand if the
supervision includes daily signing of all notes and orders, or signing of the care plan and progress
notes every other day, or making a separate entry in the patients record. Likewise, it is clear as to
how the evidence of that supervision is documented, including the frequency and location of the
documentation.
Finally, to ensure a uniform learning experience, the organization has identified and monitors the
uniform expectations for the mentoring/supervision process.
Measurable Elements of MPE.4
1. Organization policy identifies the required level of supervision for each level of trainee.
2. The level to be provided is based on the demonstrated competency of the trainee.
3. Each trainee understands the level, frequency, and documentation of their supervision.
4. The organization provides the required level of supervision for each trainee.
5. There is a uniform process for documenting the required supervision that is consistent with
organization policy, program goals, and the quality and safety of patient care.
6. The organization has established uniform expectations for the all staff providing supervision to
ensure the process results in uniform student experiences.
7. Patient care records are reviewed for compliance with the documentation requirements and
frequency.
Standard MPE.5
Medical education provided in the organization is coordinated and managed through a defined
operational mechanism and leadership structure.
Intent of MPE.5
Medical education programs in hospitals require an effective leadership structure and a commitment
of staff time for their coordination and daily operation. The agreements between the organization
and the medical school need to be established and then monitored. There is an accurate list of all
students in the organization. For each student, there is documentation of
a)
b)
c)
d)
e)
f)
g)
When an academic program is sponsored by the organization, it is determined how and where these
activities are conducted.
Intent of MPE.6
Training programs and their students are a critical factor in overall quality of care and patient safety.
Although it would be desirable for each trainee to have basic education on quality and patient safety
in their respective academic program, this rarely happens. Thus, the organization must have a
planned and deliberate program to introduce such concepts, support the trainees in complying with
relevant policies and guidelines, and including trainees in all quality and safety monitoring programs.
For example, trainees would be educated to comply with the International Patient Safety Goals.
Also, required clinical practice guidelines, surgical time-out procedures, medication-ordering
policies, and other mechanisms to reduce variation in care processesand thus reduce the risk in
those processesis part of all trainees initial orientation and ongoing training and monitoring. The
orientation for the trainee includes at least
a)
b)
c)
d)
e)
f)
Those persons providing trainee supervision ensure that all trainees are knowledgeable about these
quality and safety programs and are included in the monitoring process.
Intent of MPE.7
The laws and regulations in many countries permit medical trainees, as they advance in their
program, to provide services to the organization outside of their academic program. For example, a
medical trainee may provide medical care in the organizations emergency department in evenings
or on weekends, or may function as the house doctor during the night shift. In these
circumstances, the individual trainee must be evaluated and given permission to provide those
services through the normal established processes for such professionals as described in the Staff
Qualifications and Education (SQE) standards. Their work is evaluated as required by the SQE
standards.
Standards
The following is a list of all standards for this function. They are presented here for your
convenience without their intent statements or measurable elements. For more information about
these standards, please see the next section in this chapter, Standards, Intents, and Measurable
Elements.
HRP.1 The organizations leaders are accountable for the protection of human research subjects.
HRP.1.1 The leaders comply with all regulatory and professional requirements and
provided adequate resources for effective operation of the research program.
HRP.2 The organizations leaders establish the scope of research activities.
HRP.3 The organizations leaders establish requirements for sponsors of research to ensure their
commitment to the conduct of ethical research.
HRP.3.1 When one or more of the research-related duties and functions of the sponsor
are provided through an outside commercial or academic contract research organization, the
accountabilities of the outside contract research organization are clearly defined.
HRP.4 The organizations leaders create or contract for a process to provide the initial and
ongoing review of all human subject research.
HRP.5 The organization identifies and manages conflicts of interest with research conducted at the
organization.
HRP.6 The organization integrates the human subject research program into the quality and
patient safety programs of the organization.
HRP.7 The organization establishes those policies and procedures necessary to inform and protect
patients during the selection process for research subjects and during the research.
HRP.7.1 The organization informs patients and families about how to gain access to
clinical research, clinical investigation, or clinical trials involving human subjects.
HRP.7.2 The organization informs patients and families about how patients who choose to
participate in clinical research, clinical investigation, or clinical trials are protected.
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Standard HRP.1
The organizations leaders are accountable for the protection of human research subjects.
Standard HRP.1.1
The leaders comply with all regulatory and professional requirements and provided adequate
resources for effective operation of the research program.
Intent of HRP.1 and HRP.1.1
Human subject research is a complex and significant endeavor for a health care organization. The
leaders of the organization recognize the required level of commitment and personal involvement
required to advance scientific inquiry in the context of protecting the patients for whom they have
made a commitment to diagnose and treat.
The administrative, clinical and research leaders commitment to human subject research is not
separate from their commitment to patient carecommitment is integrated at all levels. Thus,
ethical considerations, good communications, responsible leaders, regulatory compliance, and
financial and nonfinancial resources are components of this commitment. One such resource is
adequate indemnity insurance to compensate patients for adverse events due to the research
protocol. The leaders recognize the obligation to protect patients irrespective of the sponsor of the
research.
The leaders are knowledgeable about and comply with those sources of regulation and professional
standards specific for clinical research, such as those from the International Conference on
Harmonization (ICH)/World Health Organization Good Clinical Practice (GCP) standards (see
Endnotes).
4. The leaders assume responsibility for patient protection irrespective of the sponsor of the
research.
Measurable Elements of HRP.1.1
1. The leaders recognize and establish mechanisms for compliance with all regulatory and
professional requirements related to research.
2. The leaders have a process for budgeting to provide adequate resources for effective operation of
the research program.
3. The leaders provide or ensure that there is adequate indemnity insurance to compensate patients
participating in clinical research who experience an adverse event.
Standard HRP.2
The organizations leaders establish the scope of research activities.
Intent of HRP.2
Research activities can be limited to one clinical unit or spread throughout an organization. The
research can be of one or more typesfor example, related to devices, drugs (experimental and offlabel), or behavioral change. To ensure that adequate control and resources support all the research
within the organization, it is important that the leaders make deliberate decisions regarding the
scope of the research activities, including types and locations. The leaders are also responsible for
ensuring an adequate number of properly trained staff to serve as principal investigators and other
investigators in the research. There is documentation of the required qualifications. The leaders also
must set parameters for when a staff member of the organization may participate as a research
subject.
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Intent of HRP.3
The sponsor of a research protocol must be qualified and accountable. Thus, the organizations
leaders must have clear requirements for sponsors of research within their organization. Sponsors
are accountable for every aspect of the specific research including
monitoring the quality and safety of the research;
use of trained and qualified research teams;
protection of the data generated in terms of reliability and validity to ensure that the
results are statistically and ethically correct;
protection of the privacy of subject data; and
ensuring that patient or research incentives do not compromise the integrity of the
research.
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Standard HRP.3.1
When one or more of the research-related duties and functions of the sponsor are provided
through an outside commercial or academic contract research organization, the accountabilities of
the outside contract research organization are clearly defined.
Intent of HRP.3.1
Human subject research has many components, some of which a sponsor may choose to contract
to an outside organization, usually termed a contract research organization. Such components may
include subject recruitment, conducting of the research, providing data management, or serving as
the research review mechanism. The organization and sponsor are responsible for the careful
selection of a contract research organization, the clear delineation of accountability, and for the
monitoring of compliance under the contract. When regulations relate to the duties transferred by
the sponsor to the contract research organization, the sponsor monitors compliance with those
regulations as a part of contract review.
Intent of HRP.4
One of the most important functions related to human subject research is review and monitoring by
an independent group of individuals, commonly referred to as an institutional review board (IRB),
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an ethics committee, or similar designation. The composition, scope of responsibilities, and other
factors may be described in laws or regulations. This group monitors all aspects of the research
protocol to ensure patient protection and safe research. This function may be contracted to an
outside organization such as a contract research organization. The policies, procedures, and
structure of this research review function are specified by the hospitals leaders, as well as what
functions may or may not be transferred to a contract research organization. Also, the leaders are
responsible for identifying the types of research that are exempt from this review function and the
documentation of the activities of the review group. This documentation is an important
component of the leaders responsibility to review, at least on an annual basis, how well the research
review function is operating.
Intent of HRP.5
Conflicts of interest can arise from many sources and in many forms for those sponsoring or
participating in human subject research. The conflicts may be financial (such as payment for
recruitment of certain types of subjects) or nonfinancial (such as trips to speak at conferences). The
research review process can identify and mitigate such conflicts, or the organization can use or
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develop another type of mechanism to monitor and mitigate conflicts. The mechanism includes
education about what constitutes a conflict and how conflicts can be successfully managed.
Intent of HRP.6
Human subject research may involve new types of surgical procedures, the use of new
pharmaceuticals or the off-label use of current formulary drugs, the use of adult treatment
modalities on pediatric populations, among others. Of primary importance is the inclusion of
research activities in the routine process of the organization; for example, the ordering, dispensing,
and administration process for medications under study. Routine processes also include the
reporting of adverse events through the quality and patient safety monitoring processes. Thus,
reporting an adverse event related to a hospital patient on a research protocol should be to the
quality monitoring mechanism of the hospital as well as to the sponsor of the research or the
contract research organization.
Reporting of events related to research protocols can be very informative toward understanding the
overall quality and patient safety of care in the organization. For example, a significant adverse
event when a drug is used for an off-label purpose is important patient safety information that
should be part of the organizations ongoing medication monitoring process. Equally important is
the handling and disposal of certain experimental research pharmaceuticals which should be a
component of the management of hazardous materials. Also, equipment used in experimental
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procedures should be monitored and maintained along with other biomedical equipment in the
organization.
Thus, every aspect of the human subject research program should be evaluated as to what quality
and safety programs of the hospital are applicable, and then the reporting and monitoring processes
ongoing within the organization should be included in the research program. This should also be
the case when some research activities are provided by a contract research organization.
Standard HRP.7.1
The organization informs patients and families about how to gain access to clinical research, clinical
investigation, or clinical trials involving human subjects.
Standard HRP.7.2
The organization informs patients and families about how patients who choose to participate in
clinical research, clinical investigation, or clinical trials are protected.
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Endnotes
<L3>International Conference on Harmonisation (ICH)/World Health Organization
(WHO) Good Clinical Practice (GCP) standards. Clinical studies should be carried out
according to International Conference on Harmonisation (ICH)/World Health Organization
(WHO) Good Clinical Practice (GCP) standards. This provides a unified standard for the European
Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and
the WHO. Thus, any country that adopts this guideline technically follows this same standard.
The ICH is a unique project that brings together the regulatory authorities of Europe, Japan, and
the United States and experts from the pharmaceutical industry in the three regions to discuss
scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve greater harmonization in the
interpretation and application of technical guidelines and requirements for product registration in
order to reduce or obviate the need to duplicate the testing carried out during the research and
development of new medicines. The objective of such harmonization is a more economical use of
human, animal and material resources, and the elimination of unnecessary delay in the global
development and availability of new medicines whilst maintaining safeguards on quality, safety and
efficacy, and regulatory obligations to protect public health. This mission is embodied in the Terms
of Reference of ICH.
Specifically pertaining to CROs providing clinical-trials services, the ICH-GCP (E6 1.20) defines a
contract research organization (CRO) as: "a person or an organization (commercial, academic, or other)
contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions."
Furthermore, it states that:
(5.2.1) A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a
CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with
the sponsor. The CRO should implement quality assurance and quality control.
(5.2.2) Any trial-related duty and function that is transferred to and assumed by a CRO should be
specified in writing.
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(5.2.3) Any trial-related duties and functions not specifically transferred to and assumed by a CRO
are retained by the sponsor.
(5.2.4) All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO
has assumed the trial related duties and functions of a sponsor.
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