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JOINT COMMISSION INTERNATIONAL

ACCREDITATION STANDARDS FOR


HOSPITALS
Supplement
to 4th
Edition

Standards for Academic


Medical Center Hospitals:
Medical Education Programs
Clinical Research Programs

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.

Medical Professional Education


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.
MPE.1 Those responsible for governance and leadership of the organization approve and monitor
the participation of the organization in providing medical education.
MPE.2 The organizations professional staff, patient population, technology, and facility are
consistent with the goals and objectives of the education program.
MPE.3 Clinical teaching staff members are identified and each staff members role and relationship
to the academic institution is defined.
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.
MPE.5 Medical education provided in the organization is coordinated and managed through a
defined operational mechanism and leadership structure.
MPE.6 Trainees comply with all organization policies and procedures, and all care is provided
within the quality and patient safety parameters of the organization.
MPE.7 Medical trainees who provide care or services within the organizationoutside of the
parameters of their academic programare granted permission to provide those services through
the organizations established credentialing, privileging, job specification, or other relevant program.

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.

Measurable Elements of MPE.1


1. The decision to provide medical education is made at the highest level of governance and
leadership of the hospital, is consistent with the organizations mission and is documented.
2. Hospital governance and leadership obtain, review, and accept the parameters of the participating
medical school and this action is documented.
3. Hospital governance and leadership endorse a set of metrics to monitor and evaluate the ongoing
operation of medical education programs and there is documented review of the monitoring data.
4. Hospital governance and leadership review, at least annually, the medical education programs
within the organization and the review is documented.
5. The review includes the satisfaction of patients and staff with the clinical care provided under 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.

Measurable Elements of MPE.2


1. There is evidence that the professional staff of the organization are in adequate number and have
the education, training, and competence to support and advance the agreed-upon student learning.
2. There is evidence that the organizations patient population is adequate in number and clinical
needs to support the agreed-upon student learning.
3. There is evidence that the organizations facilities, technology, and other resources support the
agreed-upon student learning.
Standard MPE.3
Clinical teaching staff members are identified and each staff members role and relationship to the
academic institution is defined.
Intent of MPE.3
Those clinical staff members who have responsibility for student education and student supervision
are clearly identified so that the students and other organization staff understand educational
accountabilities and authority. For example, when any organization staff member has a comment,
concern, or other matter related to the educational program or students, they will understand who is
accountable for receiving and acting on that information.
The relationship of the clinical teaching staff of the organization to the sponsoring academic
institution(s) needs to be clear. For example, when academic titles are conferred on clinical staff
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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)

their enrollment status;


academic classification;
any required licensure or certification;
reports of student achievements;
identification of student competencies;
any known factors that will require accommodation; and
any know factors that may influence the level of supervision required.

When an academic program is sponsored by the organization, it is determined how and where these
activities are conducted.

Measurable Elements of MPE.5


1. The operational structure for medical education in the organization has been determined and is in
operation as required.
2. The leadership structure for medical education in the organization has been determined and is in
operation as required.
3. There is a complete and current list of all students in the organization.
4. For each student, there is documentation of at least a) through g) in the intent statement.
Standard MPE.6
Trainees comply with all organization policies and procedures, and all care is provided within the
quality and patient safety parameters of the organization.

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)

organization quality and patient safety program;


infection control program;
medication safety program;
the International Patient Safety Goals;
all other required organization orientation, including at the department and unit level; and
any ongoing required education.
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Those persons providing trainee supervision ensure that all trainees are knowledgeable about these
quality and safety programs and are included in the monitoring process.

Measurable Elements of MPE.6


1. All trainees are provided an orientation that includes at least a) through f) of the intent statement.
2. Trainees are included in the data collection for the organizations quality monitoring programs.
3. Those supervising trainees ensure the trainees are knowledgeable of the program and participate
in the programs.
4. Trainees can demonstrate knowledge of these programs.
5. Those supervising trainees consider compliance with these programs in their evaluation of trainee
performance.
Standard MPE.7
Medical trainees who provide care or services within the organizationoutside of the parameters of
their academic programare granted permission to provide those services through the
organizations established credentialing, privileging, job specification, or other relevant program.

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.

Measurable Elements of MPE.7


1. The organization determines what types of trainees and under which circumstances trainees can
be hired or otherwise engaged by the organization to provide patient care or other services.
2. Trainees providing such services meet all the relevant standards, including competency, and are
evaluated as required by the SQE standards.
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Human Subject Research Programs

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).

Measurable Elements of HRP.1


1. The leaders establish and promote a code of ethical professional behavior.
2. The leaders, verbally and in writing, communicate within the organization their commitment to
protect human research participants and support the code of ethical professional behavior.
3. The leaders identify the official(s) responsible for maintaining the development of and
compliance with all human research policies and procedures.
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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.

Measurable Elements of HRP.2


1. The leaders identify the program scope in terms of drugs, medical devices, testing, and other
potential research topics and methodologies.
2. The leaders identify those facilities that will be included in the research function.
3. The leaders identify the qualifications of staff permitted to participate in the research program as
principal investigators or other investigators.

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4. There is documentation of the qualifications of staff permitted to participate in the research


program.
5. The leaders identify those circumstances in which staff can serve as research subjects.
Standard HRP.3
The organizations leaders establish requirements for sponsors of research to ensure their
commitment to the conduct of ethical research.

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.

Measurable Elements of HRP.3


1. The requirements include that sponsors comply with the organizations policies and processes for
the monitoring and evaluation of the quality and safety of the research.
2. The requirements include that sponsors use research teams that are trained and qualified to
conduct the research.
3. The requirements include that sponsors protect the privacy of subject data collected during the
research.
4. The requirements include that sponsors ensure the reliability and validity of the research data and
the statistical and ethical correctness of the results.
5. The requirements include that sponsors do not permit patient or researcher incentives that would
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.

Measurable Elements of HRP.3.1


1. The organization has a policy and procedure for the process to determine the activities and
responsibilities of a contract research organization.
2. The duties and functions transferred by the sponsor to the contract research organization are
contained in a written contract.
3. The contract specifies the required quality and safety program provided by the contract research
organization or the sponsor.
4. The sponsor is responsible for monitoring the contract and is responsible for the quality and
integrity of the research data.
Standard HRP.4
The organizations leaders create or contract for a process to provide the initial and ongoing review
of all human subject research.

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.

Measurable Elements of HRP.4


1. The leaders specify, in policies and procedures, the structure and operational requirements of the
research review function.
2. The research review function complies with applicable laws and regulations.
3. The leaders specify the requirements of entities outside of the organization that provide all or a
portion of the research review function, such as a contract research organization.
4. The leaders clearly identify research that is exempt from the research review process.
5. The leaders specify the requirements for documentation of the activities of the research review
function.
6. The leaders provide for a review of all research review processes at least annually.
Standard HRP.5
The organization identifies and manages conflicts of interest with research conducted at the
organization.

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.

Measurable Elements of HRP.5


1. The organization specifies the requirements for managing conflicts of interest, both financial and
nonfinancial.
2. The organization specifies the individuals, committees, and others for whom the requirements
apply.
3. The organization has an ongoing education and monitoring process to ensure compliance with
the requirements.
Standard HRP.6
The organization integrates the human subject research program into the quality and patient safety
programs of the organization.

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.

Measurable Elements of HRP.6


1. The research program is a component of the organizations processes to report and act on
sentinel events, adverse events of other types, and the processes to learn from near misses as
described in the Quality Improvement and Patient Safety (QPS) standards.
2. The research program is included in the organizations programs for hazardous material
management, biomedical equipment management, medication management, and others found in the
Medication Management and Use (MMU) and Facility Management and Safety (FMS) standards.
3. The evaluation of staff participating in the research program is incorporated into the ongoing
monitoring processes of professional performance as described in the Staff Qualifications and
Education (SQE) standards.
Standard 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.

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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Intent of HRP.7 through HRP.7.2


An organization that conducts clinical research, clinical investigations, or clinical trials involving
human subjects provides information to patients and families about how to gain access to those
activities when relevant to the patients treatment needs. When patients are asked to participate,
they need information upon which to base their decisions. That information includes
expected benefits;
potential discomforts and risks;
alternatives that might also help them; and
procedures that must be followed.
Patients are informed that they can refuse to participate or withdraw participation and that their
refusal or withdrawal will not compromise their access to the organizations services. The
organization has policies and procedures for providing patients and families with this information.
An organization conducting human subject research knows that its first responsibility is to the
patients health and well-being.
The organization informs patients and families in advance about established processes to
review research protocols;
weigh the relative risks and benefits to the subjects;
obtain subject consent; and
withdraw from participation.
This information is communicated to patients and families to assist with decisions regarding
participation.
When patients and families decide to participate in clinical research, clinical investigations, or
clinical trials, informed consent is granted. The information provided at the time the decision to
participate was made serves as the basis for the informed consent (also see PFR.6, intent statement).
The individual(s) providing the information and obtaining the consent is noted in the patients
record. Also, at times a research protocol may be altered based on early findings and the drug dose
changed. Patient consent would be obtained again under these and similar circumstances.

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Measurable Elements of HRP.7


1. Organization research policies include the inclusion or exclusion of vulnerable subjects, including
children, prisoners, pregnant women, those mentally disabled, and others who may be economically
or educationally disadvantaged.
2. The policies include how the risks and benefits of participation will be evaluated and
communicated during the recruitment process and during participation.
3. The policies include how consent for participation will be granted and documented and under
which circumstances consent will be requested again during the research.
4. The policies and procedures include the information and decision process.
Measurable Elements of HRP.7.1
1. Patients and families are identified and informed about how to gain access to clinical research,
clinical investigations, or clinical trials relevant to their treatment needs.
2. Patients asked to participate are informed about expected benefits.
3. Patients asked to participate are informed about potential discomforts and risks.
4. Patients asked to participate are informed about alternatives that might also help them.
5. Patients asked to participate are informed about the procedures that must be followed.
6. Patients are assured that their refusal to participate or withdraw from participation will not
compromise their access to the organizations services.

Measurable Elements for HRP.7.2


1. Patients and families are informed about the organizations process for reviewing research
protocols.
2. Patients and families are informed about the organizations process for weighing the benefits and
risks to the subjects.
3. Patients and families are informed about the organizations process for obtaining consent.
4. Patients and families are informed about the organizations process for withdrawing from
participation.

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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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