Academic Medical IAS401

Section III:

Academic Medical Center

Hospital Standards

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JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR HOSPITALS, 4TH EDITION (EXPANDED)

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Medical ProfessionalEducation (MPE)

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 par-

ticipation 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 supervi-

sion 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.

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Standards, Intents, and Measurable Elements

Standard MPE.1Those responsible for governance and leadership of the organization approve and monitor the participation of

the organization in providing medical education.

Intent of MPE.1Integrating 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 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 commit-

ment 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 gov-

ernance 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.2The organizations professional staff, patient population, technology, and facility are consistent with the goals

and objectives of the education program.

Intent of MPE.2Providing 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.


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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, and 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.3Clinical teaching staff members are identified, and each staff members role and relationship to the academic

institution is defined.

Intent of MPE.3Those 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, he or she 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 members, it is clear if titles

are earned or honorary, how those titles are to be used, and what the titles mean to the public. The organiza-

tion 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 redes-

ignation and to keep such titles up-to-date.

Standard MPE.4The 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.4Supervision is required to ensure safe patient care and ensure that the training program is a learning experi-

ence for the medical student and resident trainee. The required level of supervision is consistent with the level

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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 under-

stands if supervision is provided by a resident or by the patients primary physician or by a medical school fac-

ulty 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 his or her 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 organiza-

tion policy, program goals, and the quality and safety of patient care.

6. The organization has established uniform expectations for all staff providing supervision to ensure

that the process results in uniform student experiences.

7. Patient care records are reviewed for compliance with the documentation requirements and frequency.

Standard MPE.5Medical education provided in the organization is coordinated and managed through a defined operational

mechanism and leadership structure.

Intent of MPE.5Medical 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) enrollment status;

b) academic classification;

c) any required licensure or certification;

d) reports of student achievements;

e) identification of student competencies;

f ) any known factors that will require accommodation; and

g) 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.


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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.6Trainees 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.6Training 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 his or her

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 include 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 processesare part

of all trainees initial orientation and ongoing training and monitoring. The orientation for the trainee

includes at least

a) organization quality and patient safety program;

b) infection control program;

c) medication safety program;

d) the International Patient Safety Goals;

e) all other required organization orientation, including at the department and unit level; and

f ) any ongoing required education.

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 that 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.

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Standard MPE.7Medical trainees who provide care or services within the organizationoutside of the parameters of their aca-

demic programare granted permission to provide those services through the organizations established cre-

dentialing, privileging, job specification, or other relevant program.

Intent of MPE.7The laws and regulations in many countries permit medical trainees, as they advance in their program, to pro-

vide services to the organization outside of their academic program. For example, a medical trainee may pro-

vide 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. His or her 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 evalu-

ated as required by the SQE standards.


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Human SubjectResearch Programs(HRP)

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 provide ade-

quate 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 commit-

ment to the conduct of ethical research.

HRP.3.1 When one or more of the research-related duties and functions of the sponsor are pro-

vided 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 organi-

zation.

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 investigations, or clinical trials involving human subjects.

HRP.7.2 The organization informs patients and families about how patients who choose to par-

ticipate in clinical research, clinical investigations, or clinical trials are protected.

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Standards, Intents, and Measurable Elements

Standard HRP.1The organizations leaders are accountable for the protection of human research subjects.

Standard HRP.1.1The leaders comply with all regulatory and professional requirements and provide adequate resources for

effective operation of the research program.

Intent of HRP.1 and HRP.1.1Human 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 diag-

nose 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 irre-

spective 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 Harmonisation (ICH)/

World Health Organization (WHO) Good Clinical Practice (GCP) standards (see Endnotes on page 264).

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 pro-

tect 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 subject research policies and procedures.

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 par-

ticipating in clinical research who experience an adverse event.


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HUMAN SUBJECT RESEARCH PROGRAMS (HRP)

Standard HRP.2The organizations leaders establish the scope of research activities.

Intent of HRP.2Research 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 off-label), 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 poten-

tial 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.

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.3The organizations leaders establish requirements for sponsors of research to ensure their commitment to the

conduct of ethical research.

Intent of HRP.3The 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 statisti-

cally 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.

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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.

Standard HRP.3.1When one or more of the research-related duties and functions of the sponsor are provided through an out-

side commercial or academic contract research organization, the accountabilities of the outside contract

research organization are clearly defined.

Intent of HRP.3.1Human subject research has many components, some of which a sponsor may choose to contract to an out-

side 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 mecha-

nism. The organization and sponsor are responsible for the careful selection of a contract research organiza-

tion, the clear delineation of accountability, and 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 responsi-

bilities of a contract research organization.

2. The duties and functions transferred by the sponsor to the contract research organization are con-

tained 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.4The organizations leaders create or contract for a process to provide the initial and ongoing review of all

human subject research.

Intent of HRP.4One of the most important functions related to human subject research is review and monitoring by an inde-

pendent group of individuals, commonly referred to as an institutional review board (IRB), an ethics commit-

tee, 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 organiza-

tion. The policies, procedures, and structure of this research review function are specified by the hospitals

leaders, as well as which 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.


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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 por-

tion 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.5The organization identifies and manages conflicts of interest with research conducted at the organization.

Intent of HRP.5Conflicts 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 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.6The organization integrates the human subject research program into the quality and patient safety programs

of the organization.

Intent of HRP.6Human 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, and

many other research topics and methodologies. 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 quali-

ty 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.

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Reporting events related to research protocols can provide vital information toward understanding the overall

quality and safety of patient 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 experimen-

tal research pharmaceuticals, which should be a component of the management of hazardous materials. Also,

equipment used in experimental procedures should be monitored and maintained along with other biomed-

ical equipment in the organization.

Thus, every aspect of the human subject research program should be evaluated as to which 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 moni-

toring processes of professional performance as described in the Staff Qualifications and Education

(SQE) standards.

Standard HRP.7The 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.7.1The organization informs patients and families about how to gain access to clinical research, clinical investiga-

tions, or clinical trials involving human subjects.

Standard HRP.7.2The organization informs patients and families about how patients who choose to participate in clinical

research, clinical investigations, or clinical trials are protected.

Intent of HRP.7 through HRP.7.2An organization that conducts clinical research, clinical investigations, or clinical trials involving human sub-

jects 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.


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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 sub-

ject 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.

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, clini-

cal 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 compro-

mise 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 participa-

tion.

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Endnotes

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 for Australia, Canada, the Nordic countries, and 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 objec-

tives of such harmonization are 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 while maintain-

ing 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 contract research organization (CROs) providing clinical-trials services, the ICH-

GCP (E6 1.20) defines a CRO as: a person or an organization (commercial, academic, or other) contracted

by the sponsor to perform one or more of a sponsors trial-related duties and functions.

Furthermore, it states that:

(5.2.1) A sponsor may transfer any or all of the sponsors 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.

(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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Documents

Academic Medical IAS401