Standards › ASF Health Standards v10 › Standard 22
Standard 22
Academic Medical Centre
Academic medical centre: trainee scope and supervision, informing patients, research ethics approval, separate research consent, conflicts of interest and faculty competency.
Each criterion is shown in three settings: Humanitarian settings, Transition and fragile, and Standard. In standard settings, every criterion is Must.
Training colours: red means essential, green recommended, yellow optional. Each course shows its level for each setting: humanitarian, transition and fragile, and standard.
22.1Resident and Trainee Supervision With Verified, Graduated AutonomyHumanitarian settings: MustTransition and fragile: MustStandard: Must
Each resident or trainee’s current scope of independent practice is explicitly defined and documented, matched to their verified competency progression, with supervising physician involvement available at the level that scope requires.
Why it matters. A trainee who operates alone before they are competent puts the patient at risk. Each trainee’s independent scope, matched to verified competency, makes sure the level of supervision fits the person.
How the surveyor verifies this criterion
Sample. Review the scope of independent practice record for 5 trainees, anonymised.
1. Each trainee has a written scope of independent practice.
Method. Check each sampled trainee for a recorded scope.
Evidence to show. Trainee scope and competency register (TCH-REG-001).
Pass when. Every sampled trainee has a written scope recorded.
2. The scope is matched to verified competency.
Method. Check the competency verification date against the scope.
Evidence to show. Trainee scope and competency register (TCH-REG-001).
Pass when. Every scope is matched to a verified competency.
3. Supervision is available at the level the scope requires.
Method. Check the supervision level recorded against the scope, and the supervision record.
Evidence to show. Trainee scope and competency register (TCH-REG-001).
Pass when. Every trainee has the supervision level recorded and available.
Immediate fail (any one means the criterion is not met). A first-year trainee operates alone with no record of scope.
Staff responsible
| Role | Responsibility | Level |
|---|---|---|
| Specialist physician (ISCO 2212) | Sets the scope and supervision level for each trainee | Must |
| Manager (ISCO 1342) | Checks the register against the scope | Must |
Documents: who does each step
| Document | Writes | Approves | Fills in | Checks and signs | Files and uploads |
|---|---|---|---|---|---|
| TCH-REG-001 · Trainee scope and competency register | Secretary (ISCO 3344) | Chief executive (ISCO 1120) | Secretary (ISCO 3344) | Manager (ISCO 1342) | Secretary (ISCO 3344) |
| TCH-POL-001 · Trainee scope of independent practice and supervision | Chief executive (ISCO 1120) | Governing body members | N/A | Chief executive (ISCO 1120) | Secretary (ISCO 3344) |
E-learning: who must take each course
| Course | Who must take it |
|---|---|
| Credentialing, Competence and the Training Matrix (T-14) | Manager; Specialist physician |
References
- WFME Global Standards for Quality Improvement: Postgraduate Medical Education (World Federation for Medical Education, 2023)
22.2Patients Are Informed of Trainee Involvement in Their CareHumanitarian settings: MinimumTransition and fragile: MediumStandard: Must
Patients are clearly informed before or at admission that a teaching facility’s care model involves residents and trainees, with an opportunity to ask questions about who is involved in their care.
Why it matters. Patients in a teaching hospital are often seen by trainees. They have a right to know this before they are treated, and to ask questions about it.
How the surveyor verifies this criterion
Sample. Review the patient information on trainee involvement and 10 admission records showing it was given.
1. Patients are informed of trainee involvement before or at admission.
Method. Check each sampled admission record for the information given.
Evidence to show. Trainee involvement information and admission record (TCH-FRM-001).
Pass when. At least 95% of admissions show the information given.
2. The information explains who is involved in care.
Method. Check the current patient information for the explanation.
Evidence to show. Trainee involvement information and admission record (TCH-FRM-001).
Pass when. The information explains the involvement of trainees.
3. The patient has the chance to ask questions.
Method. Check each record for the questions invited and answered.
Evidence to show. Trainee involvement information and admission record (TCH-FRM-001).
Pass when. At least 90% of records show questions invited and answered.
Immediate fail (any one means the criterion is not met). A patient is unaware that a trainee performed the examination.
Staff responsible
| Role | Responsibility | Level |
|---|---|---|
| Nurse (ISCO 2221) | Gives the trainee information at admission | Medium |
| Specialist physician (ISCO 2212) | Answers the patient’s questions | Medium |
Documents: who does each step
| Document | Writes | Approves | Fills in | Checks and signs | Files and uploads |
|---|---|---|---|---|---|
| TCH-FRM-001 · Trainee involvement information and admission record | Manager (ISCO 1342) | Chief executive (ISCO 1120) | Secretary (ISCO 3344) | Manager (ISCO 1342) | Secretary (ISCO 3344) |
E-learning: who must take each course
| Course | Who must take it |
|---|---|
| Patient Identification, Informed Consent and Patient Rights (T-07) | Nurse; Specialist physician |
References
- World Medical Association (2015). Declaration of Lisbon on the Rights of the Patient. Used for: the patient’s right to be informed about who is involved in their care. https://news.gmj.ge/guideline/wma-declaration-of-lisbon-on-the-rights-of-the-patient/
22.3Research Activity Operates Under Independent Ethics Review Before EnrolmentHumanitarian settings: MinimumTransition and fragile: MustStandard: Must
No patient is enrolled in a research study until that study has received approval from an independent ethics review board, with the approval current and the enrolled patient’s participation falling within the approved protocol.
Why it matters. Research on patients must be approved by an independent ethics board before the first person is enrolled. Otherwise patients are used for research without protection.
How the surveyor verifies this criterion
Sample. Review the ethics approval for each research study, with the first enrolment date.
1. Each study has approval from an independent ethics review board before enrolment.
Method. Check each study’s approval date against its first enrolment date.
Evidence to show. Research ethics approval register (TCH-REG-002).
Pass when. Every study has approval before its first enrolment.
2. The approval is current.
Method. Check each approval for its expiry against the enrolment dates.
Evidence to show. Research ethics approval register (TCH-REG-002).
Pass when. Every enrolment falls within a current approval.
3. Each enrolled patient’s participation falls within the approved protocol.
Method. Check each enrolment against the approved protocol.
Evidence to show. Research ethics approval register (TCH-REG-002).
Pass when. Every enrolment falls within the approved protocol.
Immediate fail (any one means the criterion is not met). A study enrols patients with no ethics approval.
Staff responsible
| Role | Responsibility | Level |
|---|---|---|
| Manager (ISCO 1342) | Checks approval before enrolment | Must |
| Secretary (ISCO 3344) | Keeps the approval register | Must |
Documents: who does each step
| Document | Writes | Approves | Fills in | Checks and signs | Files and uploads |
|---|---|---|---|---|---|
| TCH-REG-002 · Research ethics approval register | Secretary (ISCO 3344) | Chief executive (ISCO 1120) | Secretary (ISCO 3344) | Manager (ISCO 1342) | Secretary (ISCO 3344) |
E-learning: who must take each course
In process of development. Will be available soon.
References
- Pan American Health Organization (2020). Guidance for Ethics Oversight of COVID-19 Research in Response to Emerging Evidence. Used for: ethics review committee oversight of research before and during enrolment (COVID-era). https://news.gmj.ge/guideline/guidance-for-ethics-oversight-of-covid-19-research-in-response-to-emerging-evidence/
- Pan American Health Organization (2020). Ethics guidance on issues raised by the novel coronavirus disease (COVID-19) pandemic. Used for: research ethics, consent and review committee guidance (COVID-era). https://news.gmj.ge/guideline/ethics-guidance-on-issues-raised-by-the-novel-coronavirus-disease-covid-19-pandemic/
- Pan American Health Organization (2020). Considerations for Regulatory Oversight of Clinical Trials in the COVID-19 Pandemic. Used for: regulatory approval of clinical trials before enrolment (COVID-era). https://news.gmj.ge/guideline/considerations-for-regulatory-oversight-of-clinical-trials-in-the-covid-19-pandemic/
22.4Clinical Care and Research Participation Are Clearly Separated in ConsentHumanitarian settings: MinimumTransition and fragile: MediumStandard: Must
A patient understands which elements of their care are standard clinical treatment and which are research participation, with declining research participation never affecting the standard care they receive.
Why it matters. A patient who agrees to care may not know that part of it is research. Separating the two in the consent, and letting the patient refuse research without losing standard care, protects their choice.
How the surveyor verifies this criterion
Sample. Review the separate consent forms for standard care and research, and 5 signed forms.
1. Research participation is consented on a form separate from standard care.
Method. Check the consent forms for two separate forms.
Evidence to show. Research participation consent form (TCH-FRM-002).
Pass when. Research and standard care consent are separate forms.
2. The patient understands which care is research.
Method. Check each signed form for the explanation of research and standard care.
Evidence to show. Research participation consent form (TCH-FRM-002).
Pass when. Every signed form shows the explanation.
3. Declining research does not affect standard care.
Method. Check the form statement and the care recorded for a patient who declined.
Evidence to show. Research participation consent form (TCH-FRM-002).
Pass when. Every form states declining does not affect standard care.
Immediate fail (any one means the criterion is not met). A patient is enrolled in research without knowing it.
Staff responsible
| Role | Responsibility | Level |
|---|---|---|
| Specialist physician (ISCO 2212) | Explains research and standard care to the patient | Medium |
| Nurse (ISCO 2221) | Witnesses the signed form | Medium |
Documents: who does each step
| Document | Writes | Approves | Fills in | Checks and signs | Files and uploads |
|---|---|---|---|---|---|
| TCH-FRM-002 · Research participation consent form | Manager (ISCO 1342) | Chief executive (ISCO 1120) | Secretary (ISCO 3344) | Manager (ISCO 1342) | Secretary (ISCO 3344) |
E-learning: who must take each course
| Course | Who must take it |
|---|---|
| Patient Identification, Informed Consent and Patient Rights (T-07) | Nurse; Specialist physician |
References
- Pan American Health Organization (2020). Ethics guidance on issues raised by the novel coronavirus disease (COVID-19) pandemic. Used for: research ethics, consent and review committee guidance (COVID-era). https://news.gmj.ge/guideline/ethics-guidance-on-issues-raised-by-the-novel-coronavirus-disease-covid-19-pandemic/
22.5Conflicts of Interest Between Research and Clinical Care Are Disclosed and ManagedHumanitarian settings: MinimumTransition and fragile: MediumStandard: Must
A clinician’s financial or other significant interest connected to a research study is disclosed through a defined process and managed, such as separating the clinician’s research role from their direct clinical decision-making for enrolled patients.
Why it matters. A clinician who is paid by a company that sponsors a study may be biased in their clinical choices. Declaring the interest and managing it protects the patient and the research.
How the surveyor verifies this criterion
Sample. Review the research conflict of interest register and the management record for each study.
1. A clinician’s significant interest connected to a study is disclosed through a defined process.
Method. Check the register for a declaration for each clinician on each study.
Evidence to show. Research conflict of interest register (TCH-REG-003).
Pass when. Every interest is disclosed for each study.
2. Each disclosed interest has a management action.
Method. Check each declaration for the management action.
Evidence to show. Study conflict management record (TCH-FRM-003).
Pass when. Every declared interest has a management action recorded.
3. The clinician’s research role is separated from direct decisions for enrolled patients.
Method. Check the role separation for each study.
Evidence to show. Study conflict management record (TCH-FRM-003).
Pass when. Every declared interest has role separation recorded where it applies.
Immediate fail (any one means the criterion is not met). A clinician enrols patients in a study paid by a drug company with no declaration.
Staff responsible
| Role | Responsibility | Level |
|---|---|---|
| Specialist physician (ISCO 2212) | Declares significant interests | Medium |
| Manager (ISCO 1342) | Manages each declared interest | Medium |
Documents: who does each step
| Document | Writes | Approves | Fills in | Checks and signs | Files and uploads |
|---|---|---|---|---|---|
| TCH-REG-003 · Research conflict of interest register | Secretary (ISCO 3344) | Chief executive (ISCO 1120) | Secretary (ISCO 3344) | Manager (ISCO 1342) | Secretary (ISCO 3344) |
| TCH-FRM-003 · Study conflict management record | Manager (ISCO 1342) | Chief executive (ISCO 1120) | Secretary (ISCO 3344) | Manager (ISCO 1342) | Secretary (ISCO 3344) |
E-learning: who must take each course
In process of development. Will be available soon.
References
- WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants (World Medical Association, 2024 (amended October 2024))
22.6Teaching Faculty Maintain Verified, Current Clinical CompetencyHumanitarian settings: MinimumTransition and fragile: MediumStandard: Must
Faculty teaching clinical skills maintain active, verified clinical competency in the skill being taught, confirmed through a defined process.
Why it matters. Trainees learn skills from the people who teach them. A faculty member who has not practised a skill for years may teach an old or unsafe method.
How the surveyor verifies this criterion
Sample. Review the faculty competency register, with the verification records for the teachers of clinical skills.
1. Faculty teaching clinical skills have active, verified clinical competency in the skill taught.
Method. Check each teacher for the verification record for each skill taught.
Evidence to show. Faculty clinical competency register (TCH-REG-004).
Pass when. Every teacher of a clinical skill has a verified competency recorded.
2. Verification is current.
Method. Check each verification date against the due date.
Evidence to show. Faculty clinical competency register (TCH-REG-004).
Pass when. Every verification is within its due date.
3. The verification is through a defined process.
Method. Check the process used and the record for each verification.
Evidence to show. Faculty clinical competency register (TCH-REG-004).
Pass when. Every verification follows the defined process.
Immediate fail (any one means the criterion is not met). A teacher demonstrates a procedure they have not done for ten years.
Staff responsible
| Role | Responsibility | Level |
|---|---|---|
| Manager (ISCO 1342) | Verifies faculty competency on schedule | Medium |
| Specialist physician (ISCO 2212) | Confirms their own clinical skill | Medium |
Documents: who does each step
| Document | Writes | Approves | Fills in | Checks and signs | Files and uploads |
|---|---|---|---|---|---|
| TCH-REG-004 · Faculty clinical competency register | Secretary (ISCO 3344) | Chief executive (ISCO 1120) | Secretary (ISCO 3344) | Manager (ISCO 1342) | Secretary (ISCO 3344) |
E-learning: who must take each course
| Course | Who must take it |
|---|---|
| Credentialing, Competence and the Training Matrix (T-14) | Manager; Specialist physician |
References
- WFME Global Standards for Quality Improvement: Postgraduate Medical Education (World Federation for Medical Education, 2023)
Who is responsible for Standard 22
Each criterion names the positions responsible for it. Every position links to its own terms of reference.
| Criterion | Responsible | Supports |
|---|---|---|
| 22.1 Resident and Trainee Supervision With Verified, Graduated Autonomy | Medical educator Consultant physician (internal medicine) |
Resident physician / house officer |
| 22.2 Patients Are Informed of Trainee Involvement in Their Care | Resident physician / house officer Complaints and patient experience officer |
Medical educator |
| 22.3 Research Activity Operates Under Independent Ethics Review Before Enrolment | Director of research Ethics committee secretary |
Clinical trials manager |
| 22.4 Clinical Care and Research Participation Are Clearly Separated in Consent | Clinical trials manager Legal counsel |
Clinical researcher |
| 22.5 Conflicts of Interest Between Research and Clinical Care Are Disclosed and Managed | Compliance officer Director of research |
Legal counsel |
| 22.6 Teaching Faculty Maintain Verified, Current Clinical Competency | Medical educator Competency assessor |
Training and education manager |
Role details: reporting, supervision and training
Training shown is the general recommendation. Role-specific training is set in the next improvement round.
| Role | Reports to | Supervises | Recommended training |
|---|---|---|---|
| Legal counsel | Chief executive officer (CEO) | None | Facility induction; safeguarding adults (general recommendation) |
| Compliance officer | Chief executive officer (CEO) | None | Facility induction; safeguarding adults (general recommendation) |
| Ethics committee secretary | Medical director | None | Facility induction; safeguarding adults (general recommendation) |
| Complaints and patient experience officer | Quality manager | None | Facility induction; safeguarding adults (general recommendation) |
| Consultant physician (internal medicine) | Head of department (per specialty) | Resident physician / house officer | Facility induction; safeguarding adults (general recommendation) |
| Resident physician / house officer | Consultant physician (internal medicine) | None | Facility induction; safeguarding adults (general recommendation) |
| Training and education manager | Chief human resources officer | Training coordinator, Staff development officer, Competency assessor | Facility induction; safeguarding adults (general recommendation) |
| Competency assessor | Training and education manager | None | Facility induction; safeguarding adults (general recommendation) |
| Director of research | Chief strategy and development officer | Clinical researcher, Clinical trials manager | Facility induction; safeguarding adults (general recommendation) |
| Clinical researcher | Director of research | None | Facility induction; safeguarding adults (general recommendation) |
| Clinical trials manager | Director of research | None | Facility induction; safeguarding adults (general recommendation) |
| Medical educator | Medical director | None | Facility induction; safeguarding adults (general recommendation) |
Questions and answers
The criterion text is the authority. These answers summarise it.
Who does Standard 17 apply to?
A facility that combines patient care with teaching and research, with residents and trainees involved in care.
What do the colours mean for this standard?
Red (Must) is required. Green (Medium) is recommended. Yellow (Minimum) is the lowest acceptable level in humanitarian settings. Standard setting is Must on every criterion.
Why is 22.1 red in humanitarian settings?
A trainee who operates alone before being competent can harm a patient directly. The other criteria are yellow in humanitarian settings.
Can a patient be enrolled in research before ethics approval?
No. Under 22.3 each study needs independent ethics approval before the first enrolment, and each enrolment must fall within a current approval and the approved protocol.
Does refusing research affect a patient’s care?
No. Under 22.4 declining research must never affect the standard care the patient receives.
Do I have to use the documents on this page?
No. The policies, SOPs, forms and registers are drafts to help you. Adapt them to your facility, write your own, or upload your own. What the assessor checks is that the criterion is met and that you can show how.
What does In process of development mean?
That part of the standard is still being prepared. It may be a document, a course, a reference or a role table. It will be added in a later version.
Guidelines for this standard
19 guideline(s) are held in the GMJ Guidelines Library and listed here. Each link opens the full guideline on news.gmj.ge. The complete library, grouped by standard, is at Guidelines.
- WMA Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants (WMA)
- WFME Global Standards for Quality Improvement: Postgraduate Medical Education (WFME)
- Principles of Medical Ethics (Protection of Prisoners Against Torture) (United Nations (GA resolution 37/194))
- Nurse staffing and education and hospital mortality in nine European countries: a retrospective observational study (The Lancet)
- Considerations for Regulatory Oversight of Clinical Trials in the COVID-19 Pandemic (Pan American Health Organization)
- Template and operational guidance for the ethics review and oversight of COVID-19-related research (Pan American Health Organization)
- Guidance and strategies to streamline ethics review and oversight of COVID-19-related research (Pan American Health Organization)
- COVID-19: Chloroquine and hydroxychloroquine research (Pan American Health Organization)
- Managing People with Asthma during COVID-19: Considerations for Health Providers (Pan American Health Organization)
- Technical and Regulatory Aspects of the Use of Pulse Oximeters in Monitoring COVID-19 Patients (Pan American Health Organization)
- Considerations for the Use of Hotels during the COVID-19 Pandemic (issuer not stated)
- Considerations for the Reorganization of Cancer Services during the COVID-19 Pandemic (Pan American Health Organization)
- Guidance for Ethics Oversight of COVID-19 Research in Response to Emerging Evidence (Pan American Health Organization)
- Considerations for the Implementation and Management of Contact Tracing for Coronavirus Disease 2019 (COVID-19) in the Region of the Americas (Pan American Health Organization)
- COVID-19: Chloroquine and hydroxychloroquine research (Pan American Health Organization)
- Regulatory considerations on authorization of the use of convalescent plasma (CP) to address the COVID-19 emergency (Pan American Health Organization)
- Ethics guidance on issues raised by the novel coronavirus disease (COVID-19) pandemic (Pan American Health Organization)
- How Can Research Transparency Be Promoted? Actions for National Health Authorities During the COVID-19 Pandemic (Pan American Health Organization)
- Emergency Use of Unproven Interventions Outside of Research: Ethics Guidance for the COVID-19 Pandemic (Pan American Health Organization)