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 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 — not assumed from training year or general programme level alone.
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.
Documents
No documents yet.
E-learning
References
- World Health Organization. Transforming and scaling up health professionals’ education and training. Geneva: WHO; 2013.
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 — not a line buried in general admission paperwork that provides no understanding.
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.
Documents
No documents yet.
E-learning
References
- World Health Organization Regional Office for Europe. Declaration on the Promotion of Patients’ Rights in Europe. Copenhagen: WHO Regional Office for Europe; 1994.
No patient is enrolled in a research study until that study has received approval from an independent ethics review board (IRB or equivalent), with the approval current and the enrolled patient’s participation falling within the approved protocol — not research activity proceeding ahead of, or outside the scope of, that approval.
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.
Documents
No documents yet.
E-learning
No course linked yet.
Planned course: Research ethics approval before enrolment. New course planned.
References
- World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human participants. Ferney-Voltaire: WMA; latest revision.
- Council for International Organizations of Medical Sciences. International Ethical Guidelines for Health-related Research Involving Humans. Geneva: CIOMS; 2016.
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 — not a blurred consent process that leaves a patient unclear what they are agreeing to.
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.
Documents
No documents yet.
E-learning
References
- Council for International Organizations of Medical Sciences. International Ethical Guidelines for Health-related Research Involving Humans. Geneva: CIOMS; 2016.
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 — not left undisclosed or disclosed without any management action following.
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.
Documents
No documents yet.
E-learning
No course linked yet.
Planned course: Conflicts of interest in research. New course planned.
References
- International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. ICMJE; updated periodically.
Faculty teaching clinical skills maintain active, verified clinical competency in the skill being taught, confirmed through a defined process — not a teaching role assumed to carry current clinical competency simply from past experience or academic seniority.
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.
Documents
No documents yet.
E-learning
References
- World Health Organization. Transforming and scaling up health professionals’ education and training. Geneva: WHO; 2013.
Additional resources: guidelines in the GMJ library
These guidelines are held in the GMJ guideline library (news.gmj.ge). WHO and PAHO are the issuing bodies; MSF guidelines are marked MSF.
- Guidance for Ethics Oversight of COVID-19 Research in Response to Emerging Evidence · PAHO · criteria: Whole standard
Procedures for research ethics committees to oversee ongoing COVID-19 studies as evidence changes.
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