ASF Standards · Hospital · Standard 16
Standard 16 — Academic Medical Center: Teaching & Research Governance
Criteria in this standard
16.1 — Resident and Trainee Supervision With Verified, Graduated Autonomy
16.2 — Patients Are Genuinely Informed of Trainee Involvement in Their Care
16.3 — Research Activity Operates Under Independent Ethics Review Before Enrollment
16.4 — Clinical Care and Research Participation Are Clearly Separated in Consent
16.5 — Conflicts of Interest Between Research and Clinical Care Are Disclosed and Managed
16.6 — Teaching Faculty Maintain Verified, Current Clinical Competency
16.2 — Patients Are Genuinely Informed of Trainee Involvement in Their Care
16.3 — Research Activity Operates Under Independent Ethics Review Before Enrollment
16.4 — Clinical Care and Research Participation Are Clearly Separated in Consent
16.5 — Conflicts of Interest Between Research and Clinical Care Are Disclosed and Managed
16.6 — Teaching Faculty Maintain Verified, Current Clinical Competency
16.1
Resident and Trainee Supervision With Verified, Graduated Autonomy
Non-Negotiable
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 genuinely available at the level that scope requires — not assumed from training year or general program level alone.
In plain terms: Exactly what each trainee can do on their own is written down and based on what they’ve actually demonstrated — not guessed from what year of training they’re in — and real backup is actually available at the level their current scope requires.
| Facility category | Crisis | Transitional | Small | Standard |
|---|---|---|---|---|
| Applicability | Where applicable | Full | Full | Full |
Why this matters
Training year is a genuinely weak proxy for actual independent competency — two residents at the identical point in a program can have meaningfully different demonstrated ability, and treating training year as a reliable stand-in for verified competency risks granting independence beyond what a given trainee has actually shown they can safely handle. Supervising physician availability that’s generically described as “on call,” rather than genuinely matched to the specific scope a trainee is currently exercising, can leave a real gap exactly where backup is most likely to be needed.
What good looks like
- Each trainee’s current scope of independent practice is explicitly documented.
- Supervising physician availability is genuinely matched to the trainee’s actual scope.
- Scope of practice is reassessed and updated as competency genuinely progresses.
Common failure modes
- Independent scope is inferred from training year rather than documented and verified.
- Supervision is a generic on-call arrangement, not matched to actual current scope.
- Scope is fixed at program entry and never formally reassessed.
Worked example
In practice
A hospital reviewing its trainee supervision structure.
BeforeA resident’s independent scope was assumed from their training year alone, with no documented, individualized record of what specific procedures or decisions they had actually demonstrated competency to perform independently.
ActionThe hospital built an individualized, documented competency progression record for each trainee, updated as specific skills were verified, with supervising physician availability explicitly tied to each trainee’s current documented scope.
AfterThe Monitor reviewed a sample trainee’s record and found a specific, individualized documented scope matched to verified competency, not training year alone. Criterion verified.
If you are starting from zero — do this first
- Build an individualized, documented scope-of-practice record for each trainee.
- Tie supervising physician availability explicitly to each trainee’s current scope.
- Build a reassessment process that updates scope as competency is verified.
The most common mistake: Treating training year as a reliable proxy for independent competency, rather than maintaining an individualized, documented record of what each specific trainee has actually demonstrated.
Self-assessment questions
1. Is each trainee’s current scope of independent practice explicitly documented, not inferred from training year alone? — A specific, verified scope, not an assumption that a given training year implies a given level of independence.
Evidence: Trainee scope-of-practice record
Evidence: Trainee scope-of-practice record
2. Is supervising physician availability genuinely matched to the trainee’s actual current scope, not a generic on-call arrangement? — Real, appropriate availability for the specific procedure or decision a trainee is performing, not a general backup presence.
Evidence: Supervision assignment record
Evidence: Supervision assignment record
3. Is scope of practice reassessed and updated as competency genuinely progresses, not fixed at program entry? — A trainee’s verified competency can change meaningfully during training; scope should track actual demonstrated ability.
Evidence: Reassessment schedule and record
Evidence: Reassessment schedule and record
Common reasons for a PARTIAL answer
- Scope is documented at program entry but rarely formally updated.
- Supervision is generally matched to scope but not consistently documented as such.
Implementation plan
| When | What |
|---|---|
| Week 1 | Review current practice for documenting trainee scope of independent practice. |
| Week 2 | Build individualized, documented scope records tied to verified competency. |
| Week 3 | Tie supervising physician availability explicitly to documented scope. |
| Ongoing | Reassess and update scope as competency progresses. |
How the Monitor verifies this
| Method | What | Detail |
|---|---|---|
| DOCUMENT | Trainee record review | Reviews a sample trainee’s documented scope-of-practice record against actual training year to confirm individualized, verified assignment. |
Evidence base
Accreditation Council for Graduate Medical Education. Common Program Requirements. Chicago: ACGME; 2023.
16.2
Patients Are Genuinely Informed of Trainee Involvement in Their Care
Core
Patients are clearly, genuinely informed before or at admission that a teaching hospital’s care model involves residents and trainees, with a real opportunity to ask questions about who is involved in their care — not a line buried in general admission paperwork that provides no genuine understanding.
In plain terms: Patients genuinely know, and actually understand, that trainees are part of their care team — not a line they signed among many pages of paperwork without really registering it.
| Facility category | Crisis | Transitional | Small | Standard |
|---|---|---|---|---|
| Applicability | Where applicable | Full | Full | Full |
Why this matters
A disclosure line embedded among many pages of general admission paperwork provides very different genuine understanding than a clear, specific communication a patient actually registers — the distinction matters because patients have a legitimate interest in knowing who is involved in decisions about their care, and a technically-present disclosure that doesn’t achieve genuine understanding falls short of what this criterion is designed to ensure. Identifying the attending physician of record, distinct from any trainee, gives the patient clarity about who holds ultimate responsibility, which matters for both trust and practical communication.
What good looks like
- Trainee involvement is disclosed clearly and specifically, not buried in general paperwork.
- The patient has a genuine, practical opportunity to ask who is involved in their care.
- The attending physician of record is clearly identified, distinct from any trainee.
Common failure modes
- Disclosure is a single clause within lengthy general admission paperwork.
- No genuine, practical opportunity exists for the patient to ask questions.
- The attending physician of record isn’t clearly distinguished from trainees involved.
Worked example
In practice
A hospital reviewing its admission disclosure practice.
BeforeTrainee involvement was disclosed only as one clause within a lengthy general consent-to-treatment form, with no separate, specific communication and no structured opportunity for the patient to ask who specifically would be involved in their care.
ActionThe hospital built a separate, clear admission communication specifically about the teaching care model, delivered verbally at admission with a structured opportunity to ask questions, alongside clear identification of the attending physician of record.
AfterThe Monitor spoke with several recently admitted patients, who could confirm they understood trainees were involved in their care and knew who their attending physician was. Criterion verified.
If you are starting from zero — do this first
- Build a separate, clear communication specifically about trainee involvement.
- Build a structured opportunity for patients to ask who is involved in their care.
- Ensure the attending physician of record is clearly identified to each patient.
The most common mistake: Relying on a single clause within general admission paperwork as sufficient disclosure, rather than a separate, clear communication a patient actually registers and understands.
Self-assessment questions
1. Is trainee involvement disclosed clearly and specifically, not buried in general admission paperwork a patient is unlikely to genuinely read or absorb? — Clear, specific disclosure the patient actually registers, not a clause among many in a signed form.
Evidence: Admission disclosure process
Evidence: Admission disclosure process
2. Does the patient have a genuine, practical opportunity to ask who specifically is involved in their care? — A real opportunity to ask, not merely a theoretical right buried in policy.
Evidence: Patient interview
Evidence: Patient interview
3. Is the attending physician of record, distinct from any trainee, clearly identified to the patient? — The patient should know who holds ultimate responsibility for their care, separate from any trainee involved.
Evidence: Attending identification record
Evidence: Attending identification record
Common reasons for a PARTIAL answer
- Disclosure happens but isn’t consistently delivered in a way patients clearly register.
- The attending physician is documented but not consistently communicated to the patient.
Implementation plan
| When | What |
|---|---|
| Week 1 | Review current admission disclosure content and delivery. |
| Week 2 | Build a separate, clear verbal communication about trainee involvement. |
| Week 3 | Build consistent attending-physician identification practice. |
| Ongoing | Spot-check patient understanding periodically. |
How the Monitor verifies this
| Method | What | Detail |
|---|---|---|
| ASK | Patient interview | Speaks directly with recently admitted patients to confirm genuine understanding of trainee involvement and attending identification. |
Evidence base
Association of American Medical Colleges. Optimal Resuscitation Training and Patient Disclosure in Teaching Hospitals. Washington, DC: AAMC; 2021.
16.3
Research Activity Operates Under Independent Ethics Review Before Enrollment
Non-Negotiable
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 genuinely falling within the approved protocol — not research activity proceeding ahead of, or outside the scope of, that approval.
In plain terms: No patient goes into a research study until a genuinely independent ethics board has actually approved it, and what happens to that patient genuinely matches what was approved — not research moving ahead of approval, and not drifting outside what was specifically approved.
| Facility category | Crisis | Transitional | Small | Standard |
|---|---|---|---|---|
| Applicability | Where applicable | Full | Full | Full |
Why this matters
Independent ethics review exists specifically to provide a check on research design and patient protection separate from the research team’s own judgment, however well-intentioned that team may be — a board with significant overlap with the research team under review doesn’t provide that genuine independent check. Enrollment proceeding ahead of actual approval, or a patient’s real participation drifting outside the specific scope the board approved, represents a serious breach of the protective structure this criterion exists to maintain.
What good looks like
- Independent ethics board approval is genuinely obtained and current before enrollment.
- The ethics board is genuinely independent of the research team being reviewed.
- Each enrolled patient’s actual participation genuinely falls within the approved protocol.
Common failure modes
- Enrollment proceeds while ethics approval is still pending, not yet granted.
- The reviewing board has significant overlap with the research team under review.
- A patient’s actual participation drifts outside the approved protocol’s specific scope.
Worked example
In practice
A hospital reviewing its research enrollment process.
BeforeA review of research enrollment records found one instance where patient screening and preliminary enrollment steps had begun before the ethics board’s formal approval was actually finalized.
ActionThe hospital built a hard enrollment gate requiring documented, current ethics board approval before any enrollment step can begin, verified through the hospital’s research administration office rather than left to individual research teams to confirm.
AfterThe Monitor reviewed subsequent enrollment records and confirmed each had documented, current ethics approval genuinely in place before enrollment began. Criterion verified.
If you are starting from zero — do this first
- Confirm the ethics review board is genuinely independent of research teams it reviews.
- Build a hard enrollment gate requiring documented, current approval before enrollment.
- Build a verification step independent of individual research teams.
The most common mistake: Allowing preliminary screening or enrollment steps to begin while ethics board approval is still pending, rather than treating approval as a hard gate that must be genuinely in place first.
Self-assessment questions
1. Is independent ethics board approval genuinely obtained and current before any patient enrollment, not assumed pending or informally proceeding? — Approval that’s actually in place, not an application submitted with enrollment proceeding regardless.
Evidence: Ethics approval record
Evidence: Ethics approval record
2. Is the ethics board genuinely independent of the research team being reviewed, not effectively self-reviewing? — Real independence from the team whose research is under review, not a board with significant overlap or conflict.
Evidence: Ethics board composition record
Evidence: Ethics board composition record
3. Does each enrolled patient’s actual participation genuinely fall within the approved protocol’s scope? — A protocol deviation, even well-intentioned, falls outside the specific approval granted.
Evidence: Protocol compliance review
Evidence: Protocol compliance review
Common reasons for a PARTIAL answer
- Approval is generally obtained first but the enrollment gate isn’t consistently enforced.
- Protocol compliance isn’t actively monitored after initial enrollment.
Implementation plan
| When | What |
|---|---|
| Week 1 | Confirm genuine independence of the ethics review board. |
| Week 2 | Build a hard enrollment gate requiring documented current approval. |
| Week 3 | Build independent verification of the gate, separate from research teams. |
| Ongoing | Monitor protocol compliance of enrolled patients. |
How the Monitor verifies this
| Method | What | Detail |
|---|---|---|
| DOCUMENT | Enrollment record review | Checks enrollment dates against ethics approval dates for a sample of research studies to confirm approval preceded enrollment. |
Evidence base
World Medical Association. Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects. Fortaleza: WMA; 2013 (current revision).
16.4
Clinical Care and Research Participation Are Clearly Separated in Consent
Core
A patient genuinely 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’re actually agreeing to.
In plain terms: Patients genuinely know what part of their care is standard treatment and what part is research — and saying no to the research part never changes the standard care they get, which they can always genuinely withdraw from.
| Facility category | Crisis | Transitional | Small | Standard |
|---|---|---|---|---|
| Applicability | Where applicable | Full | Full | Full |
Why this matters
A consent process that presents standard care and research participation as a single blended decision, rather than clearly distinguishing them, can leave a patient genuinely unclear about what they’re actually agreeing to — and risks a patient feeling pressured toward research participation out of concern it might affect their standard treatment, when genuinely it should not. Ongoing voluntariness, meaning a patient who initially consented can genuinely withdraw at any point with that withdrawal actually honored, is a core protection this criterion exists to maintain, distinct from a one-time consent treated as binding regardless of a patient’s later wishes.
What good looks like
- Informed consent genuinely distinguishes standard clinical care from research participation.
- It’s genuinely, explicitly clear that declining research won’t affect standard care.
- A patient who initially consented can genuinely withdraw at any point.
Common failure modes
- Standard care and research participation are presented as one blended decision.
- It’s not genuinely, explicitly clear that declining research won’t affect standard care.
- Withdrawal from research is treated as difficult or discouraged in practice.
Worked example
In practice
A patient eligible for a research study alongside standard treatment.
BeforeThe consent form presented standard treatment and research participation as a single combined decision, without clearly, explicitly stating that declining the research component would not affect the standard care the patient received.
ActionThe hospital built a separated consent structure with a distinct section explicitly, clearly stating that standard care continues unaffected regardless of the research decision, plus a simple, genuinely accessible withdrawal process described upfront.
AfterThe Monitor reviewed the consent documentation and spoke with an enrolled patient, confirming genuine understanding that standard care was unaffected by the research decision. Criterion verified.
If you are starting from zero — do this first
- Build a consent structure that clearly separates standard care from research participation.
- Add an explicit statement that declining research won’t affect standard care.
- Build a genuinely accessible withdrawal process, described clearly upfront.
The most common mistake: Presenting standard treatment and research participation as a single, blended consent decision, which can leave a patient genuinely unclear whether declining the research component carries any effect on the care they receive.
Self-assessment questions
1. Does informed consent genuinely distinguish standard clinical care from research participation, not present them as a single blended decision? — Genuine clarity about which parts are standard treatment versus which are research, not a combined consent that obscures the distinction.
Evidence: Consent form structure
Evidence: Consent form structure
2. Is it genuinely, explicitly clear to the patient that declining research participation will not affect the standard care they receive? — A patient should never feel their standard treatment is contingent on research participation.
Evidence: Consent language review
Evidence: Consent language review
3. Can a patient who initially consented genuinely withdraw from research participation at any point, with that withdrawal actually honored? — Genuine ongoing voluntariness, not a one-time consent treated as irrevocable.
Evidence: Withdrawal process documentation
Evidence: Withdrawal process documentation
Common reasons for a PARTIAL answer
- Separation exists in the consent form but isn’t reinforced verbally at the time of consent.
- A withdrawal process exists but isn’t clearly communicated upfront.
Implementation plan
| When | What |
|---|---|
| Week 1 | Review current consent form structure for clarity of separation. |
| Week 2 | Build a clearly separated consent structure with explicit non-contingency language. |
| Week 3 | Build and clearly communicate a genuinely accessible withdrawal process. |
| Ongoing | Spot-check enrolled patient understanding periodically. |
How the Monitor verifies this
| Method | What | Detail |
|---|---|---|
| ASK | Patient interview | Speaks with an enrolled research patient to confirm genuine understanding that standard care is unaffected by the research decision. |
Evidence base
World Medical Association. Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects. Fortaleza: WMA; 2013 (current revision).
16.5
Conflicts of Interest Between Research and Clinical Care Are Disclosed and Managed
Core
A clinician’s financial or other significant interest connected to a research study is disclosed through a defined process and genuinely 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 real management action following.
In plain terms: When a clinician has a financial or other real stake in a research study, that’s actually disclosed through a working process and actually managed — not just noted somewhere with nothing done about it.
| Facility category | Crisis | Transitional | Small | Standard |
|---|---|---|---|---|
| Applicability | Where applicable | Full | Full | Full |
Why this matters
A financial or other significant interest connected to a research study can genuinely influence a clinician’s judgment, even with the best of intentions, which is precisely why disclosure alone, without a genuine management action following it, provides limited real protective value. Separating a clinician’s research role from their direct clinical decision-making for enrolled patients is one concrete way to manage a disclosed conflict, and the specific management action matters considerably more than the disclosure record alone.
What good looks like
- A defined, actually-used disclosure process exists for financial or other interests.
- Once disclosed, the conflict is genuinely managed through a concrete action.
- Disclosure is reviewed and refreshed periodically, not captured once only.
Common failure modes
- A disclosure policy exists on paper but isn’t actually used in practice.
- A disclosed conflict is logged with no genuine management action following.
- Disclosure happens once and is never revisited as circumstances change.
Worked example
In practice
A clinician with a financial interest connected to a research study they’re also involved in clinically.
BeforeThe clinician’s financial interest was disclosed and logged in an annual conflict-of-interest form, but no actual management step separated their research role from their direct clinical decision-making for patients enrolled in that same study.
ActionThe hospital built a concrete management step requiring a separate, uninvolved clinician to handle direct clinical decisions for patients enrolled in a study where the treating clinician has a disclosed financial interest.
AfterThe Monitor reviewed a disclosed conflict case and confirmed a genuine management action — a separate clinician handling direct clinical decisions — was actually in place. Criterion verified.
If you are starting from zero — do this first
- Build a defined, actually-used disclosure process for financial and other interests.
- Build a concrete management action for a disclosed conflict, not disclosure alone.
- Build a periodic refresh cycle for disclosure, not a one-time capture.
The most common mistake: Treating disclosure alone as sufficient, with a conflict logged on an annual form but no actual, concrete management action — such as separating research and clinical decision-making roles — genuinely following.
Self-assessment questions
1. Is there a defined, actually-used process for a clinician to disclose a financial or other significant interest connected to a research study? — A real, functioning disclosure process, not a policy that exists on paper but isn’t actually used.
Evidence: Disclosure process documentation
Evidence: Disclosure process documentation
2. Once disclosed, is the conflict genuinely managed through a concrete action, not merely logged with no follow-through? — Disclosure alone provides limited protective value without a genuine management step following it.
Evidence: Conflict management record
Evidence: Conflict management record
3. Is disclosure reviewed and refreshed periodically, not captured once and never revisited as circumstances change? — A conflict of interest can emerge or change after the original disclosure point.
Evidence: Disclosure refresh schedule
Evidence: Disclosure refresh schedule
Common reasons for a PARTIAL answer
- Disclosure happens but management actions aren’t consistently applied to every case.
- Disclosure is annual but doesn’t capture a conflict that arises mid-cycle.
Implementation plan
| When | What |
|---|---|
| Week 1 | Review current disclosure process for actual use, not just existence. |
| Week 2 | Build a concrete management action protocol for disclosed conflicts. |
| Week 3 | Build a periodic disclosure refresh cycle. |
| Ongoing | Audit conflict management follow-through periodically. |
How the Monitor verifies this
| Method | What | Detail |
|---|---|---|
| DOCUMENT | Conflict management record review | Reviews a disclosed conflict case for the specific, concrete management action that was actually taken. |
Evidence base
Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009.
16.6
Teaching Faculty Maintain Verified, Current Clinical Competency
Standard
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.
In plain terms: Faculty teaching a clinical skill are genuinely, currently good at that skill themselves, checked through a real process — not assumed to be competent just because of years of experience or academic rank.
| Facility category | Crisis | Transitional | Small | Standard |
|---|---|---|---|---|
| Applicability | Where applicable | Full | Full | Full |
Why this matters
Past experience and academic seniority are genuinely weak proxies for current clinical competency in a specific skill — a faculty member’s hands-on competency in a given procedure can meaningfully diminish over time, particularly if their current role has shifted considerably toward teaching and administration with reduced direct practice. Relying on seniority alone, without a genuine current verification process, risks a trainee learning a skill from faculty whose own current competency in that specific skill hasn’t actually been confirmed.
What good looks like
- Current clinical competency, not past experience alone, is genuinely verified.
- Competency verification is repeated on a defined schedule, not confirmed once.
- A defined process exists for addressing an identified competency gap.
Common failure modes
- Teaching competency is assumed from years of past experience or academic rank.
- Competency was verified once at initial appointment and never revisited.
- An identified gap has no defined process for being addressed.
Worked example
In practice
A hospital reviewing its teaching faculty competency process.
BeforeFaculty teaching status for a given clinical skill was assumed to continue indefinitely from initial appointment, with no periodic reverification of current, active competency in that specific skill.
ActionThe hospital built a periodic competency reverification process for teaching faculty, with a defined process for addressing an identified gap through supervised practice or, where necessary, reassignment of teaching responsibility.
AfterThe Monitor reviewed teaching faculty records and confirmed periodic competency reverification was genuinely in place, with a documented process for addressing an identified gap. Criterion verified.
If you are starting from zero — do this first
- Build a current competency verification process for teaching faculty, not reliance on seniority.
- Set a defined schedule for periodic reverification.
- Build a defined process for addressing an identified competency gap.
The most common mistake: Assuming teaching competency continues indefinitely from an initial appointment based on seniority, without a genuine periodic process to reverify current, active competency in the specific skill being taught.
Self-assessment questions
1. Is current clinical competency, not past experience alone, genuinely verified for faculty teaching a given clinical skill? — Current, active competency verified through a real process, not assumed from years of past experience or academic rank.
Evidence: Competency verification record
Evidence: Competency verification record
2. Is competency verification repeated on a defined schedule, not confirmed once at initial faculty appointment? — Clinical competency in a given skill can change over time; a one-time check at appointment doesn’t reflect current status.
Evidence: Reverification schedule
Evidence: Reverification schedule
3. Is there a defined process for addressing an identified competency gap in a teaching faculty member? — Identifying a gap without a genuine response process provides limited protective value.
Evidence: Gap-remediation protocol
Evidence: Gap-remediation protocol
Common reasons for a PARTIAL answer
- Verification exists at appointment but a periodic reverification schedule isn’t fully built.
- A gap-remediation process exists on paper but hasn’t been genuinely applied.
Implementation plan
| When | What |
|---|---|
| Week 1 | Review current practice for verifying teaching faculty clinical competency. |
| Week 2 | Build a periodic reverification schedule and process. |
| Week 3 | Build a defined gap-remediation process. |
| Ongoing | Apply and document reverification on schedule. |
How the Monitor verifies this
| Method | What | Detail |
|---|---|---|
| DOCUMENT | Faculty competency record review | Reviews teaching faculty records for current, periodic competency verification distinct from a one-time appointment check. |
Evidence base
Accreditation Council for Graduate Medical Education. Common Program Requirements. Chicago: ACGME; 2023.