Anesthesiology APPLIED Exam › OSCE: communication and professionalism

Research consent, conflicts of interest and confidentiality

OSCE: communication and professionalism·~5 min read· Physician-reviewed✓ Sourced · 10

Stem

Ms. Alvarez, a 52-year-old woman, 68 kg, is scheduled tomorrow for an elective laparoscopic colectomy. A research coordinator has invited her to join an IRB-approved, randomized, placebo-controlled trial of an investigational intravenous non-opioid analgesic given in addition to standard multimodal analgesia. You are a co-investigator, and you receive consulting fees from the drug's manufacturer. She works in the billing office of this hospital. Your task: answer her questions about the study and confirm her decision.

Question

The coordinator said you're part of this study. Is this new drug safe? And honestly, will people I work with be able to see my records?

Ideal answer

Headline"Joining is entirely your choice, and saying no changes nothing about your surgery. I'll tell you what we know, what we don't, my own tie to the company, and who can see your information."

Concern and her understanding first (shows concern). "I'm Dr. Reyes. What did the coordinator explain? Which worries you more, the drug or your privacy?"
Research, said plainly (purpose, procedures, risks). "This is research: we don't know yet whether the drug helps. Chance decides whether you get it or a salt-water look-alike, and neither of us will know which. Either way you get all your usual pain medicines. The form lists the side effects seen so far, and there may be risks nobody knows."
Disclose my financial tie (conflict of interest). "The company pays me as a consultant. The ethics board knows and approved how that's managed. If you'd rather, someone without that tie can go through the consent with you."
Privacy in her terms (confidentiality). "Only people whose job needs your chart may open it; billing colleagues looking out of curiosity would be a violation you can report. Study data are coded, and the authorization you sign names who receives them."¹
Hand back the decision (voluntariness). "You can say no, or say yes and stop later, with no penalty. What questions do you have?"

Breaking down the answer

What is scored — the outline lists investigational therapies, confidentiality and conflicts of interest among ethics topics, graded on gathering information, clarifying options, preferences and deciding.² Changes if: she lacks capacity; then her legally authorized representative decides.
The consent elements — it is research; purpose, duration, procedures, experimental parts; risks, benefits, alternatives; confidentiality; injury care above minimal risk; contacts; voluntary withdrawal without penalty.³ Changes if: she thinks treatment was chosen for her; "chance decides" corrects that misconception.
Why the IRB approved it — risks minimized and reasonable, equitable selection, consent sought and documented, safety monitoring, privacy protected.⁴ Changes if: she is vulnerable, for example impaired capacity or economic disadvantage, which needs added safeguards.⁴
Conflict managed, not hidden — manufacturers publicly report payments to physicians, and since 2021 data to CRNAs.⁵ ASA principles bar exploitive financial relationships.⁶ Changes if: she feels pressured by me; an investigator without the tie takes consent.
Access follows the job — HIPAA limits use to the minimum necessary and requires role-based access policies; treatment disclosures are exempt.⁷ Changes if: she authorizes sharing, which lifts the minimum-necessary limit.⁷

Follow-up question

Ms. Alvarez nods: "Okay, I'll sign. But only if you promise I get the real drug and not the placebo. You can arrange that, can't you?" How do you respond?

Follow-up answer

HeadlineShe is about to consent under a misunderstanding. I correct it kindly and will not enroll her on false terms.

"I can't, and I won't pretend otherwise. Chance decides, and nobody here knows which you get; that's what makes the answer trustworthy. The drug isn't available outside the study. What I can promise is that you'll get our full pain plan either way, and we'll treat pain promptly." I check her understanding in her words. If she still wants to join knowing it's chance, she enrolls; if not, I document her decision and nothing about her care changes. I tell the coordinator either way.

Pitfalls that cost points

Calling the study drug "newer, so probably better": that is undue influence, not information.
Promising total secrecy; the form states who may review study records.
Letting a fear of saying no pass unaddressed.

Rapid-fire

Q: Which groups count as vulnerable in research? A: Children, prisoners, people with impaired decision-making capacity, and the economically or educationally disadvantaged; each needs added safeguards.⁴

Q: Her husband phones asking how surgery went. What can I say? A: If she agreed, or did not object when given the chance, I can share what bears on his role in her care.⁸

Q: A rep offers me cash for an "advisory chat." A: Decline: cash in any amount, and any gift implying reciprocity, are off limits.⁹

Q: May I open a colleague's chart because I'm worried about him? A: No. Access is limited to what my job needs; curiosity or concern is not a treatment purpose.⁷

Q: What protects participants during the trial? A: The IRB requires data monitoring for safety where appropriate, usually a data and safety monitoring board.⁴

Numbers to know

Item	Value
Station time	8 min, 4-min read, warning at 6 min¹⁰
Basic consent elements (OHRP pre-2018 checklist)	12³
IRB approval criteria (full review)	7⁴
Vulnerable groups named in the rule	4⁴
Open Payments data	Published each year around June 30⁵
ASA ethics principles	Last amended October 2025⁶

Sources

1.Authorization: HIPAA Privacy Rule and research · NIH · privacyruleandresearch.nih.govCore elements include the persons who may use or receive the information and an expiration date or event.
2.APPLIED Examination OSCE Content Outline · ABA · theaba.orgSection A.3, Ethical issues: lists investigational therapies or research protocols, confidentiality and privacy, and conflicts of interest.
3.OHRP Guidance: Checklists (informed consent, 45 CFR 46.116) · HHS Office for Human Research Protections · hhs.govLists the basic elements of informed consent; the checklist predates the 2018 revised Common Rule, which added a concise key-information section.
4.45 CFR 46.111, Criteria for IRB approval of research · Electronic Code of Federal Regulations · ecfr.gov
5.The CMS Open Payments Program, also called the Sunshine Act · Johns Hopkins University Office of Policy Coordination (industry interaction) · industryinteraction.jhu.eduInstitutional summary of the federal program; CRNAs and other advanced practice providers covered from 2021 data.
6.Principles for the Ethical Practice of Anesthesiology · ASA Committee on Ethics, 2025 · asahq.orgLast amended October 15, 2025.
7.Minimum Necessary Requirement · HHS Office for Civil Rights · hhs.gov
8.Does HIPAA permit a doctor to discuss a patient's health status with the patient's family and friends? · HHS Office for Civil Rights · hhs.gov45 CFR 164.510(b).
9.Code of Medical Ethics Opinion 9.6.2: Gifts to Physicians from Industry · AMA · code-medical-ethics.ama-assn.org
10.What to Expect for Your APPLIED Exam (APPLIED Exam Manual) · ABA, 2026 · theaba.orgRevised July 2026.

Facts on this page were checked against these sources on Oct 22, 2026. Guidelines change; confirm doses against current institutional protocols.