GC159 Research Ethics (notes)
Research ethics is the framework of principles and regulatory guidelines—including informed consent, beneficence, non-maleficence, justice, and institutional review—that govern the conduct of biomedical and clinical research involving human subjects.
Research Ethics and All That Jazz
Lecture Map
Clinical research is the engine that brings new drugs and devices from the lab bench to the bedside. However, because it inherently involves using humans as experimental subjects, it demands a rigorous ethical and regulatory framework. This lecture lays out why those frameworks exist (historical atrocities), what the frameworks are (GCP, ICH, IRB/Ethics Committees, Declaration of Helsinki, Nuremberg Code), how they operate in practice (the 10 GCP principles, the 4 phases of clinical trials, informed consent), and where things go wrong (FDA audit findings). Every clinical student will eventually encounter research — as a reader, a participant, or an investigator — and ethics questions appear reliably in summative exams. [1]
By the end of the lecture the student should be able to:
- Define sponsor, investigator, IRB and GCP
- List the 10 principles of GCP
- Determine how HKU/HA Faculty of Medicine applies Research Ethics
- List 3 problems identified with Clinical Trials when audited by FDA [1]
The Handout Is a Historical Teaching Snapshot
The three-page handout was adapted from a 1998 Columbia University GCP workbook. Its ten-point list and FDA audit percentages remain examinable as lecture content, but they are not the current ICH wording or current audit prevalence. Modern practice should be checked against ICH E6(R3) (2025), the 2024 Declaration of Helsinki, applicable Hong Kong requirements and the reviewing IRB's procedures. [1][4][5]
Core Concepts and Definitions
Clinical research is conducted to evaluate the safety and efficacy of new pharmaceutical agents, or medical devices, in anticipation of widespread use by the general public. [1]
Think of it from first principles: before widespread use, a medical product needs credible evidence that its benefits and risks are acceptable for the proposed population and use. No trial proves a product absolutely safe, and laboratory or animal evidence alone cannot determine human benefit-risk. That is why well-designed research involving human participants is necessary.
But humans are not lab rats. They have rights, autonomy, and dignity. This fundamental tension — the need for human experimentation vs. the obligation to protect human subjects — is the entire reason research ethics exists.
| Term | Definition | Why It Matters |
|---|---|---|
| Sponsor | The handout says “the company that normally initiates” a trial. Current ICH defines a sponsor more broadly as an individual, company, institution or organisation responsible for initiation, management and arranging financing; more than one sponsor may be permitted. [1][4] | Sponsorship is a responsibility, not a synonym for “drug company”. Transferred activities must be documented, but the sponsor retains overall responsibility for them. |
| Investigator | The person responsible for conduct of the trial and for trial participants under their responsibility; for a team, the responsible leader may be called the principal investigator. [4] | The investigator must protect participants, supervise delegated work, follow the approved protocol and maintain reliable records. They do not merely “deliver results” to a sponsor. |
| IRB / independent ethics committee | An independent body that protects participants through ethical and scientific review of the protocol, investigator/site suitability, consent process and participant-facing material. [4][5] | Approval must precede research; oversight continues during the study, and the committee can require changes, suspend or withdraw approval. |
| GCP (Good Clinical Practice) | A standard for planning, initiating, performing, recording, oversight, evaluation, analysis and reporting of trials that protects participants and supports reliable results. [4] | GCP is not an FDA invention. ICH harmonises an ethical, scientific and quality standard that works alongside local law and regulation. |
High Yield Exam Definition
"Any research using human subjects demands the highest level of scientific rigor and ethical conduct. The roles and operating procedures is known as Good Clinical Practice (GCP)." In the handout's wording, GCP has a two-fold goal: (1) protection of human subjects and (2) maintenance of the highest standards of scientific practice. Current E6(R3) expresses the paired outcomes as protecting participants' rights, safety and well-being and ensuring reliable trial results. [1][4]
GCP guidelines have evolved over a period of time and are NOT the product of an agency such as the Food and Drug Administration (FDA) that regulates or approves medications for use. [1]
This is a critical conceptual point and a common exam trap. Students often assume GCP = FDA regulation. It's not. GCP is a set of ethical and scientific quality standards that evolved from historical events and international consensus. The FDA uses GCP, but GCP is bigger than the FDA.
Timeline of Key Documents
| Year | Document | Key Contribution |
|---|---|---|
| 1947 | Nuremberg Code | Emerged from WWII war crimes trials. Established that human subjects must not be used in clinical trials without proper welfare considerations. First codification of voluntary informed consent as an absolute requirement. [1][2] |
| 1964; revised repeatedly | Declaration of Helsinki | The Declaration was adopted in 1964, but the explicit requirement to submit a protocol to an independent committee appeared in the 1975 Tokyo revision, not the original 1964 text. The current official version is the 2024 Declaration, which requires independent prior review and ongoing oversight. [1][5][6] |
| 1996 onward; current E6(R3) adopted 2025 | ICH-GCP Guidelines | ICH harmonised GCP for international trials. E6(R3) now emphasises participant rights, quality by design, risk-proportionate processes, reliable results, data governance, clear responsibilities and transparency. [4] |
Why ICH Matters
Modern trials may span many sites, countries and data systems. ICH-GCP provides a harmonised standard, but it does not displace national law, local regulatory requirements or the reviewing ethics committee's conditions. [4]
GCP principles should be used in all 4 stages of Clinical Trials. [1]
| Phase | Name | Key Question | Details |
|---|---|---|---|
| Phase I | Clinical Pharmacology | Safety, tolerability, dose and human pharmacology | Usually small and often uses healthy volunteers, but may enrol patients—for example, many oncology first-in-human studies. Early pharmacodynamic or efficacy signals may also be explored. [1][9] |
| Phase II | Early controlled clinical studies | Preliminary effectiveness and dose, with continued safety assessment | Conducted in patients with the target disease, commonly involving up to several hundred participants. [1][9] |
| Phase III | Expanded clinical trials | Confirm benefit-risk for the proposed use | May compare with placebo, active control or another appropriate design; the question is not always “is it better?” because superiority, non-inferiority or other objectives may be valid. [1][9] |
| Phase IV | Post-authorisation studies | Effectiveness, safety and use after marketing | Can detect uncommon or delayed harms and study real-world use or additional questions; not every post-market safety signal requires exposure of “millions”. [1][9] |
Exam Trap
Students commonly confuse Phase I and Phase II. Remember the safer distinction: Phase I prioritises initial human safety, dose and pharmacology; Phase II asks for preliminary effectiveness in the target condition while safety assessment continues. “Phase I equals healthy volunteers” has important exceptions. [9]
Why use phases? They organise the questions asked as evidence accumulates: initial human pharmacology and tolerability, early evidence of effectiveness, confirmatory benefit-risk evaluation, then post-authorisation evidence. Development is not always a rigid staircase—phases can overlap, use adaptive designs, or answer several objectives in one protocol. [4][9]
This is one of the highest-yield lists in the lecture. Page 2 uses a two-column visual mnemonic: the short phrases on the left map line-by-line to the fuller statements on the right. Know this ten-item list for the lecture, but label it accurately as the handout's 1998 teaching formulation, not the current official ICH principle set. [1][4]
There are 10 basic principles of GCP:
| # | Short Summary | Full Principle | Why It Matters |
|---|---|---|---|
| 1 | The study is well thought out | The sponsor's overall clinical development plan must be well crafted | A poorly designed development program wastes resources and exposes subjects to risk without proportionate benefit. [1] |
| 2 | And scientific | Each study must be designed in accordance with sound scientific principles | Bad science = bad ethics. If a study is methodologically flawed, it cannot produce valid results, meaning subjects were exposed to risk for nothing. [1] |
| 3 | The patients' rights are protected | The rights and safety of subjects must be protected by external review and approval of proposed procedures | This is the IRB/Ethics Committee role. External review is key — you cannot mark your own homework. [1] |
| 4 | And they have given consent | Consent to participate in the study must be informed and freely given | "Informed" = the subject understands what they're agreeing to. "Freely given" = no coercion. This is the legacy of Nuremberg. [1] |
| 5 | The study adheres to guidelines | The study must be executed in conformance with accepted regulatory guidelines | Following the protocol protects data integrity and subject safety. [1] |
| 6 | And is monitored | The study must be monitored by the sponsor or its delegate for compliance with the guidelines | Trust but verify. The sponsor has a duty to check that investigators are actually following the rules. [1] |
| 7 | The data arising is accurate | The data must be complete and accurately reflect information in source documents | Fabricated or inaccurate data can lead to approval of dangerous or ineffective drugs. [1] |
| 8 | And accounted for | There must be complete accountability for test articles, their storage and final disposition | Drug accountability means knowing exactly how many doses were dispensed, used, returned, and destroyed. Prevents diversion and ensures dosing accuracy. [1] |
| 9 | And kept in a proper place | Proper record keeping and record retention practices must be followed | Records must be preserved for audit trails. If you can't prove something happened correctly, you can't claim it did. [1] |
| 10 | And that there is a plan of quality assurance | A plan of quality assurance must be in place and implemented throughout the study | QA is not an afterthought — it must be planned from the start and implemented throughout (not just at the end). [1] |
Memory Aid for 10 GCP Principles
Think of them in logical groups:
- Design (1-2): Well-crafted plan + sound science
- Protection (3-4): External review + informed consent
- Execution (5-6): Follow guidelines + monitor compliance
- Data (7-8-9): Accurate data + drug accountability + record keeping
- Quality (10): QA throughout
Current ICH E6(R3) Crosswalk
ICH E6(R3), adopted in January 2025, states 11 overarching principles. They preserve the handout's core ideas but organise them differently: [4]
| Current principle | Connection to the handout |
|---|---|
| 1. Ethics; participant rights, safety and well-being prevail | Expands handout item 3 and makes benefit-risk, inclusion and confidentiality explicit |
| 2. Free and informed consent | Handout item 4, now framed as an adaptable, ongoing process |
| 3. Independent IRB/IEC review | Handout item 3, with prior and periodic review |
| 4. Scientifically sound and current | Handout items 1-2 |
| 5. Qualified individuals | Largely implicit in the handout |
| 6. Quality built into design and conduct | Handout item 10, now explicitly “quality by design” |
| 7. Proportionate, risk-based processes without unnecessary burden | A major E6(R3) emphasis absent from the old mnemonic |
| 8. Clear, concise, feasible protocol | Handout items 1, 2 and 5 |
| 9. Reliable results, traceable records, protected data and transparency | Handout items 7-9 plus modern data governance, registration and results reporting |
| 10. Clear, documented roles and retained oversight | Handout item 6, extending beyond sponsor monitoring |
| 11. GMP manufacture and protocol-compliant management of investigational products | Extends the handout's drug-accountability item |
Exam Strategy
If asked specifically for the lecture's ten principles, reproduce the ten-item handout list. If asked for current ICH-GCP, do not claim there are only ten: use the E6(R3) eleven-principle framework and explain that participant protection and reliable results run through the entire trial life cycle. [1][4]
The IRB / Ethics Committee
The handout attributes institutional ethics-committee review to the 1964 Declaration of Helsinki. [1]
Historically, the Declaration was adopted in 1964, but independent committee review was added in the 1975 revision. The current 2024 version requires prior review by an independent, adequately resourced and diverse research ethics committee with local familiarity and a public member. The committee may monitor, require changes, suspend or withdraw approval, and must receive relevant safety information and a final report. [5][6]
The ethics committee is NOT involved with research involving animals; that is done by another committee (CULATR). [1]
CULATR = Committee on the Use of Live Animals in Teaching and Research. This is a separate body. For an HKU exam question specifically contrasting human and live-animal oversight, human studies go to the relevant human-research IRB/REC and live-animal work to CULATR. Some projects may require more than one approval if they contain distinct human and animal components. [11]
There is a combined HKU HA ethics committee (or institutional review board) that comprises members from the Faculty, a non-faculty member and a representative from the Hospital Authority. The committee reviews over 150 protocols a year in circulation as well as face to face meetings. The commitment is to adhere to the Principles of Helsinki and also to the ICH-GCP guidelines. [1]
The quoted description is a historical slide snapshot, not a current directory or workload statement. Current governance has evolved: HA integrated its cluster RECs into the HA Central IRB in the first quarter of 2024 for coordinated multi-cluster review, while the HKU/HA Hong Kong West Cluster IRB remains the relevant joint board for studies within its jurisdiction. Its terms of reference, effective November 2024, describe both initial review and continuous ethical/scientific oversight. [7][8]
| Current feature | What to remember |
|---|---|
| Composition | At least five members of both genders, including at least one scientific member, one non-scientific member and one independent unaffiliated member. [7] |
| Authority | May require modifications, approve or disapprove, audit, and suspend or terminate a study if unacceptable participant risk arises. [7] |
| Oversight | Continues after initial approval through amendments, progress/final reports, safety reporting and other required submissions. [7] |
| Application route | Current applications use the HA Clinical Research Ethics Review Portal and the route appropriate to the study's sites and jurisdiction. [8][11] |
The old “more than 150 protocols/year” figure and circulation-versus-meeting method should be treated as lecture history. They are not evidence of the board's current workload or review categories. [1]
The investigator must ensure that a proper informed consent is signed. [1]
Informed Consent in Research
The individual has been given all the information a rational person needs to assess the personal risks, requirements, and rewards of participation in a research study. [1]
Treat the handout definition as a starting point. Current guidance requires a process, not merely a signature: plain-language information, opportunity and time for questions, apparent understanding, voluntariness, capacity or an authorised representative where applicable, and proper documentation. Explain purpose, research procedures, randomisation, foreseeable risks/burdens, expected benefit or lack of direct benefit, alternatives, privacy/data access, payment and costs, injury arrangements, contacts, new information and the right to refuse or withdraw without reprisal. [4][5]
Consent Is Necessary but Not Always Sufficient
A signed form does not cure coercion, poor understanding, undisclosed conflicts or an ethically unsound protocol. Conversely, prior participant consent may be impossible in narrowly defined emergency research or impracticable for some secondary use of stored data/material; such exceptions require prior ethics approval and compliance with applicable law, followed by consent as soon as required. Never invent an informal “emergency exception” at the bedside. [4][5]
In any procedure that you are performing on a patient informed consent needs to be given. This should also be borne in mind when you are doing minor procedures. [1]
This is a practical clinical point, but keep clinical consent distinct from research consent. Permission for routine clinical venepuncture does not authorise research sampling, storage or secondary use. In regulated trials, consent is generally documented with a signed paper or electronic form; approved alternatives and exceptions are jurisdiction- and protocol-specific. [4][5]
Obtain informed consent (writing or oral) – an ongoing not singular process. Enumerate how to manage privacy and confidentiality. Data reporting, handling and disposal. [2]
Key Concept: Consent is Ongoing
Informed consent is an ongoing process, not a singular event. A patient signing a form at enrolment does not mean consent is permanently granted. Subjects must be kept informed of new findings, and consent must be reconfirmed if the study changes significantly. [2]
Participants may stop participation without penalty, but withdrawal does not necessarily erase data already lawfully collected or eliminate safety follow-up obligations. The consent material and applicable requirements should explain how data are handled after withdrawal. [4]
Routine FDA audit findings:
- Inadequate consent form: 56%
- Inadequate and inaccurate records: 23%
- Inaccurate drug accountability: 22%
- Failure to adhere to protocol: 9%
- Failure to keep IRB informed of changes: 9% [1]
These percentages come from the 1998 workbook cited in the handout footer, not a current FDA inspection dataset. They total more than 100%, so categories could overlap; the handout gives no denominator, period or sampling method. Use them to answer a lecture-specific recall question, not to state today's prevalence or rank of inspection findings. [1]
| Violation | Frequency | Why It's a Problem |
|---|---|---|
| Inadequate consent form | 56% | The highest category listed in this handout. Forms may be missing required elements, use jargon participants cannot understand, or omit relevant information. This maps to handout Principle 4. [1] |
| Inadequate and inaccurate records | 23% | If you can't trust the records, you can't trust the data. Violates GCP Principles 7 and 9. [1] |
| Inaccurate drug accountability | 22% | Not knowing where the study drug went means you don't know if subjects received the correct dose — or if drug was diverted. Violates GCP Principle 8. [1] |
| Failure to adhere to protocol | 9% | Protocol deviations compromise data integrity and may expose subjects to unanticipated risks. Violates GCP Principle 5. [1] |
| Failure to keep IRB informed of changes | 9% | The IRB can only protect subjects if it knows what's actually happening. Failing to report changes undermines the entire oversight system. Violates GCP Principle 3. [1] |
Exam High Yield
For this historical handout, the highest listed finding is inadequate consent form (56%), followed by records (23%) and drug accountability (22%). In an exam, identify the source as the lecture-era audit table rather than presenting the percentages as current FDA surveillance. [1]
Case in point: "Doctored files" (to be shown during lecture). List the following areas where Dr Poisson violated GCP principles. [1]
This refers to Dr Roger Poisson, principal investigator at St Luc Hospital in Montreal in National Surgical Adjuvant Breast and Bowel Project trials. The US Office of Research Integrity reported 115 instances of fabrication or falsification, mainly altering or fabricating eligibility-related dates or hormone-receptor values, and found scientific misconduct. This case detail is not printed in the three-page handout; it was intended to accompany the lecture's “Doctored files” video. [1][10]
GCP Principles violated by Dr. Poisson:
- Principle 2 (sound science) — knowingly including ineligible participants compromises interpretability
- Principle 5 (protocol/regulatory compliance) — eligibility criteria were not followed
- Principle 7 (accurate data) — dates and laboratory values were fabricated or falsified
- Principle 9 (proper records) — submitted records no longer faithfully represented source information
- Principles 6 and 10 (monitoring and quality assurance) — the delayed detection exposes system-level control failures
Do not automatically add a consent violation without evidence about what participants were told or consented to. The established misconduct was fabrication/falsification and protocol/eligibility non-compliance. The case illustrates why source verification, independent monitoring, audit trails and prompt escalation matter; investigator motivation does not make false data ethically acceptable. [10]
Confidentiality in Research: The Nuremberg Code, Declaration of Helsinki, Personal Data (Privacy) Ordinance, IRB, LKS Faculty of Medicine Research Ethics. [2]
Main ethical issues in human subject research: Obtain informed consent (writing or oral) – an ongoing not singular process. Enumerate how to manage privacy and confidentiality. Data reporting, handling and disposal. [2]
Research generates large amounts of personal health data. Confidentiality obligations in research include:
- Data minimisation — collect only what the protocol needs
- Coding/pseudonymisation or anonymisation where appropriate; coded data remain potentially identifiable if a re-identification key exists
- Secure, access-controlled storage with traceable changes, backups and a defined response to loss or unauthorised access
- Consent and/or another lawful, ethics-approved basis for collection, storage, linkage and foreseeable secondary use
- A justified retention and disposal plan — do not destroy essential records merely because recruitment ended
- Compliance with the Personal Data (Privacy) Ordinance (PDPO) in Hong Kong
- IRB oversight of data/material handling, including approved secondary use and biobanks [4][5]
From GC 174 and other ethics lectures, the broader ethical framework that underpins research ethics includes [2][3]:
| Framework | Application to Research Ethics |
|---|---|
| Principlism (Beauchamp & Childress) | Autonomy → informed consent; Beneficence → potential benefit to society/subjects; Non-maleficence → minimise harm to subjects; Justice → fair subject selection, equitable distribution of research benefits and burdens |
| Nuremberg Code | Voluntary consent is absolutely essential |
| Declaration of Helsinki (2024) | Prior independent review; risk-benefit assessment; fair inclusion and protection for vulnerability; consent/assent; privacy; restricted placebo use; post-trial provisions; registration and public dissemination of all results [5] |
| ICH E6(R3) | 11 current principles spanning participant protection, consent, independent review, sound science, qualified teams, quality by design, proportionate processes, feasible protocols, reliable results, clear responsibilities and investigational-product control [4] |
| PDPO | Hong Kong law governing handling of personal data — applies to research data |
For the Medical Student / Junior Doctor
- Before recruiting anyone: Verify current IRB approval, approved recruitment/consent materials, your delegated role and training, and that no study procedure occurs before valid consent unless the approved protocol permits an exception.
- For a research procedure: Separate research consent from clinical consent and make clear what care is standard versus research.
- If you notice a deviation or misconduct concern: protect participants first, preserve records and escalate through the investigator, sponsor and institutional/IRB route required by the protocol and policy. A deviation needed to remove an immediate hazard may occur first but must be documented and reported promptly. [4]
- If an adverse event occurs: provide appropriate clinical care and report it within protocol/regulatory timelines. Under ICH E6(R3), most serious adverse events are reported immediately to the sponsor after awareness; reporting to the IRB and regulators follows applicable requirements and the approved reporting plan. [4]
- If a participant wants to withdraw: they may stop participation without reprisal or loss of ordinary care. Explain any necessary safety follow-up and the approved handling of data already collected; withdrawal is not automatically a right to delete every record. [4][5]
Exam Intelligence
| Trap | Correct Understanding |
|---|---|
| "GCP was created by the FDA" | GCP guidelines are NOT the product of the FDA. They evolved from the Nuremberg Code (1947), Declaration of Helsinki (1964), and ICH consensus. The FDA uses GCP but did not create it. [1] |
| "Phase I always means healthy volunteers and no efficacy information" | Phase I prioritises initial safety, tolerability, dose and pharmacology, but may enrol patients and may explore early activity. [9] |
| "The IRB reviews animal research" | The ethics committee is NOT involved with research involving animals; that is done by another committee (CULATR). [1] |
| "Informed consent is a one-time event" | Consent is an ongoing process, not singular. Must be maintained throughout the study. [2] |
| "The FDA currently reports a 56% consent-form failure rate" | No. It is the highest figure in this 1998-derived lecture table; the handout provides no current denominator or sampling frame. [1] |
| "A sponsor must be a pharmaceutical company" | No. A sponsor may be an individual, company, institution or organisation responsible for initiation, management and financing arrangements. [4] |
| "Helsinki introduced independent committee review in 1964" | The Declaration was adopted in 1964; independent committee review was added in the 1975 revision. [6] |
| Concept A | Concept B | Key Difference |
|---|---|---|
| Nuremberg Code (1947) | Declaration of Helsinki (1964; revised) | Nuremberg foregrounded voluntary consent; Helsinki is a living framework, with independent committee review added in 1975 and the current revision adopted in 2024 |
| IRB | CULATR | IRB = human subjects; CULATR = animal subjects |
| GCP | GMP (Good Manufacturing Practice) | GCP = clinical trials; GMP = drug manufacturing |
| Phase II | Phase III | Phase II = preliminary effectiveness/dose; Phase III = confirmatory benefit-risk for the proposed use, not necessarily superiority |
High Yield Summary
- Research Ethics — What You Must Know for the Exam
- Current definitions: Sponsor may be an individual, company, institution or organisation; investigator is responsible for trial conduct and participants; the IRB independently protects participants; GCP protects participants and supports reliable results. [4]
- Historical sequence: Nuremberg Code 1947 → Helsinki adopted 1964, independent committee review added 1975 → current Helsinki 2024 and ICH E6(R3) 2025. [4][5][6]
- Trial phases: Phase I (initial safety/dose/pharmacology), Phase II (preliminary effectiveness/dose), Phase III (confirmatory benefit-risk), Phase IV (post-authorisation evidence). [9]
- Two lists: know the handout's ten-item mnemonic for a lecture-specific question, but know that current ICH E6(R3) has 11 overarching principles. [1][4]
- Consent: a voluntary, understandable and documented ongoing process; a signature alone is insufficient. Withdrawal must not prejudice ordinary care. [4][5]
- IRB oversight: prior approval plus continuing review, safety/amendment oversight and authority to suspend or terminate. Live-animal work at HKU is overseen separately by CULATR. [5][7][11]
- Audit table: 56% consent, 23% records and 22% drug accountability are historical figures from this 1998-derived handout—not current FDA prevalence. [1]
- Poisson case: established fabrication/falsification and eligibility/protocol non-compliance; do not infer a consent violation without evidence. [10]
Active Recall - Research Ethics
[1] Lecture slides: GC 159. Research Ethics (Notes).pdf (pp. 1-3) [2] Lecture slides: GC 174. Confidentiality Balancing public vs private interests.pdf (pp. 10, 27) [3] Lecture slides: GC 173. Why should I be locked up Ethics in psychiatry, Consent and Refusal in Treatment.pdf [4] International Council for Harmonisation. ICH E6(R3) Guideline for Good Clinical Practice. Step 4 final version, adopted 6 January 2025. [5] World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants. 2024 revision. [6] World Medical Association. Background information on the Declaration of Helsinki and 1975 revision. [7] HKU/HA Hong Kong West Cluster Institutional Review Board. Terms of Reference. Effective 1 November 2024. [8] Hospital Authority. Research Ethics Oversight (HA Central IRB and review portal). [9] US Food and Drug Administration. Drug Development and Review Definitions (clinical trial phases). [10] US Office of Research Integrity. ORI Newsletter, April 1993 (Poisson case findings). [11] Li Ka Shing Faculty of Medicine, HKU. Human Ethics and Animal Ethics.
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