Ethical Considerations in Research

select all that apply:

what is the biopharmaceutical research and development process?

1. discovery / preclinical

2. clinical trials (humans)

3. FDA review

4. Post-marketing (phase IV)

select all that apply:

why are RCTs the gold standard?

1. chance decides who gets the new drug vs control

2. compares against placebo or best current therapy

3. reduces bias

preclinical → file IND → phases 1-3 → file NDA/BLA → ___________.

approval

historical example of misbranding/false medical claims. FDA's role is to protect the public by policing safety, efficacy, and truthful labeling.

crazy water crystals

select all that apply:

why do ethical dilemmas happen?

1. don't know the rules

2. practice vs. personal values

3. principles collide

4. conflicts of interest/greed

5. typical unethical behaviors

reasoned standards for right action; argued and justified (what we use in professional decision making).

ethics

personal/community rules often received from an authority or tradition.

morality

organized belief system that can shape a person's morality/values.

religion

personal priorities that evolve over time (e.g., current emphasis on patient autonomy vs. past paternalism).

values

select all that apply:

what are some issues in medical ethics for providers?

1. withholding treatment due to budgets/insurance

2. taking industry money, upcoding

3. romantic relationships with patients/families

4. covering up mistakes

5. reporting an impaired colleague

6. cherry-picking patients

7. prescribing/dispensing placebos

8. defensive medicine

9. dropping insurers

10. breaching confidentiality for a health risk

select all that apply:

who decides medical ethics?

1. professional codes and guidance

2. laws & regulations

3. institutional policies and ethics committees

4. case law & standards of care.

select all that apply:

what are the pharmacist-specific dilemmas?

1. religious convictions

2. medication safety concerns

3. two policies at odds

4. law vs ethics

select all that apply:

what do you do if you spot an ethical issue?

1. identify the issue

2. apply standards

3. generate options & assess harms/benefits

4. decide and document

5. review & reflect

select all that apply:

why do these ethics rules exist?

1. Tuskegee (1932-72)

2. Nuremberg Code (1947)

3. National Research Act & 45 CFR 46 (1974)

4. Belmont Report (1979)

select all that apply:

what are the three ethical principles?

1. respect for persons

2. beneficence

3. justice

people are agents with the right to make their own choices. in research, you honor that by getting informed consent and protecting privacy.

IRB review (non-human/exempt/expedited/full committee) checks that consent and protections are appropriate. consent must be voluntary, confidential, and understandable.

respect for persons

select all that apply:

what are the four components of informed consent?

1. capacity

2. disclosure

3. comprehension

4. voluntariness

select all that apply:

who are the populations that need extra safeguards and often additional approvals?

1. adults lacking capacity

2. children/teens

3. pregnant people/fetuses

4. prisoners

5. economically/educationally disadvantaged.

do no harm and maximize benefit vs. risk.

in practice

keep the risk/benefit ratio low.

use Data & Safety Monitoring plans/boards, stopping rules, and prompt reporting of adverse events.

if risk increases during a trial, pause or stop the study.

beneficence

fairness in who bears the burdens and who gains the benefits of research.

in practice

fair recruitment and access; avoid targeting or excluding groups without good reason.

use random selection when possible.

historical cautionary tale: Tuskegee Syphilis Study—an example of profound injustice to avoid repeating.

justice

select all that apply:

what does HIPAA cover?

1. PHI (Protected Health Information)

2. the 18 identifiers

select all that apply:

what are HIPAA's three areas of compliance?

1. administrative

2. physical

3. technical

policies, training, role-based access, incident response.

administrative

facility security, locked rooms, secure disposal of papers/devices.

physical

unique logins, encryption, firewalls, audit logs, automatic time-outs.

technical

select all that apply:

what are the key ethical challenges in clinical research?

1. placebo or not

2. phase I trials

3. conflicts of interest

4. quality improvement (QI) vs research

5. genetic testing & data use

6. public trial registries

7. globalization

8. practices vs society/individual values

select all that apply:

what are five issues pharmacists may face?

1. patient confidentiality (HIPAA)

2. patient relationships

3. malpractice/negligence

4. informed consent

5. dispense or not (conscience clauses)