ethics

Question 1

What are the 4 key elements of the Nuremberg Code?

Answer 1

A requirement for voluntary consent

Research has scientific merit

Benefit of research outweigh risks

Subjects can terminate participation in the research at anytime

Question 2

What is the declaration of Helsinki (sort of an addition to the Nuremberg Code)?

Answer 2

Research study protocols should be reviewed by an independent committee prior to its initiation

Informed consent from research participants is needed

Research should be conducted by medically or scientifically qualified individuals

Risks should not exceed benefits

Question 3

What is the Belmont Report?

Answer 3

Details 3 ethical principles:
Beneficence
- the right to freedom from harm and discomfort
- the right to protection from exploitation

Justice
- the right to fair treatment
- the right to privacy
- no discrimination against a certain group of participants

Respect for human dignity
- the right to self determination
- the right to full disclosure
- informed consent
- consent should comprise of 3 elements: information, comprehension, voluntariness

Question 4

What are the 2 interfaces available in Singapore and what review boards do they involve?

Answer 4

1. Ethics and Compliance Online System (ECOS)
   - Domain Specific Review Board (DSRB)
   * National University Health System (NUHS)
   * National Healthcare Group (NHG)

• Centralised Institutional Review Board (CIRB)
• Singapore Health Services (SingHealth)

2. Integrated Research Information Management Suite (IRIMS)
   - University Institutional Review Board
   * National University of Singapore Institutional Review Board
   (NUS-IRB)
   * Department Ethics Review Committee (DERC)

Question 5

What are the types of participants for DSRB?

Answer 5

Patients, caregivers & healthcare professionals

Question 6

What are the data collection sites for DSRB?

Answer 6

NHG and NUHS entities

Question 7

Where is the principal investigator (PI) from for DSRB?

Answer 7

If the overall PI is from NUS, they need a site PI as well

Question 8

What are the types of participants for CIRB?

Answer 8

Patients, caregivers, healthcare professionals

Question 9

What are the data collection sites for CIRB?

Answer 9

SingHealth entities

Question 10

Where is the principal investigator (PI) from for CIRB?

Answer 10

If the overall PI is from NUS, they need a site PI as well

Question 11

What are the types of participants for NUS-IRB?

Answer 11

Healthy volunteers, healthcare professionals

Question 12

What are the data collection sites for NUS-IRB?

Answer 12

Community (eg. AIC roadshows), healthcare institutions not covered by the 3 clusters

Question 13

Where is the principal investigator from for NUS-IRB?

Answer 13

NUS

Question 14

[Evaluating the effects of an online resilience program
among undergraduate students: A double-blind randomized controlled trial]

Which ethics board should the researchers apply to?

Answer 14

NUS-IRB

online resilience program -> intervention -> experimental

undergraduate students -> volunteers

Question 15

[Exploring impacts of advance care planning among community- dwelling adults: A mixed methods study]

Which ethics board should the researchers apply to?

Answer 15

NUS-IRB if healthy volunteers, DSRB or CIRB if they’re patients (qn will tell u in the exam)

Question 16

[Examining cancer patients’ resilience during active treatment: A mixed methods study]

Which ethics board should the researchers apply to?

Answer 16

patients -> DSRB or CIRB depending on where the study is being conducted

Question 17

What preparations do the researchers need to do?

Answer 17

Collaborative Institutional Training Initiative (CITI) training
certificates (http://www.citiprogram.org)

Research team’s curriculum vitae (e.g., education, publications if
any, research experience)

Question 18

What preparation is there for the research study?

Answer 18

Research protocol (e.g., introduction, methods, significance of study)

Data collection tools

Participant information sheet and consent form (e.g., each board has different formats)

Question 19

What is the application process for an ethics approval?

(not sure if we need to know this whole thing)

Answer 19

Prepare necessary documents

Finalize research team members and study site(s)

Identify appropriate ethics board

Create submission in ethics board

Submit application for ethics review and approval

Ethics board secretariat conducts preliminary review and determines type of review

Secretariat may request for clarifications or missing documents

Revised application is submitted for review

Board may provide comments or approve the study

Question 20

What if a researcher is conducting a multi-site study?

Answer 20

DSRB and CIRB mutually recognise each other’s ethics approval

The researcher can apply to either depending on the overall PI’s affiliation