vulnerable participants + high risk issues

Question 1

define ethics

Answer 1

ensuring that projects minimise risk + maximise benefits

Question 2

define governance

Answer 2

ensuring that projects have appropriate permission

Question 3

define consent

Answer 3

ensuring participation is voluntary without cost.

Question 4

What types of projects do not require formal ethical approval?

Answer 4

1) Data/material already published/publicly available – Secondary Research
2) Projects on non-human subjects/materials – Non-Human Research*
3) Projects using only existing service management data – Audit/Service Evaluation
4) Projects collecting new information only on existing service delivery – Service Evaluation*

Question 5

What types of projects do require formal ethical approval?

Answer 5

• Non-human subjects/material covered by the Animals (Scientific Procedures) Act 1986
• Service Evaluations involving vulnerable participants or ethically sensitive topics/data collection

Projects involving a new intervention – Experimental Research

Projects collecting new information on more than only existing service delivery – Non-Experimental Research

Question 6

key principles of ethical research, audit + service evaluation

Answer 6

The project is conducted in compliance with an explicit protocol
An authorised research ethics committee has approved the protocol*
Further research ethics committee approval is requested if:
(i) there are any substantial changes to the project protocol
(ii) the project has any unexpected deleterious effects

Question 7

when is further esearch ethics committee approval is requested

Answer 7

(i) there are any substantial changes to the project protocol
(ii) the project has any unexpected deleterious effects

Question 8

what should the protocol include

Answer 8

why, what, how
1) why project is necessary
2) what it will involve
3 how ethical, legal, governance issues will be avoided or addressed.

Question 9

A project protocol should provide sufficient information for

Answer 9

• enable project team members to conduct the project;
• prospective project participants1 to assess whether to volunteer;
• research ethics committee members to approve, refer or reject.

Question 10

Research Ethics Committees include

Answer 10

• institutional

- government

Question 11

this comities can only approve studies which comply with what 3 points

Answer 11

minimise the risk of harm to project staff, participants and society

comply with relevant legal and regulatory requirements

comply with the requirements of professional indemnity insurance

Question 12

when must project staff reapply for research ethics clearance

Answer 12

• substantial change in protocol

- unexpected deleterious effect