What is a non-substantial amendment?
A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.
How do I file an amendment in an IRA?
Please use the Notice of Substantial Amendment form available in IRAS. This is created from the Amendment tab associated with the RTB/RDB form. The completed Notice of Substantial Amendment form should be electronically authorised by all parties listed on the form’s authorisations tab in IRAS.
Do non-substantial amendments need Rec approval?
Non-substantial amendments should be notified to the Sponsor where they may affect indemnity. However, they do not need REC, HRA or MHRA approval. Records of the amendment and when it was implemented must be kept in the Research File (Trial Master File for Clinical Trials).
Does my study need HRA approval?
A study is taking place in a community setting with individuals who are not patients but who do lack capacity to consent. As this study does not involve the NHS, HRA approval is not required but, it does involve adults that lack capacity to consent so there is a legal requirement for a NHS REC review.
What needs ethical approval?
The following types of research are considered to involve MORE than minimal risk and require ethical approval: research involving potentially vulnerable groups, for example, children and young people, those with a learning disability or cognitive impairment or individuals in a dependent or unequal relationship.
What are the ethical issues in literature review?
The key ethical issues discussed in the literature are informed consent, protection of children, anonymity and confidentiality, and payment of research participants.
What kinds of ethical issues should you consider when writing a review?
Many or even most ethical codes cover the following areas:
- Honesty and Integrity.
- Objectivity.
- Carefulness.
- Openness.
- Respect for Intellectual Property.
- Confidentiality.
- Responsible Publication.
- Legality.
Why is systematic review the highest level of evidence?
In the Pyramid of Evidence Based Medicine, a Systematic Review of Randomized Control Trials is located at the top; because so many studies are used, it greatly reduces bias. One of the first steps researchers take is to conduct an organized search to find and collect all of the relevant studies. This part is key.
What is the best and most reliable type of evidence?
For treatment decisions, there is consensus that the most reliable primary study is the randomised controlled trial (RCT). In this type of study, patients are randomly assigned to have either the treatment being tested or a comparison treatment (sometimes called the control treatment).
What is suppressed evidence fallacy?
This fallacy is as simple as it seems: one commits the fallacy when one presents evidence or an argument for a position but leaves out (or suppresses) relevant evidence that would weaken or show false one’s conclusion. Suppression of evidence is commonly found in the (mis)presentation of statistics.