We encourage researchers to use the document templates which will ensure your documents are formatted correctly to gain approval, the templates include; a research protocol and an informed consent form.  

For applications to be processed without the need for revisions the Researcher must demonstrate that they have considered what the risks are in relation to their research and show what they will do to mitigate those risks.   How will confidentiality be maintained, where and how is  the data being stored, who will have access, are they entitled to do so and do these provisions meet College regulations, GCP and in country (overseas/local) guidelines. 

For research involving children researchers must ensure adequate consideration has been given to the parental consent/ child assent process and that the consent forms appropriate for the age of the child.  Has the Researcher considered any potential coercion to consent and what steps will be put in place to address it?  Information sheets must be informative, using lay language and easily understandable by the audience.

Researchers must make the aims and objectives of their project clear and ensure the inclusion, exclusion and withdrawal criteria is clearly outlined in the application and made clear to the participants. Are the recruitment and advertising processes outlined in sufficient detail?  If your project involves participants are there contingencies in place for unexpected situations and emergencies.  

For research that is taking place overseas, Researchers need to show in their application that consideration has been given to:

  • The wider relevant (e.g. social and legal) environment in which they will work, in particular local sensitivities and politically contentious factors.
  • What contingency planning the Researcher has made to ensure that where local difficulties arise that may pose ethical problems the Researcher will be able to take appropriate and defensible action in a timely manner .e.g. in balancing the duty to respect individual confidentiality on the one hand with a wider public interest such as the reporting of malpractice to a competent authority on the other.

The Researcher must show that the proposals benefits are in satisfactory proportion to the potential adverse impacts.  In order to do this they must show that the proposal is scientifically credible.