Overview of Normative Frameworks Applicable to Health Research Involving Humans: National Instruments

3. National Instruments

Regulations or guidelines specific to research involving humans

In most countries, there are regulations or guidelines that apply to any type of research involving humans. Typically, such regulations or guidelines will cover requirements for:

Ethics review and positive opinion before the research starts.
Appropriate risk to potential benefit assessments.
Respect for autonomy - through consent and protection of confidentiality.

In addition, some countries also have regulations that apply to clinical trials for medicines and medical devices. In some countries, specific types of research (such as research involving human reproductive material) will receive additional regulatory oversight. In other countries, privacy legislation will apply to research using personally identifying information.

Broader regulations

In many countries, however, there are no research specific regulations or guidelines. This does not in any way mean that there is a gap in legal requirements. Indeed, broader based legal frameworks will provide guidance and minimal standards that must be met. Some examples are:

In many countries with a civil code or a constitution, there will be broader provisions protecting individuals’ physical integrity as well as requiring respect for autonomy.
There may be provisions that require consent to treatment or regulations around privacy.
Criminal law prohibitions could be invoked in the absence of other more specific provisions.
When researchers are also healthcare professionals (such as doctors, nurses, etc.) professional codes of conduct must be respected.