The Health Research Consent Declaration Committee will make consent declarations that the explicit consent of the data subject is not required.
The Guidance on Information Principles for Consent has been drafted by the Department of Health as a guide to assist researchers however it is not a legally binding document.
The onus is on the health researcher to justify what information is or is not provided and to ensure that the data subject is not surprised by any use or disclosure of personal health data.
The researcher must always ensure that the language used avoids jargon and is easy to comprehend. Information should be provided from the perspective of the data subject and not the researcher.
Health minister Simon Harris said the regulations will support public confidence in health research, consistent with our legal system and international best practice, by making explicit consent the default position.
"It is recognised, as it is in other countries, that in limited situations, obtaining consent for certain very worthwhile health research projects may not be possible,” he said.
He said the regulations provide for a committee which can make consent declarations that will allow researchers to collect and use personal data without explicit consent.
“To protect the individual, consent declarations may only be given by the Committee where obtaining consent is not possible and the public interest in carrying out the research concerned significantly outweighs the need for consent,” he said.
The committee has its own website
The allowed transition period for existing research comes to an end at the end of April.
The committee chair is Brigid McManus, former secretary general at the Department of Education and Skills.