All perusal of personal files should be seen as invasion of privacy, and the patient’s consent should normally be sought for this. This would apply to all circumstances except in special cases such as broadest epidemiological studies dealing only with such categories as diagnoses only, research on people incompetent to give consent, etc. However it is not always possible to obtain consent and then the matter should be referred to a research ethics committee for decision.

What guidelines are available for REC’s to use? The Royal College of Physicians published guidelines in 1994.

1.These recommend that access to records should be controlled by their custodians.

The custodians should be satisfied as to the bona fides, professional standing and competence of the investigator, and the ability of that person to handle the data securely and confidentially. The investigator should also be an appropriate senior person who is bound by code of ethical standards of a licensing body. Junior staff should be supervised by such a person.

Professsor Len Doyal compiled recommendations for records research in 1997.

2.

  • Access to the clinical record is essential for the completion of the research and consent is not practicable;
  • The research is of sufficient merit;
  • The research pertains to some future planning, preventive, or therapeutic initiative which may benefit the patients whose records are studied;
  • Where possible, identifiers have been removed from the parts of the records to which researchers have access.Where not, patients will not be identifiable when the results are made public;
  • It is not anticipated that contact will be made with the patients as a result of research findings.
  • Access is restricted to specific categories of information which have been approved by the local research ethics committee;
  • Permission is obtained from the clinician responsible for the patient’s care and, depending on the type of record and access concerned, the person responsible for its administration;
  • Researchers who are non-clinicians are formally instructed about their duty of confidentiality.

They must also have clinical supervisor who formally accepts professional responsibility for any breach of confidentiality that may occur.

The above set of guidelines would then allow the REC to waive the necessity of informed consent.

NOTE: Not al of Prof Doyal’s recommendations are universally accepted and must not be seen as absolute requirements.