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| Opting out of Research | Recruitment of Research Participants | Databases and Privacy |
| Alfred Health - Health Privacy Principles and Research | Using information from the Electoral Roll |

Opting out of Research

Patients have the right to opt out of any participation in research, and if they choose this option, the hospital has an obligation to ensure that they are not contacted inadvertently for research purposes. Health Information Services (HIS) keeps a database of all such patients.

Before any patients are approached via a mail-out approach or "cold call", researchers need to check with the HIS Privacy Officer (ph: 9076 2644, email: r.buchanan@alfred.org.au), that none of these people have opted out of any involvement in research.

Please follow this procedure before approaching patients.

Recruitment of Research Participants

The Victorian legislation on health records and information privacy requires Human Research Ethics Committees to monitor adherence to the Health Services Commissioner’s statutory guidelines on research when reviewing and approving research proposals. So that the Ethics Committee can determine whether a research protocol satisfies the requirements of the Act and the Health Privacy Principles, it needs more information about recruitment procedures than previously.

In completing Question 17 ‘Recruitment of Participants’ in Module 1 of the common ethics application form, researchers must provide a clear, detailed, step-by-step description of all aspects of the recruitment procedure, including full details of any ‘screening’ that may be done before researchers meet participants face-to-face.

Particular attention is to be paid to:

  • The name(s) and position(s) of those doing the recruiting;

  • Specifics of where and when recruitment will take place (e.g. “in X Outpatients Clinic at The Alfred hospital when patients attend their next scheduled visit ”);

  • The source(s) of the participants (relevant questions here include: How did participants come to be seeing the researchers?  Are they public or private patients of the researchers?  Have they been referred by another physician?  Are patients responding to an advertisement, etc.);

  • Details of any form of “screening” of records, files or databases to be used to identify potentially suitable participants before a direct approach is made (e.g. what type(s) of records will be looked at, to whom do the records belong, who will be viewing the records and doing the screening, what information will be collected etc.)

  • Details and copies of all forms of advertising material that may be used in a recruitment strategy (include printed advertisements and letters of invitation, transcripts of television and radio advertisements etc).

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Databases and Privacy

The new Victorian legislation on health records and information privacy, which came into effect on 1 July 2002, sets out requirements for the collection, handling, use and disclosure of personal and health information. Much of this information is held in identifiable form on various “research” databases within The Alfred hospital. Staff and researchers should be aware of their obligations with regard to the creation and use of such databases.

Databases maintained and used for internal purposes
These are typically maintained at a ward, department or unit level and are used for internal audit or quality assurance. These databases and information systems do not include those that are maintained for direct patient care purposes.

Privacy principle 1.4 of the Health Records Act 2001 allows the collection of information for the purpose of database management provided that the organisation takes steps to ensure that the individual is generally aware of the purposes for which the information is being collected, who you would usually disclose information of that kind to, how they can gain access to the information about them if they wish and the main consequences for the individual (if any) if the information is not provided. The Ethics Committee recommends that patients be given this information at their first or next contact with you, preferably in writing.

Section 2.2(f) of the Health Records Act 2001 permits the use and disclosure of information for the purpose of funding, management, planning, monitoring, improvement or evaluation of health services provided that reasonable steps are taken to de-identify the information. It is acceptable for a research nurse or other staff member associated with a unit to access the information in its identifiable form as long as this information is de-identified prior to it being presented in any way.

Any formal research in which the information contained within the database is to be used or disclosed must first be approved by The Alfred Ethics Committee as has always been the case.

Disclosure of information for the purpose of National or International database management
You may share or disclose information to other organisations if the information is de-identified (i.e. stripped of details such as UR, name, address, initials, etc.).

If it is necessary to provide identifiable information to national or international databases, then it is acceptable for this information to be provided if the purpose of the database is continuing care of the patient. This type of information disclosure is permitted under S141 of the Health Services Act 1988.

If the purpose of the database is not continuing care of the patient, and it is absolutely necessary to provide identifiable information, then information can be provided as long as:

  • Patient consent to disclose this information for this purpose is obtained. Consent can be explicit (i.e. written) or implied. For instance, if patients are provided with information that tells them that this type of information is disclosed for this purpose and they are given information about how they can “opt-out” of this type of information sharing, then their consent is implied if they do not “opt-out”. Note that this implied consent can be sought prior to the disclosure of information, at the time of disclosure or as soon as practicable; AND/OR

  • The disclosure of the information has been appropriately considered and approved by The Alfred Human Research Ethics Committee; AND/OR

  • The database had been established prior to 1 July 2002 and the disclosure of the information was legally permissible prior to 1 July 2002. To assess this, units and departments that disclose identifiable information that they believe falls into this category should endeavour to ascertain with the database administrators exactly what processes occurred in the past to establish the database (e.g. government approvals, ethics approvals, etc.).

At The Alfred, first option is the preferred mechanism for appropriate disclosure of identifiable information for this purpose.

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Alfred Health - Health Privacy Principles and Research

The following summary was provided by the Alfred Health Privacy Officer, June 2002.

The new Health Privacy Principles (HPPs) and the associated Regulations are binding on all Victorian health service providers, public and private, from 1 July 2002. They form part of the Health Records Act 2001.

The HPPs apply whenever patient information is collected, used or disclosed for the purposes of research.

Individual consent is required if the information is identifiable. The only exemption is as follows:

  • the research is deemed necessary; AND

  • the research is in the public interest; AND
  • the purpose cannot be served by collection that does not identify the individual; AND

  • it is impracticable to seek consent.

In these situations, Alfred and/or other appropriate ethics approval would be vital. It is not up to individual researchers to make this determination.

Consent is not required when de-identified health information is collected, used or disclosed. This is defined as information from which the identity of the person to whom the information relates cannot be reasonably ascertained.

When disclosing information without patient consent, the disclosing agency must reasonably believe that the recipient of the information will not further disclose the information, and that the disclosure will not be published in an identifying form.

At the point of information collection, it will be up to the hospital (either orally or through pamphlets) to advise patients that their health information may be used for research purposes. They will be given the option of “opting out”.

Obviously, patients participating in a clinical trial or study will need to provide informed consent. The pamphlet will advise them that they may be approached to be involved in a trial or study.

Research involving humans is defined as systematic investigation to establish facts, principles and knowledge. It is important to distinguish it from QA, which is a monitoring activity performed to assess the effectiveness and appropriateness of a service, and determine whether the outcome was satisfactory. QA activities can be conducted by hospitals without the consent of patients. Certain QA privileges are provided in the Health Services Act 1988.

More detailed information can be obtained from the Health Services Commissioner’s website at www.health.vic.gov.au/hsc.The issues paper can be obtained as a PDF file.

Using information from the Electoral Roll in Medical Research

In January 2011, the Australian Electoral Commission (AEC) undertook a review of the information it provides about access to data from the Commonwealth Electoral Roll for the purposes of research.

You can find a summary here.

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This page was last modified on 17/02/12


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