HOLDSWORTH HOUSE MEDICAL PRACTICE - CLINICAL RESEARCH UNIT
PATIENT INFORMATION STATEMENT AND CONSENT FORM
1. INTRODUCTION
You are being asked to take part in Clinical research because you are a patient of Holdsworth House Medical Practice (HHMP). The purpose of this notice is to inform you of the ways in which your health information is handled and to seek your consent to this. Before you can decide whether or not to take part in research, we would like to explain the purpose of the research, how it may help you, any risks to you, and what is expected of you.
2. YOUR PARTICIPATION IS VOLUNTARY
This information statement gives you information about the research that will be discussed with you. Once you understand the research, and if you agree to take part, you will be asked to sign a consent form. You will be given a copy to keep.
Before you learn about the research, it is important that you know the following:
- Your participation is voluntary;
- You may decide not to take part or to withdraw from the research at any time without losing the benefits of your routine medical care at HHMP.
3. WAYS IN WHICH HEALTH INFORMATION IS COLLECTED
All patients seen at HHMP have a set of medical records which are used by all personnel involved with your medical care. In addition, the specialist in charge of your care at HHMP, may keep his/her own set of private medical records for the patients they see. These are accessible only to your treating HHMP Doctor and with their permission, to members of your treating doctor’s team. Aside from these records, there are a number of other ways in which health information is collected within HHMP, are described below are also contained in our Privacy Statement + also Confidentiality.
By volunteering for an HHMP Trial your consent is implied, we will not approach you for consent for every individual observational study. You will not be identified in any report or publication arising from this research.
4. WHAT IS THE PURPOSE OF THIS HEALTH INFORMATION RESEARCH?
The terms of the Health Records and Information Privacy Act 2002 (NSW) mean that when enrolling for a Clinical Trial at HHMP we must now seek your consent in order to continue to handle your health information
The primary purpose of handling our health information in the ways described above is to ensure that appropriate medical care is provided to you by all healthcare personnel who can contribute to your medical wellbeing. This means that your medical case may be discussed within HHMP in order to improve your health outcomes.
The secondary purpose of handling your health information in the ways described above include:
a) Identifying areas of need within the service provided by HHMP. For example the database may be searched specifically for patients who have a specific medical problem in order to identify whether our service is meeting their needs adequately. This is an important form of internal audit;
b) To identify people who might be eligible for participation in other clinical research/trials.
c) To collect clinical information on patients who can participate in research which does not involve any intervention (i.e. medication/specific treatment). Such research is often described as “observational” research and can provide valuable information on safety and efficacy of treatment as well as the natural history of disease processes including HIV infection. All such research is approved by the Director of Clinical Trials at HHMP, Dr Mark Bloch.
d) For education purposes. The HHMP Clinical Research Unit takes an active role in education. The forms of education might include discussion at the multidisciplinary meting in which the patients may be identified by name or other identifying features.
5. CAN MY HEALTH INFORMATION BE PASSED ON TO OTHER PARTIES OUTSIDE THIS UNIT?
Yes, but every attempt will be made to ensure your privacy is maintained unless the circumstances are such that we do need to identify you. Examples of where we do pass on health information include:
- To health authorities in order to provide health statistics. This is a crucial component of our service and ensures that we receive ongoing funding. All health information passed on in this way is completely de-identified i.e. it cannot be linked to you by name;
- For education purposes. Here, your clinical case may be presented to other medical practitioners in order to educate them about certain aspects of health care. In these situations you are always de-identified;
- If required to do so by law.
6. WHAT MEASURES ARE IN PLACE TO PROTECT MY HEALTH INFORMATION?
HHMP medical records are kept in a secure medical records department and strict procedures govern who has access to these records (www.fda.gov/ora/compliance_ref/part11 )
Private medical records are kept in locked cabinets with restricted access (CCTV monitored).
The unit’s databases are accessible by security passwords and only to approved personnel with an audit trail that allows System Administrator to see who has accessed or looked at your electronic medical file if needs be. See also www.holdsworthhouse.com.au/profile_confidentiality.php
7. BENEFITS
Sharing health information in these ways is expected to provide direct and indirect benefits to your health care as described above.
8. DISADVANTAGES
Although every effort will be made to protect the privacy of your health information, we cannot absolutely guarantee this.
9. ALTERNATIVES TO PARTICIPATION
Before you decide to take part in this research, your doctor will talk with you about the other options that are available to you.
10. COSTS TO YOU
There are no costs to you for allowing us to share your health information as described above.
11. PROBLEMS OR QUESTIONS
If you ever have questions about this research or the Health Records and Information Privacy Act 2002 (NSW), you can contact:
Peter Marks CEO on 02 9331 7228 or fax (02) 9331 6183 or ceo@holdsworthhouse.com.au
OR
The Office of the NSW Privacy Commissioner on (02) 9268 5588 or fax (02) 9268 5501 or privacy_nsw@agd.nsw.gov.au |
