Treating Schizophrenia in the Prodromal Phase by Alison Yung & Lisa Phillips & Patrick D. McGorry

Author:Alison Yung & Lisa Phillips & Patrick D. McGorry
Language: eng
Format: mobi
Tags: Psychiatry, Medical, General
ISBN: 9781841843278
Publisher: CRC PRESS
Published: 2004-03-31T21:00:00+00:00

6

The clinical research interface

The development of valid criteria for the identification of young people at heightened risk of developing a psychotic disorder has paved the way for a new era of research into the etiology of psychotic disorders, as well as the development of preventive interventions.

Integration of research and clinical functions is a key element of many services but the research-clinical links are even closer in the ultra high risk (UHR) services, such as at the PACE Clinic, as this is a new type of service delivering treatment to a new patient population. There are no standardized rules or guidelines for how to manage the young people who seek help from such services. Thus, every aspect of practice within these services must be continually evaluated and modified in response to this evaluation in a constant feedback loop.

Almost all patients who attend the PACE Clinic are given the opportunity of participating in one or more of the many studies taking place within the Clinic. However, enrolling in a project is not mandatory.

When setting up a research programme involving UHR individuals, both the ethics of the research and the practicalities must be considered.

Ethics of ultra high risk (UHR) research

The following areas are relevant to UHR research, and will be discussed in turn:

• General ethical issues, pertinent to all clinical research studies involving humans.

• Issues of particular relevance to UHR research.

• Special issues unique to UHR research.

General ethical issues

Standard guidelines should always be followed when recruiting UHR individuals into research projects. These include the guiding principles of the Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (first adopted by the 18th World Medical Association General Assembly, Helsinki, Finland, June 1964 with subsequent amendments—available at: http://www.wma.net/e/policy/b3.htm). Additional broad guidelines for the involvement of human participants in research are available at: http://www.nhmrc.gov.au/issues/researchethics.htm, and

http://www.nserc.ca/programs/ethics/english/policy.htm. Pertinent considerations are outlined in Box 6.1.

The clinical research interface 77

Issues of particular relevance to ultra high risk (UHR) research

Recruiting minors into research

Ultra high risk (UHR) research tends to involve young people aged 14–15 years up to 25–30 years of age. Thus, a substantial number of potential research participants are aged under 18 and thus are considered to be minors under Australian law (the definition of a

‘minor’ may differ in other countries). Some jurisdictions will have a blanket prohibition against the inclusion of minors in research—particularly clinical trials. Others are more liberal and allow for their inclusion if a parent or guardian consents for the adolescent, usually with the adolescent providing assent. There has also been debate about adolescents’ ability to consent for themselves, even in the absence of parental consent. It is argued that young people aged approximately between 14 and 18 are usually able to

Box 6.1

General ethical principles for research on humans

Informed consent

Research participants must be given sufficient information, which they clearly understand, about the research project. They must be allowed sufficient opportunity to discuss the potential involvement with those conducting the research as well as impartial independent people as considered necessary.

Separation of clinical care and research

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