1. Ethics Approval: Before a trial can go ahead it needs to be approved by independent ethics committees that operate according the guidelines issued by the National Health and Medical Research Council (NHMRC Guidelines). ASN studies have approval of one or more Research Committees (composed of 6 experts / members) and Ethics Committees (composed of 7 members).
The role of the committees is to evaluate the research design and to ensure that the trial is conducted in a way that ensures the safety and privacy of participants in the study.
2. Information Leaflets and Consent Forms: All participants are provided with an information leaflet which explains the procedures and requirements of the study. The explanation of the study will include things such as the eligibility criteria; possible risks and benefits of the new medicine; the risks of any side-effects; the type, frequency and risks of any medical tests or procedures that may be undertaken as part of the trial; and the person's rights and responsibilities.
Potential participants are made aware that they can withdraw from a study at any time and that their involvement is entirely voluntary. Once a person has read the information Leaflet and agree to enter the trial, they sign the Consent Form. These documents must be approved for use by the Ethics Committees.
3. Approved Listed Medicines: ASN only conducts research on foods and approved listed medicines (TGA registered). All ingredients and/or products are available over the counter in pharmacy & health foodstores.
4. Eligibility for participation in ASN trials: Potential participants are assessed individually for inclusion. The following groups of people are ALWAYS EXCLUDED from participating in ASN trials as they are considered high risk groups for complications and possible nutrient/herb/drug interactions.
a. Pregnancy or not using a form of contraception to prevent pregnancy
b. Lactating (breastfeeding) women
c. Participation in other trials (taking an investigation drug) within the last 30 days
d. Had major surgery on the last 6 months
e. Have cancer or have had cancer (treated) less than 5 years ago
f. Have chronic diseases that require significant drug therapy; including heart attacks and strokes) and considered unstable.
g. Have thrombosis (blood clotting conditions) or are on Warfarin or Heparin
h. Have unstable depression or being treated for any psychological disorder (ADHD etc)
i. Using a drug/natural therapy for PARTICULAR Condition being assessed within the last 30 days
j. Using a drug/natural therapy which is a know antagonist (has interactions) to an ingredient in the trial product.
k. Those who are, themselves, unable to provide informed consent (mental and physical handicaps).
l. Those whose life expectancy is severely limited due to pre-existing malignancy or other disease (<1 year).
m. Those that are have alcohol and drug dependency problems including those still in rehabitation.
ASN trials products on participants, who,
apart from the condition we are testing, are otherwise well.
5. Types of trials: ASN conduct both single pilot studies and double blind studies. In pilot studies, all participants are given the product (ACTIVE treatment (and the effectiveness is based on the difference prior to and after treatment) in each individual participant.
In double blind studies, one group (the test group) is given the trial medicine while the other group (the control or reference group) is given the standard treatment for the disease or condition. Where there is no pre-existing standard treatment a placebo – a look-alike or dummy medicine containing no active ingredient – may be given to the control group instead. Participants are randomly assigned to either group.
Ideally, neither researchers nor participants should know which group a particular patient is in. However, safety does come first. Should a participant develop an unexpected or serious side effect the blinding of the trial can be broken so that appropriate action can be taken. |
