What is Parents as Partners in Research?
Parents as Partners in Research is a new initiative of the National Alliance for Autism Research that connects parents and families of individuals with autism spectrum disorders with investigators conducting clinical autism research studies aimed at diagnosing autism earlier, developing and evaluating treatments and eventually, finding a cure.
Parents as Partners in Research provides an opportunity for families directly affected by autism to take a more active role in accelerating the pace of research. The program is designed to better enable families interested in taking part in research studies to locate investigators in need of children, adolescents and adults with autism spectrum disorders to participate in their studies. Our goal is to match a researcher's specific criteria with a family's interest in a particular study and ensure that all eligibility requirements are met.
If love could cure autism, the devastating disorder would not exist. But autism does exist and research is the only way we will ever learn what causes the disorder, develop methods to diagnose autism earlier, develop more targeted interventions and someday, find a cure. Parents as Partners in Research is driven by parents and family members affected by autism. Therefore, we are asking parents and other family members to consider becoming an active participant in autism research projects.
What is Clinical Research?
Clinical research is the study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or to determine its safety and efficacy. Clinical investigations are systematic studies designed to evaluate a product (drug, device, or biologic) using human subjects, in the treatment, prevention, or diagnosis of a disease or condition, as determined by the product's benefits relative to its risks. Clinical investigations can only be conducted with the approval of the Food and Drug Administration (FDA). Clinical trials refer to any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent's safety and efficacy.
What Are the Benefits and Potential Risks of Participation?
There are a number of benefits to families participating in the Parents as Partners in Research program. An extensive evaluation is offered by the research center that typically includes comprehensive psychiatric and diagnostic evaluations as well as extensive neuropsychological and neuropsychiatric assessments and a medical screening. This screening and evaluation is a necessary step to confirm the diagnosis and participate in research studies. In most cases, the principle investigator of the study will also arrange personal one-on-one synopsis of the research results to discuss with you. Additionally, all services provided in research studies are free of cost to eligible participants.
There may be risks associated with taking part in clinical research, such as an adverse drug reaction, which is an unintended reaction to a drug taken at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function; or an adverse event, which is a negative experience encountered by an individual during the course of a clinical trial typically associated with a drug or medical procedure, such as a MRI scan.
Parents considering enrolling their children in a clinical research project, and adults with autism considering participating in clinical research should discuss the issue with their physicians, medical caregivers, family members and the principal investigator involved in the study.
The rights and safety of anyone taking part in clinical research are protected in two important ways. First, all investigators funded by NAAR or the National Institutes of Health must obtain approval to conduct the study from an Institutional Review Board. The review board, which is usually composed of physicians and lay people, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.
Criteria for Parents as Partners in Research:
In order for a study to be accepted for listing on this site, NAAR's Chief Science Officer must find the following:
- The study design appears likely to produce scientifically meaningful information
- The study appears to have a favorable risk-benefit ratio for subjects
- The study has been approved by an Institutional Review Board
Submit a Study for Parents as Partners in Research:
For each study, please submit the following:
- Protocol for the study (must identify sponsor, principal investigator, and name of medication(s), if any)
- Consent/assent forms
- A one-paragraph description for posting, if accepted
- IRB approval letter
Documents should be e-mailed to Denise Soto at firstname.lastname@example.org in Microsoft Word format. Fax the IRB letter to Denise Soto at (609) 430-9505. Documents will be handled in confidence for discussion with NAAR's Director of Research & Programs. The materials will be reviewed and you will be notified if the study meets its criteria as set forth above. NAAR does not charge a fee for listing of approved studies.