Nov 29, 2015
Research risk management strategies at the Institute
The development of new, more effective trauma-healing techniques, peak state processes, or disease treatment involves explorations into previously undiscovered areas of the psyche and biology of consciousness. Thus, there can be hazards and problems that have never been encountered before (or if encountered, had remained unrecognized as to cause).
As a separate issue, disease treatments or peak states processes that work by using powerful trauma healing techniques (such as EMDR, WHH, TIR, EFT, etc.) will also suffer from the occasional known potential risks associated with these same trauma techniques. Fortunately, trauma therapists are trained to recognize and deal with these trauma-therapy issues as they arise.
To help minimize the risks associated with investigating and creating new processes and techniques, the Institute for the Study of Peak States has several layers of precautions in effect. These precautions can be divided up into three different degrees of risk depending on your involvement with the Institute - research, professional training, or clients. New material is first developed and tested in the small Institute research group, with special attention on finding any safety problems. Then the new process is tested on a larger number of highly trained Institute clinic therapists, increasing the likelihood of finding any problems due to unusual situations in rare people. Given effectiveness and a lack of problems, the process is then cautiously tested on volunteer therapist trainees (or, in the case of uncommon diseases, on volunteer patients working directly with the research staff). This testing structure can be visualized as concentric rings, with the research team in the smallest center ring, then a larger surrounding ring of therapists, and finally clients in the largest, outermost ring. On average, the safety testing procedure takes 2 years after the process has been developed and considered effective and safe by the research group. Only then is the process released to private therapists (who are trained and certified by the Institute) to use with clients. Below is the testing sequence, from the last, safest stage (clients) to the earliest, most risky stage (basic research with Institute staff):
- Clients (Least risk): After a multi-year process of testing, we finally release the new process or technique to Institute certified therapists for use with clients. Some of these new techniques eventually get released to the public and are published; some continue to remain restricted for various reasons (such as improving effectiveness, further testing, and so on). Since certified therapist use a large range of techniques, both from the Institute and from other sources, risk is hard to evaluate. However, it is only prudent to assume that in some people unusual problems will still occur. As this can happen with any therapy, it is legally required in most countries that clients understand and sign liability and informed consent waivers before starting therapy. But risk management does not end here - all certified therapists have 24/7 backup support from our worldwide clinics for their difficult cases (something unique in the field of therapy, as far as we know). Finally, there is another distinct category of clients, since Institute certified therapists also offer peak states processes. As these processes target areas of the psyche that aren't normally accessible, we assume risk to be higher to some degree than for standard trauma therapy. Thus as a precaution, most of these state processes are restricted to mentally healthy people.
- Private Practice Certified Therapists (Low risk): Essentially, certification means that we've verified that they understand the problems of working with a variety of clients, know what to do when things go wrong, know what clients exceed their training level, have legal approval for working with clients, and have liability insurance. Most of these requirements are met by professional psychological training who have a specialization in trauma, with a few additional courses involving the specialized nature of peak states work (such as spiritual emergency, etc.) Risk of testing new processes is lower for this group than that for our student trainees (below) for several reasons: they are already trained and practiced in handling unusual problems; and the new techniques have previously been tested in residential, month-long training settings.
- Professional Training (Low risk): The material that we teach our students is both restricted to material we believe is relatively safe (i.e., either no known risks, or risks are identified and ways to minimize or avoid them are taught as part of the training). They are required to sign student liability and informed consent forms before starting the training; and are informed about any new processes, so they can volunteer for testing if they choose to. Our students who volunteer become, in effect, the 'beta' testers for new processes. Since at this stage the number of people who use the test process increases, the chance that some unusual problem might be encountered also increases (a problem well known in the testing of new drugs or medical procedures). As trainings are held in a month-long residential setting, any problems become immediately apparent; and since we only permit advanced clinic and research staff to teach, on the remote chance that intervention is needed, they have the skill. As an added precaution, we also do long-term followups after trainings; have an email group to act as a safety announcement mechanism; and post any safety warnings on this website to inform students that are no longer in contact with us.
- Institute Clinic Therapists (Moderate to high risk): This early level of testing involves our advanced-level Institute clinic therapists, who are highly trained and skilled (their training typically takes 2 years) and are part of the Institute but are not part of the research group. Since only a few people in research have previously tested the material, the risk level of triggering something completely unknown is still significant as more people are tested. However, their level of training and experience makes it very likely that they will notice any problems if they occur, and be able to deal with them with the help of the research staff.
- Institute Research Staff (Very high risk): The Institute research staff explore entirely new phenomenon. These phenomenon can be deadly - over the last ten years, the average death rate for people investigating peak states has been about 1 in 5 (i.e., it is slightly safer to play Russian Roulette than it is to work on the research). Worse, if one includes long term mental or physical problems that become activated by the research, the long term probability that one will be killed or injured by this research work becomes 1 in 2. Obviously, this means that only volunteers who feel strongly about the benefits of this work to mankind should be involved at this level.
Risk management for Institute clinical research project volunteers
The patients who volunteer to test new clinical projects treatments for specific diseases (autism, diabetes, etc.) have their own individualized liability and risk forms depending on the condition we're working with. We use the Stanford University format for the disclosure of risk form as modified to our procedures (non-physically invasive, no drugs, etc.) The risk to the clients doing the work is relatively minimal, as we are applying (in most cases) techniques that we've worked out in other settings; and the clinic therapists are very highly trained, with advanced skills, and work directly with the research team. Empirically, after about 10 clients have been treated without any problems, we usually release the given process to the Institute clinics as a product. Usually after about 2 to 4 years of in-house experience with a process, we release it to our private practice certified therapists.
Over time, we occasionally find that a process that had no problems during in-house testing can have a problem for some individuals when larger groups are tested. To address this, in 2006 we established an email group so that safety announcements could be made to our trained therapists. Over the following years, we had three safety alerts issued for processes that were taught to therapist trainees. In 2012 we switched to an online forum format for safety announcements. Safety alerts are also published online on our website.
Practitioner support forum
If you are a graduate of our basic Whole-Hearted Healing® therapy or PeakStates® training, we highly recommend that you sign up for our practitioner-only support discussion forum. It gives us a way to send out any new safety alerts, let you know about updates in technique or process changes, receive new information, ask questions or share experiences, and will help increase your professional skills. (Note, this group is only for people who have taken our courses.) The public forum also contains current information and is searchable on the webpage.
- Handbook for Good Clinical Research Practice (GCP): guidance for implementation (2005). World Health Organization. This applies to both drug and psychological research. You can download this book for free from the WHO link.
- "Drug Discovery and Development: A Step by Step Guide" Oct 22, 2021, PharmaCentral.com. Although only about drug research, this online article gives a good overview of the research and development process and how it is organized for safety.
- Responsible Research: A systems approach to protecting research participants (2003) by D. Federman, K. Hanna, L. Rodriguez (ed.), National Academy of Sciences. You can download this book for free from the US National Institutes of Health link here.
- "Going for the cure" Family Therapy Networker, by Mary S. Wylie, 1996, July/August 20(4), 20-37. The first peer reviewed article on the first successful PTSD therapies. This article is also found in Chapter 8 of Traumatic Incident Reduction: Research and Results (2008) by Victor Volkman (ed).
- Stanford University informed consent forms for research: consent process overview; psychology sample form; medicine sample form.
...or visit our Forum
PeakStates news (RSS)
Apr 26, 2023: Added an 2021 Institute in-house training video on psycho-immunology safety testing.
Nov 29, 2015: Deleted the signup for the WHH e-group, and replaced it with the forum information.
Jan 25, 2014: Re-wrote some material that was not clear. Added a link to the new suicide information page.
Sep 16, 2008: Deleted references to 'level 1' training and replaced it with 'basic' training.