Informed Consent and Debriefing

The purpose of this paper is to create an informed consent form and a debriefing form that explain the nature and true purpose of a proposed clinical study concerning the use of legal, edible cannabis products to treat post-traumatic stress disorder (PTSD) among American male combat veterans of all ages and branches of military service. Cannabis products are currently legal in more than half of U.S. states and the recreational use of these products has been legalized by numerous others. There is also movement in the U.S. Congress to legalize cannabis products at the federal level, opening the way for veterans to receive them as part of their health care regimen (Hill, Loughlin, Nichter et al., 2021).

Although younger veterans tend to report significantly higher usage rates of cannabis products compared to their older counterparts, the research to date confirms that overall usage of cannabis among veterans has increased in recent years (Hill et al., 2021). In addition, the use of cannabis products among combat veterans of all ages is also higher compared to noncombat veterans (Hill et al., 2021). These are important issues since more than a half million veterans in the post-Vietnam era have been diagnosed with PTSD, and the numbers may be far higher due to a lack of identified cases (PRNewswire, 2021).

At present, though, because cannabis remains a scheduled narcotic under federal law, there has been a dearth of timely and relevant research concerning its medicinal effects in general and for the treatment of the symptoms of post-traumatic stress disorder (PTSD) in particular. The scant amount of research that has been conducted, however, suggests that male veterans of all ages benefit more from cannabis use and there are a number of ongoing clinical trials being conducted to explore these issues further. In addition, anecdotal evidence and empirical observations indicate that cannabis products can alleviate symptoms and provide relief for veterans suffering from PTSD (PRNewswire, 2021). The informed consent form and debriefing form which follow below are intended for use in a proposed clinical study concerning the efficacy of using edible cannabis products selected and purchased by combat veterans with valid medical marijuana licenses in their respective states.

Medical Marijuana Consent Form

First and foremost, it is important to note that qualified physicians are not authorized to assign the responsibility of obtaining written informed consent to another person and all qualified patients must initial each section of this consent form to indicate that their physician thoroughly and clearly explained the information and, together with the qualified physician, must sign and date the informed consent form set forth below. Study...

…risks, complications, and expected benefits of any recommended treatment, including its likelihood of success and failure. I acknowledge that Dr. Smith informed me of any alternatives to the recommended treatment, including the alternative of no treatment, and the risks and benefits. Finally, Dr. Smith has also explained the information in this consent form about the medical use of marijuana.

Patient (print name) __________________________________________________

Patient signature or signature of the patients authorized caregiver:

_________________________________________________________________________

Date ___________

I have explained the information in this consent form about the medical use of marijuana to

(Print patient name) _______________________________________________________

Qualified physician signature

_________________________________________________________________________

Source: adapted from Medical marijuana consent form, 2020

Debriefing Form:

The purpose of this study was to evaluate the effectiveness of using of legal, edible cannabis products to treat post-traumatic stress disorder among American male combat veterans of all ages and branches of military service. It was the hypothesis of this study that participants would experience significant benefits from their use of edible cannabis products in treating their PTSD symptoms.

I have read aloud and discussed all of these points with the participant and allowed her/him to ask questions.

_____________________ ___________

Researcher Date

I have had all the points on this form explained to me, and I had the opportunity to ask questions about the true purpose and experimental manipulations that took place in this study.

_____________________ ___________

Participant Date

Source: Adapted from Debriefing form sample,…