Recruitment and Consent Process Paper

Recruitment and Consent Process Paper

Recruitment and Consent Process Paper

The recruitment process for research participants takes several forms which involve presenting potential participants with adequate information regarding the study being conducted, before their enrollment, to help establish willingness and interest to serve as the study subjects (Arigo et al., 2018). This is usually the first information potential participants normally see regarding the study and is considered the beginning of the informed consent process by the IRB and the federal regulations. This discussion aims at formulating the most effective strategy for the recruitment and consent process for my research study.

Study Population

My study focuses on the use of CBD-based therapy for the management of THC intoxication in the emergency department. The target population for this study is adults between the ages of 18 and 45 years old, who frequently use marijuana. The potential participants will be required to attend at least 3 out of 4 study visits in addition to complying with other additional requirements within 21 days before beginning taking part in the study (Arigo et al., 2018). Since Financially and socially vulnerable groups are among the frequent users of cannabis, they will serve as potential participants in this study. Close attention will be directed towards these vulnerable populations by assessing whether they meet all the eligibility criteria for this study, to protect their autonomy and prevent undue influence to take part in the study.

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Potential Risks to Participants

            Just like any other cannabis user, the study participants are at risk of acute THC intoxication which presents with symptoms such as anxiety, agitation, euphoria and disinhibition, low power of judgment, hallucination, and impaired performance (Borodovsky et al., 2018). The potential risks mentioned above are however short-term and will be resolved using CBD-based therapy.

IRB Review and Approval

In carrying out this study, human participants will be involved hence the need for an IRB review and approval. Generally, the research team will be required to systematically collect both qualitative and quantitative data to promote the incorporation of CBD-based intervention for the management of THC intoxication in the emergency room of hospitals across the United States (Borodovsky et al., 2018).

Informed Consent Process

            To optimize the participant’s comprehension of the informed consent process for this project, one on one interaction with each participant with a member of the research team who is knowledgeable about the study will be necessary (Arigo et al., 2018). The study participants will also receive slide show messages to help promote their understanding of the study being carried out before signing the informed consent form.

Participants’ Privacy and Confidentiality

The IRB requires studies involving human participants to respect and uphold their privacy and confidentiality. To protect the privacy of the health information and confidentiality of participants in this study, several methods will be utilized such as the use of participants’ codes to label data rather than using names, and not publishing too much information which can lead to the identification of the participant (Arigo et al., 2018).

Investigator Misconduct

            Some of the consequences of investigator misconduct that might occur in this study can be severe leading to mental disorders such as anxiety disorder and acute psychosis (Borodovsky et al., 2018). These consequences may result due to misinformation in the published literature undermining the health of the study participants.

Conclusion

The recruitment process is a very crucial part of conducting medical studies which require human subjects. This process involves informing the target population regarding all that is entailed in the study including the associated risks to promote their autonomy before signing the informed consent form.

References

Arigo, D., Pagoto, S., Carter-Harris, L., Lillie, S. E., & Nebeker, C. (2018). Using social media for health research: Methodological and ethical considerations for recruitment and intervention delivery. Digital health, 4, 2055207618771757. https://doi.org/10.1177/2055207618771757

Borodovsky, J. T., Marsch, L. A., & Budney, A. J. (2018). Studying cannabis use behaviors with Facebook and web surveys: methods and insights. JMIR public health and surveillance, 4(2), e9408. https://preprints.jmir.org/preprint/9408

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Formulate your approach to the recruitment and consent process for your research study. Using the required resources as a guide, demonstrate a strategy for protecting vulnerable participants and identifying anticipated ethical issues that may arise in your study design.
Include answers to the following prompts in your submission:
What is your target study population? What vulnerabilities does your population face? (examples: pediatric patients, medical frailty, cognitive impairment, low health literacy, financial challenges, environmental challenges, risks of adverse outcomes, etc)
What are the potential risks to participants in your study?
Will your study design and methodology require IRB review and approval? Explain why or why not.
How will you optimize participant comprehension in your informed consent process?
What methods will you use to protect the private health information and confidentiality of participants?
Name two possible consequences of investigator misconduct in your study.