Research Proposal Editing

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Project Information Form

Date: September 26, 2017

Project Title: First Non-Medical Use of College Age Users: Where did the Opioid come from?

Researcher Name: Harjeet Kaur

All sections of the form must be completed within the field provided (do not attach a separate form with your responses). Type as much as you need, each field will expand to accommodate your answers. You must use 12 pt font. Do not leave any sections blank. Answer all questions asked in each section. Incomplete and/or handwritten forms will be returned.

Section 1 Background and Purpose of the Study

· Provide a concise description of the research project.

· State the objectives, and rationale.

· Provide background information on the hypothesis and/or research question to be tested including references/citations, if applicable.

Do NOT delete the above instructions and type your response below this line.

The study is to investigate one aspect of the current opioid crisis in America. All people who use opioids recreationally (for fun, pleasure, or enjoyment, not for a medical reason under the care of a physician) obtain those opioids one way or another. This investigation is to determine the modality by which those pills or drugs are obtained. That determination can lead to important policy interventions.

The objective of the investigation is to create a typology of the ways that first-recreational-use opioids are obtained, whether legally or illegally. If the drugs are obtained by an individual receiving them by gift, or by pilfering them from a family member’s medication, there might be interdictory measure that can be taken. The same is true with illegal drug transfers from friends or strangers by gift or sale. A public health information campaign might be able to reduce the numbers of opioids so transferred.

It is commonly known that the United States is in the midst of an opioid crisis. That crisis has ramifications for public health and the maintenance of social capital.

Kohlhatkar (2017) argues that the opioid crisis is a costly epidemic and that it would behoove President Trump to tackle it. In order to tackle it, social workers and law enforcement needs to know the source of the opioid for first recreational use, since that kind of use is one of the categories of opioid use. There has been research by McCabe and Boyd (2005) indicating that prescription medication is a major source for illicit use, but the research does not identify the source for first recreational use. Asbridge, Cartwright, and Langille (2015) are among a number of studies that detail the amount of recreational opioid use – they look at Canadian teens – but are not focused on first use.

References

Asbridge, M. Cartwright, J. & Langille, D. (2015). Driving under the influence of opioids among high school students in Atlantic Canada: Prevalence, correlates, and the role of medical versus recreational consumption. Accident Analysis and Prevention, 75, 184-191.

Kolhatkar, S. (September 18, 2017). The cost of the opioid crisis: Trump says he wants an economic revival. He could start by tackling an epidemic. The New Yorker. Retrieved September 26, 2017 at: https://www.newyorker.com/magazine/2017/09/18/the-cost-of-the-opioid-crisis.

McCabe, S. E., & Boyd, C. J. (2005). Sources of prescription drugs for illicit use. Addictive Behaviors, 30(7), 1342–1350. http://doi.org/10.1016/j.addbeh.2005.01.012

Section 2 Subject Information and Recruitment Procedures.

Subjects

· Identify the study population (age, gender, health, etc.).

· What are the inclusion and exclusion criteria?

· If vulnerable (such as minors, prisoners or cognitively or emotionally impaired) please describe extra protections of rights and welfare.

Recruitment

· How will subjects be recruited?

· Will a screening device be used to select from the wider subject pool?

· Will there be any deception (that is, not telling subjects exactly what is being tested)? If so, provide a justification and plans for debriefing.

· Describe your procedures for consent (include minors (assent) and adult and/or parental consent)?

· If advertisements (e.g. craigslist, Facebook, newspaper, etc.), a letter of invitation, or fliers will be used to recruit, attach copies.

Do NOT delete the above instructions and type your response below this line.

The study population is a convenience sample of people over the age of 18 who respond to an online survey that will be publicized at various social media sites. Only those over the age of 18 will complete the survey; there is no need for parental consent. The survey will be anonymous.

Section 3 Research Methodology and Study Procedures.

Procedure

· Describe in a step by step fashion, what subjects will experience in the research. For example, what will happen first, next, and so on. This should include the researcher’s introductory remarks to participants, all testing, questions, observations, follow-up and debriefing of the study.

· Include the time duration of each part of the research.

· Will subjects be compensated for their participation? If so, describe. This may include cash or gift certificates or course credit. However, subjects cannot receive both course credit AND compensation.

· Specify the duration of each procedure.

· Identify any new procedures that you are investigating in the study and explain how they differ from standard procedures (medical, psychological, or educational).

· If deception is used, provide justification and plans for debriefing.

Instruments

· Attach the exact data collection instruments to be used in the study. If open-ended questions are asked, give examples of prompts to encourage responses.

· If translations are required, include those as well.

· If permission to use a copyrighted instrument is required, please include that as well.

Do NOT delete the above instructions and type your response below this line.

Subjects will be recruited by a social media announcement that says the following:

“This survey is being administered in partial fulfillment of the requirements of a graduate student at this university’s program for a Master’s. It is very short and completely anonymous. You do not need to supply your name. The survey has to do with opioids like Viocidin, Tramadol, Percocet, Fentanyl, Oxycodone, Methadone, heroin, and the like. It asks about your possible first use of one of those drugs for recreational (fun, enjoyment, non-medical) purposes, and how you obtained the drug. If you have never used an opioid for any reason beyond than according to a doctor’s prescription, there is a way to indicate that on the survey.”

There will be no compensation for completing the survey, which should take about ten minutes to complete.

Section 4 Anticipated Risks and Minimization of Risks

· List any potential risks to subjects and what steps have been or will be taken to minimize these risks.

Do NOT delete the above instructions and type your response below this line.

Potential risks include peer pressure from others in the room with the survey respondent that leads to discomfort for survey participants, survey participants providing identifying information (despite having been requested to remain anonymous) which leads to jeopardy for these non-complying participants, disclosure of private information to others, and triggering of thoughts about misuse of opioids.

Risks will be minimized by the speed in which the instrument may be completed, and underscoring in the instructions that the instrument is to be filled out anonymously. Extra caution will be taken with the completed survey instruments.

Section 5 Potential Benefits

· Specify the benefits that this project will have to society and specify how the project will directly benefit the subject.

· If the project will not benefit subjects directly then please state so.

· Explain why the risks are reasonable in relation to the potential benefits to subjects and to society.

· Do not include compensation in this section, as it is not a benefit.

Do NOT delete the above instructions and type your response below this line.

There are many benefits to this study. The researcher anticipates that there will be one of the following methods of opioid procurement for recreational use reported by any subject:

1. Medical prescription to the patient, but used much later than needed, recreationally

2. Pilfered from a family member’s prescription

3. Pilfered from a non-family member

4. Given to the subject by a friend

5. Sold to the subject by a friend or stranger

Understanding the percentages of how first non-medical use of opioids is made can lead to a focusing of policy on preventing that kind of use. The benefit for the subject that all subjects will need to think about the type of their first non-prescription use, and perhaps alter behaviors that would have them providing opioids to others either by accident or on purpose.

Section 6 Confidentiality of Research Information/Data

· Explain how confidentiality of subject information will be maintained.

· Specify whether data will be collected anonymously (i.e. no direct identifying information such as name, email, address, or birth date, and no codes linking back to identifiers will be created/accessed.)

· Specify where study records will be stored, how they will be secured, and who will have access. (Identifiable data and de-identified data cannot be stored in the same location)

· Types of data:

· Identifiable information

· List linking the identifiable information and de-identified information (i.e. list of pseudonyms and participant names)

· De-identified information

· If you intend to collect identifiable information specify when identifiable information will be destroyed, who will have access to identifiable information, where it will be stored and how it will be made secure.

· Specify the planned final disposition of all data after the study is complete (e.g. the data will be maintained for 3 years after the conclusion of the study and then destroyed, the data will be destroyed at the conclusion of the study, etc.)

Do NOT delete the above instructions and type your response below this line.

Research will be anonymously, and any printed surveys will be kept under lock and key. Online data will be behind a secure password. There will be no way to tie respondents to their surveys. The data will be maintained for three years after the conclusion of the study and then destroyed.

Section 7 Potential Outcomes of Study

· Describe the projected outcomes of the project and how they relate to your hypothesis.

· Include the significance of your project to your discipline, department, school, university, community, etc.

Do NOT delete the above instructions and type your response below this line.

The projected outcome of the study will be that most people will report first recreational use of opioids coming from their own prescriptions or prescriptions of family members or friends. This survey can provide data that might lead to an interdiction of these pathways, better control of prescription drugs, accountability, etc. It can conceive help to lessen the scope of the opioid epidemic.

Section 8 Researcher Qualifications and Expertise

· Summarize your qualifications to conduct this project (include prior research and training--resumés may be attached)

Do NOT delete the above instructions and type your response below this line.

The researcher has been trained as a graduate student at this university, and has studied social science research methods.

CSUN Office Of Research and Sponsored Projects | Committee for the Protection of Human Subjects

Revised 9/13