Assignment 3.1 IRB research

IRB RESEARCH PROTOCOL APPLICATION 1. What is the purpose and significance of this study? a. Explain the purpose and/or research questions/hypotheses of the study. At an outpatient substance abuse treatment clinic, patients with substance use disorder (SUD) receive detoxification treatment, but nutritional aspects of substance use treatment is not being currently addressed. To address this gap in treatment the author will implement a nutrition education intervention as a quality improvement project. The purpose of the project is to determine if the implementation of nutrition education for a select period of time will improve retention rate of patients with SUD seen for detoxification, compared to the retention rate from a similar period of time in the previous year when patients did not receive nutrition education. The overall aim of the project is to improve the quality of care and patient outcomes at the author’s clinic by implementing individualized one-on-one nutrition education by a registered nurse and providing customized nutrition recommendations to patients with SUD. b. Indicate how the purpose of the study relates to previous research by including a of the literature. It is especially important to indicate how experts in this area have previously studied the topic/construct so that the multidisciplinary Board has a clear indication of the appropriateness of the intervention. If the design is highly experimental, a more exhaustive literature review is required. Malnutrition is a prevalent problem among individuals with SUD and can lead to poor recovery from substance abuse. Incorporation of nutrition interventions is instrumental to patient recovery and rehabilitation (Cowan & Devine, 2013; Neale et al., 2012; Li et al., 2016). Reduced food intake and poor absorption of essential macro- and micronutrients result in nutritional deficiencies among individuals with substance use disorder (Ross et al., 2012). Micro and micronutrient deficiencies can also increase an individual's risk for depression, anxiety, and mood and can potentially contribute to relapse (Rao et al., 2008). The prevalence of nutritional deficiencies and subsequent negative consequences are the impetus for creating nutrition intervention programs for individuals with SUD. The interventions range from individual to group nutrition education classes, and most interventions were adopted from the food pyramid (Barbadoro et al., 2011; Cowan & Devine, 2013; Juel et al., 2017; Sason et al., 2018). In theory, nutrition intervention can lead to improvement in a variety of patient outcomes. Nutrition education by trained professionals, including nurses and registered dieticians, based on healthy eating principles from nationally recognized nutrition guidelines such as SNAP-Ed can have effects on patients’ nutrition intake, nutrition knowledge, Body Mass Index (BMI), Waist-Hip Circumference (WHC), relapse rate, cravings, mood, behavior, and sleep (Angeles-Agdeppa et al., 2021; Barbadoro et al., (2010); Cowan & Devine, 2013; Grant et al., 2004; Juel et al., 2017; Martinotti et al., 2010; Sason et al., 2018; Waddington et al., 2015). Based on these studies, multiple outcomes can result from nutrition interventions. Angeles-Agdeppa, I., Santos Arias, F., Pascual Sy, J., & Pabustan Garingo, R. (2021). Nutrition care processes can improve the nutritional status and quality of life of persons who use drugs .

International Journal of High-Risk Behaviors and Addiction, 10 (1), 5-14 https://doi.org/10.5812/ijhrba.114975 Barbadoro, P., Ponzio, E., Petrosa, M., Aliotta, F., D'Errico, M., Prospero, E., & Minelli, A. (2010). The effects of educational intervention on nutritional behavior in alcohol dependent patients. Alcohol and Alcoholism, 46 (1) , 77–79 . https://doi.org/10.1093/alcalc/agq075 Cowan, J. A., & Devine, C. M. (2013). Diet and body composition outcomes of an environmental and educational intervention among men in treatment for substance addiction.  Journal of Nutrition Education and Behavior, 45 (2), 154–158. https://doi.org/10.1016/j.jneb.2011.10.011 Grant, L. P., Haughton, B., & Sachan, D. S. (2004). Nutrition education is positively associated with substance abuse treatment program outcomes.  Journal of the American Dietetic Association, 104 (4), 604–610. https://doi.org/10.1016/j.jada.2004.01.008 Juel, A., Kristiansen, C. B., Madsen, N. J., Munk-Jørgensen, P., & Hjorth, P. (2017). Interventions to improve lifestyle and quality-of-life in patients with concurrent mental illness and substance use . Nordic Journal of Psychiatry, 71 (3), 197–204. https://doi.org/10.1080/08039488.2016.1251610 Li, S. S., Ryan, L., & Neale, J. (2016). Diet and nutrient intake of people receiving opioid agonist treatment (OAT): Implications for recovery. Drugs and Alcohol Today, 16 (1), 59-71. Martinotti, G., Reina, D., Di Nicola, M., Andreoli, S., Tedeschi, D., Ortolani, I., Pozzi, G., Iannoni, E., D, I. S., & Janiri, L. (2010). Acetyl-L-Carnitine for Alcohol Craving and Relapse Prevention in Anhedonic Alcoholics: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial. Alcohol

clinic during a similar period in the prior year from DATE through DATE who did not participate in the nutrition education will also be reviewed retrospectively for potential inclusion. b. For each participant group, describe the basic characteristics of potential participants (e.g., anticipated number of subjects, age range, gender, racial/ethnic background) and indicate any special criteria for including or excluding individuals from participation (specific diagnosis necessary, etc). If the researcher will exclude individuals with certain criteria (e.g., under 18, too many falls in 3-month period), indicate HOW the researcher will determine whether or not the participants meet the inclusion or exclusion criteria (e.g. inclusion/exclusion items at the beginning of questionnaire). The author anticipates reviewing 154 patient records for the project to yield a power of 0.080. The abstracted data from the EMR will consist of patients who are 98% Caucasian and 2% from other ethnic groups and who have a documented diagnosis of substance use and are admitted to the outpatient detoxification program. The age of the patients will be 18 years or older. All genders will be included in the data collection. Inclusion criteria for the participants’ EMRs to be included in the data collection are the following: 1. The participant is 18 years or older with an upper limit of 89 years. 2. The EMR has documentation that patient is enrolled in the clinic’s detoxification program. 3. The EMR has documentation of patient having a diagnosis of substance use including alcohol, opioids, and amphetamines. 4. The EMR has documentation that the patient was seen at the clinic between DATE through DATE and participated in the nutrition education intervention, OR the EMR has documentation that the patient was seen at the clinic between DATE through DATE in the previous year but did not participate in the nutrition education intervention. 5. The EMR has documentation of whether nutrition education was provided to patient, and will be coded as 1=yes or 2=no. 6. The EMR has documentation that the patient has completed the detoxification treatment and will be coded as 1=yes; 2=no. 7. The EMR has documentation that the patient was seen at the clinic one to two months post detoxification for long term follow up and will be coded as 1=yes and 2=no. The EMRs of potential participants will be excluded in a specific order. The exclusion of the EMR will be carefully examined in the following order: 1. If the patient is less than 18 years of age or over 89 years of age, the EMR will be closed, and no data will be retrieved. 2. If the patient did not complete the nutrition education during the period between DATE through DATE when the nutrition education was delivered to patients, the EMR will be closed, and no data will be retrieved. 3. If the EMR has documentation that the patient was enrolled in the detoxification program for less than three consecutive days, the EMR will be closed, and no data will be retrieved. 4. If the EMR has no documentation of a diagnosis of substance use, the EMR will be closed, and no data will be retrieved. 5. If the EMR has no documentation that the patient was enrolled in the detoxification program, the EMR will be closed, and no data will be retrieved.

c. If this research involves vulnerable populations (e.g., children, the mentally disabled, prisoners) or others who cannot fully give informed consent, justify their inclusion in this research study. N/A- Not Applicable. d. Describe any relationship that currently exists between the researcher and potential participants (e.g., teacher-student; OT-patient; nurse-patient; administrator-teacher) and how that relationship will be delineated for purposes of this research. The author of the project currently works on an as-needed basis as a Registered Nurse at the clinic. The author has complete access to the clinic’s EMR system. The clinic’s owner has permitted the author to carry out the project and to review charts retrospectively for data collection to prove usefulness of implementation of nutrition education (See Appendix A). The author will provide education to all the Registered Nurses at the clinic who will then be providing the nutrition education to all patients. The author will not participate in providing nutrition education to the patients as the author will not be on the schedule to work during the months the nutrition education will be implemented at the clinic. 3. How will potential participants be identified and recruited? a. Describe how the researcher will gain access to potential participants/participant groups, how participants will be contacted, and what information will be given to them as part of the recruitment process. A letter of approval has been obtained from the clinic’s owner to provide evidence for permission to release the EMRs of adult patients who were seen at the clinic with a diagnosis of substance use disorder and participated in the quality improvement project from DATE through DATE (See Appendix A). In addition, the clinic owner has provided the author permission to access records of patients from the previous year who did not receive nutrition education from DATE through DATE (See Appendix A). Therefore, patient records from DATE through DATE of current and past years will be retrospectively reviewed by the author of the study. The author has access to the clinic’s EMR due to employment status and has completed required HIPAA training from clinic. The author will adhere to the clinic’s policies regarding accessing patient records. The abstracted data will constitute the minimum necessary data to accomplish the goals of the project (See Appendix B). b. If participants will be compensated in any way (monetary, gifts, course credit), indicate the nature of the compensation and the source of the funds to be used. N/A- Not Applicable c. Attach copies of all materials in the appendices that will be used to recruit participant (e.g., letters, advertisements, announcements, script). N/A- Not Applicable

Step 3: The data will be recorded using coded data collection sheets (Appendix B), while ensuring confidentiality and compliance with HIPAA regulations. Step 4: Each EMR used in the project will be given a numerical number. The EMR will be assigned a number on the data collection sheet (See Appendix B). Step 5: The minimum necessary data will be collected on the data collection sheet to achieve the goals of the project (Appendix B). No patient identifiers will be included in the data collection process (Appendix B). Step 6: The data collection process will conclude upon reviewing the anticipated 157 EMRs required to achieve statistical significance. Step 7: Statistical analysis will be performed on the data extracted to compare outcomes between participants who received nutrition education and those who did not. Step 8: Findings will be interpreted to assess the effectiveness of the quality improvement project involving nutrition intervention. The reports of the study findings will be prepared for dissemination to relevant stakeholders. b. If the research is being conducted in an applied setting (hospital, school, clinic, business) distinguish between programs or procedures already in place and those being added for this study. The outpatient substance abuse treatment clinic currently provides detoxification treatment to patients who are diagnosed with substance use disorder. Nutrition education is not a current practice at the clinic. The quality improvement project introduces individualized nutrition education conducted by the clinic’s Registered Nurses. This nutrition education is not part of the clinic’s standard treatment protocol and is being introduced specifically for this study to determine its impact on retention rates. The quality improvement project will be implemented at the clinic by the author in collaboration with the providers, registered nurses, clinic manager, and owner. The following strategies will be implemented: 1) an educational intervention will be provided to the providers and registered nurses that includes current nutritional guidelines for healthy eating (See Appendix C); 2) a pamphlet called, “Build a Healthy Eating Routine” which contains current guidelines on healthy earing will be distributed to each patient who receives the verbal nutrition education (See Appendix D); 3) documentation of delivery of nutrition education to the patient will be seamlessly embedded into the nurse visit template in the clinic’s EMR; and 4) education will be provided to the registered nurses about the addition of the section on nutrition education in the template to ensure accurate and efficient documentation. c. If this project is qualitative or an oral history project involving semi-structured or unstructured interviews or observations, provide a detailed description of the nature and scope of these procedures. This description should include the purpose of the interviews or observations plus information about where and by whom they will be conducted, the skill or training level of those conducting the interviews, how long the interviews will be, the type of information to be gathered and general areas to be covered, and sample questions or behaviors to be observed. N/A- Not Applicable.

d. If archival data (data already collected for other purposes and on file) will be used for any portion of this study, the nature of the data archive should be described and the specific data to be accessed for the present study should be indicated. If the data are publicly available, state this. If not, describe how the researcher will gain access to these data and provide documentation of authorization to do so. If the project requires access to protected health information, indicate how the researcher will be meeting the expectations of the HIPAA Privacy Rule. Also note whether the researcher is seeking a Waiver of Authorization and if so, be sure to include the “Waiver of Authorization” form with the protocol. The study will utilize archival data from EMRs collected for routine clinical purposes at the substance abuse treatment clinic. Access to the data will be facilitated by the author's employment status at the clinic and adherence to clinic policies. The data will be de-identified to maintain patient confidentiality. Data will be collected in compliance with HIPAA regulations, with all necessary precautions taken to ensure confidentiality and privacy. No waiver of authorization is required as the data will be de-identified during analysis. e. If deception is to be involved or if information is to be withheld from subjects, explain why this is necessary and describe procedures for debriefing participants. N/A- Not Applicable. f. Attach copies of all instruments that are being used for the purpose of the study (e.g., tests, surveys, observations recording sheets, interview questions, laboratory reporting sheets, data collection sheets, debriefing materials). For all instruments not specifically created for this study, indicate whether Maryville owns the instrument or provide documentation (i.e., specific copyright release) of permission to reproduce or use the instrument in your research. A data collection sheet has been specifically created for this project using an extensive literature review (See Appendix B). In addition, a pamphlet, “Build a Healthy Eating Routine”, located on the Myplate.gov website, is publicly available for use by patients and health care professionals (See Appendix D). 5. What are the potential risks to participants and what will be done to minimize these risks? a. Discuss any physical, psychological, social/economic, or legal risks that might result from participation in this research and assess the likelihood and seriousness of these risks. If methods will be used which create risks, explain why these methods are being used. In particular, note if pregnancy status or participation in other medical research creates a risk if this information is not disclosed by participants.  Again, be specific here – include such things as potential for discomfort with the nature or content of the questions, potential breach of confidentiality, potential for embarrassment, etc. (as appropriate to the study)  Be clear about cases where there is an inherent relationship (esp. a power differential)  It is rare that a study has NO risks, so think broadly here about the potential for risks.

 This is typically a concern only in cases when sensitive information is being collected and participants have a presumption of confidentiality for information they are sharing with researchers.  If this is an issue for the research project, make a note of the circumstances under which confidentiality may be broken and to whom information would be shared (For example: Observing teachers in a classroom on pedagogy or talking with patients about a treatment area, but notice a student or patient who appears to be abused – need to break confidentiality as the researcher in the project to protect their safety.)  Ideally, the researcher is taking great care with the procedures to minimize this need. c. If audio-recording or video recording is involved, describe how recordings will be stored and what will be done with them at conclusion of study (destroyed/deleted; stored for a period of time then destroyed/deleted; archived for further study).  It is typical that original audio recordings are destroyed immediately after being transcribed and verified against the original.  It is also typical that original recordings or digital files are destroyed not later than 3 years following the conclusion of the data collection. d. If Internet or Web-based surveys are used, describe procedures for guaranteeing confidentiality.  Ideally, IP addresses are not being collected so that confidentiality is more likely to be maintained.  It is possible that a web-based survey would include the use of IMPLIED consent rather than Informed Consent. If so, the first page of the study would include the Informed Consent template with a statement at the bottom that says, “By clicking the ‘NEXT’ button and completing the survey in whole or in part, you acknowledge that you are at least 18 years of age and that you are participating in this survey voluntarily based on the information presented to you. Please e-mail the principal researcher at _____________if you have any questions.”  If creating and using an electronic survey, be sure to use the Maryville connection to Qualtrics (rather than Survey Monkey) for this purpose. e. If data are being collected anonymously, describe procedures for ensuring that no information that can identify participants is collected.  Be sure that data are anonymous and not just confidential.  Make sure that demographic categories are broad enough that any given participant is not identifiable from his/her responses to those categories. 8. What procedures will be used to obtain informed consent? a. Describe the process involved in obtaining consent (e.g., when, where, and by whom consent will be secured, how information about the study will be communicated).  Be specific here about the steps taken to collect informed consent from the prospective participants.  Be sure to note if / how different procedures will be used for a mixed methods study. b. If an oral consent procedure will be used, explain why this is necessary and attach a copy of a script that will be followed in obtaining oral consent.  This should be used only in very rare circumstances, but may be appropriate if working with people who may not be able to read or write.

 This might also be used if recruiting participants at a health fair booth or something similar and need to keep participants anonymous, so are seeking implied consent. c. If you are requesting waiver of certain elements of informed consent, indicate this and explain why this is necessary.  In some cases, if using “Implied Consent,” the researcher may be seeking to waive the requirement of a signature acknowledging consent. This is OK, just articulate that here and why it is appropriate for the proposed study.  It is most appropriate to use Implied Consent with a survey where it is important to maintain anonymity. Once the researcher collect a signature on an Informed Consent document, participants are no longer anonymous. d. If participants are members of a vulnerable population, or are vulnerable because of their relationship with the researcher, explain what special procedures will be followed to ensure informed and voluntary consent. (Please indicate if using implied consent.)  This is particularly important if using minors or participants over whom the researcher has a particular relationship (e.g., in a class or therapeutic or care-giving relationship).  Principle of autonomy is at stake here and the IRB needs to be sure people are truly volunteer participants.  In some cases, it may be appropriate for a third person to obtain and hold copies of the informed consent documents – this should be relevant to the study. e. If participants are minors between 7 and 17, outline procedures for ensuring their assent to participate. Outline procedures for obtaining parental/caretaker consent.  It does not matter in what order parental consent and minor assent are obtained, but both are needed. When in doubt, obtain parental consent first.  It should be clear how and by whom procedures will be explained/presented to minors and that the assent document is in a language/format that they can understand (i.e., age and cognitive- capacity appropriate).  If using a broad age range of minors (e.g., 7-15), it may be appropriate to use two different assent forms (one for younger children and one for older children) since they have different levels of cognitive abilities. f. If deception is involved, explain how this will affect informed consent.  This should be tied to response in Q.4e.  As closely as possible, information should be shared with potential participants so they understand what they are expected to do as participants in the research. Nature of the deception should influence degree of debriefing involved, and participants should be reminded that they have the right to remove their results from inclusion in the study. g. Attach copies of all consent and assent forms that will be used. Be sure to follow specifications for information to be included and format to be used in Informed Consent document. Attachments: The following documents are typically required for all protocols – Please PROVIDE A LIST/LABEL for all Attachments - such as Appendix A, B, C, etc. with a title, so they are easy to recognize. Include the following types of documents ( if applicable): Copies of all subject recruitment documents (flyer, e-mail, script, etc.)

Informed Consent Informed consent is a significant component involved in the review of institutional research that utilizes human subjects. The following are the items which MUST be included in the forms (or scripts) for informed consent. Final informed consent and assent documents must be submitted with this application. It is HIGHLY recommended that the applicant use the template provided later in this document as a guide. Place informed/implied consent on letterhead.  Title of the research project included at the top of the form  Investigator’s name(s) and position(s) –Student investigators should also indicate that they are “working under the direction of …” and list the name and title of their faculty advisor. If data are being collected at a particular site where the Investigator also has a relationship, that job title should be disclosed in this first paragraph as well.  Informed consent should be on Maryville letterhead if Maryville is the only institution “approving” the project. Logos from cooperating agencies/institutions may also be included, if appropriate.  Explanation of purpose and justification of research (noted from Q.1 of protocol)  Description of what subjects are asked to do through their participation (noted from Q.4 of protocol)  Explanation of the amount of time participation will take (noted from Q.4 of protocol)  Description of risks and how risks are being minimized (noted from Q.5 of protocol)  Description of alternative treatment (if applicable) (noted from Q.5 of protocol)  Statement of pregnancy status (if applicable) (noted from Q.5 of protocol)  Statement of nonparticipation in other medical research (if applicable) (noted from Q.5 of protocol)  Description of benefits to subject/society (noted from Q.6 of protocol)  Declaration and explanation of confidentiality or anonymity (noted from Q.7 of protocol) (Detail how the researcher will guarantee confidentiality and under what circumstances, if any, the researcher is required to break confidentiality.)  Statement of how the results will be shared (publication, presentation, report to organization’s officials) (noted from Q.7 of protocol)  If applicable, give instructions for how participants may receive a copy of the final report.  Explanation that individual test results might not be shared with participant if the tester/researcher is learning a technique/diagnostic procedure and is thus not certified to provide/share results (typically only required with student research). Possible language may be: “diagnostic feedback will not be provided, as this research serves as a training exercise for the researcher.”  Phone number of researcher (and faculty advisor for student researchers) who will answer questions  Name and phone number of Chair of Maryville’s IRB (currently, Dr. Robert Bertolino at 314-529-9659)  Statement of liability in case of injury, if injury is possible; Statement referring subjects to IRB in case of injury. (If project does not involve physical risks, these lines are not necessary to include.)  Statement of research integrity and name and phone number of Maryville’s Research Integrity Officer (currently, Dr. Kimberly Allen at 314-529-6685)  Statement that subject has read and understands consent form  Statement that subject has received copy of the consent form  Explanation of voluntary participation and withdrawal without penalty  Statement regarding use or non-use of de-identified data for future research studies  Line for participant to sign and date the consent/assent (each page should have lines to be initialed and dated by participant)  Statement that a stamp will appear on consent form indicating approval of the project by the Maryville University IRB.

One (1) copy of all materials [signed application cover sheet, IRB Research Protocol, consent/assent forms, Exempt or Expedited Checklist (if necessary/appropriate), subject recruitment document(s), research instruments, off-site approvals, certifications of Human Subjects protection training for all researchers] must be submitted ELECTRONICALLY to the Administrator of the Maryville University Institutional Review Board, Dr. Kimberly Allen at irb@maryville.edu . Please note submission deadlines/guidelines vary depending on the level of review required for the IRB Research Protocol. No applications will be reviewed unless complete and signed material is submitted. INFORMED CONSENT Sample Template These instructions include a template for a consent form. The template includes the elements of the form the researcher must create. It is suggested that you use the language of the form.  The consent form should be on Maryville University letterhead (or possibly dual organizations’ letterhead if a co-sponsored study) .  The title of the study should appear at the top of the page.  All pages should be numbered with a place for the participant’s initials and date at the bottom of EACH page (except the final page since the participant’s signature will appear there – this requirement is waived if using Implied consent).  The language of the form should be simple and understandable to a layperson. Avoid the use of discipline-specific jargon or technical terms.  All consent documents MUST include the final four paragraphs below about questions being directed to IRB chair and ethics concerns directed to Research Integrity Officer.  Include the final statement signifying IRB approval.  Possible wording is in italics. Language that is bolded should be completed. [Note: Upon completion of this document, it is best to remove the formatting with exception to bolded items for emphasis.] ***********************************

Confidentiality To maintain confidentiality about your personal records the researcher will (indicate how data will be coded, stored, identifiers removed, how long it will be retained, and how it will be destroyed when appropriate). [if a mandated reporter, insert the following statement] As stated by law, if during the research process the researcher learns of any information that would put the participant at risk such as child/elder abuse/neglect and/or thoughts of suicide/homicide, the researcher is mandated to report that information to the proper authorities. Dissemination The results of this study will be (printed in a doctoral project; shared with my research advisor; shared as a poster session at a local conference; shared with school district administrators, etc.) The data collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies. [or select the following statement if using broad consent] Additionally, de-identified data collected from this study could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative. [The following five paragraphs are required with very minimal modifications.] Explanation of voluntary participation Participation in this study is completely voluntary. Not participating in this study does not involve a penalty of any kind. Participants may withdraw from this study at any time even after the (interview, focus group, intervention) has occurred and data collected. Questions If you have any questions regarding this study, or if any problems arise, you may call the researcher, ( name) at (phone number) (or the researcher’s faculty advisor [name] at [phone number]). You may also ask questions, state concerns regarding your rights as a research subject, or express any feelings of pressure to participate by contacting: Dr. Robert Bertolino, Chair of the Institutional Review Board at Maryville University, (314) 529-9659. Integrity Maryville University recognizes its federally mandated responsibility to ensure that research be conducted in an ethical and scholarly manner, respecting the rights and welfare of all the human participants. Any research misconduct including but not limited to fabrication, falsification, or plagiarism in proposing, performing and reviewing research, or in reporting research results, should be reported to Dr. Kimberly Allen, the Research Integrity Officer at Maryville University at (314) 529-6685. Initials ______ Date ______

Maryville University investigators, and their colleagues who are conducting research, recognize the importance of your contribution to the research studies which are designed to improve (therapeutic care; educational learning environments – insert whatever is appropriate given the purpose of your study). Maryville University investigators and their staffs will make every effort to minimize, control, and treat any complication that may arise as a result of this research. Research involving physical tasks or other health-related treatments need to add , if applicable: If you believe you are injured solely as a result of the research question being asked in this study, please contact the principal investigator or the Chair of the Institutional Review Board. Maryville reserves the right to make decisions concerning payment for medical treatments for injuries solely and directly related to your participation in the research. By signing this form, you acknowledge that you are at least 18 years of age, that you have read and understand this form, and that you have had an opportunity to ask questions about the research project. You are voluntarily agreeing to participate in a study based on the information presented to you. You may choose to withdraw at any time without prejudice or penalty. You will receive a copy of this form, which will include the name and phone number of the researcher and the IRB at Maryville University, should you have any questions. [ Alternate to this final paragraph if seeking implied consent may be “By returning the survey(s) completed in whole or in part, you acknowledge that you are at least 18 years of age and have read and understand this form, and that you have had an opportunity to ask questions about the research project. You are voluntarily agreeing to participate in a study based on the information presented to you. You may choose to withdraw at any time without prejudice or penalty. You may print a copy of this page, which includes the name and phone number of the researcher and the IRB at Maryville University, should you have any questions.” Please note, a participant’s signature is not required, and initials and date are not needed on each page. Researcher should still sign the form.] ___________________________________________________ ______________ Subject / participant’s signature Date _______________________________________ __________________ ______________ Researcher’s signature Date Phone Number The date approval stamp on this consent form indicates that the project has been reviewed and approved by the Maryville University Institutional Review Board.

Informed Consent (if necessary) Yes No Consent Form Elements (see pages 9-10 of the Policies document) ____ ____ Form is on Maryville University letterhead (if Maryville is only institution approving the project; if not, then letterhead of home institution of principal investigator) ____ ____ Investigator’s name and position are included (and that of faculty advisor, if student researcher) ____ ____ Explanation of purpose and justification of research ____ ____ Clear description of what subjects will be asked to do through their participation ____ ____ Description of risks and minimization of risks is clear ____ ____ Declaration and explanation of confidentiality or anonymity and any limits to maintaining confidentiality (i.e., threats to self or others must be disclosed) ____ ____ Description of benefits to subject/society is clear including incentives if applicable ____ ____ Description of alternative treatment, if applicable ____ ____ Statement of pregnancy status (if applicable) ____ ____ Statement of nonparticipation in other medical research (if applicable) ____ ____ Phone number of researcher who will answer questions ____ ____ Statement of liability in case of injury ____ ____ Statement referring subjects to IRB in case of injury ____ ____ Statement that subject has read and understands consent ____ ____ Statement that subject has received copy of consent form ____ ____ Explanation of voluntary participation and withdrawal without penalty ____ ____ Line for participant to sign and date the consent/assent form (Initial and date additional pages) ____ ____ Consent form (and/or assent form) is written in language participant can understand. I have reviewed the enclosed protocol and recommend the following action: ________ Full Approval ________ Contingent Approval (explain clearly on back what needs to be done) ________ Tabling (give explanation on back) ________ Denial (give explanation on back) ______________________________ ___________________ Signature of Reviewer Date

WhiteTree MEDICAL White Tree Medical www . whitetreemedical.com Phone: 801-877-0705 Fax: 801-335-5957 Email: clcanfield@whitetreemedical.com 08/17/2023 Dear Maryville DNP Project Committee, Based on my review of the proposed research by Hannah Backman, I give permission for her to conduct the project entitled 'Implementation of nutrition education at an outpatient substance addiction treatment clinic' within White Tree Medical Clinic. As part of this project, I authorize the DNP student to train nurses and providers on nutritional concerns and requirements of our patients, retrospectively review patient charts to obtain necessary qualitative data, and disseminate information about project at the clinic. Individuals' participation will be voluntary and at their own discretion. We understand that our organization's responsibilities include personnel, rooms, education material copies, and supervision by the medical director. We reserve the right to withdraw from the project at any time if our circumstances change. We understand that the DNP student will interact with providers and nurses to train them on specifics of nutrition education to be provided to patients, provide nutrition education to patients, and obtain data for pre-and post-tests. This authorization covers the time period of8 / 17 / 23 to 4/30/25. I confirm that I am authorized to approve projects in this setting and that we do not have a facility IRB. I Sincerely,