Self Check Application for Research Ethics Approval
Form C: ETHICS SELF-CHECK APPLICATION FOR RESEARCH ETHICS APPROVAL INSTRUCTIONS: Section 1: The researcher must complete the brown column A of the table below to document how the research procedures comply with the university’s 40 ethical standards for research studies. Section 2: Provide electronic signature. Section 3 (students only): The student’s faculty supervisor must review this form and supporting documents so they can enter their email address to provide an electronic signature. Then the student will need to copy (CC) their supervisor when they submit to [email protected]. The IRB staff cannot accept any forms or documents unless the supervising faculty member is CC’d on the submission. Research ethics approval will be issued when the department of Research Ethics, Compliance, and Partnerships (RECP) confirms that there is adequate evidence that the university’s ethical standards have been met, based on this form and the supporting attachments. Within 10 business days of the researcher’s submission (including all applicable attachments), the researcher will be notified via email of one of the following outcomes: (a) ethics approval has been provided based on the submitted documents; or (b) that the researcher needs to provide revisions and/or additional documentation as specified in the Ethics Reviewer’s column (such as column B for the first review or, if needed, column D for the second review). Questions can be sent to [email protected]. Click here to view IRB policies, sample informed consent documents, and FAQs about conducting research in specialized contexts such as international, workplace, educational, or clinical/intervention settings. IMPORTANT: • The footnotes in this document contain examples and definitions that will help you effectively confirm each ethical standard. Using these footnotes will reduce the likelihood of needing revisions. • Questions below that begin with “If” can be marked NA if they are not applicable. All other questions must be answered as “yes” with supporting details. • The most common delays in approval are due to discrepancies from various proposal stages. So check carefully to ensure that all documents reflect the final set of data collection steps. SECTION I: CONFIRMATION OF ETHICAL A. In this column, the researcher should confirm STANDARDS COMPLIANCE compliance with each ethical standard by marking Yes or NA, and defending the response by providing supporting details. B. Ethics reviewer will confirm compliance with each ethical standard in this column by entering “Confirmed” or providing a request for revisions. C. Researcher response: The researcher must use this column to describe how and where each of the ethics reviewer’s concerns (in the yellow column) has been addressed. The researcher’s questions or explanations are also appropriate here if a D. Second ethics review (if needed): Ethics reviewer will confirm whether the responses in column C meet the ethical standard by entering “Confirmed” or providing a request for revisions. E. Researcher’s second response (if needed): The researcher must use this column to describe how and where each of the ethics reviewer’s concerns (in the orange column) has been addressed. Additional columns will be added by researcher wishes for the IRB to reconsider an issue. For those rows containing “NA” or “Confirmed” in Column B, no researcher response is necessary. 1. Has each recruitment, consent, and data collection step been articulated such that the responsibilities of the researcher and any partner organization(s) are clearly documented? Provide a numbered list of the data collection steps that includes how/who/where1 details for each step, in sequential order. Here are samples. Describe pilot2 steps first if you are doing a pilot or road test. Yes No ☒ ☐ Recruitment and data collection steps: Yes, each recruitment, consent, and data collection step has been articulated to clearly document the responsibilities of the researcher and any partner organization(s). The following is a numbered list of the data collection steps with details for each step: Pilot Testing (if applicable): Conducted by the researcher, Kathy Green Location: Preselected participants for pilot testing Purpose: To ensure the clarity and effectiveness of data collection instruments and procedures Recruitment: Conducted by the researcher, Kathy Green Target population: Formerly incarcerated individuals who have completed a prerelease reentry program in California and have successfully reintegrated into society without recidivating for at least one year Methods: Contacting reentry program organizations and 1 The nature of the pilot study is unclear, as what you describe to the left does not match your Form A. In section 4 of your Form A you stated that you would only be conducting practice interviews with friends or family to get some experience in interviewing. What you state to the left is quite different, since it seems you intend to conduct the pilot with those meeting your final study inclusion criteria. To that end, your overall steps are unclear as column A to the left seems to only be describing your pilot study. It is thus unclear HOW = Write this like a recipe, including enough details so that a reader could replicate your study. Submit copies of any of the following that apply: flyer, invitation email, ad/posting. WHO = Which parties are involved in each step? In particular, we need details about any partners who might be assisting the researcher in identifying or contacting participants. Note that doctoral students may not delegate the tasks of obtaining consent or collecting data to anyone else. WHERE = Specify whether the interactions will take place via phone, email, online, or in-person at a specific location. 2 It is fine to road test an interview or survey with friends or family prior to IRB approval and that data may not be used in the study’s analysis. However, any piloting done outside of friends/family requires prior IRB approval, regardless of whether the data would be included in the final analysis or not. the IRB as needed. requesting their assistance in identifying potential participants Distributing flyers and information about the study in community centers and support groups for formerly incarcerated individuals Utilizing online platforms and social media to reach out to potential participants Initial Contact and Screening: Conducted by the researcher, Kathy Green Location: Phone or email communication Purpose: Explaining the study purpose and procedures Verifying eligibility criteria (e.g., completion of a prerelease reentry program, successful reintegration without recidivism for at least one year) Informed Consent: Conducted by the researcher, Kathy Green Location: Face-to-face or virtual meeting Purpose: Providing detailed information about the study, including its purpose, procedures, risks, and benefits Answering any questions or concerns from potential participants Obtaining voluntary and informed consent from eligible participants Data Collection: Conducted by the researcher, Kathy Green Location: Skype or video conferencing platform Procedure: Conducting one-hour Skype interviews with participants Asking questions about their experiences with the prerelease reentry program and successful reintegration into society Audio recording the interviews for transcription what your final study steps will involve. Whether and what additional materials may be needed cannot be determined until the steps of your pilot study and final study are clarified. It would be useful if you described the steps for the pilot study and final study separately, using the format identified in the Form C samples available here (which are also hyperlinked in the far-left column). Please also ensure you review all comments throughout this self-check form as there are concerns with your overall procedures that you will need to account for when describing the steps of your study. and analysis purposes Follow-up and Member Checking: 2. Will the research procedures ensure privacy3 during data collection? Describe how you will prevent others overhearing or seeing the participant’s responses. 3. Will data be stored and shared4 in a secured manner that provides access only to you and your supervising faculty members? Researchers conducting studies involving identifiers and more than minimal risks will be directed to provide additional information and assurances in Form E (Data Security Checklist). 3 Conducted by the researcher, Kathy Green Location: Phone or email communication Purpose: Sharing summarized findings with participants to validate accuracy and interpretation of their responses Allowing participants to provide additional insights or clarifications if desired Yes No ☒ ☐ Supporting details: Yes, the research procedures will ensure privacy during data collection. To prevent others from overhearing or seeing the participant’s responses, the data collection will take place in a confidential and secure setting. This might remember leading meetings for a confidential room or utilizing scrambled correspondence channels for online meetings. It will be assured to participants that their responses will not be disclosed to anyone outside of the research team without their explicit consent. Please confirm each of the data security measures below (no supporting details needed for these). Yes No a. Do you confirm that you will only store the dataset on ☒ ☐ devices that are owned by you and in your sole control? Yes No b. Will you take reasonable precautions to ensure that ☒ ☐ Please clarify how interviews will be held. Will they all be done virtually (i.e., via phone or video conferencing) or will some interviews be done in-person? If you will be conducting in-person interview, please identify the types of locations where they would be held. Adult volunteers are typically able to select how much privacy they desire while they complete a phone interview or online survey. However, for in-person data collection, the researcher is responsible for ensuring that no one can see or overhear their responses. 4 Unless the IRB authorizes an exception, data shared with supervisors and future collaborators must have names and other identifiers removed first. Yes ☒ No ☐ Yes ☒ No ☐ Yes ☒ No ☐ Yes ☒ No ☐ Yes ☐ No ☐ NA ☒ Yes ☒ No ☐ NA ☐ Yes ☒ No ☐ NA ☐ the device(s) and drive(s) storing the data are not stolen? (i.e., not leave it unattended in public, keep it in a locked area when not in use) c. Will you be the only person with the password to access to any devices, drives, or clouds on which electronic data will be stored? d. Will you set up a screen lock to require the password to be re-entered if any data storage device is idle for 15 minutes or more? e. Have you installed all available updates for the operating system of the device(s) that will be used to access, store, and analyze data? f. Does your anti-virus software have current virus definitions? g. If the data will be coded, and if there is a linked list of codes and identifiers, will this list be stored separately from all coded data? h. If there will be any data in paper format, will you be the only person with access? i. If you are conducting an anonymous online survey: Will you ensure that your turn off IP address tracking in the survey platform and select the setting that is truly Subpart g. is applicable. Presumably some sort of coding system would be used as it would not be appropriate to identify participants in your final dissertation. Subpart i. is not applicable to your study. You are neither administering a survey nor will participants be anonymous. anonymous, allowing no respondent-tracking or follow ups? 4. Will the data be stored for at least 5 years? Describe how data disposal will occur. 5. If participants’ names or contact info will be obtained at any time: Is this absolutely necessary5? Describe why or confirm that data collection is 100% anonymous6 (which is preferable). 6a. If the research topic involves stigma (e.g., workplace bullying): Can you confirm that the volunteering and data collection processes will be discreet enough to prevent others from learning of your 5 Yes No ☒ ☐ Supporting details: After the data has been analyzed and the study is complete, the audio recordings and any identifying information will be securely deleted. The remaining de-identified data will be stored on encrypted devices for a period of at least 5 years, as required by Walden University. Yes No NA ☒ ☐ ☐ Supporting details: Yes, obtaining participants’ names or contact information is absolutely necessary for this study. To guarantee participant identification and follow-up throughout the research process, this information was gathered. In any case, it is vital to take note of that while names and contact data are gathered, measures will be taken to guarantee that the information assortment stays 100 percent mysterious. Yes No NA ☒ ☐ ☐ Supporting details: Yes, in order to guarantee that participants’ participation in the study remains confidential, the processes of volunteering and collecting data No. Deleting the recordings when you have analyzed the data would not be compliant with Walden’s requirement that all dataincluding interview recordings-be retained a minimum of 5 years. Confirmed (though ‘mysterious’ does not seem to be the correct word here, you will know who is participating and thus can only keep participants’ identities confidential). Confirmed Retaining contact information might be necessary if the researcher needs to follow up for a member-checking step or to provide the thank-you gift. Contact information is NOT necessary to share study results if the consent form provides a website where results will later be posted. Note that consent signatures are NOT necessarry if the participant can indicate consent by some action such as clicking on a link, returning a completed survey, verbally stating “I consent” on the audio-recording, etc. For any topic that is remotely sensitive, data should be collected without names or contact information when possible. 6 “Anonymous” means that no one (not even the researcher) knows who volunteered or declined. If a researcher documents consent in a manner that tracks their names, then the data is “confidential” rather than “anonymous.” volunteers’ participation in the study? will be carried out in a discrete manner. Members won’t be distinguished by name or some other This is NA if the study topic has no stigma actually recognizable data in any reports or attached. distributions. The researcher will take necessary precautions to maintain the privacy and confidentiality of the participants. 6b. If participants’ demographic details (such as Yes No NA gender, ethnicity, number of years in a position) ☒ ☐ ☐ are going to be shared in the final results: Supporting details: Yes, readers will not be able to determine the Will the demographic details be shared in a identity of any individual participant because the manner that will prevent readers from demographic information about participants will deducing7 a participant’s identity? be shared in a consolidated manner. To maintain confidentiality, any identifying information will be anonymized or removed from the final results. 6c. The standard for Walden capstones is to not Yes No NA name the partner organization in published reports, ☒ ☐ ☐ including ProQuest. Supporting details: Yes, the partner organization’s identity will be If you are partnering with any organizations to masked in all published reports and presentations. identify participants or collect data, will you The organization will not be named in the mask the organization’s identity in published doctoral project report or any other publications reports and presentations? to maintain confidentiality and protect the privacy of the organization and its participants. Exceptions to the organization-masking practice must be granted by the Program Director and approved by the IRB. Place an X here ☐ if you were granted an exception as part of your Please clarify your response to the left. Are you intending to collect demographic data? If so, please submit a copy of the demographic questions you intend to ask, You refer to the “Alternative Custody Program” in your research question. Is this a specific program offered by only one organization? If so, identifying it in your research question would not be appropriate, since this would effectively identify by extension who your partner organization is. Participant identities might be indirectly and unintentionally disclosed if a researcher’s final research report fails to withhold demographic details that might permit a reader to figure out the identity of a participant. So the researcher needs to think carefully about which demographic descriptors are most important to collect and report, while ensuring that the identity of individual participants is protected. For example, readers may be able to deduce a participant’s identity if a qualitative analysis stated, “One female African-American vice-principal with 14 years of administrative experience described her professional development experience as…” A general rule of thumb is to only include a particular demographic descriptor combination if at least 3 people in the population have that combination of demographic details. So if a district had 4 African-American vice-principals with 10+ years experience but only 2 were female, then you would just mask the gender variable and an appropriate demographic description might be: “One African-American vice-principal with 10+ years of administrative experience described the professional development experience as…” However, it would be a good idea to carefully examine whether ethnicity is a relevant demographic detail to report or not, given the topic. 7 prospectus approval. 7. If you will be sharing the raw data (including names) with a transcriber, translator, or anyone8 outside your Walden supervisors: Will they be signing a confidentiality agreement9? If so, submit a blank copy and confirm that you will keep signed copies in your research files. 8. The ProQuest publication at the end of the doctoral program is for the community of fellow scholars. Is a specific plan10 in place for sharing results with the participants and community stakeholders using a brief, audienceappropriate format? Yes No NA ☒ ☐ ☐ Supporting details: Yes, anybody beyond my Walden bosses who will approach the crude information, including names, will be expected to consent to a classification arrangement. Because of this agreement, they will know how important it is to keep the data private and confidential, and they will not use or disclose the data for anything other than the research study. Yes No ☒ ☐ Description of results dissemination plan for laypersons: Yes, a specific plan is in place to share the results of the study with the participants and community stakeholders using a brief and audienceappropriate format. This may include summarizing the findings in plain language, creating infographics, or organizing community presentations to effectively communicate the research outcomes and their implications to a broader audience. What is a “classification agreement,” which you reference in your response to the left? Individuals (beyond your committee) who will have access to identifiable data Please explain how you will share a summary of the results with participants directly, as this can be a way of giving back for the assistance they provided. Refer to footnote 10 for additional information in this regard. Social science research typically involves minimal11 risks and sometimes involves 8 Some professional transcribers/translators address confidentiality in their work agreement and this is acceptable. No confidentiality agreement is needed for the researcher or Walden staff because they are already bound to confidentiality. 9 A sample confidentiality agreement can be found here. 10 Typically, a 1 to 2 page summary or verbal presentation is most appropriate. Sharing the study’s results with participants is required. It is important that the format is audience-appropriate. Stakeholders may lack the time or inclination to digest a full dissertation. Note that member checking and transcript review are not applicable to this section. If you plan to do transcript review or memberchecking, these steps need to be described as part of your data collection procedures in #1 above. 11 Minimal risk is defined as follows in U.S. federal regulations: “that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves THAN THOSE ORDINARILY ENCOUNTERED IN DAILY LIFE or during the performance of routine physical or psychological examinations or tests.” substantial12 risks. Those risks must be acknowledged and described in order to mitigate them and document that they are outweighed by the study’s benefits (in #12 below). 9a. Are potential psychological13 risks acknowledged and described here? 9b. Are potential relationship14 risks acknowledged and described here? 9c. Are potential legal15 risks acknowledged and described here? Mark one: ☐ NA ☒ Minimal psychological risks include: Participants may experience mild emotional discomfort or reflection while discussing their experiences with the prerelease reentry program and their successful reintegration into society. ☐ Substantial psychological risks include: Mark one: ☐ NA ☒ Minimal relationship risks include: Participants may experience discomfort or sensitivity when discussing their relationships with individuals involved in their prerelease reentry program or their reintegration process. ☐ Substantial relationship risks include: Mark one: ☐ NA ☒ Minimal legal risks include: There is a minimal risk of potential breaches of confidentiality or unintentional disclosure of sensitive information during data collection and Confirmed Confirmed Confirmed Substantial risk is anything beyond the “minimal risks” of daily life. Substantial risks are acceptable when justified by the research problem and research design, as long as adequate preventive protections are in place. 13 Psychological risks are present if materials or questions could be considered embarrassing, stressful, sensitive, offensive, threatening, judgmental, triggering, etc. Psychological risks are typically present if any of the other risks below are also present. SAMPLE DESCRIPTION: Some participants might disclose things that they later regret sharing, causing distress. 14 Relationship risks are present if the recruitment or data collection process could impact the existing dynamics between the researcher and participant (who may be coworkers or have some professional relationship), dynamics among participants (if they know one another), or dynamics between the participant and the participant’s friends, coworkers, or family members. SAMPLE DESCRIPTION: Since I am recruiting people I know professionally, they might have concerns about how volunteering or declining could impact our professional relationship. 15 Legal risks are present if data collection might result in a participant’s disclosure of violation of laws (by the participant or others). SAMPLE DESCRIPTION: Participants could inadvertently disclose a legal violation during the course of the interview. 12 9d. Are potential economic/professional16 risks acknowledged and described here? 9e. If there are any other potential risks, have they been acknowledged and described here? 10. Have the above risks been minimized as much as possible? In other words, are measures in place to provide participants with reasonable protection from loss of privacy, psychological distress, relationship harm, legal risks, economic loss, and damage to professional reputation? In the brown column, explain how each risk identified in #9 above will be minimized. 16 storage, which could have legal implications if not properly managed. ☐ Substantial legal risks include: Mark one: ☒ NA ☐ Minimal professional risks include: ☐ Substantial professional risks include: Mark one: ☒ NA ☐ Other minimal risks include: ☐ Other substantial risks include: Yes No ☒ ☐ Supporting details: Yes, the above risks have been limited however much as could reasonably be expected. Measures have been executed to safeguard members’ protection, for example, de-distinguishing the information and putting away it safely. It will be possible for participants to withdraw from the study at any time, minimizing any potential risks to their relationships or psychological well-being. The scientist will comply with legitimate and moral rules all through the review, guaranteeing the security of members’ privileges. Professional risks will be minimized by anonymizing any identifying information and presenting the results in an aggregated manner to prevent participants from being personally identifiable. Confirmed Confirmed Please clarify your response to the left. What “legitimate and moral rules” are you referring to and how would than minimize risks to participants? Please also note, anonymity in research only occurs when no one, not even the researcher, knows who participated. As you will be conducting interviews, you will know who is participating and thus can only keep participants and their data confidential. Use of codes or pseudonyms helps maintain Economic/professional risks are present if data collection could result in the participant disclosing violation of workplace policies, disagreement with leadership decisions, poor work performance, or anything else that could be damaging to the participant’s position, professional reputation, promotability, or employability. SAMPLE DESCRIPTION: Since the questionnaire asks participants to rate their agreement with leadership decisions in their workplace, there could be an impact on a participant’s promotion opportunities if there were a confidentiality breach. participant confidentiality but does not provide anonymity. Please revise your IRB materials accordingly. Your interview questions also ask how the program impacted their mental health. As you are promoting this study from the perspective of what skills they learned to reenter society, participants may be confused and alarmed at being asked such a personal (and possibly triggering) question. To minimize this risk you need to explain on both the invitation and the consent form that the interview will ask about their mental health. 11. If the researcher is known to the participants in some professional role: Will the researcher be proactively managing any potential conflicts of interest17? 12. Are the research risks and burdens18 reasonable, in consideration of the new knowledge19 that this research design can offer? 17 Yes No NA ☒ ☐ ☐ Supporting details: Yes, if the researcher is known to the participants in some professional role, any potential conflicts of interest will be proactively managed. The researcher will ensure that the study’s objectivity and integrity are not compromised by their professional relationship with the participants. Any irreconcilable situations will be uncovered and suitable advances will be taken to relieve their effect on the examination interaction and results. Yes No ☒ ☐ Supporting details: Please clarify your response to the left. How would you have a professional relationship with potential participants? Are you involved in their probation or parole? Are you involved in providing services to them when they are re-entering their community after incarceration? Something else? A conflict of interest is caused when the researcher has some sort of dual role in the research context, such as being a teacher, therapist, investor, business-owner, manager, etc. Conflict of interest must be managed to ensure that the research reveals “truth,” not just the outcome that the researcher might desire to see due to their other role. The simplest way to ensure this impartiality is to conduct research OUTSIDE of one’s own context but other methods are possible (e.g., using anonymous data collection to encourage honest responses). 18 Even low-risk research activities place some degree of burden on the participants by asking the participants to share personal information, volunteer time, and assume risks. 19 Examples of “new knowledge” include: effectively addressing a gap in the literature, generating new theory, enhancing understanding of a phenomenon, assessing effectiveness of a particular professional practice, addressing a local practical problem via data analysis. Yes, the research risks and burdens are reasonable considering the potential new knowledge that this research design can offer. The study aims to explore the perceptions of formerly incarcerated individuals regarding the influence of prerelease reentry program characteristics on their successful reintegration into society, which can contribute valuable insights to the development of more effective reentry programs and reducing recidivism rates. 13. If the study involves one or more partner Yes No NA organizations: ☒ ☐ ☐ Supporting details: Will20 the research partner organization(s) Yes, the research partner organization(s) will grant permission21 for all relevant data22 access, grant permission for all relevant data access, access to participants, facility use, and/or use of access to participants, facility use, and/or use of personnel time for research purposes? personnel time for research purposes. Written partner organization approval will be obtained IRB staff will advise which type of partner before Walden ethics approval to ensure agreement is needed, if applicable. State whether collaboration and compliance with all necessary you will be obtaining written partner organization requirements. approval before or after Walden ethics approval. Describe why. This cannot be determined until the issues raised throughout this self-check form are addressed. The draft site letter you submitted is not appropriate and needs to be discarded, as it contains text that cannot be approved and other information that is not relevant to the site’s role. Please draft a letter of cooperation using this template, but do not seek a signature at this time. The IRB will need to confirm the terms are aligned with your proposed study. You also refer to recruiting via the Walden Participant Pool in your Form A, but that is not described in this self-check form. It is thus unknown if this is a recruitment method you intend to use. Please clarify. It also appears that participants need to reside in California. Please note that the Participant Pool is open to Walden students and faculty employed in a range of positions, throughout the world. Studies that involve a If a partner organization requires the researcher to obtain Walden’s IRB approval before they can provide their written approval, that’s fine. (Walden can issue a “conditional IRB approval” letter to the researcher and then Walden’s IRB approval will then be finalized once the Walden IRB receives the partner organization’s letter of cooperation.) 21 No Letter of Cooperation is required (a) if the researcher will simply be asking organizations to distribute research invitations on the researcher’s behalf, or (b) if the researcher is using only public means to identify/contact participants. 22 Note that when medical, educational, or any type of operational records would be analyzed or used to identify potential research participants, the partner organization needs to explicitly approve access to data for research purposes (even if the researcher normally has access to that data to perform their job). 20 narrow geographic focus such as yours typically are not ideal for the Participant Pool. Note-permission to recruit using the Participant Pool is granted by an authorizing representative outside of the IRB. If you retain this recruitment method, the IRB will coordinate your request with the authorizing representative on your behalf, but want you to be aware of potential limitations. If you feel this would be a viable method of recruitment, please provide an explanation in column C to the right so the authorizing representative can better understand your perspective. 14. Is participant recruitment coordinated in a manner that is non-coercive23? Describe. Coercive elements include: leveraging an existing relationship to “encourage” participation, recruiting in a group24 setting, extravagant compensation, recruiting individuals in a school/work25 setting, involving a service provider26 in the recruitment process, etc. When the researcher may already be known to the 23 Yes No ☒ ☐ Supporting details: Yes, participant recruitment is coordinated in a non-coercive manner. To minimize perceptions of coerced research participation, the researcher will ensure that recruitment is conducted in a neutral and voluntary manner. Existing relationships will not be leveraged to pressure individuals into participating, group recruitment settings will be Unclear. The draft site letter you submitted gives the impression that you expect them to aid in recruitment. This would not be appropriate, as others cannot recruit for you. Your exact recruitment procedures are also not consistently described. You indicate in #6a that the site will provide you with contact information for potential For example, anonymous surveys and/or low-pressure communications such as flyers or email invitations permit potential participants to opt out with minimal fear of retaliation or other negative consequences. 24 It is not ethically acceptable to invite a “captive audience” to participate in research on the spot (i.e., to ask an entire class or a group of meeting attendees to complete a survey during their session). Such a dynamic would not provide sufficient privacy or respect for their right to decline research participation. However, a researcher may use the last few minutes of a class session or meeting to introduce a study and distribute materials, such that the potential participants can then take their time to decide later about participation. 25 Generally, data collection cannot be approved during work hours or school hours unless a “free period” has been identified (e.g., break, study hall) so the research activities can be separated from the participants’ regular activities. It is important to maintain an “opt in” dynamic rather than implying that employees/students/group members are expected to participate. 26 A researcher can ask a service provider (nurse, physician, therapist, shelter staff etc.) to give research invitations to clients who meet the inclusion criteria. However, we cannot approve for the service provider to answer questions about the study, obtain consent, or collect data (unless the data is being collected by the organization itself for purposes other than the study). participants, we need to document how perceptions of coerced research participation will be minimized27. 15. If you were directed to complete Form D in order to specifically recruit certain vulnerable individuals28 as participants: 27 avoided, compensation will be reasonable and not extravagant, and recruitment in school/work settings or involvement of service providers will not be employed. The researcher will emphasize the voluntary nature of participation and provide clear and unbiased information about the study to potential participants. Yes No NA ☐ ☐ ☒ Supporting details: participants, thus suggesting you will reach out to potential participants. However, section 8a of Form A refers to the site posting flyers. To that end, you have only submitted an email invitation, but no flyer, To add further confusion, #1 above refers to recruiting through community centers, though you have not identified recruiting through such centers in your Form A. #1 above also refers to recruiting through support groups, but recruiting in a group environment would not be appropriate (as per footnote 24). Please clarify and revise as needed to ensure your recruitment procedures are consistently described and align with Walden’s ethical standards as outlined in the far-left column and relevant footnotes. The invitation you submitted is difficult to follow and uses inappropriate terms (such as ‘review’-you are not conducting a review, but a research study for your dissertation). Please discard or revise, noting that when drafting/revising your invitation(s), please use the template available online. N/A Doctoral research directly benefits the student (allowing him or her to obtain a degree), and so the researcher should minimize the potential for either (a) conflict of interest or (b) perceived coercion to participate. Researchers who are in positions of authority or familiarity must take extra precautions to ensure that potential participants are not pressured to take part in their study. EXAMPLES: • A professor researcher may recruit her students AFTER grades have been assigned. • A psychologist researcher may recruit clients from ANOTHER psychologist’s practice. • A manager researcher may conduct ANONYMOUS data collection so that subordinates do not perceive their responses or [non]participation as being associated with their job standing. 28 For this purpose, vulnerable individuals include children, prisoners, people with severe cognitive or emotional disabilities, on-duty military personnel, and people living in an institutional setting such as a prison, inpatient care, rehab center, or shelter. Is targeting this population justified29 by a research design that will specifically benefit that vulnerable group at large? Describe why. If you were not directed to complete Form D, mark NA. 16. Even when a researcher is not specifically seeking to recruit vulnerable individuals, any adult sample could by chance include some people who happen to have a disability, a low income, a crisis in their lives, or another vulnerable status (without the researcher’s awareness). It is important to include30 their perspectives, as long as we document here that there are sufficient protections in place. Would the benefits of including these individuals outweigh the risks, given that they would be protected by the informed consent process and the voluntary nature of the study? 17. If anyone would be excluded from participating: Is their exclusion31 justified and handled respectfully (without marginalization or stigma32)? 29 Yes No ☒ ☐ Supporting details: Yes, the benefits of including individuals with vulnerable statuses in the study outweigh the Confirmed risks. These individuals will be protected through the informed consent process, ensuring their voluntary participation and safeguarding their rights and well-being. Additionally, their perspectives will contribute valuable insights to the research, enhancing its overall quality and relevance. Yes No NA ☒ ☐ ☐ Supporting details: Yes, the exclusion of certain individuals from participating is justified and handled respectfully, Confirmed Convenience sampling is not approvable. Targeted recruitment of children can only be approved when a majority of the IRB votes that the study’s benefits justify its risks/burdens (such as disruption to instructional time). For recruitment of adult vulnerable populations, IRB staff will determine on a case-by-case basis whether approval must be issued via the full board’s vote (as opposed to expedited ethics review). 30 It is ethically appropriate to include certain vulnerable adult populations in social science research when screening for that particular status would be overly invasive, given the research topic and when they are sufficiently protected by the informed consent process and the voluntary nature of the study. For example, a researcher might unknowingly have some participants who happen to be disabled, low-income, in-crisis, elderly, facility residents, or pregnant. We don’t expect researchers to screen for these statuses routinely in minimal risk social science research. However, minors may never be unknowingly recruited; adult recruitment procedures must deliberately avoid recruiting minors and when there is room for ambiguity, recruitment materials must state that only those aged 18+ may volunteer. 31 Exclusion criteria are not just the opposite of inclusion criteria (a common misconception). Exclusion criteria are used ONLY when the researcher has good reasons to disqualify certain individuals who otherwise meet the inclusion criteria. For example, when a volunteer happens to 18. Researchers are only permitted to break33 confidentiality (i.e., share a participant’s identity along with their disclosures) when the researcher is legally required to report certain information to authorities in the very rare case of subpoena or the following mandated reporting instances: a. If you will be collecting data related to children in Delaware, Florida, Idaho, Indiana, Kentucky, Maryland, Mississippi, Nebraska, New Hampshire, New Jersey, New Mexico, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Utah, and/or Wyoming: These states have laws requiring everyone to report suspected child abuse or neglect. Have you described your mandated reporting responsibility in clear layperson language in the consent/assent forms? This is NA if your data collection couldn’t possibly relate to children or if you won’t knowingly be collecting data in the states listed above. b. If your professional licensure34 mandates that you report child or elder abuse or neglect: Have you described your mandated reporting responsibility in clear layperson without marginalization or stigma. The exclusion criteria are based on specific requirements or goals for the research and are not intended to stigmatize any particular group or individual. All potential participants will be treated with dignity and respect during the fair and impartial exclusion procedure. Yes No NA ☒ ☐ ☐ Supporting details: As it appears that participants need to reside in California, this ethical standard is not applicable to your study (as it is not one of the listed states). Yes, the researcher has described their mandated reporting responsibility in clear layperson language in the consent/assent forms for the states listed above. This ensures that participants are aware of the researcher’s legal obligation to report suspected child abuse or neglect in those specific jurisdictions. Yes No NA ☒ ☐ ☐ Supporting details: Yes, the researcher has described their mandated The consent form contains no so information. Please add your reporting obligations to the Privacy section of your consent form so that individuals are aware of be the researcher’s own student or have a condition that would bias the results. Outside of these situations, efforts should be made to be as inclusive as possible. Exclusions need to be justified by either theoretical or empirical support. 32 Inclusion and exclusion criteria should be listed upfront in the recruitment material (flyer, invitation email, etc.) to prevent situations in which the researcher needs to screen using invasive questions or reject volunteers in a stigmatizing manner. 33 Any limits to confidentiality (i.e., duty to report) must be mentioned in the consent form. Outside of mandated reporting and supervision by Walden supervisors, researchers are expected to maintain confidentiality of all participants’ identities. 34 Typically applies to licensed teachers, social workers, health providers, mental health providers, etc. language in the consent/assent forms? c. If you are collecting data about possible violations of law/policy and have sworn a professional oath35 that requires you to report such activities even when you are off-duty: Describe your employer’s ethics code regarding off-duty reporting requirements and ensure that your consent form is clear in describing your reporting obligations in clear layperson language. 19. If the data collection steps could reveal or create an acute psychological state: Has a free or low-cost referral36 been provided in the consent form? 20. If the research design has multiple groups: Are measures in place to ensure that all participants can potentially benefit equally37 35 reporting responsibility in clear layperson language in the consent/assent forms for cases where their professional licensure mandates reporting child or elder abuse or neglect. This ensures that participants are informed about the researcher’s legal obligation to report such incidents in accordance with their professional requirements. Yes No NA ☒ ☐ ☐ Supporting details: Yes, the researcher has described their reporting obligations regarding possible violations of law/policy in clear layperson language in the consent form. In addition, they have made certain that their employer’s ethics code regarding the requirements for off-duty reporting is taken into consideration. This guarantees that participants are aware of the researcher’s responsibilities to report such activities even when they are not present. Yes No NA ☒ ☐ ☐ Supporting details: Yes, a free or low-cost referral has been provided in the consent form to address any acute psychological state that may arise during the data collection steps. Participants have access to appropriate resources to seek support if needed. Yes No NA ☒ ☐ ☐ Supporting details: the limits of your confidentiality. The consent form contains no so information. Please add your reporting obligations to the Privacy section of your consent form so that individuals are aware of the limits of your confidentiality. The consent form contains no such resource. If you feel this is necessary, you need to add this to the Risks section. You further would need to revise the risks on the consent form to more fully articulate the risks of your study as sharing sensitive information would not necessitate referral information. You need to explain the risks so as to provide context for why you are providing the referral information. It is unclear why you checked ‘yes’ as you do not identify collecting data from multiple participant groups elsewhere in your materials. If you will be collecting data from Can sometimes to apply to officers of the court, law enforcement officers, military officers but many departments only require reporting crimes in progress or those likely to cause serious bodily harm. 36 Possible referrals in the USA can be found at https://www.mentalhealth.gov/get-help/immediate-help or you could provide local, communitybased resources. Do not direct research participants to use 911. from the research? 21. If the researcher is a student: Will the student researcher be appropriately qualified38 and supervised39 in all data collection procedures? 22. If an existing survey or other data collection tool will be used: Has the researcher appropriately complied with the requirements40 for legal usage? 37 Yes, measures are set up to guarantee that all members can possibly benefit similarly from the exploration. This includes employing random assignment or other appropriate strategies to minimize any potential bias or favoritism in the research design and guaranteeing an equitable distribution of participants across groups maximizing any potential bias or favoritism in the research design. Yes No NA ☒ ☐ ☐ Supporting details: Yes, the student researcher will be appropriately qualified and supervised in all data collection procedures. The researcher will receive guidance and supervision from their supervising faculty member at Walden University, who will ensure that the researcher is competent and capable of conducting the data collection procedures effectively and ethically. Yes No NA ☒ ☐ ☐ Supporting details: Yes, the researcher has appropriately complied anyone other than individuals who were previously incarcerated and are not reintegrated into their community, you need to fully describe that in your IRB materials. If you have only the one participant group, then this ethical standard would not be applicable to your study. Confirmed If you are using or modifying an existing data collection tool, please submit documentation that confirms you have the necessary approval to use it. If the tool is part of the public domain, submit Control groups must be eligible to partake in the intervention after the study, if results show the intervention to be beneficial. If the design does not involve a control group, then the researcher only needs to ensure that all participants have equal access to the study results. 38 If your study is targeting a vulnerable population or involves a sensitive topic, describe any additional training you have completed beyond the research courses and ethics training. Researchers must be able to document their training in the data collection techniques and the IRB might require the researcher to obtain additional training prior to ethics approval. For most student researchers, the research course sequence is sufficient but some research procedures (such as interviewing victims or people with mental disabilities) may require additional training. For psychological assessments, the manual indicates specific qualifications required. Data collection from children requires a background check/clearance through a local agency. 39 Remote supervision is suitable for most studies but onsite supervision may be required for certain types of sensitive data collection (e.g., interviews or assessment regarding emotional topics). 40 IF YOU ARE USING A PUBLISHED INSTRUMENT: Many assessment instruments published in journals can be used in research as long as commercial gain is not sought and proper credit is given to the original source (United States Code, 17USC107). However, publication of an assessment tool’s results in a journal does not necessarily indicate that the tool is in the public domain. The copyright holder of each assessment determines whether permission and payment are necessary for use of that assessment tool. Note that the copyright holder could be either the Describe how and submit relevant documentation. with the requirements for legal usage of an documentation that confirms that (i.e., existing survey or other data collection tool. The PsycTest printout, weblink, etc.). Otherwise, analyst has acquired the essential authorizations submit documentation that you have and licenses to utilize the apparatus, guaranteeing approval from the instrument author (email that its use is lawful and in consistence with any copy is fine). copyright or licensed innovation guidelines. As supporting evidence, relevant documentation, such as licenses or permission letters, will be submitted, will be submitted as supporting evidence. Questions 23-40 pertain to the process of ensuring that potential participants make an informed decision about the study, in accordance with the ethical principle of “respect for persons.” 23. Do the informed consent41 procedures Yes No provide invitees adequate time to review the ☒ ☐ study information and ask questions before Please explain how and when the consent Supporting details: they are asked to consent? process will occur. Will you email the Yes, the informed consent procedures provide consent forms? Obtain consent at the time of invitees with adequate time to review the study in-person interviews? Something else? information and ask questions before they are asked to consent. The consent forms are provided to the participants in advance, allowing them sufficient time to read and understand the study details. Additionally, the researcher is available to answer any questions or concerns raised by the publisher or the author or another entity (such as the Myers and Briggs Foundation, which holds the copyright to the popular Myers-Briggs personality assessment). The researcher is responsible for identifying and contacting the copyright holder to determine which of the following are required for legal usage of the instrument: purchasing legal copies, purchasing a manual, purchasing scoring tools, obtaining written permission, obtaining explicit permission to reproduce the instrument in the dissertation, or simply confirming that the tool is public domain and providing credit by citation. Even for public domain instruments, Walden University encourages students to provide the professional courtesy of notifying the primary author of the student’s plan to use that tool in their own research. Sometimes this is not possible or there is no response. We recommend that the student make at least three attempts to contact the author at his or her most recently listed institution across a reasonable time period (such as 2 weeks). The author often provides helpful updates or usage tips and asks to receive a copy of the results. This type of communication with the author is not necessary when a website or publisher clearly states that the tool is public domain or can be used for academic/research purposes. Some psychological assessments are restricted for use only by suitably qualified individuals and these requirements are typically covered in the assessment’s manual. When in doubt, researchers must check with the assessment’s publisher to make sure that the student (or their faculty supervisor) is qualified to administer and interpret any particular assessments that they wish to use. IF YOU ARE CREATING YOUR OWN INSTRUMENT OR MODIFYING AN EXISTING INSTRUMENT: It is only acceptable to modify data collection tools if one explicitly cites the original work and details the precise nature of the revisions. Note that even slight modifications to items or instructions threaten the reliability and validity of the tool and make comparisons to other research findings difficult, if not impossible. 41 Informed consent is not just a form; it is a process of explaining the study to the participant and encouraging questions before the participant makes a decision about participation. 24. Will informed consent be appropriately42 documented? 25. Has the Consent Form Template been tailored using language that will be understandable43 to the potential participants? 26. Does the consent form explain the sample’s inclusion criteria in such a way that the participants can understand why THEY are being asked to participate? participants before they provide their consent. Yes No ☒ ☐ Supporting details: Yes, informed consent will be appropriately documented. The researcher will ensure that each participant completes and signs a consent form, indicating their voluntary participation in the study and their understanding of the study procedures, risks, benefits, and confidentiality measures. These consent forms will be securely stored and kept as a record of participants’ informed consent. Yes No ☒ ☐ Supporting details: Yes, the Consent Form Template has been tailored using language that will be understandable to the potential participants. The researcher has ensured that the consent form is written in clear and concise language, avoiding technical jargon or complex terminology. The form has been reviewed and edited to ensure its readability and comprehensibility for the target population. Yes No ☒ ☐ Supporting details: Yes, the consent form explains the sample’s inclusion criteria in a manner that participants can understand why they are being asked to participate. The researcher has clearly outlined the specific characteristics or criteria that make No. The statement of consent on the consent form is incomplete. You need to tailor this section to be consistent with the consent method used. Refer to the consent template for instructions in this regard. The inclusion criteria as stated on your consent form do not match what is on your invitation. When drafting your revised invitation, please ensure your inclusion criteria are consistently stated across documents. While documenting consent via signature is common, note that anonymous surveys can obtain “implied consent” by informing the participant, “To protect your privacy, no consent signature is requested. Instead, you may indicate your consent by clicking here/returning this survey in the enclosed envelope.”) Audiorecording verbal consent is also an option just before interviews. See posted sample consent form for email options. 43 Walden encourages tailoring the language to the readers as long as a professional tone is maintained. For the general population in the USA, aim for grade 5 to 7 reading level. 42 27. Does the consent form include an understandable explanation of the study purpose? 28. Does the consent form include an understandable description of the data collection procedures? 29. Does the consent form include an estimate individuals eligible for participation in the study. The language used in the consent form is clear and concise, ensuring that potential participants can easily comprehend the reasons for their selection to participate in the research. Yes No ☒ ☐ Supporting details: Yes, the consent form includes an understandable explanation of the study purpose. It provides a clear and concise description of the research aims and objectives, outlining what the study seeks to investigate or achieve. The language used in the consent form is designed to be accessible to potential participants, ensuring that they can comprehend the overall purpose of the research before providing their informed consent. Yes No ☒ ☐ Supporting details: Yes, the consent form includes an understandable description of the data collection procedures. It outlines the specific steps and activities that participants will be involved in during the research process, providing clear explanations of what will be expected from them. The language used in the consent form is designed to be easily comprehensible to potential participants, ensuring that they have a clear understanding of how their data will be collected. Yes No Confirmed Please add to the consent form that the interviews will be audio recorded. It seems you also intend to use a member checking step. This also should be described in the Procedures section on the consent form, ensuring it is described in lay language (focus on what you are asking participants to do). The sample questions on the consent form do not match questions on your interview protocol. Please clarify and revise as needed, noting that the sample questions on the consent form need to match exactly what will be asked in the interview. Given the difference in questions, this also calls into question whether the IRB has all of your interview questions. Please ensure you submit all interview questions you plan to ask to the IRB. Please add to the consent form about how of the time commitment44 for participation? 30. Does the consent form clearly state that participation is voluntary and that the participant has the right to decline or stop participation at any time? When recruitment occurs through the researcher’s network or through an organization, the consent form must include written assurance that declining or stopping will not negatively impact the participant’s relationship with the researcher or access to services provided by the organization, as applicable). 31. Does the consent form state how many participants the researcher is seeking? 32. Does the consent form include a description of reasonably foreseeable risks45 or discomforts? 44 ☒ ☐ Supporting details: Yes, the consent form includes an estimate of the time commitment for participation. It provides participants with an understanding of how much time they can expect to dedicate to the research study. This helps them make an informed decision about their willingness and availability to participate based on the time requirements outlined in the consent form. Yes No ☒ ☐ Supporting details: Yes, the consent form clearly states that participation is voluntary and that the participant has the right to decline or stop participation at any time. It includes a written assurance that declining or stopping will not negatively impact the participant’s relationship with the researcher or access to services provided by the organization, if applicable. This ensures that participants feel empowered to make their own decisions and are aware that they can withdraw from the study without any repercussions. Yes No ☒ ☐ Supporting details: Yes, the consent form states how many participants the researcher is seeking. This helps potential participants understand the scope of the study and provides transparency about the researcher’s recruitment goals. Yes No ☒ ☐ Supporting details: long, in minutes, the member checking step will be. Confirmed Confirmed This cannot be determined until the issues raised above are addressed. Provide an estimate (in minutes or hours) of each component of data collection (e.g., survey, interview, memberchecking. etc. ) The consent form should state that the minimal risks are similar to those encountered in daily life, in addition to describing any risks that are substantial. 45 33. Does the consent form include a brief description of anticipated benefits to participants46 and/or society? 34. Does the consent form describe any thank you gifts47, compensation, or lack thereof? 46 Yes, the consent form includes a description of reasonably foreseeable risks or discomforts. This ensures that potential participants are informed about any potential negative experiences or adverse effects they may encounter as a result of their participation in the study. Providing this information allows participants to make an informed decision about whether or not to participate. Yes No ☒ ☐ Supporting details: Yes, the consent form includes a brief description of anticipated benefits to participants and/or society. This is important to inform potential participants about the potential positive outcomes or contributions that may result from their participation in the study. It helps them understand the value and significance of their involvement. Yes No ☒ ☐ Supporting details: Yes, the consent form describes any thank you gifts, compensation, or lack thereof. This is important to provide transparency and clarity to participants regarding any form of reimbursement or compensation they may receive for their participation, or if there are no such incentives provided. It ensures that participants are fully The consent form states: The aim of this study is to benefit society by contributing to the development of more effective prerelease reentry programs and reducing recidivism. This is not appropriate and will need to be revised as you cannot know how the results of your study may be used nor will it reduce recidivism. The benefits of your study need to align with your research question, which is focused on understanding pre-release program participants’ perceptions towards the program and their re-entry. Such information could be used to inform on possible improvements. This is a subtle but critical distinction. Confirmed For most social science studies, it is appropriate to state that there are no particular direct benefits to the individual. In this case, just present the benefits to society and/or benefits to the group to which the participant belongs (i.e., teachers). 47 Offering a modest gift card (between $5 and $20) is common for interview studies and questionnaires that are not anonymous. Questionnaire studies more often provide a nominal donation to a relevant charity for each survey completed. Note that raffles are not permitted. 37. Is the consent document free of language that would waive the participant’s legal50 rights? informed about what they can expect in terms of any rewards or benefits. Yes No ☒ ☐ Supporting details: Yes, the consent form describes how privacy will be maintained and explicitly states that the data will not be used for any purposes other than research. It ensures that participants understand the confidentiality of their data and have reassurance that their information will be handled with care. Additionally, if there are any mandated reporting obligations, they are appropriately described in the consent form. Yes No ☒ ☐ Supporting details: Yes, the consent form appropriately discloses all potential conflicts of interest if the researcher is already known to the participants in another role or if the researcher will receive direct financial benefit from the study. It ensures transparency and allows participants to make an informed decision about their participation, knowing any potential conflicts of interest that may exist. Yes No ☒ ☐ Supporting details: The Walden template is free of exculpatory Yes, the consent document is free of language that 35. Does the consent form describe how privacy will be maintained48 and state that that the data will not be used for any purposes other than research? For this item, we strongly recommend using the language in Walden’s consent form template. This is also where any mandated reporting obligations should be described. 36. If the researcher would already be known in some other role to the participants or if the researcher will receive direct financial benefit from the study: Does the consent form disclose all potential49 conflicts of interest? 48 Confirmed No. Information above suggests that you may know, or be known to, potential participants. You thus need to acknowledge this on the consent form, along with a statement that this study is separate from that role. The consent template has language that would need to be used in this regard. Confirmed See posted template. The consent form should explain any coding system that will permit the researcher to withhold names in the research report; how names, contact info, and research data will be secured and eventually destroyed; and that the data will not be used for any purposes other than research. It is not always clear to participants how a research interview is different from a journalistic interview, in which informants might be named. So the consent form should make this distinction clear. For sensitive interviews, the researcher might also want to assure participants that recordings will be destroyed immediately after transcription. 49 Typically applicable only when the researcher has a dual role in relation to the participant (i.e., is known to the participant as a teacher, nurse, or similar professional role) or if the researcher is being compensated by some entity with a financial stake in the topic under study. 50 In some settings, consent forms include exculpatory language and/or ask the signer to waive rights. Walden does not permit that. language so be sure not to add anything exculpatory or asking participants to waive their rights. 38. Does the consent form explain how the participant can contact the researcher (for general questions about the study) and the university’s Research Participant Advocate (if they have questions about their rights as participants)? Contact info is 612-312-1210 or [email protected]). Provide international code if outside the USA. 39. Does the consent form include a statement that the participant should consider keeping a copy of the consent form? 40. If any aspect of the study is experimental (unproven), is that stated in the consent form? would waive the participant’s legal rights. It adheres to the guidelines provided in the Walden template and does not include any exculpatory language or requests for participants to waive their rights. This ensures that participants’ rights are protected throughout the research process. Yes No ☒ ☐ Supporting details: Yes, the consent form includes clear information on how participants can contact the researcher for general questions about the study. Additionally, it provides the contact information for the university’s Research Participant Advocate, including the phone number (612-3121210) and email address ([email protected]). The international code is provided if participants are located outside the USA. This ensures that participants have access to the necessary contacts for any inquiries or concerns they may have during their participation in the study. Yes No ☒ ☐ Supporting details: Yes, the consent form includes a statement advising participants to consider keeping a copy of the consent form for their records. This encourages participants to retain a copy of the document for future reference and to ensure they have access to the information provided to them throughout the study. Yes No NA ☒ ☐ ☐ Supporting details: Yes, if any aspect of the study is experimental or unproven, it is stated in the consent form. This ensures that participants are fully aware of the experimental nature of the study and have the Confirmed Confirmed This ethical standard is not applicable, as no aspect of your study is experimental in nature. opportunity to make an informed decision about their participation. It promotes transparency and allows participants to understand the potential risks and benefits associated with the experimental elements of the study. General comments from the IRB reviewer(s) that might not be directly related to research ethics: Your research question is oddly phrased by asking what “traits” were obtained through the program. Traits are not really something that people learn, since the definition of a trait is that it is something constant. (Note: the comments above are offered collegially in the interest of promoting top quality research, and are NOT stipulations for IRB approval.) SECTION II: RESEARCHER’S ELECTRONIC SIGNATURE By placing an X next to each of the following boxes and submitting this document from my official Walden email address, I (the researcher) am providing an electronic signature certifying that each of the statements below is true. X The information provided in this application form is correct, and was completed after reading all relevant instructions. I understand that I am requesting the university’s ethics approval to conduct the exact procedures described above. I understand that the IRB does not X review the proposal so I am responsible for ensuring that this form fully reflects the final set of procedures. I understand that any deviation from the participant recruitment and data collection procedures referenced in this form can result in invalidation of the X data and dismissal from the university. I will request IRB approval before making any modification to the participant recruitment and data collection procedures or forms, using the Request X for Change in Procedures Form on the Walden IRB Web site. I will report any mandatory reporting incidents or other adverse events within one week using the Adverse Event Reporting Form on the Walden IRB X Web site. X Neither recruitment nor data collection will be initiated until notification of approval to conduct research is received from [email protected]. X I understand that this research, once approved, is subject to continuing review and approval by the Committee Chair and the IRB. I will maintain complete and accurate records of all research activities (including consent forms and collected data, as per the Doctoral Student X Responsibilities Regarding Research Data outlined in the student handbook) and I will be prepared to submit them upon request to the IRB. X I understand that if any of the conditions above are not met, this research could be suspended and/or not recognized by Walden University. I understand that my data and research activities are subject to audit at any time by the university’s compliance office within the Center for Research X Quality. I have conducted my own inquiries to ensure that I am aware of any applicable state or international regulations that might apply to my proposed data collection (e.g., mandated reporting, privacy, protection of minors or other vulnerable populations). X Note to researcher: State-level professional organizations and licensing entities for your field are a good source of this information. An international compilation of human subjects policies can be found at this link: http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html To electronically* sign this document, the researcher must enter his or her official Walden email address below and send the materials from this Walden account: [email protected] Recidivism and Reentry Programs: Putting a stop to the Revolving Door Students must also provide their student number: A00690083 SECTION III: SUPERVISING FACULTY MEMBER ELECTRONIC SIGNATURE As the faculty member supervising this research, I assume responsibility for ensuring that the student complies with University requirements and US federal regulations regarding the use of human participants in research. By placing an X in each of these boxes and asking the student to CC my official Walden email address when submitting this document, I am providing an electronic signature certifying that each of the statements below is true. I have reviewed the researcher’s entries on this form as well as the supporting documents (e.g., consent form) and I confirm that they are consistent X with the procedures in the proposal. I will ensure that the researcher properly requests any protocol changes using the Request for Change in Procedures Form on the Walden IRB Web X site. I will ensure that the student promptly reports any unexpected or otherwise significant adverse events and general problems within 1 week using the X Adverse Event Reporting Form on the Walden IRB Web site. I will report any noncompliance on the part of the researcher by emailing notification to [email protected]. X To electronically* sign this document, the supervising faculty member must enter his or her official Walden email address below and then have the student CC this email address when the student submits these materials from his/her Walden account. A faculty member should notify [email protected] if a student submits any documents that the faculty member has not approved. [email protected] *IRB Policy on Electronic Signatures Electronic signatures are only accepted when the signer is either (a) the sender of the email, or (b) copied on the email containing the signed document. Electronic signatures are regulated by the Uniform Electronic Transactions Act.
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