or ask the signer to waive rights. Walden does not permit that. The Walden consent form template does not ask participants to waive any 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 irb@mail.waldenu.edu). 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?

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SECTION I: RESEARCHER’S CONFIRMATION OF ETHICAL STANDARDS COMPLIANCE	Answer each question below with yes, no, or N/A. If you cannot easily answer “yes” or “N/A” to each of the ethical standards below, then you probably need to build extra protections into your research procedures.
Sample: Will data be stored securely?	Sample response: Yes. Supporting details: Paper surveys will be stored in a locked file cabinet at the researcher’s home. Electronic files will be stored on the researcher’s password-protected computer and backed up on a password-protected cloud drive.
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/where[footnoteRef:1] details for each step, in sequential order. Here are samples . Describe pilot[footnoteRef:2] steps first if you are doing a pilot or road test.) [1: HOW = Write this like a recipe, including enough details so that a person 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.]
2. Will the research procedures ensure privacy[footnoteRef:3] during data collection? Describe how. [3: Privacy risks might include unintended breach of confidential information (such as educational or medical records); being observed/overheard by others while providing data; or intrusion on the privacy of others who not involved in study (e.g. participant’s family).]
3. Will data be stored securely[footnoteRef:4]? Describe how. [4: Secure data storage requires password protection on electronic files and locks for physical data.]
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 recorded in the research records, are they absolutely necessary[footnoteRef:5]? Describe why or clarify that data collection is 100% anonymous[footnoteRef:6] (which is preferable). [5: Retaining identifiers and/or contact information might be necessary if the researcher needs to follow up for a memberchecking step. Note that consent forms do not require signatures if the participant can indicate consent by some action such as clicking on a link, returning a completed survey, etc. Whenever possible, data should be collected without names or other identifiers.] [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.”]
6. The research procedures and analysis/writeup plans must include all possible measures to ensure that participant identities are not directly or indirectly disclosed. a. Only for research topics that possibly involve some stigma (i.e., workplace bullying): Can you confirm that the volunteering and data collection process will not result in others learning of your volunteers’ participation in the study?
b. For all topics: If participant demographic details (i.e., age, ethnicity, number of years in a position) are going to be shared in the final results, will they be shared in a manner that will not render certain participants identifiable[footnoteRef:7]? [7: Participant identities might be indirectly and unintentionally disclosed if a researcher’s final research report fails to withhold demographic details or site descriptions that might permit a reader to deduce the identity of a participant. So the researcher needs to think 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 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 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 an appropriate demographic description would be: “One African-American vice-principal with 10+ years of administrative experience described the professional development experience as…”]
c. For all topics: The standard for Walden capstones is to not name the partner organization in published reports, including ProQuest. Will you mask the identity of any partner organizations that are playing a role in data collection and/or recruitment of potential 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 prospectus approval.
7. Will confidentiality agreements[footnoteRef:8] be signed by anyone[footnoteRef:9] who may view data that that contains identifiers? (e.g., transcriber, translator) If so, submit a blank copy. If only the researcher and Walden faculty/staff will view the raw data, then enter NA. [8: A sample confidentiality agreement can be found here.] [9: Confidentiality agreements are required for transcribers or translators but not for the researcher or Walden faculty/staff (who are all automatically bound to confidentiality). Some professional transcribers/statisticians/etc address confidentiality in their work agreement and this is acceptable.]
8. The ProQuest publication at the end of the doctoral program is for the academic community. Is a specific plan[footnoteRef:10] in place for sharing results with the participants and community stakeholders? Describe. [10: 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. Typically, a 1 to 2 page summary or verbal presentation is most appropriate. Note, 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. Privacy risks are present if there is any possibility of data being linked to participants’ identities or if anyone could possibly see or hear responses during data collection. ]
9. Social science research typically involves minimal[footnoteRef:11] risks and sometimes involves substantial[footnoteRef:12] 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). [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.” ] [12: 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.] a. Are potential psychological[footnoteRef:13] risks acknowledged and described here? [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 mild distress.]	Mark one: NA Minimal psychological risks include: Substantial psychological risks include:
b. Are potential relationship[footnoteRef:14] risks acknowledged and described here? [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.]	Mark one: NA Minimal relationship risks include: Substantial relationship risks include:
c. Are potential legal[footnoteRef:15] risks acknowledged and described here? [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.]	Mark one: NA Minimal legal risks include: Substantial legal psychological risks include:
d. Are potential economic/professional[footnoteRef:16] risks acknowledged and described here? [16: 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.]	Mark one: NA Minimal professional risks include: Substantial professional risks include:
e. If there are any other potential risks, have they been acknowledged and described here?	Mark one: NA Other minimal risks include: Other substantial risks include:
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.
11. Will the researcher be proactively managing any potential conflicts of interest[footnoteRef:17] (particularly when researcher is known to the participants in some professional role)? Describe how. [17: 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).]
12. Are the research risks and burdens[footnoteRef:18] reasonable, in consideration of the new knowledge[footnoteRef:19] that this research design can offer? Describe why. [18: All 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.]
13. Will[footnoteRef:20] the research partner organization(s) grant permission[footnoteRef:21] for all relevant data[footnoteRef:22] access, access to participants, facility use, and/or use of personnel time for research purposes? IRB staff will advise which type of partner agreement is needed, if any. State whether you will be obtaining written partner organization approval before or after Walden IRB approval. [20: 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).]
14. Is participant recruitment coordinated in a manner that is non-coercive[footnoteRef:23]? Describe. Coercive elements include: leveraging an existing relationship to “encourage” participation, recruiting in a group[footnoteRef:24] setting, extravagant compensation, recruiting individuals in a school/work[footnoteRef:25] setting, involving a service provider[footnoteRef:26] in the recruitment process, etc. A researcher must disclose here whether/how the researcher may already be known to the participants and explain how perceptions of coerced research participation will be minimized[footnoteRef:27] . [23: For example, anonymous surveys and/or low-pressure communications such as 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, etc.) or an aid provider (shelter staff) to give research invitations to clients who meet the inclusion criteria. However, we cannot approve for the service/aid 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).] [27: 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.]
15. If you were directed to complete Form D in order to specifically recruit certain vulnerable individuals[footnoteRef:28] as participants, answer the following question: Is targeting this population justified[footnoteRef:29] by a research design that will specifically benefit that vulnerable group at large? Describe why. [28: For this purpose, vulnerable individuals include children, prisoners, people with cognitive impairments, on-duty military personnel, people living in an institutional setting such as a prison, inpatient care, rehab center, or shelter.] [29: Convenience sampling is not approvable. Targeted recruitment of children as participants can only be approved when a majority of the IRB votes that the study’s benefits justify its risks/costs (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).] If you were not directed to complete Form D, enter NA.
16. All samples could potentially include adults who are vulnerable[footnoteRef:30] (without the researcher’s awareness) and it is important to include their perspectives. Would the benefits of including these individuals outweigh the risks? [30: It is ethically appropriate to include certain vulnerable adult populations if screening for that particular status would be overly invasive, given the research topic. For example, a researcher might unknowingly have participants who happen to be pregnant, residents of a facility, low-income, mentally/emotionally disabled, victims of a crisis, or elderly. We don’t expect researchers to screen for these statuses routinely for minimal risk research. However, minors may never be unknowingly recruited; adult recruitment procedures must deliberately avoid recruiting minors and/or include a reliable way of discerning that participants are 18 or older.]
17. If anyone would be excluded from participating, is their exclusion justified? Is their exclusion handled respectfully and without stigma[footnoteRef:31] ? Describe. [31: When a study has exclusion criteria, they should be listed upfront in the recruitment material (flyer, invitation email,etc.) or consent form to prevent situations in which the researcher rejects volunteers in a stigmatizing manner.]
18. If the research procedures might reveal criminal activity or child/elder abuse that necessitates[footnoteRef:32] reporting, are there suitable procedures in place for managing this? Describe. [32: Typically, researchers only break confidentiality when they are LEGALLY REQUIRED to report certain information to authorities. Mandated reporting requirements in the USA vary by state so researchers will need to make themselves aware of state requirements. (Typically, mandated reporting only applies to researchers in professions that involve a sworn oath such as police officers or professions with licensure requirements, such as teachers and some other care providers.) Outside of mandated reporting, researchers are expected to maintain confidentiality. Any professional limits to confidentiality (i.e., duty to report) must be mentioned in the consent form. ]
19. If the research procedures might reveal or create an acute psychological state that necessitates referral, are there suitable procedures[footnoteRef:33] in place to manage this? Describe. [33: At minimum, the consent form should describe a free or low-cost referral to a support resource when it is possible that the study activities may cause distress.]
20. If the research design has multiple groups, are measures in place to ensure that all participants can potentially benefit equally[footnoteRef:34] from the research? Describe how. [34: 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.]
21. Applicable for all student researchers: Will this researcher be appropriately qualified[footnoteRef:35] and supervised[footnoteRef:36] in all data collection procedures? Describe how[footnoteRef:37] . [35: 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 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.] [36: 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).] [37: If your study is targeting a vulnerable population or involves a sensitive topic, describe any additional training or experience beyond the research courses and ethics training you have completed.]
22. If an existing survey or other data collection tool will be used, has the researcher appropriately complied with the requirements[footnoteRef:38] for legal usage? Describe how and submit relevant documentation. [38: 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 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. ]
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 consent[footnoteRef:39] procedures provide adequate time to review the study information and ask questions before giving consent? [39: 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. The IRB website provides an informed consent form template that researchers are invited (but not required) to use.]
24. Will informed consent be appropriately[footnoteRef:40] documented? [40: 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.”) See posted sample consent form for email options.]
25. Has the Consent Form Template been tailored using language that will be understandable[footnoteRef:41] to the potential participants? [41: 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.]
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?
27. Does the consent form include an understandable explanation of the research purpose?
28. Does the consent form include an understandable description of the data collection procedures?
29. Does the consent form include an estimate of the time commitment[footnoteRef:42] for participation? [42: Provide an estimate (in minutes or hours) of each component of data collection (e.g., survey, interview, memberchecking. etc. )]
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 risks[footnoteRef:43] or discomforts? [43: 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.]
33. Does the consent form include a description of anticipated benefits to participants[footnoteRef:44] and/or society? [44: 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).]
34. Does the consent form describe any thank you gifts[footnoteRef:45], compensation, or reimbursement (for travel costs, etc.) or lack thereof? [45: Offering a modest gift card (between $5 and $20) is common for interview studies and questionnaires that are not anonymous. Note that raffles are not permitted.]
35. Does the consent form describe how privacy will be maintained[footnoteRef:46] 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 . [46: The consent form should explain any coding system that will permit the researcher to not use 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.]
36. Does the consent form disclose all potential[footnoteRef:47] conflicts of interest? [47: Only applicable if 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).]
37. Does the consent document preserve the participant’s legal[footnoteRef:48] rights? [48: In some settings, consent forms include exculpatory language and/or ask the signer to waive rights. Walden does not permit that. The Walden consent form template does not ask participants to waive any 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 irb@mail.waldenu.edu). 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?

RESEARCH ETHICS APPROVAL CHECKLIST (PLANNING WORKSHEET) This worksheet is designed to help a student researcher anticipate and manage possible ethical concerns that are relevant to planning and executing a study

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