RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT
RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT
This worksheet is designed to help a student researcher anticipate and manage possible ethical concerns that are relevant to planning and executing a study. After proposal approval, the 40 ethical standards below will be used by the IRB (Institutional Review Board) to evaluate your study. RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT
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INSTRUCTIONS: To ensure a smooth ethics review, build your proposal and your research design so that the answer to each question below is “yes.” You should be as objective and self-critical as possible during this self-evaluation in order to spot and resolve any potential ethical challenges in advance.
Researchers proposing to complete research in the following specialized areas should first review the relevant research ethics FAQs on the IRB website:
Clinical or Intervention Research
Research in One’s Own Workplace
Research about Bullying or Other Potential Issues Related to Safety
If you don’t know how to address one of the ethical standards below, just email IRB@mail.waldenu.edu for support or join the IRB office hours at one of the posted times.
Hover the mouse over the blue footnoted words to view tips and definitions.
| The first 13 questions apply to all studies (even when the researcher is not interacting with participants to collect new data). | |
| 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. | |
| 1. Has each data collection step[a] been articulated in the method section of the proposal? |
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| 2. Will the research procedures ensure privacy[b] during data collection? | |
| 3. Will data be stored securely[c]? | |
| 4. Will the data be stored for at least 5 years? | |
| 5. If participants’ names or contact info will be recorded in the research records, are they absolutely necessary[d]? | |
| 6. The research procedures and analysis/writeup plans must include all possible measures to ensure that participant identities are not directly or indirectly[e] disclosed. | |
| a. For research topics that might 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? RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT | |
| 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? | |
| c. For all topics: The standard for Walden capstones is to NOT name the partner organization. Will you mask the identity of any partner organizations that are playing a role in data collection and/or identification of potential participants?
Exceptions to the organization-masking practice must be granted by the Program Director (via Prospectus Review) and approved by the IRB. |
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| 7. Have confidentiality agreements[f] been signed by anyone[g] who may view data that that contains identifiers? (e.g., transcriber, translator) | |
| 8. Has the researcher articulated a specific plan[h] for sharing results with the participants and community stakeholders? | |
| 9. Have all potential psychological[i], relationship[j], legal[k], economic/professional[l], physical[m], and other risks been fully acknowledged[n] and described? | |
| 10. Have the above risks been minimized as much as possible? Are measures in place to provide participants with reasonable protection from loss of privacy, distress, psychological harm, economic loss, damage to professional reputation, and physical harm? | |
| 11. Has the researcher proactively managed any potential conflicts of interest[o]? | |
| 12. Are the research risks and burdens[p] reasonable, in consideration of the new knowledge[q] that this research design can offer? | |
| 13. Is the research site willing[r] to provide a Letter of Cooperation and/or Data Use Agreement granting permission[s] for all relevant data[t] access, access to participants, facility use, and/or use of personnel time for research purposes? IRB staff will advise which type of site agreement is needed. State whether you will be obtaining written site approval before or after Walden IRB approval. | |
| The remaining questions only apply to studies that involve recruiting participants to collect new data. | |
| 14. Is participant recruitment coordinated in a manner that is non-coercive[u]? Coercive elements include: recruiting in a group[v] setting, extravagant compensation, recruiting individuals in a context of their treatment or evaluation[w], 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[x]. RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT | |
| 15. If vulnerable[y] individuals will be specifically sought out as participants, is such targeted recruitment justified[z] by a research design that will specifically benefit that vulnerable group at large? | |
| 16. If vulnerable[aa] adults might happen to be included (without the researcher’s knowledge), would their inclusion be justified[bb]? | |
| 17. If anyone would be excluded from participating, is their exclusion justified? Is their exclusion handled respectfully and without stigma[cc]? | |
| 18. If the research procedures might reveal criminal activity or child/elder abuse that necessitates[dd] reporting, are there suitable procedures in place for managing this? | |
| 19. If the research procedures might reveal or create an acute psychological state that necessitates referral, are there suitable procedures in place to manage this? | |
| 20. Does the research design ensure that all participants can potentially benefit equally[ee] from the research? | |
| 21. Applicable for student researchers: Will this researcher be appropriately qualified[ff] and supervised[gg] 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 requirements[hh] for legal usage? | |
| 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[ii] procedures provide adequate time to review the study information and ask questions before giving consent? | |
| 24. Will informed consent be appropriately[jj] documented? | |
| 25. Is the consent form written using language that will be understandable[kk] to the potential participants? | |
| 26. Does the consent form explain the sample’s inclusion criteria in such a way that the participants can understand how/why THEY are being asked to participate? RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT | |
| 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[ll] for participation? | |
| 30. Does the consent form clearly state that participation is voluntary? | |
| 31. Does the consent form convey that the participant has the right to decline or discontinue participation at any time? When the researcher is already known to the participant, the consent form must include written assurance that declining or discontinuing will not negatively impact the participant’s relationship with the researcher or (if applicable) the participant’s access to services. | |
| 32. Does the consent form include a description of reasonably foreseeable risks[mm] or discomforts? | |
| 33. Does the consent form include a description of anticipated benefits to participants[nn] and/or others? | |
| 34. Does the consent form describe any thank you gift(s), compensation, or reimbursement (for travel costs, etc.) or lack thereof? | |
| 35. Does the consent form describe how privacy will be maintained[oo]? | |
| 36. Does the consent form disclose all potential conflicts of interest? | |
| 37. Does the consent document preserve the participant’s legal[pp] rights? | |
| 38. Does the consent form explain how the participant can contact the researcher and the university’s Research Participant Advocate? (USA number 001-612-312-1210 or email address irb@mail.waldenu.edu). | |
| 39. Does the consent form include a statement that the participant should keep/print a copy of the consent form? | |
| 40. If any aspect of the study is experimental (unproven), is that stated in the consent form? | |
FOOTNOTES:
[a] In order to weigh potential risks against benefits, the researcher first needs to plan and clearly articulate all of the following that apply:
how existing data or contact information of potential participants will be obtained,
format and context of the initial contact with potential participants,
informed consent procedures,
assignment to groups (if applicable),
description of any pilot activities,
data collection steps,
transcript review and/or membercheck (if applicable), and
how results will be shared with stakeholders.
[b] Privacy risks might include unintended breach of confidential information (such as educational or medical records); being observed/overheard by others while meeting researcher or providing data; or intrusion on the privacy of others who not involved in study (e.g. participant’s family).
[c] Secure data storage requires password protection on electronic files and locks for physical data.
[d] 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.
[e] Participant identities might be “indirectly” and unintentionally disclosed if a researcher’s final research report fails to withold 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 would likely 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…” RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT
[f] A sample confidentiality agreement can be found on the IRB website.
[g] Confidentiality agreements are required for transcribers or interpreters but not for the researcher or Walden faculty/staff who are automatically bound to confidentiality. Some professional transcribers/statisticians/etc address confidentiality in their work agreement and this is acceptable.
[h] It is important that the format is audience-appropriate. Stakeholders may lack the time or inclination to digest a full research article or dissertation. Typically a 1 to 2 page summary or verbal presentation is most appropriate.
[i] Psychological risks include stress greater than what one would experience in daily life (e.g., materials or topics that could be considered sensitive, offensive, threatening, degrading).
[j] Relationship risks are present if the recruitment or data collection process are likely to alter the existing dynamics between the researcher and participant (who may be coworkers or have some professional relationship), among participants (if they know one another), or between the participant and the participant’s friends, coworkers, or family members.
[k] Legal risks are present if data collection might result in a participant’s disclosure of violation of laws.
[l] 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.
[m] Physical risks are not common in social science research but would involve risk of serious physical injury.
[n] Minimal risks are acceptable but must be identified upfront. Minimal risk is defined as when: “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.”
[o] 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).
[p] All research activities place some degree of burden on the participants by asking the participants to share personal information, volunteer time, and assume risks.
[q] 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.
[r] If a site 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 community partner’s letter of cooperation.)
[s] 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.
[t] Note that when medical, educational, or business records would be analyzed or used to identify potential research participants, the site needs to explicitly approve access to data for research purposes (even if the researcher normally has access to that data to perform their job).
[u] 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.
[v] 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.
[w] Generally, data collection cannot be approved during work hours or school hours unless a “free period” has been identified (e.g., lunch, 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.
[x] 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. RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT
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
[y] Vulnerable participants include students, patients, the researcher’s subordinates, children, prisoners, residents of any facility, mentally/emotionally disabled individuals, crisis victims, or anyone else who might feel undue pressure to participate in the study or be in any way limited in protecting their own best interests. Pregnant women (and their unborn children) are only considered a vulnerable population when a study involves physically risky data collection.
[z]Targetted 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 to must be issued via the full board’s vote (as opposed to expedited ethics review).
[aa] It is ethically acceptable to unknowingly 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, 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.
[bb] Usually, studies possibly involving unknowing inclusion of vulnerable adults are still eligible for expedited ethics review.
[cc] When applicable, the exclusion criteria should be listed on the recruitment material (flyer, invitation email,etc.) or consent form to prevent situations in which the researcher rejects volunteers in a stigmatizing manner.
[dd] Any limits to confidentiality (i.e., duty to report) must be mentioned in the consent form.
[ee] 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.
[ff]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.
[gg] 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).
[hh] READ THIS IF YOU ARE USING A PUBLISHED INSTRUMENT: RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT
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.
Even for public domain instruments, Walden University requires students to provide the professional courtesy of notifying the primary author of your plan to use that tool in their own research. Sometimes this is not possible, but at least three attempts should be made to contact the author at his or her most recently listed institution across a reasonable time period (such as 2 weeks). The author typically provides helpful updates or usage tips and asks to receive a copy of the results.
Many psychological assessments are restricted for use only by suitably qualified individuals. When in doubt, researchers must check with the test’s publisher to make sure that they are qualified to administer and interpret any particular assessments that they wish to use.
READ THIS IF YOU ARE CREATING YOUR OWN INSTRUMENT OR MODIFYING AN EXISTING INSTRUMENT: RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT
It is not acceptable to modify assessment tools without explicitly citing the original work and detailing 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. Therefore, unless a purpose of the study is to compare the validity and reliability of a revised measure with that of one that has already been validated, changes should not be made to existing measures.
[ii]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 participant. The IRB website provides an informed consent form template that researchers are invited (but not required) to use.
[jj] 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.”)
[kk] Walden encourages tailoring the language to the readers as long as a professional tone is maintained.
[ll] Provide an estimate (in minutes or hours) of each component of data collection (e.g., survey, interview, memberchecking. etc. )
[mm] Describe only the possible harms that go beyond the risks of daily life.
[nn] For most 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.
[oo] 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.
[pp] A consent form should not ask a participant to waive any legal rights. RESEARCH ETHICS PLANNING WORKSHEET ASSIGNMENT