Journal Assignment Week 9

RESEARCH ETHICS 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. After proposal approval, the IRB (Institutional Review Board) will evaluate your study based on the 40 ethical standards below.

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. While you may not complete the IRB application until your proposal has been approved, the IRB recommends that you make notes on each ethical standard below while planning your study (since the IRB application will ask these same 40 questions).

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

Educational Research

International 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 [email protected] for support.

Hover the mouse over the blue footnoted words to view tips and definitions.

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. Also, the name of the site/organization is typically masked in scholarly research such as the dissertation though in some cases, the organization can elect to publicize their name along with the research results.

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. 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.

ab Usually, studies possibly involving unknowing inclusion of vulnerable adults are still eligible for expedited ethics review.

ac 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.

ad Any limits to confidentiality (i.e., duty to report) must be mentioned in the consent form.

ae 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.

af 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.

ag 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).

ah READ THIS 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.

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:

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.

ai 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.

aj 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.”)

ak Walden encourages tailoring the language to the readers as long as a professional tone is maintained.

al Provide an estimate (in minutes or hours) of each component of data collection (e.g., survey, interview, memberchecking. etc. )

am Describe only the possible harms that go beyond the risks of daily life.

an 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.

ao 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.

ap A consent form should not ask a participant to waive any legal rights.