Sample irb application completed walden university

ETHICS SELF-CHECK APPLICATION FOR IRB 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. Mark “Not Applicable” only when there is no possible way to address that ethical issue.

Section 2: Attach enclosures as indicated in section II (yellow section).

Section 3: Provide electronic signature.

Section 4 (students only): Have your faculty supervisor review the entire form and then provide an electronic signature.

IRB approval will be issued when the IRB confirms that there is adequate evidence that the university’s ethical standards have been met, based on this form and the attachments listed in Section II of this form. Within 10 business days of receiving a researcher’s submission, the IRB will notify the researcher of one of the following outcomes:

(a) that the IRB has provided ethics approval based on the submitted documents; or

(b) that the IRB requires revisions and/or additional documentation (will be specified in Column B).

Questions can be sent to IRB@waldenu.edu . Click here to view IRB policies, forms, samples, and FAQs about conducting research in specialized contexts such as international, educational, or clinical/intervention settings.

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[endnoteRef:1]? Describe. Coercive elements include: leveraging an existing relationship to “encourage” participation, recruiting in a group[endnoteRef:2] setting, extravagant compensation, recruiting individuals in a school/work[endnoteRef:3] setting, involving a service/aid provider[endnoteRef:4] 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[endnoteRef:5]. [1: 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.] [2: 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. ] [3: 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.] [4: 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).] [5: 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 vulnerable[endnoteRef:6] individuals will be specifically sought out as participants, is such targeted recruitment justified[endnoteRef:7] by a research design that will specifically benefit that vulnerable group at large? Describe why. To specifically recruit vulnerable individuals as participants, the researcher will need to submit Form D for Non-expeditable Studies in addition to this self-check. [6: 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.] [7: 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).]

16. If vulnerable[endnoteRef:8] adults might happen to be included (without the researcher’s knowledge), would their inclusion be justified[endnoteRef:9]? Describe why. [8: 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.] [9: Usually, studies possibly involving unknowing inclusion of vulnerable adults are still eligible for expedited ethics review.]

17. If anyone would be excluded from participating, is their exclusion justified? Is their exclusion handled respectfully and without stigma[endnoteRef:10]? Describe. [10: 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.]

18. If the research procedures might reveal criminal activity or child/elder abuse that necessitates[endnoteRef:11] reporting, are there suitable procedures in place for managing this? Describe. [11: Any 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 in place to manage this? Describe.

20. If the research design has multiple groups, are measures in place to ensure that all participants can potentially benefit equally[endnoteRef:12] from the research? Describe how. [12: 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 student researchers: Will this researcher be appropriately qualified[endnoteRef:13] and supervised[endnoteRef:14] in all data collection procedures? Describe how. [13: 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.] [14: 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).]

22. If an existing survey or other data collection tool will be used, has the researcher appropriately complied with the requirements[endnoteRef:15] for legal usage? Describe how. [15: 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. This type of communication with the author is not necessary when a website or publisher clearly states that the tool is publicly domain. 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. ]