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).]