Every student must secure approval by Walden’s Institutional Review Board in order to conduct your research. The Institutional Review Board (IRB) is comprised of faculty members, dedicated staff, and at least one external reviewer at all times. The purpose of the IRB is to ensure ethical research involving human subjects—this research should be conducted with respect for individual choice; enacted with the greatest degree of beneficence/non-maleficence possible; protection of participants, particularly those of vulnerable populations; and with appropriate oversight. Though formal IRB consideration of a doctoral student’s study is not conducted until one’s proposal defense is successfully completed, students should be well-familiar with the requirements and recommendations of the IRB as they begin even the first steps of conceptualizing their work.
Keeping in mind a few helpful hints about the expectations of the IRB and common pitfalls should help ensure successful navigation of the process:
- There are few absolutes in the IRB process. The IRB is concerned with ensuring safety; primarily the board does this by ensuring that researchers have reasoned through all risks and benefits and have adjusted their protocols accordingly.
- Vulnerable populations require additional levels of protection. In general, persons from these populations may not truly have the capacity to sufficiently weigh the risks and benefits for participating in a study. They may be unduly influenced by any potentially coercive elements and may be at additional risk for emotional or physical harm. Vulnerable populations include, but are not limited to: children under the age of 18, pregnant women and fetuses, physically disabled persons, emotionally disabled persons, hospitalized persons, incarcerated persons, persons under community supervision for a crime, elderly persons, etc. Work with vulnerable populations is by no means impossible; however, in general, these studies are much more heavily scrutinized, any undue influence must be minimized to the greatest extent possible, and any guardians or conservators must give consent for participation for those who are unable to fully consent for themselves.
- Letters of informed consent and all instrumentation or interview questions must be in a format that is absorbable by the potential participants. Elements of importance include: grade level of language, jargon, transparency, etc. An example of an important consideration could include research conducted on clients with developmental disabilities; beyond the protections afforded them due to their vulnerable status, the language of informed consent documents would need to be very basic, in keeping with their level of cognitive functionality.
- Instrumentation should be appropriate for use with the identified population.
- Direct interventions tend to be rare for Walden University students. It is possible to have these approved; however, in approvable circumstances, usually the researcher is not the interventionist. Also, if the research is conducted at a school or similar setting, the institution will likely need to sponsor the research. Program analysis is similarly rare.
- Remuneration is acceptable as a thank you for participation. Remuneration must be considered in light of the particulars of the population being studied. Valuable items may present undue, coercive influence if the value is sufficiently large for the population. For instance, a $75.00 gift card to an adolescent may be large enough that the student could not reasonably turn down an offer to participate even if she or he would not otherwise wish to do so. Likewise, if remuneration is offered it should be offered in full to anyone who chooses to participate, even if they wish to withdraw from a study early.
- Avoid creating protocols that include selection of one’s own subordinates, students, clients, etc. These individuals could be influenced in a number of ways that would prevent them from making a reasoned choice to participate. For instance, subordinates may believe that they will receive special treatment to participate or that there would be negative repercussions should they choose not to participate. In instances of dual relationships, in general, potential participants may feel relationally responsible to participate.
- Dutifully reason through each of the potential risks outlined on the IRB application. Many students will select No Risk, even though there clearly could be instances in which the risk may occur. For instance, if one is conducting research with girls or women between the ages of 13 and 50, most should select at least Minimal Risk related to pregnant women participating in the study—the exception would be when inclusionary and exclusionary criteria that is explicitly laid out in the informed consent document prevents pregnant women from participating. An appropriate selection of No Risk for every item is rare.
- Member checking is not simply having participants review their transcripts. Member checking involves having participants actively involved in reviewing emergent themes and conclusions.
- Transcriptionists and any others who might have access to any protected information need to be written into the IRB application.
- Even after a protocol is approved, the IRB needs to be notified of any potential changes to a protocol, including adding a transcriptionist, changes to interview questions, etc.
- Anonymity and confidentiality are not the same things. Anonymity provides an extra level of protection. In this, no identifying information is obtained and, therefore, it is impossible to tie the data collected to any participant.
- Consent and assent are not the same—consent requires written documentation, while assent implies that continuing forward in a research study assumes assent to participate. An example of this might be having parents complete a consent form for a child, but allowing the child the ability to assent by choosing to continue or not in data collection by clicking forward through a computerized survey.