RESEARCH ETHICS FAQS FOR
DOCTORAL STUDENTS IN THE CLINICAL/INTERVENTION FIELDS:
PRACTICAL TIPS FOR AVOIDING DELAYS AND PROBLEMS
IN THE RESEARCH APPROVAL PROCESS
This guide is designed to help students consider the ethical issues relevant to doctoral research occurring in clinical and intervention settings. These tips will be most helpful to students early in the research planning process, when they are considering potential research designs, sites, and samples. In this guide, the term, “intervention” refers to any form of therapeutic program, clinical treatment, psychotherapy, support groups, psychoeducational programs, training, or professional practice designed to promote change or development in individuals.
All doctoral students are required to obtain ethical approval from the university’s Institutional Review Board (IRB) before recruiting research participants or collecting data. The IRB’s ethical approval can only be given when the researcher demonstrates that potential benefits of the study are likely to outweigh the risks and burdens placed on participants, in accordance with the university's ethical standards as well as U.S. federal regulations.
Students may complete Form A to obtain preliminary feedback once they have submitted their proposal to the URR. However, final IRB approval cannot be provided until after the defended proposal has been approved by the full committee. Research ethics questions may be posed to the IRB at any time by emailing IRB@mail.waldenu.edu.
Service providers may analyze data from their own clients when it is either
-ongoing assessments that document progress
-worksheets or journals that primarily serve therapeutic purposes (as opposed to research purposes)
-any other data that is generated as a result of regular intervention activities
While it would not be ethical for a service provider student to leverage his/her authority in the organization to coerce patients/clients into providing data in order to achieve the personal goal of completing a doctoral degree, there are many situations in which it is ethically appropriate for a researcher’s doctoral study to consist of a secondary analysis of data that was primarily collected for the patient’s needs (for example: intake assessment, progress assessment, therapeutic journaling, therapeutic notes). A secondary data analysis of a patient records be possible if ALL of the following questions can be answered with a “yes.”
1. Aside from your study, would the data be used in some way that will directly benefit the patient/client?
2. Is the provider’s employer comfortable overseeing this type of data collection under its own policies and procedures (including the employer’s own consent form, if applicable)?
3. Is it possible for you to conduct your study without recording any names or other identifiers of individuals in your research records?
4. Is the organization’s research gatekeeper (i.e., C.E.O. or designee) comfortable signing a data use agreement releasing the de-identified patient records to you for research purposes?
5. (if applicable) This question only applies to those studies in which the researcher proposes to adjust some aspect of the patient assessment in order to make the data more amenable to research (for example: atypical timing of data collection, use of alternative or additional data collection tools, adding a reflective component, etc.):
Has the organization’s research gatekeeper explicitly approved any adjustments you propose to data collection that would depart from regular practices? Note that this explicit approval must be indicated in the organization’s letter of cooperation.
6. (if applicable) This final question only applies to those studies examining outcomes of an intervention (i.e., any system or program implemented to obtain desired outcomes):
Is the organization agreeing to fully sponsor and supervise the target intervention within the scope of its standard operations? Note that this explicit approval must be indicated in the organization’s letter of cooperation.
-surveys or assessments that are for research purposes only and serve no direct purpose for the client’s benefit
People in treatment (or preparing to begin treatment) are more vulnerable than the general population so clinical researchers are encouraged to address research question(s) using data from clients who have completed treatment whenever possible. Another ethical alternative is to conduct secondary analysis on treatment records. When these options are not feasible, then recruiting current intervention/therapy clients into an interview or questionnaire study is generally approvable, as long as (a) the data collection activities will not interfere with treatment progress (this will be assessed by the IRB), (b) the researcher is not a trusted or authority figure to the clients, and (c) recruitment ensures voluntary research participation by meeting each of the criteria below:
The site’s signed approval documentation is not required at the time the IRB application is submitted; a conditional IRB approval can be issued without the signed letter (and then the final IRB approval will be issued when the site’s approval documentation is received by the IRB). Prior to having the site agreement signed, we recommend having the IRB review a draft of the site agreement during the preliminary ethics review (during the URR phase). The option to obtain conditional approval is helpful when the site prefers that IRB review occur prior to their signing of the letter of cooperation. Students are encouraged to confer with the site early in the proposal development process to learn about the site’s research policies and preferences. However, it is generally not a good idea to ask them to actually sign a letter until the recruitment and data collection procedures have been finalized.
The letter of cooperation should include the following:
Yes, and the IRB staff will support clinical researchers in developing a protocol that will help them ensure that they meet the following additional ethical obligations for clinical research:
As per APA ethics code (section 2.01 on Boundaries of Competence), doctoral research must stay within the scope of the program’s coursework and may only cross over into other domains when the researcher’s coursework, training, and committee configuration support an interdisciplinary approach. Typically, a local site will need to oversee this type of data collection.
Yes, in many cases the IRB will require that researchers demonstrate or supplement their qualifications before they can be approved to conduct research with a vulnerable clinical population (e.g., individuals with mental or emotional disabilities). As per APA ethics code (section 2.01 on Boundaries of Competence), the IRB can only approve students to complete tasks for which they have adequate training, experience, and supervision. The IRB will work with the committee to develop a training plan. For example, the student may be required to first conduct a videorecorded pilot interview, which would be reviewed by a faculty member for feedback. In some cases, a mock interview with a faculty member might be required before the researcher can be approved to work with the clinical population.
The IRB cautions students against attempting this type of study for the doctoral dissertation. While prospective quantitative designs involving random assignment to experimental/control groups continue to be the clinical effectiveness “gold standard,” they are very difficult, expensive, and time-consuming for novice researchers to implement in such a manner that potential benefits outweigh potential risks. Even if the difficulty, expense, and time factors could be overcome, the main challenge is that Walden cannot sponsor or oversee interventions, so that means the Walden student may not manipulate the intervention for research purposes. In other words, Walden students may not randomly assign clients to different treatment conditions or have them delay their treatment in order to serve as a control group). The only possible exception (that would permit random assignment to groups) would be if the site has its own IRB that can oversee the intervention delivery and if the Walden student is eligible to serve as a primary investigator under the site’s IRB (e.g., if the student is employed by the site).
With the ability to randomize groups being limited for most students, the strongest quantitative option to compare two treatment approaches would be a quasi-experimental design (comparison of pre-existing groups). Note that it may be possible to retrospectively compare groups that received different types of treatment by performing secondary analysis of archival data from intake/final assessments. Another retrospective option might be a qualitative approach (such as phenomenology or case study) to analyze interview data from individuals who have experienced the two types of treatment the researcher wishes to compare.
Because a dissertation earns the student a doctoral degree, the ethical issues are inherently different from other types of clinical research. Below are some research design tips designed specifically for Walden doctoral students in clinical programs:
Walden’s IRB policy prohibits students who are service providers from recruiting their own clients into any type of “opt in” data collection including interviews, surveys, or assessments that are not part of the clients’ care. (Note that performing secondary analysis on a provider’s own archival records is permitted because it is far less likely to disrupt the client’s ongoing treatment and generally presents fewer risks to the client). The ethical rationale for prohibiting providers from collecting “opt in” data their own clients is based on several aspects of the fundamental research ethics principle of "respect for persons," as follows:
Below are the solutions to the most frequently occurring ethical challenges in doctoral research:
This is the simplest way to avoid pressuring subordinates, students, or other vulnerable individuals to participate in your doctoral research.
The IRB can only approve those specific components of data collection that show promise of effectively addressing the research question(s). Misalignment will cause approval delays.
Secondary data analysis (aka archival data analysis) is the most ethical way to study your own subordinates, students, clients, or any other vulnerable group because it does not ask them to do anything out of the ordinary for research purposes. Risks to these vulnerable individuals are managed by removing all identifiers from the dataset.
Unless the specific purpose of the doctoral research is the validation of a new measure, creating a new instrument is typically beyond the scope of a doctoral study.
The IRB does not review the entire proposal and can only approve the procedures that are listed in the IRB application itself. Thus, all participant recruitment and data collection procedures MUST be described in the IRB application. If an audit reveals that a student deviated from that specific list of IRB-approved procedures, then the data can be invalidated and the final doctoral study rejected.