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Research Ethics & Compliance: FAQs: Clinical /Intervention Settings

FAQs: CLINICAL/INTERVENTION SETTINGS

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.         

What is Institutional Review Board (IRB) approval?

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.

 

When does IRB approval happen?

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.

WHAT KINDS OF DATA MAY I ANALYZE FROM MY OWN CLIENTS/PATIENTS VIA SECONDARY ANALYSIS?

Service providers may analyze data from their own clients when it is either

 

  1. Collected anonymously via surveys (such that the provider doesn’t know who volunteered and who declined, and doesn’t know which responses belong to which participant), or
  2. A secondary analysis of data that meets all of the following criteria: (i) generated as a byproduct of normal intervention practices, (ii) no client names/identifiers are recorded in the research documents, and (iii) the IRB determines that the study is eligible for a HIPAA-compliant waiver of authorization to use protected health information for research purposes. This approach is sometimes called chart review, archival analysis, or secondary data analysis. It can also be used to analyze other providers’ records. Secondary data analysis can be approved for the following:

-intake assessments

-ongoing assessments that document progress

-worksheets or journals that primarily serve therapeutic purposes (as opposed to research purposes)

-clinical records

-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.

 

WHAT KINDS OF DATA MAY NOT BE COLLECTED FROM MY OWN CLIENTS/PATIENTS?

-interviews

-focus groups

-surveys or assessments that are for research purposes only and serve no direct purpose for the client’s benefit

CAN I INTERVIEW OR SURVEY PEOPLE WHO ARE UNDERGOING TREATMENT?

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:

 

  1. Recruitment materials must present the study as research not as therapeutic opportunity. While prospective designs in which the researcher recruits the participant for intervention + research are common elsewhere, these are not approvable at Walden because the university does not sponsor/oversee interventions. It is most appropriate to advertise the research opportunity among those who are already seeking or undergoing therapeutic services.
  2. In a treatment setting, researchers may not recruit participants in a manner that blurs the line between intervention and research. The separation between intervention and research must be very clear, with the Walden student solely responsible for the research component and not at all involved in the intervention component. Note that unobtrusive recruitment methods such as research invitations or flyers mailed or distributed from a clinic would be permissible as long as (a) the patient’s private information is not shared with the researcher without the client’s prior authorization, (b) the distinction between intervention and research activities is clear, and (c) the clinic’s IRB has either approved or exempted the data collection.
  3. The consent form must describe data collection activities in a manner that makes them very distinct from intervention activities.

 

WHAT DETAILS ARE IMPORTANT IN SETTING UP THE RESEARCH AGREEMENT WITH MY PARTNER SITE? WHEN SHOULD I ASK THE SITE TO SIGN A LETTER OF COOPERATION?

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:

  1. Detailed description of any recruitment, data collection, memberchecking, and results dissemination activities that will occur at the site.
  2. Detailed description of the involvement of any of the site’s personnel, rooms, or resources. Be sure to specify whether the personnel are to provide data during personal time or paid time.
  3. Clarity regarding whether the site personnel are providing any supervision of the research activities (particularly if the local personnel will be relied upon to help resolve a crisis situation). If not, then it is assumed that only the remote faculty members are supervising the researcher.
  4. Clear indication of the facility's role in sponsoring and assuming liability for the therapy/intervention under study. (Walden cannot sponsor, oversee,  or assume liability for interventions.) If the site is making any modifications to its standard intervention procedures in order to accommodate the research study, the letter needs to confirm that the site is willingly adopting these changes as part of their normal operations during the course of the study.

 

DOES CLINICAL RESEARCH INVOLVE ANY EXTRA RESPONSIBILITIES BEYOND THE REGULAR ETHICAL OBLIGATIONS THAT APPLY TO OTHER TYPES OF RESEARCH?

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:

 

  1. The arrangement between the researcher and intervention site must avoid any dynamic that makes it likely for the research dropouts to have decreased access to therapeutic services, a strained relationship with the service provider, or inferior quality of service. It is generally best if the provider(s) are blind as to who is participating in the research study.
  2. For particularly vulnerable clinical populations, the IRB may require a researcher to determine whether research participation could possibly undermine the client’s therapy or otherwise interfere with their therapeutic progress. The IRB will support the researcher in developing an appropriate plan for screening potential participants.
  3. For clients with mental disabilities, the researcher might be required to build in a comprehension check or mental status evaluation to determine whether the individual has the cognitive capacity to consent to research participation.
  4. Even though the intervention delivery is not under Walden’s purview, the university can only partner with reputable providers. So the researcher must be prepared to document the qualifications, current licensure, and liability coverage (if applicable) for any intervention agents (i.e., counselors, nutritionists, etc.) at the intervention partner sites. Note that researchers may not enlist care providers who are family members (or anyone with a conflict of interest) as intervention partners.
  5. In rare, exceptional circumstances, intervention researchers may be required to make regular reports to Walden’s Data and Safety Monitoring Board. There is a 2-page supplement to the IRB application that the IRB will give to intervention researchers, as needed.

CAN A PSYCHOLOGY STUDENT ANALYZE PHYSIOLOGICAL OUTCOMES (CORTISOL LEVELS, NEUROLOGICAL FUNCTIONING, ETC?)

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.

DO I NEED SPECIAL TRAINING TO COLLECT DATA FROM A VULNERABLE CLINICAL POPULATION?

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.

CAN I COMPARE TWO TREATMENT APPROACHES? OR COMPARE A TREATMENT AND CONTROL GROUP?

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.

 

WHICH RESEARCH DESIGNS TEND TO WORK BEST FOR DOCTORAL RESEARCH IN CLINICAL AREAS?

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:

 

  1. When a prospective design is not feasible, considering using a retrospective design, such as performing secondary analysis of clinical records. This will usually enable a larger sample size and much quicker data collection/analysis period. Client consent can often be waived (as per HIPAA) for analysis of records, if the provider removes identifiers from the records before sharing them with the researcher or the researcher performs the “chart review” in such a way that names are not recorded in the researcher’s records.

 

  1. When researchers are interested in studying data from standard, validated measures, we encourage them look into whether any de-identified data sets already exist. The university has a subscription to ICPSR, which permits students and faculty to access data from hundreds of clinical, social, and political studies across the world.

 

  1. Strong clinical studies at Walden have used the following designs:
    1. phenomenological studies on past therapeutic experiences
    2. case studies triangulating multiple data sources
    3. followup studies to learn about longterm effects of a prior intervention
    4. regression studies looking at response predictors based on archival records or surveys (i.e., which client characteristics predict better responses to intervention?)
    5. regression studies looking at which formats, levels, and combinations of therapies resulted in most positive outcomes based on archival records
    6. surveys or interviews of clinicians to gain insight on clinical training, practices, burnout, efficacy, job satisfaction, supports, etc.
    7. studying one or more mental health facilities’ operational data to examine variables such as client outcomes, demographics of clients served, clients lost to followup versus clients completing therapy, personnel retention, repeat clients, impacts of leadership transitions, impacts of other staff transitions

WHY CAN’T I INTERVIEW OR SURVEY MY OWN CLIENTS?

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:

  1. Conflict of interest: The researcher role introduces potential conflicts of interest with the service provider role, regarding whether research participation is in the client’s best interest. Conflicts of interest may also arise regarding client assessment, client outcomes, and research results.
  2. Competence in protecting research participants: Student researchers are less experienced in protecting potential participants from adverse consequences of declining participation or withdrawing from participation.  Walden acknowledges that APA does not prohibit experienced researchers from inviting clients to participate in research, provided that the necessary protections are in place.
  3. Inherent coercion when a provider invites a client to participate in research: Despite any assurances that the provider may give on a consent form about the voluntary nature of the study, the relationship between the provider and client is likely to cause the client to feel pressured to participate in the provider’s study even when it may not be in the client’s best interest.
  4. Straining provider-client relationship for personal gain: Even if the participant declines, the dynamic of declining is likely to negatively impact the provider-client relationship, which then impacts ongoing care. Straining the provider-client relationship for personal gain (earning a doctoral degree) would not be ethical.

 

General tips for avoiding ethical problems in doctoral research

 Below are the solutions to the most frequently occurring ethical challenges in doctoral research:

  1. Use anonymous methods if possible.

This is the simplest way to avoid pressuring subordinates, students, or other vulnerable individuals to participate in your doctoral research.

  1. Pay very close attention to alignment among the research question(s), planned analyses, and components of the proposed data collection.

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.

  1. Use existing data whenever possible.

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.

  1. Use existing measures whenever possible.

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.

  1. Check and double-check that all IRB materials reflect the final set of research questions and procedures.

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.