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. 1. WHAT IS 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. 2. WHEN DOES IRB APPROVAL HAPPEN? The IRB’s ethical review occurs after the defended proposal has been approved by the full committee. However, research ethics questions may be posed to the IRB at any time by emailing [email protected]. 3. 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 (A) 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 (B) 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 analysi ...

1. 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.
1. WHAT IS 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.
2. WHEN DOES IRB APPROVAL HAPPEN?
The IRB’s ethical review occurs after the defended proposal has

2. been approved by the full committee. However, research ethics
questions may be posed to the IRB at any time by emailing
[email protected].
3. 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
(A) 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
(B) 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

3. 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
(samples can be found here).
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):

4. 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 (samples can be found
here).
4. 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
5. 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:
a. 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

5. 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.
b. 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.
c. The consent form must describe data collection activities in a
manner that makes them very distinct from intervention
activities.
6. WHAT DETAILS ARE IMPORTANT IN SETTING UP THE
RESEARCH ARRANGEMENTS WITH MY PARTNER SITE?
WHEN SHOULD I ASK THE SITE TO SIGN A LETTER OF
COOPERATION?
Unless participant recruitment will occur via the Walden
participant pool or public methods (newspaper, phone book,
etc.), each study will require some sort of letter of cooperation
from the partner site(s). The signed letter 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 signed letter is
received by the IRB). 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

6. 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:
a. Detailed description of any recruitment, data collection,
memberchecking, and results dissemination activities that will
occur at the site.
b. 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.
c. 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.
d. 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.
7. 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:
a. The arrangement between the researcher and intervention site
must avoid any dynamic that makes it likely for the research

7. 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.
b. 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.
c. 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.
d. 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.
e. 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.
8. 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

8. committee configuration support an interdisciplinary approach.
Typically, a local site will need to oversee this type of data
collection.
9. 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.
10. 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

9. 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.
11. 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:
a. 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.
b. 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

10. studies across the world.
c. Strong clinical studies at Walden have used the following
designs:
i. phenomenological studies on past therapeutic experiences
ii. case studies triangulating multiple data sources
iii. followup studies to learn about longterm effects of a prior
intervention
iv. regression studies looking at response predictors based on
archival records or surveys (i.e., which client characteristics
predict better responses to intervention?)
v. regression studies looking at which formats, levels, and
combinations of therapies resulted in most positive outcomes
based on archival records
vi. surveys or interviews of clinicians to gain insight on clinical
training, practices, burnout, efficacy, job satisfaction, supports,
etc.
vii. 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
11. 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

11. 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 KEEPING DOCTORAL RESEARCH
AS ETHICAL AS POSSIBLE
Below are the solutions to the most frequently occurring ethical
challenges in doctoral research:

12. 1. Use anonymous methods if possible.
This is the simplest way to avoid pressuring subordinates,
students, or any other vulnerable individuals to participate in
your doctoral research.
2. Pay very close attention to alignment among the research
question, planned analyses, and types of data collection
proposed.
The IRB can only approve those specific components of data
collection that show promise of effectively addressing the
research question(s).
3. Use existing data whenever possible.
This avoids burdening others with risky or time-consuming
tasks just for the sake of research. When collection of new data
poses substantial time demands or privacy/safety risks to
participants, the research design will be closely examined so
that the potential benefits can be weighed against potential
risks.
4. Use existing measures whenever possible.
Unless the dissertation is being conducted specifically to
validate a new measure, creating a new instrument is typically
beyond the scope of a dissertation.
5. Check and DOUBLECHECK 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 item 12 of the IRB
application. If an audit reveals that a student deviated from that

13. specific list of IRB-approved procedures, then the data can be
invalidated and the final doctoral study rejected.
Posted October 20, 2015. The current version of this document
can be found here.
.
Week 4 Presentation:
Please use resources from Weeks 1 – 3 for this assignment.
From the list below, answer the following questions in
your PowerPoint presentation. This presentation should be no
less than twelve slides, not including title and Reference slide.
Your presentation should include graphics, as well as utilizing
the Note portion of the PowerPoint template. There are several
YouTube tutorials available to help guide you through this
presentation,
e.g. https://www.youtube.com/watch?v=lbc1HX8Jccw
Your presentation should include the following subsets of
psychology: Developmental, Personality, Learning/Memory and
Psychopathology, BioPsychology and Perception Psychology.
The following questions should be substantively addressed and
answered.
· What is your current interest in each of the above subfields of
psychology covered thus far?
· How can one utilize a degree in each of these fields of
psychology?
· What should your undergraduate degree plan be for the field
that interests you the most?
· Will you need to go to Graduate School to pursue these
careers?
· What surprised you the most about each of these fields?
· Thinking about the career field that interests you the most,
what do you believe you will have to improve upon to meet or

14. exceed expectations?
· The last two – four slides of your presentation should
substantively summarize what you found most interesting while
completing this assignment and at least one element you learned
during this assignment of which you can benefit in knowing
more.
Your presentation should include:
1. Title Slide
2. Body of slides, with Note portions (8-10 slides)
3. Conclusion/Summary (2-4 slides)
4. Reference Slide (at least three academic references)
IMPORTANT: You MUST utilize the Note portion of the
PowerPoint. Each slide should have at least one substantive
paragraph, e.g. five- seven sentences regarding what you have
highlighted on the slides. The Note portion is worth a
significant amount of points for this assignment.
Once you have completed the above assignment, please save as
a .pptx file and upload to the assignment link for Week 4.