Protection of Human Subjects

A. Risk to Human Subjects

A.1. Human Subjects Involvement, Characteristics, and Design. Participants in this
study will include pregnant and parenting women of all ages and ethnicities who present with
two or more comorbidities. Comorbidities are defined as having two or more health conditions at
the same time. Researchers will be overseen by Mental Health Occupational Therapist Dr.
Pitonyak. The study will benefit from involving pregnant and parenting women because this
would add valuable information to our research about the comorbidities that women are facing.
We will exclude all participants that do not meet the study requirements. We will survey all
participants that volunteer to participate in the study but only interview 10 women. The study
will persist for 8 months and data will be collected for 6-8 weeks. The study will take place at
Triumph Treatment Services (TTS).
A.2. Sources of Research Material. The study will include IRB approved flyers that will
be distributed to the women during their intervention at TTS and they will have a week to
determine whether they want to be a part of the study. Dr. Jennifer Pitonyak will be
administering the Canadian Occupational Performance Measure (COPM) on the women. There
will be a pretest and posttest to compare data. Additional information about the participants will
be collected through their occupational profile by Dr. Pitonyak. The occupational profile will
include questions about comorbidities and health promotion. Student researchers will give
prompts in journals resulting in written communication or drawings after the women receive the
occupational intervention. Participant confidentiality will be protected by assigning research
numbers to participants. Hard copies of participant information will be stored in a secure locked
file and will be destroyed after the study is completed. Microsoft Teams will be used to secure
and store participant data collection and information. Microsoft Teams is secured through the
university firewall. We will get permission from the women to scan their journals and upload a
copy to Microsoft Teams. We will be monitoring participants to ensure participant safety.
A.3. Potential Risks. The risks of engaging in this study are minimal. The risks include
discussing difficult topics that bring up past trauma, discomfort with disclosing personal
information, stress to additional commitments, symptoms of previous or current health
conditions that arise. Medical records, journals, and daily notes will be accessible to researchers
through TTS. We will be working with vulnerable populations, such as pregnant women. The
women may fatigue or feel unwell while participating in the journaling activity. If this happens,
we will ensure that we give them flexibility to complete their journal.
B. Adequacy of Protection Against Risks.
B.1. Recruitment and Informed Consent. Consent will be obtained from the women
who are interested in the study after being handed an IRB approved flyer. There will be a consent
form already approved by the IRB. The consent form will be given to the participants by
research supervisor Dr. Pitonyak. The consent form will have the study's purpose, duration and
nature, voluntary participation, and the right to withdraw if the study becomes too much to
handle. The women will be provided with a copy of the consent form that they fill out. The
women who cannot consent will not be involved in the study. Consent forms will be secured in a
locked cabinet file by Dr. Pitonyak.
B.2. Protection Against Risk. We will keep all information strictly confidential. The
only identifier that we will be asking for is their names. We will turn their name into a research
ID number. All records will be kept safely in a Teams file. The audio recordings and transcribed
data will be kept in a password protected computer. The only people able to retrieve the
information are the researchers and Integrated Clinical Education Experience (ICEE) leader. No
identifying information will be disclosed. The IRB will have access to verify appropriate human
subject protection plan. To minimize emotional risks researchers will avoid asking questions that
bring up past trauma. If in any case researchers, ask a question that provokes strong emotions we
will not continue with the questioning. Given that this study involves vulnerable subjects such as
pregnant women, researchers will be mindful of this and make accommodations for women
experiencing negative side effects from the pregnancy.
B.3. Potential Benefits and Importance of Knowledge to be Gained.
The women will benefit from this study by understanding how their comorbidities affect
their life, children, and their participation in the recovery process. They will benefit from being
educated about their health and talking about the barriers they are facing. We will address the
barriers women face when trying to access treatment and understand motivating factors that
contribute to participation in the recovery process. This is important because if we discern how
comorbidities affect the women, we will be able to create environments where they will be able
to participate fully. Participating in treatment means overcoming substance abuse or mental
health problems. Once the women know how to participate in the treatment, the health of
themselves and their children will be improved. The women will self-reflect on the role they play
in their health by using the video logs. We will learn the role of occupational therapy in
residential treatment settings. The risks are reasonable because the comorbidities may already be
negatively affecting the women. Studying the role these comorbidities have on women’s ability
to participate in the recovery process will help alleviate some of that negativity.