Liberty University, Nursing
Through
Dr. Susan Sterrett, EdD, MSN, MBA
Liberty University, Nursing
IRB CHAIR
Liberty University
Dear Dr. Riordan,
Ref: IRB Required Revision for the EBP project : "Weight Management for Patients with
Schizophrenia on Second-Generation-Antipsychotic"
Thank you for the review of the above named EBP project and the highlights of the areas that
need clarification. Below are the clarifications and the revision required thereof.
Q1. Competency of the participants. The facility where the Evidence Based Practice (EBP)
project will be implemented is Partial Day Program in the suburban of northern New Jersey
which admit patients with psychiatric/mental illness who have been stabilized from the
surrounding hospitals and also from other acute partial hospitalization programs for the
continuity of care and medication management. The patients’ population is composed mainly of
patients with schizophrenia, schizoaffective, depression, and bipolar disorders, who are currently
living in the community with their families, boarding homes, group homes or even shelters
awaiting placement to a housing program. The patients are admitted to the program only when
they are stable psychiatrically and are on medication, but need continuity of care, therapy and
medication management, beside a place where they can spend part of their day for those
who work within the community. Many of these patients are able to work, and are competent
and able to consent for themselves. As psychiatric nurse practitioner treating these patients, I
cannot initiate any treatment without their signed consent. If they are not competent and capable
to consent they are not eligible for admission, and this determination is competed during the
admission process.
Q2. Unit leaders. The program is designed and organized into five different units, namely
Clerical unit, Food unit, House unit, Members unit and Senior unit. Each of these units is headed
by a “Unit Leader,” who is responsible for the management of the units. During the admission,
the patients are assigned a unit depending on their age, abilities and preferences. Each of the
units has different activities that are tailored to the needs of the patients in that unit. For example,
the Food units, patients are able to learn how to prepare different meals, and are help in lunch
preparation, and any time there are holiday celebrations, like Thanks Giving. Clerical unit,
patients are able to help in preparing educational materials used in the entire program. Therefore,
the patients in this unit are good in computers, and may have history of working with computers.
The Project Investigator (PI) will be the main person who will spread the word about the project
and its objective. The PI will announce about the intention of the project and will invite the
patients to be participants through the use of the flyers. However, since this may not be sufficient
since not all patients attends the program every day, the Unit Leaders will be formally briefed in
the first week once the semester start about the intention and objectives of the project. The
briefing is necessary but not mandatory but will be for the good of the Unit Leaders to know
what will be going on with those patients who will chose to participate in the project. The script
the unit leaders will read is the same from the flyer (Appendix C of the documents attached)
which the PI will use to reach to the patients as well for consistency, and also part of the
information from cover letter (Appendix B) whose excerpts are below:
From the flyer:
From the cover letter:
Hello all! My name is Joseph Kimani. I am currently pursuing a doctoral degree at Chatham
University, in Pittsburgh, Pennsylvania. I have chosen as my doctoral project weight management for
clients with schizophrenia on second-generation antipsychotics through use of an exercise program
and education on dietary strategies. This facility has agreed to allow me to present my project to clients
with schizophrenia who are treated with these medications in order to help manage weight gain and
obesity problem related to the use of these types of antipsychotics. You are eligible to participate in my
project if you are 18 years of age and older and currently on any type of second-generation
antipsychotics.
Your participation in this project is completely voluntary. If so desired, you may choose not to
participate at all. You may withdraw from the project at any time for any reason. Also, you may refuse
to answer any questions that you do not feel comfortable answering. The results of this project may be
published or presented at a professional conference. All of the collected information will be analyzed
and reported as aggregate data, meaning your results will be combined with the results of other
participants.
I am asking you to consider participating in this educational program. If you are interested in
participating, or have any questions or concerns the best way to reach me is by phone at 732-322-1807.
Thank you for your time and consideration.
Volunteers are the participants who will volunteer to participate in the EBP project after information
about the project is presented by the PI and also by the Unit Leaders.
About signing of consent forms: The PI will be responsible to for the consent forms for those selected.
PI will be looking forward for about 20 to 25 patients out of 68 patients (Current number in the program,
which may increase before the beginning of the semester) with schizophrenia on second-generation
antipsychotics to participate in this project for those who meet the criteria of selection. There will be no
coercion, and only one consent form will be signed. The unit leaders will be helping the PI to collect the
forms for participants from their respective units in the presence of the PI. The statement “ensuring the
form are duly completed and signed” means the unit leaders will help PI cross check that consent forms
are signed. The signing will be voluntarily without any coercion. Those who volunteer to participate from
each unit will meet in the conference room where the consent forms will be given to each patient
individually and allowed time to ask any question, and PI will be more than happy to answer and clarify
any information that the patient may have.
“it sounds like you are going to have 3 information sessions at which potential participants will be told about the
project by a unit leader and allowed to ask questions. They will be given a flyer with the PI’s number on it so they can
call with any more questions. Those who are interested will be given a consent form by the unit leader and the unit
leader will help them understand the language and sign it if they choose to do so. As mentioned earlier about
the information session, the PI will be the initial person who will herald the information about
the project in each unit. The Unit Leaders will be assisting the PI since they will be part of the
collaborative team. They will have the same information and will help the potential participate to
get the information about the project particularly for those who are absent on the days when the
PI will have given the information sessions. Through this, there will be equal opportunity for all
the patients during the first week of the semester to make informed decision about their
participation in the project.
After signing, the participants will be weighed and have their BMI calculated, and their charts checked to ensure they
are medically cleared, after which they will be told if they are eligible to continue in the project or not. Would you say
this is the basic recruitment procedure? If not, please clarify”
Yes, this portion is part of the basic recruitment procedure.
How medical clearance will be obtained. The facility has a medical section which addresses all the
medical needs except for medical emergencies for the patients who attend this partial day program. The
medical section has an attending physician who is responsible for all the medical clearance for all the
patients within the facility. The PI will liaise with this medical doctor for the medical clearance of those
who volunteer to participate in the project. The PI already designed a form (Appendix E of the
documents uploaded) which was accepted by the facility physician as a generic form which the physician
will sign once he examine the potential participants and clear them as fit to participate in a physical
exercise. The document will be placed in patient’s chart in the medical section. The information
contained in this form will be shared with the patient by the PI to let the patient know if he or she is
cleared to participate. Those who will not be medically cleared to participate will be educated on the
reasons why as per the physician’s examination. The patients who will be medically cleared will then be
weighed and their Body Mass Index (BMI) calculated to meet the criteria of weight.
Week One: Sign-up sheet. Each participants selected after meeting the criteria for selection will meet
with PI privately in the PI’s office and given an identifier number (IN) running from 01 as they sign-up.
After sign-up, the participant will be weighed and their weight recorded against their IN for privacy.
There will be no names used in the sign-up sheet and, the sheet will be kept by the PI in a lockable
cabinet for confidentiality of the participant’s information on IN and their initial weight, BMI and future
weights and BMIs.
Do you have evidence available showing that the BSQ is freely available for research use?
Yes, below is an excerpt indicating that the BSQ can be used by all people without any freely, provided
the BSQ it is not altered.
Retrieved from https://www.psyctc.org/tools/bsq/
The cover letter and the consent forms with the changes suggested will be uploaded in the
document center for you perusal.
HIPAA Waiver: After carefully looking at the information contained in this waiver, I totally
agree with you that it is not necessary since there will be no significant chart review and the
weight information will be gotten directly from patients.
The use of research funds: The PI will buy a lockable cabinet, a laptop, a thumb drive, pencils,
and photocopying papers. The research funds will be used to buy these equipment and materials.
The facility director agreed to supplement for the fruits and vegetables which will be used every
two weeks for the celebration time.
