IRB Expedited and Full Review Application Form

Instructions: Complete this form to request an expedited IRB review of research involving human
participants. The checklist below is for general guidance to help researchers submit complete application materials
and facilitate the review process. Incomplete or unreadable applications will extend the IRB review process. If you
are collecting data at a hospital, please seek hospital IRB approval prior to Regis College IRB approval. Please note,
pilot studies and scale development studies should be submitted to the IRB as well. Please submit an electronic
application and all research materials (consent form, surveys, interview guides, etc.) to [email protected].

A Complete Application Packet Should Include:

An electronic copy of the IRB application form, research summary, and research instruments. Types
of research instruments that should be attached include:
• Recruitment materials: emails, letters, recruitment scripts, flyers, posters, brochures, etc.
• Data collection materials: questionnaires, surveys, data collection forms, focus group scripts, interview
scripts, etc.
Signature page with faculty advisor and student signatures
(Approval will be withheld without signatures.)
Copies of CITI training certificates for all key research personnel who will interact with
subjects or collect data
Consent forms(s)—You must use the Regis College IRB Informed Consent Template
found on the Regis College IRB website when creating your informed consent form(s).
If minors (under 18) will be research participants, you must create a Child Assent Form
and a Debriefing Form using the templates found on the Regis College IRB website.
All appendices are labeled and are in order.

NOTE: DO NOT REMOVE THE HEADINGS FROM THIS APPLICATION!

Student Researchers:
Faculty research advisor was consulted in the study design and has reviewed and signed the application.

Research in Hospitals or HIPAA-Covered Entities

Submit copies of the IRB approval letter and IRB approved consent form(s) from the participating institution(s).

Research in Public Schools:

Submit copies of the permission letter to perform research from each school principal via email.
Submit copies of IRB approval if the school has an IRB.

Research at sites other than Regis College:

Submit copies of the site permission letter to perform research from administrator via email.
Submit copies of IRB approval if the site has an IRB.

Federally funded research: Wait until you have been funded before submitting an IRB Application.
Submit documentation of funding status with this protocol application.
Submit a complete copy of the federal grant/contract proposal including face page.

Regis IRB Expedited and Full Application Submit materials in a single PDF by E-mail: Page 1 of 20
Form [email protected]

Revised 11.1.22
 Regis College Institutional Review Board
Office of Academic Affairs
235 Wellesley Street
Weston, MA 02493-1571
(781) 768-7430
email: [email protected]
IRB Expedited and Full Application Form
For Initial IRB Review Only
I. Study Title: Utilizing an Educational Intervention to Increase Non- Today’s Date:
(If funded, the study
title must match the
Oncology-Based Registered Nurses' Self-Efficacy and
sponsored title.) Confidence Related to Breast Cancer Prevention in
Low-Income Women

II. Principal Investigator Information

A. Name of Principal Investigator Carine Meguem B. Are You? (Please check)

Faculty
Staff
C. Mailing Address: 8861 NW 78th Place, Tamarac, FL, 33321
Undergraduate Student
Graduate Student
D. Department: Nursing
Postdoctoral fellow
E. Email address: [email protected] Other:
F. Primary Phone Number: 7866009912 G. Alternate Phone:
I. Faculty Advisor’s
H. Faculty Advisor’s Name: Dr. Celeste Baldwin
Phone: 8082691219
J. Faculty Advisor’s E-mail: [email protected]
III. Funding
A. None (Go on to Section IV)
Do you plan to apply for funding in the future? Yes No If yes, please explain:
B. University Funded: List source:
C. External, non-federal*: List source and grant number:
D. Federal*: List agency, department, and sponsor’s award number:

*Wait until you have been notified that your project will be funded before seeking IRB approval unless otherwise instructed by the funding source. If
federal funding is involved, submit documentation of funding status with a complete copy of the funding proposal with this form.

E. Is Regis College the primary awardee for the grant? Yes No If no, please list primary awardee:
F. Are there subcontracts? Yes No If yes please list sub-contractors:

IV. General Study Information

A. Anticipated number of participants: C. Estimated Project Duration
20 *Start Date: 4 weeks End Date: 4 weeks

B. Participant Ages (please check) D. Why is this project being conducted?

0-7 (requires written parental informed consent and oral child assent) Faculty/Staff Research
7-17 (requires written parental informed consent and child written assent) Undergraduate Coursework
18-65 (requires written informed consent) Master’s Thesis
65+ (requires written informed consent) Doctoral Research
Quality Improvement or Evaluation
Other:
*Project cannot start without IRB approval.
E. Will this study involve long-term follow-up with participants? Yes No
If yes, please describe:

F. Vulnerable Populations (Check if applicable.)

Minors (under 18 years)
Pregnant women and fetuses
Neonates
Prisoners
Cognitively impaired (Diminished capacity for consent)

Regis IRB Expedited and Full Application Submit materials in a single PDF by E-mail: Page 2 of 20
Form [email protected]

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Other:

V. Research Risk
Research must present no more than minimal risk to human participants in order to qualify for expedited review. Minimal risk means
that the “probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (45 CFR
46.102)
A. Does the research propose greater than minimal risk to participants? Yes* No
*If yes, skip to part C of this section.

B. Does the research include prisoners? Yes* No

*If research includes prisoners, the application must be reviewed by the full IRB.

C. Check all procedures that apply to the research:

(1) Clinical studies of drugs and medical devices.
(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.
(3) Prospective collection of biological specimens for research purposes by noninvasive means. Examples: hair and nail clippings; saliva;
deciduous teeth at time of exfoliation or extracted during routine care; excreta and external secretions (including sweat); un-cannulated
mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization.
(4) Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving x-rays or
microwaves. Examples: physical sensors that are applied either to the surface of the body or at a distance and do not involve input of
significant amounts of energy into the participant or an invasion of the participant’s privacy; weighing or testing sensory acuity; magnetic
resonance imaging; electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity,
electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; moderate exercise, muscular
strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-
research purposes (such as medical treatment or diagnosis).
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation,
identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history,
focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
(8) Continuing review of research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to
the enrollment of new participants, (ii) all participants have completed all research-related interventions, and (iii) the research remains active
only for long-term follow-up of participants; or (b) where no participants have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
None of the above categories apply.

For a comprehensive list of expedited categories see http://www.hhs.gov/ohrp/policy/expedited98.html

D. Does this study involve any of the following? (Check all that apply.)
Deception
Punishment
Use of drugs
Covert observation
Induction of mental and/or physical stress
Procedures which may risk physical/mental harm to the participant
Materials/issues commonly regarded as socially unacceptable
Information relating to sexual attitudes, sexual orientation, or practices
Information relating to the use of alcohol, drugs, or other addictive products
Procedures that might be regarded as an invasion of privacy
Information pertaining to illegal conduct
Genetic information that may be linked to a participant’s health status, such as genetic markers for cancer, heart disease, etc.
Information normally recorded in a patient's medical record, which if disclosed could reasonably lead to social stigmatization or discrimination
Information pertaining to an individual's psychological wellbeing or mental health
Information that if released could reasonably damage an individual's financial standing, employability, or reputation within the community

Regis IRB Expedited and Full Application Submit materials in a single PDF by E-mail: Page 3 of 20
Form [email protected]

Revised 11.1.22
Please provide details on all procedures checked above: How are they integral to the study?

VI. Research or EBP Summary:

Please insert responses to each question using the topic headers A-I below (do NOT attach separate answers for each
question – answer ON this form). Be sure to dedicate about 1 page to the review of literature and include 3-5
references at the end of this review. Please use simple language and avoid technical jargon. Be sure to address each
item.
Note: Grant, thesis, dissertation or course work proposals may not be submitted in lieu of the Research Summary because traditional proposals do
not include specific information on risks, benefits and detailed informed consent procedures. Please insert responses to each question under each
question on this
A. Introduction and Background:
1. State the research, clinical practice, or evaluation question.
2. Provide the scientific or scholarly literature for this study and background on the topic (maximum of one page with 3-5 references).

Introduction

Breast cancer prevention is crucial for low-income women who face barriers to healthcare access.

Non-oncology based registered nurses (RNs) play a key role in educating and supporting these

women. However, RNs may have low self-efficacy and confidence levels in providing breast cancer

prevention information. This Doctor of Nursing Practice (DNP) project aims to develop an

educational intervention to enhance the self-efficacy and confidence of non-oncology-based RNs in

educating low-income women about breast cancer prevention.

Background

Breast cancer is the leading cause of cancer death among women globally, with an estimated 2.3 million

new cases and 685,000 deaths reported in 2020 alone. If strategies are not implemented to control and manage

advanced diagnosis, the number of cases is expected to increase to at least 4.4 million by 2070 (Lei et al., 2021).

The main risks associated with breast cancer diagnosis are linked to age, breast density, and family history,

among other factors. Disparities in screening strategies, population structure, size, access to healthcare services,

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Form [email protected]

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insurance coverage, attitudes, and knowledge of breast cancer severity contribute to the burden on healthcare

systems.

Treating and managing breast cancer can be a significant financial burden for individuals and healthcare

systems. Breast cancer treatment often involves a multidisciplinary approach that includes surgery,

chemotherapy, radiation therapy, targeted therapies, and hormonal therapies. Each of these modalities comes

with its own costs, including medication expenses, hospital stays, laboratory tests, imaging studies, and

supportive care services. Freund et al. (2019) state that cumulative costs can be substantial, especially for

individuals who require long-term or advanced treatment options. In addition to direct medical costs, there are

also indirect costs associated with breast cancer, such as loss of productivity, caregiving expenses, and

transportation costs (Dignam, 2020). The financial impact extends beyond the individual diagnosed with breast

cancer to their families and caregivers, who may experience reduced income and increased caregiving

responsibilities. Furthermore, as Babatunde et al. (2020) emphasized, long-term management of breast cancer,

including follow-up visits, surveillance imaging, and hormonal therapies, adds to the ongoing financial burden.

The high cost of treatment and management of breast cancer underscores the need for accessible and affordable

healthcare services and comprehensive insurance coverage to ensure that individuals can receive the necessary

care without facing undue financial hardship.

Breast cancer is treatable if detected early (non-metastatic stage), with a 70-80% survival rate for most

patients (Harbeck et al., 2019). Regardless of age, ethnicity, or social income, early breast cancer screening can

significantly improve outcomes by detecting abnormalities or cancerous cells in the non-metastatic stage

(Ginsburg et al., 2020). Unfortunately, breast cancer screening is not equally provided to all women, with

disparities existing among ethnicities, races, and social income levels. This inequality in access to early

screening contributes to disparities in breast cancer morbidity and mortality.

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 Unfortunately, the cause of the lack of screening in other women is not due to their unwillingness to

perform breast cancer screening but rather due to the lack of information regarding access to health in general

and screening, most likely. Minority women are more likely than other groups not to get screened for breast

cancer because of some factors such as poverty, low educational level, and structural elements (Babatunde et

al., 2020). Most women must pay to get screened, whether enrolled in commercial insurance, Medicaid,

Medicare, or completely uninsured. (Nguyen et al., 2021). Poor women are not likely to get screened or follow

up with screening because diagnostic mammography is too expensive for them, and they are not always aware

of the importance of the diagnostic screening (Nguyen et al., 2021). Patients with low income trying to get help

from some organizations that help with breast cancer screening and treatment are not always getting a positive

response because they are slightly above the poverty baseline (Dignam, 2020). The truth is that being above the

poverty baseline does not mean having an income that can allow you to meet your needs and access care easily.

Recently, an African American lady asked what she had to do to gain access to breast cancer screening and

treatment without health insurance. She explained that she was slightly above the poverty baseline, did not have

the right to Medicare, or Medicaid, could not afford private insurance, and most organizations that help women

with breast cancer prevention had refused to help her because of her income. Because she could not overcome

her health barriers, she felt she would be unable to do anything about her health, leaving her at risk of death.

From her statement, It is evident that barriers to health can negatively impact breast cancer survival, and it is

important to do some research to help.

According to much research, breast cancer screening is necessary for all women, regardless of race or

ethnicity, to attain the effectiveness of treatment (Nguyen et al., 2021). Nurses and healthcare professionals need

to find ways to help women gain access to breast cancer prevention, screening, and treatment. The healthcare

system does not have a universal health system like other developed countries. Healthcare in those countries

focuses on breast cancer prevention through education and screening but is also involved in treatment and

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Form [email protected]

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follow-ups. According to Babatunde et al. (2020) not having universal health in the United States should not

hinder overcoming health barriers. The population education on breast cancer screening and financial help for

breast cancer screening and treatment can lower the disparity in breast cancer treatment and improve the

outcome.

B. Specific Aims/Study Objectives:

1. List the purpose(s) of the study (What you are hoping to learn or discover as a result of the study?).

1. Assess baseline self-efficacy and confidence levels of non-oncology based RNs in providing

breast cancer prevention education to low-income women.

2. Design and develop an evidence-based educational intervention to enhance knowledge, self-

efficacy, and confidence of non-oncology based RNs in breast cancer prevention.

3. Implement the educational intervention and evaluate its effectiveness in improving the self-

efficacy and confidence levels of non-oncology-based RNs.

4. Assess the impact of the intervention on non-oncology based RNs' knowledge and attitudes

toward breast cancer prevention in low-income women.

5. Explore non-oncology-based RNs' perceptions of the educational intervention and its impact

on their practice.

C. Materials, Methods, and Analysis (quantitative and qualitative):

1. Describe data collection methods (procedures)—Be specific.
2. Describe the specific materials or tools that will be used to collect the data. Include proposed measures as an appendix.
3. Describe timeline of the procedures and how long each procedure will last.
4. Describe how you will analyze your data based on the modality; describe the analysis type and procedures including statistics and
scientific or scholarly justification for the use of these analyses—be specific.

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Form [email protected]

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 This chapter presents the methodology and approach employed in the research project to enhance

breast cancer prevention education among non-oncology-based Registered Nurses (RNs) serving low-income

women. The research is divided into three primary phases: Assessment of Baseline Self-Efficacy and

Confidence, Educational Intervention Development, Implementation analysis, and Evaluation. The

effectiveness of the educational intervention will be assessed by measuring changes in self-efficacy and

confidence levels of non-oncology-based RNs before and after the intervention. To ensure precise and

dependable measurements, the study will employ two established instruments: the Self-Efficacy/Self-Care

Instrument (Luszczynska & Schwarzer, 2020) and the Confidence Scale (C-Scale). The assessment phase will

utilize the Self-Efficacy/Self-Care Instrument based on social cognitive theory (Luszczynska & Schwarzer,

2020). The instrument will enable the measurement of baseline self-efficacy levels of RNs in their ability to

effectively provide breast cancer prevention education. The Confidence Scale (C-Scale), grounded in social

cognitive theory (Bandur, 1986), will assess the RNs' confidence levels in delivering breast cancer prevention

information.

Subsequently, the educational intervention will be developed, considering the insights from the

supporting literature, including relevant research articles and studies. The intervention aims to enhance the

RNs' knowledge and skills in breast cancer prevention, considering factors such as social determinants of

health, behavioral theories, and the impact of insurance stability on cancer screening behaviors (Nelson et al.,

2016; Watkins, 2019; Wilkinson & Gathani, 2022). During the implementation phase, the simulation-based

education approach will be employed, drawing inspiration from Garmon's (2020) presentation on simulation-

based education for the administration of chemotherapy and biotherapy. This method provides a safe and

controlled learning environment, enabling RNs to practice breast cancer prevention techniques with greater

confidence and competence. Finally, the evaluation phase will utilize the Self-Efficacy/Self-Care Instrument

and the Confidence Scale (C-Scale) to assess the RNs' self-efficacy and confidence levels post-intervention.

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Revised 11.1.22
The research will measure the effectiveness of the educational intervention by comparing the pre and post-

intervention scores.

The intervention development and implementation will be iterative and guided by the Plan-Do-Study-

Act (PDSA) cycle. The PDSA cycle allows for continuous improvement and adjustment of the intervention

based on feedback and outcomes observed during the study. The educational intervention will comprise

workshops, case-based learning, and educational materials. Workshops will facilitate interactive learning

experiences, engaging participants actively. Case-based learning will present real-life scenarios, enabling the

practical application of the acquired knowledge. Educational materials, such as brochures and pamphlets, will

provide additional resources for reference and distribution to patients. The iterative nature of the intervention

development will ensure that the educational program is tailored to meet the specific needs of the non-

oncology-based RNs, increasing the chances of successful implementation and positive outcomes.

Data analysis in this research project will involve using descriptive and inferential statistics, such as

means, standard deviations, and t-tests. This research project will employ a mixed methods design to enhance

breast cancer prevention education among non-oncology-based Registered Nurses (RNs) serving low-income

women. Using these data analysis approaches will enable comprehensive insights into the effectiveness of the

educational intervention. Quantitative data analysis will utilize descriptive and inferential statistics, including

means, standard deviations, and t-tests. These statistical measures will help quantify changes in self-efficacy

and confidence levels of non-oncology-based RNs aged 40 before and after the educational intervention. The

quantitative analysis will provide numerical evidence of the intervention's impact on breast cancer prevention

knowledge and awareness among this specific age group.

Qualitative data analysis will complement the quantitative findings by exploring the perceptions and

experiences of the participating nurses aged 40 in-depth. This aspect of the research will involve thematic

analysis of interviews or open-ended survey responses from the RNs. Through qualitative analysis, the

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Form [email protected]

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researchers will understand how the educational intervention influenced the nurses' practice, attitudes, and

overall approach to breast cancer prevention in the 40-year-old age group. Furthermore, to ensure ethical

considerations, all participants aged 40 will be required to provide informed consent before participating in the

study. The confidentiality and privacy of the participants will be rigorously protected throughout the research

process, following the guidelines set forth by the Institutional Review Board (IRB).

The study will be conducted in a clinical practice setting at a community health center in a low-income

neighborhood with a significant proportion of uninsured or underserved patients (Luszczynska & Schwarzer,

2020). The participants will consist of registered nurses aged 40 who provide direct patient care to women

aged 50 and older at the community health center. This mixed methods approach will enable a comprehensive

evaluation of the educational intervention's effectiveness in enhancing breast cancer prevention knowledge

and awareness among non-oncology-based RNs in the specific age group while gaining valuable insights into

the nurses' perspectives and experiences.

D. Research Population & Recruitment Methods:

Describe:
1. Inclusion and exclusion criteria (What participant traits are needed to be included? What traits exclude participants?) (please put in a
list format)
2. What is the scientific or scholarly justification for the number, gender, age, or race of the population you intend to recruit?
3. How did you choose the source of participants or data?
4. Recruitment procedure (if applicable) including who will recruit participants.
5. Tools that will be used to recruit (payment, advertisements and flyers—Attach copies to this application.)
(Note: participant payment beyond $600 must be reported to the IRS, and this requirement must be added to the consent form. Incentives should
not exceed $50 per participant)

A convenience sampling technique will be used to recruit participants for this study. Non-oncology-based RNs

working in acute care settings will be invited to participate voluntarily. Convenience sampling is chosen for its

practicality and accessibility in recruiting participants, given the time and resource constraints of the study.

While convenience sampling might introduce some degree of sampling bias, the study focuses on assessing

the educational intervention's effectiveness rather than making generalizations about the entire population. The

research team will ensure that participants represent a diverse range of RNs from different departments and

specialties to enhance the study's external validity and applicability to real-world nursing practice. These

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Form [email protected]

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nurses will be selected through a purposive sampling method, which means that participants will be

purposefully chosen based on specific criteria that align with the research objectives.

Data Collection Procedures

The project will focus on non-oncology-based Registered Nurses (RNs) working in acute care settings with

experience in patient education and caring for women. A purposive sampling method will identify potential

participants from targeted acute care facilities. The inclusion criteria will be applied to select RNs who meet

eligibility requirements, such as having experience in patient education and working with women. The nursing

administration at each facility will collaborate with the research team to provide a list of eligible RNs, and

invitations to participate will be extended to those individuals.

Procedure for Obtaining Data

Data for this project will be collected using a mixed-methods approach, combining quantitative surveys,

qualitative interviews, and focus groups. Pre-intervention surveys will be administered to assess the baseline

self-efficacy and confidence levels of the identified non-oncology RNs. These surveys will be distributed

electronically through a secure platform to ensure data privacy. For the qualitative aspect, individual

interviews and focus groups will be conducted to gather participants' feedback regarding their educational

intervention experiences. All interviews and focus groups will be recorded and subsequently transcribed for

analysis.

E. Informed Consent Procedure:

Describe:
1. Who will perform the informed consent procedure?
2. How will that person be trained? (previous related coursework, previous experience, one-on-one training with PI or faculty, etc.)
3. How will the prospective participant’s competence or understanding of the procedures be assessed? Will participants be asked
questions about the procedures or encouraged to ask questions?

F. Confidentiality:
Describe the provisions for participant and data confidentiality:
1. Where will the data be stored, and who will have access to the data and the area (note: data should be kept for a minimum of three
years)?
2. How and in what format (hard or electronic copy, identifiable or de-identified) will the data be stored?

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Form [email protected]

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Maintaining Confidentiality of Subject Records/Data

Multiple measures will be implemented to ensure the confidentiality of subject records and data. Firstly, all

participant data will be de-identified using unique project identification numbers instead of personal

identifiers. This step ensures the research team cannot link any responses or information to individual

participants. Secondly, any identifying information obtained during interviews or focus groups will be kept

strictly confidential and solely used for scheduling and conducting the sessions. All data will be securely

stored and encrypted to prevent unauthorized access.

Data/Records Storage and Access.

The collected data and records will be securely stored in password-protected electronic databases accessible

solely to designated research team members. Physical records, including interview transcripts, consent forms,

and surveys, will be stored in locked filing cabinets at a secure location. Access to the data and records will be

limited to the principal investigator and authorized research team members directly involved in data analysis

and processing. Any data shared for collaborative purposes or data monitoring will adhere to confidentiality

agreements and data protection protocols. Institutional policies and relevant regulations will dictate the

retention period for the data. After the project's completion, the data may be archived for potential future

research while ensuring the participants' anonymity and confidentiality.

3. Will the participants’ identities be coded? Will the codes to identify participants be stored with the data? (Note: If you are working
with a hospital or clinic, please see information on HIPAA and research at http://privacyruleandresearch.nih.gov/ )

G. Potential Research Risks or Discomforts to Participants:

1. Indicate the type of risk that may result from participation. Consider psychological or emotional risks, social stigma, change in status
or employment, physical risks or harms, information risks including breach of confidentiality and any effect loss of confidentiality may
have on status, employment, or insurability. If the protocol involves treatment, what are the risks compared to other treatments in
terms of “standard of care”? (For example: Psych Referral 24 hours 7 days a week; This study poses minimal risks to participants. Two
potential but unlikely risks that you may experience are fatigue and possible emotional distress about the topic. Should the intervention make you
feel distressed or upset, please utilize the National Institute of Health link here to access counseling or providers immediately nationwide
https://www.nimh.nih.gov/health/find-help)
2. Consider the likelihood and magnitude of the risks or discomforts occurring? Are they unlikely or likely to occur, and what effect
would the discomforts or risks have on the individual should they occur?
3. How will you minimize risks? Some examples include informed consent, adequate staff training and experience, debriefing, and
monitoring adverse effects on participants.

H. Potential Research Benefits to Participants:

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 1. Indicate the type of benefit that may result from participation. Consider psychological or emotional benefits, learning benefits,
physical benefits and discuss if participant will benefit directly or if the benefit is largely to gather generalizable knowledge or provide
scientific or social information on a topic that may benefit society. DO NOT OVERSTATE the benefit.

This research project can potentially create sustainable changes in breast cancer prevention practices

among non-oncology-based RNs serving low-income women. By integrating the educational intervention into

regular training programs, gaining institutional support, collaborating with community organizations, and

training RNs as "trainers," the project can foster continuous improvement in breast cancer prevention

education. Regular evaluation and policy advocacy will enhance its impact and contribute to broader

healthcare policies. Overall, the study's findings and successful intervention implementation can significantly

improve breast cancer prevention efforts and positively impact the health outcomes of underserved women in

the long term.

I. Investigator Experience. Please complete the NIH Bio Sketch below for the PI.

BIOGRAPHICAL SKETCH for PI

Provide the following information for the PI and other significant contributors.
Follow this format for each person. DO NOT EXCEED ONE PAGE.

NAME:

POSITION TITLE:

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency
training if applicable. Add/delete rows as necessary.)

DEGREE Completion Date

FIELD OF STUDY
INSTITUTION AND LOCATION (if applicable) MM/YYYY

A. Personal Statement

B. Positions and Honors

C. Contributions to Science

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D. Additional Information: Research Support and/or Scholastic Performance

VII. Informed Consent

A. The informed consent document should include all required elements of consent (See the Regis IRB informed
consent template on our website and/or below). Confirm that each element is included in your consent form:
A statement that the study involves research
A statement that they are being asked to participate in research and how they were selected to participate
The purpose of the research in lay terms (in language understandable to the participants)
The expected duration of the participants’ participation (e.g., “You will be asked to complete a survey every month for 1 year.”)
The total time commitment of participation in the procedures (e.g., “The survey will take 20 minutes to complete.”)
A brief but complete description of all procedures to be followed (Invasive biological, clinical, or behavioral interventions require specific
descriptions of the procedure. If research includes treatment, describe which procedures are experimental and alternatives to those
procedures.)
The benefits to the participant or others that are reasonably expected from the research
The risks or discomforts that are reasonably expected from the research and a statement that “There may be unknown risks.”
A statement describing any payments for being in the study or that there is no payment for being in the study
A statement indicating that there is no cost to the participant for being in the study
A statement that participation is entirely voluntary and may be discontinued at any time
A statement that withdrawal from participation will not result in denial of entitled benefits or harm the participant’s relationship with
Regis
A statement of confidentiality describing how the participants’ personal information will be kept private
A statement that provides the participants with a contact at the institution who may be reached if injury occurs or confidentiality is
breached
The consent form must be signed and dated, or oral consent must be witnessed and signed and dated by the witness.

Note: Individuals with added protections require both permission of a legal representative and assent of the individual.

Regis College [school or department name]

Informed Consent to Participate in [title of study]
Researcher: [name of principal investigator (PI)]

Introduction

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Form [email protected]

Revised 11.1.22
Please read this form carefully. You are being asked to participate in a research study of [Insert a general
statement about the study]. You were selected to participate in this study because [List inclusion criteria]. You
are not eligible to participate if [List exclusion criteria]. Please ask any questions you may have before you
agree to participate in the study.

Purpose of the Study

The purpose of this study is [Explain the research question and purpose in simple language].

Description of Study Details

If you agree to participate in this study, we would ask you to [Explain procedures and tasks. Identify any
procedures that are experimental. Describe the length of time for participation, frequency, and duration of
procedures, etc. For example, if participants will be interviewed during the study you would describe: how
many interviews, the length of each interview, and/or where the interview will take place. Also, please provide
the questions being asked].

Benefits of Being in this Study

The benefits of being in this study are [State the anticipated benefits the research will produce for society
and/or the participants. If there are no expected benefits, state as such.]

Risks and Discomforts of Being in this Study

The study has the following risks. First, [Explain the first risk, its likelihood, and how it will be minimized].
Second, [Explain the second risk, its likelihood, and how it will be minimized]. Third, . . . [If there are no
foreseeable risks, state that there are no risks beyond what the participant experiences in daily life].

To the extent the study requires or involves physical interaction with other people or otherwise occurs within
space shared with other individuals there is a risk of transmission of and/or infection by communicable disease
including, but not limited to, the 2019 Novel Coronavirus (COVID-19). The study will be conducted in
compliance with local, state, and federal guidance related to COVID-19, but despite these efforts the risks of
transmission and/or infection cannot be completely eliminated.

Payments
You will receive the following payment for being in the study: [Explain the amount of payment or other
reimbursement information (e.g., class points, tokens, donations, etc.), as well as when payment and/or
reimbursement will occur and in what cases payment will not occur, if any.
If there is no payment, state: There is no payment for being in this study].

Cost
There is no cost to you for being in this research study.

Choosing to participate in the Study and Choosing to Quit the Study

It is your choice to participate in this study. If you choose not to participate in this study, it will not affect your
current or future relations with Regis. You are free to decline to answer questions or quit at any time, for any
reason. There is no penalty for not taking part or for quitting. [If you are using students, you must include a
statement that participating or not participating in the study will have no impact on their academic status. If
you are using employees, you must state that participating or not participating in the study will have no impact
on their employment status. Explain consequences (e.g., adjusted monetary benefits) of early withdrawal, if
any.]

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Form [email protected]

Revised 11.1.22
Getting Dismissed from the Study
The researcher may dismiss you from the study at any time for the following reasons: [Include the reasons,
for example, “(1) it is in your best interests (e.g., side effects or distress), (2) you have not followed the study
rules, or (3) the study sponsor decided to end the study.”].

Privacy
The records of this study will be kept private. This study is [Select one: anonymous, confidential, or open].
[Explain how information about the participants will be protected, for example, “Research records will be kept
in a locked file” or “All electronic information will be coded and secured using a password-protected file.”
Explain who will have access to the study records, and when and how they will be destroyed. Responses are
anonymous when the researcher does not know the identity or any identifying information about who wrote
them. If you are keeping a list connecting participants’ names to ID numbers, explain how you will keep that
information protected and separate from your data analysis. If applicable, state that the responses are meant to
be combined with other participants’ data and are not meant to gather information about specific individuals.]
No published reports will include any information that will make it possible to identify you.

Contacts and Questions

The researcher conducting this study is: [PI’s name]. The researcher will be available to answer any questions
about the study at: [phone number and email address]. If you have questions or concerns about your rights,
you may contact the Regis Institutional Review Board Chair:

Dr. Colleen C. Malachowski, PhD

781-768-7373
[email protected]

Statement of Consent [Choose only one statement according to the type of consent form.]

[Adult Participant Informed Consent]

I have read this form (or have had it read to me). I have been encouraged to ask questions. I have received
answers to my questions. I give my consent to participate in this study. I understand the risks and discomforts
associated with the above study and understand that I may quit the study at any time without penalty.

[Parent/Guardian Informed Consent for Participants Ages 17 and Younger]

I have read this form (or have had it read to me). I have been encouraged to ask questions. I have received
answers to my questions. I give my consent for my child to participate in this study. I understand the risks and
discomforts associated with the above study and understand that my child may quit the study at any time
without penalty.

If applicable to your study:

I agree to be audio and/or video recorded (Check One):

_____Yes _____No

Signature(s)/Date [Delete any that do not apply to your protocol.]

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Form [email protected]

Revised 11.1.22
[Adult Participant Informed Consent]

Participant Printed Name: ___________________________________

Participant Signature: ___________________________________ Date: __________

[Parent/Guardian Informed Consent for Participants Ages 17 and Younger]

Study Participant Printed Name: ___________________________________

Parent/Guardian Printed Name: ___________________________________

Parent/Guardian Signature: ___________________________________ Date: __________

[Interpreter for Non-English-Speaking Participants]

Interpreter Printed Name: ___________________________________

Interpreter Signature: ___________________________________ Date: __________

[Participant’s Legal Representative]

Participant Printed Name: ___________________________________

Legal Representative Printed Name: ___________________________________

Legal Representative Signature: ________________________________ Date: __________

Witness Printed Name: ___________________________________

Witness Signature: ___________________________________ Date: __________

C. The Regis IRB recommends that the reading level of the informed consent document should be no higher than an 8th grade level. The
IRB recognizes that some consent forms are of such a technical nature that it may not be possible to keep to an 8 th grade reading
level. The comprehension level of the consent document must be verified to ensure it is consistent with the
comprehension level of the participants. Please use the Flesch-Kincaid Grade Level score to verify the comprehension
level and insert it below. Instructions for assessing the Flesch-Kincaid Grade Level score using MSWord are
on the first page of the informed consent and child assent templates, or you can paste your text into

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Form [email protected]

Revised 11.1.22
 www.readability-score.com . (After pasting the text in the box, place the curser at the end of the text and hit
“Enter” or you will not get a reading from the website.)

Flesch-Kincaid Grade Level Score:

VIII. Research Staff (e.g., PI, Co-PI, Research Assistant, etc.). Please attach a list and submit CITI certificates for all personnel
who will interact or collect data. The CITI Training is required.
Name and Date of CITI Research Role University/Department
Credentials Training Certificate

IX. Performance Sites:

If the institution has an IRB, IRB approval may have to be received from that institution as well as Regis College. If the institution
does not have an IRB, the institution must authorize or provide permission for the research activities (Please include a site permission
letter from an institutional official – these letters should be signed by an official on the institutions letterhead. If you are using social
media sites, please include permission from the administrator of that site). If you are collecting data at a hospital with an IRB, seek
hospital approval prior to submitting the Regis IRB initial application form. Please also include any data use agreements and/or
review agreements.
Name of Institution Date of IRB Approval

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Form [email protected]

Revised 11.1.22
X. Acknowledgement
SUBMISSION OF A PROPOSAL TO THE REGIS COLLEGE IRB REQUIRES THAT THE PRINCIPAL INVESTIGATOR (AND
MENTOR IF THE PI IS A STUDENT OR FELLOW) READ THE DEFINITION OF “SCIENTIFIC MISCONDUCT” AND ANSWER
ALL “CONFLICT OF INTEREST” QUESTIONS BELOW.

A. Scientific Misconduct
“Scientific Misconduct” shall be considered to include:
1. Fabrication, falsification, plagiarism or other unaccepted practices in proposing, carrying out, or reporting results from research;
2. Material failure to comply with federal requirements for the protection of human participants, researchers and/or the public;
3. Failure to meet other material legal requirements governing research;
4. Failure to comply with established standards regarding author names on publications;
5. Failure to adhere to issues of confidentiality as provided in the participant consent form, the study protocol, and as outlined in the Code of
Federal Regulations (45 CFR 46).

B. Conflict of Interest

1. Are you or any member of your immediate family (spouse or domestic partner and/or dependent children) an officer, director,
partner, trustee, employee, advisory board member, or agent of any of the following: (Check all that apply.)
An external organization funding this project
Any external organization from which goods and services will be obtained under this project (including
those to which you may be subcontracting a portion of the project work)
Any external organization whose financial condition could benefit from the results of this project
Any external organization having business dealings in an area related to the work under this project

2. Are you or any immediate family member the actual or beneficial owner of more than five percent (5%) of the voting stock or
controlling interest of (a) the external organization funding this project, (b) any external organization from which goods and
services will be obtained under this project (including those to which you may be subcontracting a portion of the project work),
(c) any external organization whose financial condition could benefit from the results of this project, or (d) any external
organization having business dealings in an area related to the work under this project? Yes No

3. Have you or any member of your immediate family derived income within the past year, or do you or any member of your
immediate family anticipate deriving income, exceeding $10,000 per year from: (Check all that apply.)
An external organization funding this project
Any external organization from which goods and services will be obtained under this project (including those to which you
may be subcontracting a portion of the project work),
Any external organization whose financial condition could benefit from the results of this project
Any external organization having business dealings in an area related to the work under this project
Do not include funds that would pay your university salary under a sponsored project budget.

*If you checked any of the above, please specify the extent of involvement:

4. For those projects funded by any external entities, do you have a current, up-to-date Conflict of Interest Disclosure on file with
the Office of Academic Affairs that describes this financial relationship? Yes No (If no, you must submit an undated COI
disclosure before IRB review.)

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Form [email protected]

Revised 11.1.22
 SIGNATURES
SIGNATURE OF PRINCIPAL INVESTIGATOR

The undersigned accept(s) responsibility for the study, including adherence to the ethical guidelines set forth in the Belmont Report,
Declaration of Helsinki, the Nuremberg Code, the ethical principles of your discipline, the Common Rule and Regis policies regarding
protections of the rights and welfare of human participants participating in this study. In the case of student protocols, the faculty
supervisor and the student share responsibility for adherence to policies.

Printed Name of Principal Investigator Signature of Principal Investigator Date

SIGNATURE OF FACULTY RESEARCH SUPERVISOR--REQUIRED FOR STUDENT RESEARCH
By signing this form, the faculty research supervisor attests that s/he has read the attached protocol submitted for Regis IRB review and
agrees to provide appropriate education and supervision of the student investigator and share the above Principal Investigator
responsibilities.

Printed Name of Faculty Research Supervisor Signature of Faculty Research Supervisor Date
SIGNATURE OF DEPARTMENT CHAIR OR ASSISTANT/ASSOCIATE DEAN--REQUIRED FOR FACULTY RESEARCH ONLY
Your signature below affirms that you have been informed of the research.

Printed Name of Department Chair or Dean Signature of Department Chair or Dean Date

Regis IRB Expedited and Full Application Submit materials in a single PDF by E-mail: Page 20 of 20
Form [email protected]

Revised 11.1.22