SibACCESS: Developing a Telehealth Intervention to Address Unmet Psychosocial Needs of Siblings of Children With Cancer
Phase: NA
Conditions: Siblings, Childhood Cancer, Pediatric Cancer, Posttraumatic Stress Disorder
Sponsor: Boston University Charles River Campus

 
 
 
   
 
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Version:  November 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The following includes the full study protocol for project  
“SibACCESS: Developing a Telehealth Intervention to Address Unmet 
Psychosocial Needs of Siblings of Children with Cancer” (NCT04889755) 
 
Protocol most recently approved by the Boston University Charles River IRB on 
March 31, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
   
 
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Version:  November 2019 
BU Charles River IRB 
Application Form (Full Board and Expedited Review) 
 
SECTION A:  PROTOCOL AND CONTACT INFORMATION 
Protocol Title:   
SibACCESS: Developing a Telehealth Intervention to Address 
Unmet Psychosocial Needs of Siblings of Children with Cancer 
Principal Investigator 
(Name, degrees, licenses, etc.): 
☐ Mr.   ☐ Ms. 
Kristin Long, PhD 
             Department/School: Department of Psychological and Brain Sciences, CAS 
BU Mailing Address: 
900 Commonwealth Ave., 2nd Floor, Boston MA 02215  
             Email: 
kalong@bu.edu 
             Telephone: 
(617) 358-4296 
Additional Contact Person: 
Alix Paredes Molina 
              Email: 
apmolina@bu.edu 
              Telephone: 
(617) 358-1633 
☒ YES 
(REQUIRED) 
I confirm that I qualify to serve as the Principal Investigator of this study and 
am in compliance with the following policies: 
http://www.bu.edu/researchsupport/compliance/human-subjects/  
 
SECTION B:  FUNDING 
Provide information regarding ALL funding sources for this project, including existing funding, 
pending funding, and funding that has been applied for to support this research.  
Please check all that apply: 
☒ 
This research is funded 
 
☐ 
Funding has been requested  
Have you received Just In Time (JIT) Notification?   ☒ Yes    ☐ No 
NOTE: Once the funding has been awarded, submit an amendment to the IRB to 
add the funding source 
 
 
☐ 
Research is not funded 
 
If the research is funded or funding has been requested, it is REQUIRED that you complete 
the box below.  If you don’t have an award #, please state that in the box below.  If you have 
multiple funding sources, add additional boxes as necessary. 
Sponsor Name 
National Cancer Institute (NCI) 
Title of 
Grant/Proposal 
SibACCESS: Developing a Telehealth Intervention to Address Unmet 
Psychosocial Needs of Siblings of Children with Cancer 
Sponsor Award # 
(REQUIRED)* 
*If Award is pending, 
put “pending”.   
R03 CA259898 
 

 
 
 
   
 
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YES 
NO 
 
☒ 
☐ 
Is Boston University the Prime Awardee of the grant? 
☐ 
☒ 
Is Boston University receiving a sub-award? 
Name of Prime Recipient: 
☐ 
☒ 
Is the research being supported by an Industry Contract or Clinical Trial 
Agreement?  
*NOTES:   
 Provide a copy of the grant application, funding proposal, contract/agreement, scope of work, 
or sub-award agreement supporting the research. If an award is pending, once the funding has 
been awarded, submit an amendment to the IRB to add the funding source. 
 If this research study is for your dissertation, provide a copy of your prospectus (if available). 
 
SECTION C:  CONFLCT OF INTEREST 
☒ YES 
(REQUIRED) 
I confirm that ALL those responsible for the design, conduct, or reporting 
of the proposed research, including at minimum, all Senior/key personnel in 
the grant application, have completed the financial interest disclosure forms, 
submitted them to the COI office, and completed training as dictated at: 
http://www.bu.edu/researchsupport/compliance/conflicts-of-interest/,  and 
as provided under the Boston University Investigator Conflicts of Interest 
Policy for Research.     
 
NOTE:  You must attach a copy of the PI’s COI submission confirmation 
email. COI submission confirmation emails for all other study staff 
should be maintained at the research site.     
Of the financial interest disclosure forms submitted, did you check “yes” to any of the questions 
on either the FIND1 or NONFIND1 form?               ☐ Yes*     ☒ No 
*If you checked “yes” to any of the questions on either the FIND1 or NONFIND1 form, the 
IRB Director will contact the COI office to obtain the disclosure information. 
 
SECTION D:  TYPE OF REVIEW 
For Guidance regarding Type of Review please refer to the CRC IRB website  
 
I. 
FULL BOARD ☐ 
Please refer to the CRC IRB website for Full Board submission deadlines and meeting dates. 
 
II. 
EXPEDITED ☒ 
In order to qualify for expedited review, the study must be no more than minimal risk* AND 
must fall into one of the categories below.  Check all that apply: 
 
1. ☐ Clinical studies of drugs and medical devices only when an investigational new drug 
application (IND) or investigational device exemption application (IDE) is not required 
 

 
 
 
   
 
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2. ☐ Collection of blood samples by finger stick, heel-stick, ear stick, or venipuncture as 
follows: 
a. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, 
the amounts drawn may not exceed 550 ml in an 8-week period and collection may 
not occur more frequently than 2 times per week; or 
b. From other adults and children, considering the age, weight, and health of the 
subjects, the collection procedure, the amount of blood to be collected, and the 
frequency with which it will be collected. For these subjects, the amount drawn may 
not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may 
not occur more frequently than 2 times per week. 
 
3. ☐ Prospective collection of biological specimens for research purposes by 
noninvasive means. Examples include hair and nail clippings, saliva or cheek swabs, 
sweat, etc. 
 
4. ☐ Collection of data through noninvasive procedures (not involving general 
anesthesia or sedation) routinely employed in clinical practice, excluding procedures 
involving x-rays or microwaves. Where medical devices are employed, they must be 
cleared/approved for marketing. 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 subject or an 
invasion of the subject’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.  
  

 
 
 
   
 
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Note:  The IRB will make the final determination on the Type of 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. 
 
SECTION E:  STUDY STAFF AND HUMAN SUBJECTS TRAINING 
List ALL current members of the research team in the table below.  Add more rows as necessary. 
 
STUDENT RESEARCH: 
The Faculty Advisor must be listed as a co-investigator in this section and must complete the 
Human Subjects training requirements. Faculty Advisors are responsible for reviewing the IRB 
application, agreeing to serve as the Co-PI for this study with the student and are responsible for 
the ethical conduct of this student’s human subjects research. Faculty Advisors must sign this 
Application prior to it being submitted to the IRB. 
 
BU CHARLES RIVER CAMPUS (CRC) INVESTIGATORS/STUDY STAFF 
Note: Boston University Medical Campus (BUMC) investigators/study staff should be listed in 
the NON-BU INVESTIGATOR/STUDY STAFF section 
Name, Degree, Department,  
School 
Study Role (e.g. co-investigator, 
research coordinator, research 
assistant, project manager, lab 
manager) 
*Training 
Kristin Long, PhD, Dept. 
Psychological and Brain 
Sciences, CAS 
Principal Investigator 
☒ CITI 06/14/2023 
☐ **Other:  
 
Suma Suswaram, PhD, Dept. 
of Psychological and Brain 
Sciences, CAS 
Post-Doctoral Associate 
☒ CITI 07/12/2022 
☐ **Other: 
Monica Gordillo, M.A., 
Dept. Psychological and 
Brain Sciences, CAS 
Doctoral Student Researcher 
☒ CITI 5/08/2022 
☐ **Other: 
 
Jenna Eilenberg, M.A., 
MPH, Dept. of Psychological 
and Brain Sciences, CAS 
Doctoral Student Researcher 
☒ CITI 09/25/2023 
☐ **Other: 
 
Nicole Cardona, M.A., Dept. 
Psychological and Brain 
Sciences, CAS 
Doctoral Student Researcher 
☒ CITI 08/22/2021 
☐ **Other: 
 
Ariel Blakey, M.A., Dept. 
Psychological and Brain 
Sciences, CAS 
Doctoral Student Researcher 
☒ CITI 09/06/2022 
☐ **Other: 
 
Kathryn Davis, M.A., Dept. 
Psychological and Brain 
Sciences, CAS 
Doctoral Student Researcher 
☒ CITI 08/05/2022 
☐ **Other: 
 

 
 
 
   
 
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John “Jay” Wilson, M.A., 
Dept. of Psychological and 
Brain Sciences, CAS 
Doctoral Student Researcher 
☒ CITI 09/08/2023 
☐ **Other: 
 
Mikaela De Lemos, B.A., 
Dept. Psychological and 
Brain Sciences, CAS 
Doctoral Student Researcher  
☒ CITI 09/10/2023 
☐ **Other: 
 
Alix Paredes, BA 
Dept. of Psychological and 
Brain Sciences, CAS 
Lab Manager 
☒ CITI 01/28/2022 
☐ **Other: 
Shumin Guan, Dept. of 
Psychological and Brain 
Sciences, CAS 
Undergraduate Student 
Researcher (Staff) 
☒ CITI 10/25/2021 
☐ **Other: 
Samuel Lai, Dept. of 
Psychological and Brain 
Sciences, CAS 
Undergraduate Student 
Researcher 
☒ CITI 5/15/2022 
☐ **Other:  
 
Illari Cazorla-Garcia, Dept. 
of Psychological and Brain 
Sciences, CAS 
Undergraduate Student 
Researcher 
☒ CITI 09/30/2022 
☐ **Other: 
Dara Oliveira, Dept. of 
Psychological and Brain 
Sciences, CAS 
Undergraduate Student 
Researcher 
☒ CITI 09/29/2022 
☐ **Other: 
Samantha Brayton, Dept. of 
Psychological and Brain 
Sciences, CAS 
Undergraduate Student 
Researcher 
☒ CITI 04/17/2022 
☐ **Other: 
Joshua Dela Cruz, Dept. of 
Psychological and Brain 
Sciences, CAS 
Undergraduate Student 
Researcher 
☒ CITI 01/11/2023 
☐ **Other: 
Yudi Wang, Dept. of 
Psychological and Brain 
Sciences, CAS 
Undergraduate Student 
Researcher 
☒ CITI 02/03/2023 
☐ **Other: 
 *For more information regarding the Human Subjects Training Policy, refer to the ‘Training’ 
section of the Policies & Guidance section IRB website.  
 **If the investigator/study staff did not complete CITI, you must submit a copy of his/her 
training certificate. 
 
NON-BU INVESTIGATORS/STUDY STAFF*  
 
 
☐ N/A 
Note: BUMC and BMC staff are considered non-BU staff and should be listed in this section. Add 
more rows as necessary. All the columns in the box below must be completed.  In addition, you 
must complete the box that follows with a description of the activities for each staff member.   

 
 
 
   
 
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Name, Degree, 
Institution 
Study Role 
Staff Information 
Will IRB Approval 
be Obtained from 
Non-BU Institution? 
Anna Muriel, M.D., 
MPH 
 
Dana Farber Cancer 
Institute 
Collaborator 
1. Will this staff 
interact with subjects? 
☐ Yes          ☒ No 
 
2.Will this staff have 
access to identifiable 
information? 
☐ Yes          ☒ No 
 
3.Is the work that the 
staff will complete 
related to their role or 
coursework at their 
institution.? 
☒ Yes          ☐ No 
☐ Yes; provide copy 
of IRB approval letter  
 
☒ No (provide 
reason):   
Dana Farber Cancer 
Institute will be a 
recruitment site only. 
Dr. Muriel will have 
access to deidentified 
data. 
Melissa Alderfer, PhD 
 
Nemours Children’s 
Health System 
Collaborator 
1. Will this staff 
interact with subjects? 
☐ Yes          ☒ No 
 
2.Will this staff have 
access to identifiable 
information? 
☐ Yes          ☒ No 
 
3.Is the work that the 
staff will complete 
related to their role or 
coursework at their 
institution.? 
☒ Yes          ☐ No 
☐ Yes; provide copy 
of IRB approval letter 
 
☒ No (provide 
reason):   
 
No study activities 
will take place at 
Nemours. Dr. Alderfer 
will have access to 
deidentified data. 
*If IRB approval will be obtained from the affiliate site, only list the lead investigator from the 
affiliate on this form. 
 
The box below must be completed.  Include a summary for each staff listed in the above box.  
If any of the investigators listed on this form are not affiliated with BU, provide a summary of the 
study activities that he/she will conduct.  If IRB approval is not being obtained at the affiliate 
institution, provide an explanation.  NOTE:  Non-BU staff may be required to complete an 
Individual Investigator Agreement (IIA).  The IRB will notify you if this form is required. 
Dr. Anna Muriel will act as collaborator on the present study. She will contribute to the design 
of the research (e.g., finalizing the qualitative interview guide and crafting the treatment manual) 
and will contribute to interpretation and dissemination of findings. She will have access to de-

 
 
 
   
 
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identified data only. IRB approval will not be obtained from Dana Farber Cancer Institute 
(DFCI) as DFCI will serve only as a recruitment site for parts 1 and 2 of the present study. 
 
Dr. Melissa Alderfer will act as collaborator on the present study. She will contribute to the 
design of the research (e.g., finalizing the qualitative interview guide and crafting the treatment 
manual) and will contribute to the analysis, interpretation, and dissemination of findings. She 
will have access to de-identified data only. IRB approval will not be obtained from Nemours 
Children's Health System, as no study activities will take place at this site. 
 
 
 
 
REQUIRED GOOD CLINICAL PRACTICE TRAINING FOR NIH-FUNDED 
CLINICAL TRIALS 
YES* 
NO 
NIH-FUNDED CLINICAL TRIALS 
☒ 
☐ 
Is your study NIH-Funded AND meet the definition of a clinical trial as defined 
in the NIH policy?    
 
SECTION F:  LOCATION OF THE RESEARCH 
YES* 
NO 
 
☐ 
☒ 
Will this research take place at sites/locations other than Boston University? 
Note:  If the research will take place at Boston University, state the location 
(Building and Room number):  
Due to the remote operation plans implemented in response to SARS-CoV-2, 
Boston University study staff completing interviews or group pilot sessions 
remotely will conduct study activities via telephone or the Zoom video-
teleconferencing platform from a private room or office with a door that can be 
closed to ensure that interviews and research calls are not heard by individuals 
not on the Boston University study staff. 
*If YES, please complete the boxes below 
 
NOTE:  You are responsible for obtaining permission/letters of support for research conducted 
off-site. This may include locations such as schools, workplaces, community organizations, etc.  
You must submit the letters/documentation of support with this application. 
Institution Name and 
Address (if known) 
Describe Involvement 
(recruiting, consenting, data 
analysis, etc.) of the site.  If the 
site or the site staff is not 
involved (engaged)1 in research 
procedures, state NONE. 
IRB/Ethics Approval/Site 
Permission Attached?  If 
no2, explain the plan to 
obtain this approval.  If the 
site is not engaged in the 
research, you do not need 
to complete the box. 
 
 
 
 
 
 
1Guidance on Engagement of Institutions in Human Subjects Research  
2If IRB approval will not be obtained at the site, describe the IRB oversight arrangements here:  

 
 
 
   
 
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YES* 
NO 
 
☐ 
☒ 
Is the off-site location requesting that the Boston University IRB review the 
protocol in place of local IRB review? If YES, complete the Single IRB Review 
Form “Boston University is Institution A”  
 
YES* 
NO 
 
☐ 
☐ 
Is the BU PI the lead investigator OR is BU the lead site for this research? 
Note:  This box only needs to be completed if the off-site location is engaged 
in the research. 
*If YES, provide the following information in this box:  
 The plan for collection and management of data from all the sites 
 The plan for reporting and evaluating: 
 Unanticipated problems 
 Serious and/or continuing non-compliance 
 Suspensions and terminations of research 
 Interim results 
 Protocol modifications 
 The name of the Principal Investigator from each site  
 If IRB approval will be obtained at the site, confirmation that you have a copy (or will 
obtain a copy) of the IRB approval letters and the IRB-approved protocols from each site  
 
If IRB approval will be obtained at the site, confirmation that the site IRB has a 
FederalWide assurance (FWA)  
 
YES* 
NO 
 
☐ 
☒ 
Will this research be conducted outside of the United States?  
If YES, complete the International Research Form.  
 
SECTION G:  STUDY SUMMARY 
Summarize the study in lay language (do not copy from the grant/scope of work/proposal, 
etc.). This summary should include the research design, purpose, objectives, research 
question, hypothesis, and any relevant background information.   
 
Do not include a list of citations in this section.  Please limit this section to no more than 300 
words. 
Prolonged, complicated, and intensive cancer treatment regimens challenge and disrupt the entire 
family (Alderfer & Kazak, 2006; Faulkner & Davey, 2002) Adolescents and young adults who 
are the child of or sibling to an immediate family member with cancer are a psychosocially at-
risk and underserved group. Siblings of youth with cancer frequently report strong negative 
emotions, disruptions to family life, poorer academic functioning, more school absenteeism 
(school-aged siblings), and riskier health behaviors and poorer health outcomes than 
comparisons (adult siblings) (Long et al., 2018). Similarly, adolescent and young adult children 
affected by parental cancer report anxiety, depression, low self-esteem, poor health-related 

 
 
 
   
 
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quality of life, and higher school absenteeism (Walczak et al., 2018; Zheng et al., 2022). 
Approximately one-quarter of siblings (Kaplan et al., 2013) and one quarter of children (Egberts 
et al., 2022) of individuals with cancer meet diagnostic criteria for cancer-related posttraumatic 
stress disorders (PTSD). Additionally, both siblings and children of immediate family members 
with cancer report feelings of isolation and indicate a strong desire to connect with peers with 
similar experiences (Long et al., 2018; Geertz et al., 2023). The need psychosocial supports for 
siblings of children with cancer (Gerhardt et al., 2015) and children of parents with cancer (Ohan 
et al., 2020) is well established. Unfortunately, these supports are not routinely available in 
clinical practice (Davis et al., 2022; Alexander et al., 2019) and the psychosocial needs of 
adolescents and young adultsh affected by an immediate family member’s cancer remain largely 
unmet (Patterson et al., 2014; Ohan et al., 2020). 
The present study aims to address barriers to psychosocial care for siblings and children of 
individuals with cancer by developing a group-based telehealth program with an accompanying 
parent session. In Phase 1 of the present study, study staff will interview a diverse sample of 
English- and Spanish-speaking families and psychosocial providers to assess preferences for 
program content, format, timing, and cultural feasibility and acceptability, while considering 
ideas to minimize participation barriers. In Phase 2, a pilot version of the SibACCESS program 
will be tested with a small group of families located in Massachusetts, Rhode Island, and/or 
Delaware using video-teleconferencing technology. The pilot trial includes a preliminary joining 
session, a parent informational webinar, and 9 program sessions. Families will complete pre- and 
post-intervention quantitative measures in addition to exit interviews to assess preliminary 
program acceptability and perceived benefits. 
 
SECTION H: RESEARCH METHODS AND ACTIVITIES  
(Check all that apply) 
☒ 
Collection of audio, video, digital, or image recordings 
☐ 
Biological samples  Complete Biological Samples Form 
Examples:  blood, hair, cheek swab, urine, tears, saliva, etc. 
☐ 
Collection of data that may be sensitive and if disclosed could put subjects at risk for 
legal or social harms. (e.g. Illegal behaviors, HIV status, psychiatric illness, information 
related to sexual behaviors, etc. 
☐ 
Coordinating Center/Lead Site 
☐ 
Deception 
☐ 
Devices  Complete Devices Form 

 
 
 
   
 
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☐ 
Drugs  Complete Drugs Form 
☐ 
Ethnographic: The study of people in their own environment through the use of 
methods such as participant observation and face-to-face interviewing 
☐ 
Focus Groups 
☐ 
Genetics Testing  Complete Genetics Form  
☐ 
MRI 
☐ 
Placebo 
☐ 
Pregnancy Testing 
☐ 
Randomization 
☒ 
Surveys, interviews, questionnaires 
☐ 
Secondary Data Analysis 
☐ 
Other (please describe):  
 
SECTION I:  PARTICIPANT POPULATION 
Provide the Number of Participants to be Enrolled. If you have sub-groups or more than 
one arm, please separate out these enrollment numbers. Note: Please account for 
participants who may drop out or be withdrawn from the study. Anyone who signs a consent 
form is considered to be enrolled in the research regardless of whether they complete any study 
procedures. 
 
Phase 1 (Development of the SibACCESS Telehealth Program) 
 
N = 35 Families (For adolescent participants between the age of 12-17 years old, a family unit 
will include both a parent and the adolescent. Up to 2 parents and 2 adolescents can participate 
from each family. Young adult participants (i.e. 18-30 year old siblings or children of an 
immediate family member who has been diagnosed with cancer) may participate as 
individuals or with a parent). 
N = 15 Psychosocial Providers 
 
Phase 2 (Pilot of the SibACCESS Telehealth Program) 
 
N=20 Families (This will include 20 parents and 20 siblings, for a total of 40 family members. 
Up to 2 siblings can participate from each family). 

 
 
 
   
 
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Check all categories that apply to your participant population: 
☒ 
Adults 
 
☒ 
Children (< 18 years of age) 
☐ 
Adults with Limited Decision-Making Capacity 
☒ 
Non-English Speaking 
☐ 
Prisoners 
☐ 
BU Employees 
☐ 
BU Students 
☐ 
Wards of the state 
☐ 
Other (please describe): 
 
If a population other than ‘Adults’ has been checked, describe the additional safeguards 
that have or will be put in place to protect those individuals, and provide the rationale for 
including this population in the research study. For information on additional protections, 
please see the ‘Supplemental Guidance’ section of the CRC IRB webpage.  
 
Children or young adults diagnosed with cancer are not eligible to participate in the present 
study. Only siblings or children of an immediate family member diagnosed children with 
cancer are eligible to participate. The present study involves youth and young adults ages 12 
to 30 in Phase 1 and only youth 12-17 in Phase 2. 
Phase 1 (Development of the SibACCESS Telehealth Program) 
In Phase 1, youth/young adults and parents will complete qualitative interviews with a 
member of the research team in their primary language (English or Spanish). A member of the 
research team will explain to the participant Phase 1 study details (e.g., details regarding 
purpose of the qualitative interview) in developmentally-appropriate language and in their 
native language (Spanish or English). Staff will emphasize that study participation is 
voluntary. Participants will be given ample time to ask questions and decide whether or not to 

 
 
 
   
 
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participate. Youth participants under the age of 18 will have at least one parent indicate their 
consent for the youth’s participation in the qualitative interview and the youth will be asked to 
provide verbal assent (see Phase 1 Verbal Consent Form and Phase 1 Child Verbal Assent 
Form). Young adults who are ages 18-30 will complete their own consent form if they choose 
to participate (see Phase 1 Verbal Consent Form).During interviews, interviewers will 
attempt to minimize distress associated with discussion of sensitive topics surrounding cancer 
diagnoses and treatment by re-iterating to participants that they are not required to answer 
questions that they are uncomfortable answering. No greater than minimal risk is present for 
participants in this research study.  
Phase 2 (Pilot of the SibACCESS Telehealth Program) 
In Phase 2, families will be enrolled in a pilot version of the SibACCESS program and will 
complete pre/post-quantitative measures and qualitative exit interviews. A member of the 
research team will explain Phase 2 study details (e.g., how many meetings are included in the 
program, who will be at the meeting, what information might be covered in the meetings, the 
purpose of the qualitative exit interview, etc.) to the sibling and parent participants. At least 
one parent will indicate their consent for the sibling’s participation in the SibACCESS pilot 
program and data collection, and siblings will be asked to provide verbal assent (see Phase 2 
SibACCESS Altered Consent Script [REDCap] and Phase 2 SibACCESS Sibling Assent 
Script [REDCap]). 
As in Phase 1, study staff conducting Phase 2 qualitative exit interviews with siblings and 
parents will attempt to minimize distress associated with discussion of sensitive topics 
surrounding cancer and treatment by re-iterating to particpants that they are not required to 
answer questions that make them uncomfortable to answer. 
Phase 1 and Phase 2 (Pertaining to the Disclosure of Mental Health Risk) 
Should a youth/young adult participant or parent disclose imminent mental health risks to 
study staff during qualitative interviews (Phase 1 or Phase 2) or during the course of the 
SibACCESS pilot intervention trial or associated research procedures (Phase 2), study staff 
will immediately contact the PI (Kristin Long, PhD). Dr. Long is a licensed clinical 
psychologist (licensed in MA and RI) who is trained in management of mental health risk. She 
will be on call at all times and will be available to provide guidance to address imminent risk 
discovered during research activities. Should a parent provide written consent, a mental health 
referral may be made as indicated. Additionally, a list of crisis resources (see Phase 2 
SibACCESS Crisis Resource List) for the states in which participating families reside will 
be available to families at the time of risk disclosure. 
 
Eligibility Criteria 
Inclusion Criteria:  

 
 
 
   
 
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Phase 1 (Development of the SibACCESS Telehealth Program) 
Family Inclusion Criteria  
 Youth/young adult participants who are either the sibling or child of an immediate 
family member with a current or past cancer diagnosis. 
o Youth/young adult can be biologically-related sibling/child, step-sibling/child, 
or adopted sibling/child of the individual diagnosed with cancer 
 Youth/young adult 12-30 years of age 
o Youth/young adult must report at least mild posttraumatic stress (for youth <18 
years of age, score ≥11 on Child Posttraumatic Stress Scale for DSM-5; for 
young adults ≥18 years of age, score ≥11 on the Posttraumatic Diagnostic Scale 
(PDS) for DSM-5) 
 Youth/young adult must be fluent in English or Spanish 
o For families with youth <18 years of age, participating parent must also be 
fluent in English or Spanish 
 
Provider Inclusion Criteria 
 Psychosocial provider (i.e., psychologist, psychiatrist, or licensed clinical social 
worker) within an oncology program  
 > two years of experience in cancer (does not have to be current or consecutive) 
 Fluency in English or Spanish 
 
Phase 2 (Pilot of the SibACCESS Telehealth Program) 
Family Inclusion Criteria 
 2 or more children in the family (i.e., child with cancer and >1 sibling) 
o Sibling(s) and child with cancer each under the age of 18 at the time of cancer 
diagnosis 
o Sibling(s) can be biologically-related, step-siblings, foster-siblings, or adopted-
siblings 
 Parent and sibling(s) fluent in English 
 Sibling(s) 12-17 years of age 
 Sibling report of at least mild posttraumatic stress (score >11 on the Child 
Posttraumatic Stress Scale for DSM-5) 
 Child with cancer must have received cancer diagnosis at least 3 months prior to the 
family’s enrollment in the study 
 
Exclusion Criteria (exclusion criteria are the specific criteria which would disqualify an 
individual from participating in the study not simply the opposite of the inclusion criteria):  

 
 
 
   
 
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Phase 1 (Development of the SibACCESS Telehealth Program) 
Family Exclusion Criteria 
 A cognitive impairment that would interfere with interview completion (as reported by 
a parent or by the young adult) 
 Bereavement 
 Immediate family member with cancer residing and receiving cancer treatment outside 
of the United States 
 Family residing outside of the United States 
Provider Exclusion Criteria 
 Practicing outside of the United States 
 
Phase 2 (Pilot of the SibACCESS Telehealth Program) 
Family Exclusion Criteria 
 A cognitive impairment that would interfere with pilot program and interview 
completion (as reported by parent) 
 Bereavement 
 Significant externalizing behaviors that would interfere with group participation (as 
reported by parent) 
 Child with cancer residing and receiving cancer treatment outside of the United States 
 Family residing outside of the United States 
 
SECTION J:  RECRUITMENT 
Provide a summary of the recruitment process, including who will recruit, when and 
where recruitment will occur, and how subjects will be identified 
 
Submit all recruitment materials (e.g. advertisements, brochures, flyers, letters/e-mails, 
scripts, etc.) as separate documents in either Word or PDF format. 
Families will be recruited in four ways. First, Boston University study staff will re-contact 
families who participated in past research studies and consented to be re-contacted about 
future study opportunities. Families may only participate in phase 1 or phase 2 of the present 
study (not both). Second, Boston University study staff will recruit from the pediatric 
oncology service within health care centers to ensure the inclusion of culturally diverse 
families and those who are receiving active cancer treatment. These sites (e.g., Dana Farber 
Cancer Institute) will serve as recruitment-only sites and will not be involved in consenting or 
data collection. Third, Boston University study staff will recruit from a contact list provided 

 
 
 
   
 
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by Alex’s Lemonade Stand Foundation. Finally, Boston University study staff will use other 
forms of community outreach to reach families who would otherwise not be aware of the 
study through the two recruitment methods described above. This may include social media 
postings in order to communicate information about the present study (see Phase 1 and Phase 
2 Social Media Phrasing document). 
Phase 1 (Development of the SibACCESS Telehealth Program)  
For previous participants (families and providers) for whom we have email addresses, we will 
send an email outlining the present study’s purpose and details (e.g., outline qualitative 
interview process) (see Phase 1 Young Adult – Study Details Email, Phase 1 Family Study 
Details Email and Phase 1 Provider Study Details Email). In addition to study details, the 
email will indicate to families and providers that they should expect follow-up telephone 
outreach from Boston University study staff, unless they “opt-out” of further contact by 
responding to the study details email within 1-week. Families and providers who do not opt-
out will be eligible to be contacted via text, telephone call, and/or email  by Boston University 
study staff once the 1-week opt-out period has elapsed.  
For previous participants (families and providers) for whom we have email addresses, we will 
send an email outlining the present study’s purpose and details (e.g., outline qualitative 
interview process) (see Phase 1 Young Adult – Study Details Email, Phase 1 Family Study 
Details Email and Phase 1 Provider Study Details Email). In addition to study details, the 
email will indicate to families and providers that they should expect follow-up telephone 
outreach from Boston University study staff, unless they “opt-out” of further contact by 
responding to the study details email within 1-week. Families and providers who do not opt-
out will be eligible to be contacted via text, telephone call, and/or email  by Boston University 
study staff once the 1-week opt-out period has elapsed.  
For previous participants (families and providers) for whom we only have telephone numbers 
(and no email addresses) or for whom the email address proves to be outdated (e.g., delivery 
failure message is received), we will reach out by telephone to determine interest in the 
present study (see Phase 1 Family Telephone Script and Eligibility Screen and Phase 1 
Provider Telephone Script and Eligibility Screen). 
For families recruited from Alex’s Lemonade Stand foundation, we will mail and/or email an 
informational letter regarding the present study (ALSF Recruitment Letter (Mail Version) 
and ALSF Recruitment Letter (Email Version)) to those for whom we have contact 
information. Approximately 2 weeks after the mailing and/or emailing of the letters, Boston 
University study staff will reach out via telephone to gauge family interest in hearing more 
about the student and to determine eligibility (Phase 1 Family Telephone Script and 
Eligibility Screen). 

 
 
 
   
 
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Families recruited from the pediatric oncology service within healthcare centers will need to 
“opt-in” to be contacted by Boston University study staff. Families may be approached by 
their psychosocial provider in person at a clinic visit and given a brief overview of the study, 
or they may receive information about the study from newsletters, fliers, or other media. 
Families interested in study participation will be directed to independently complete an online 
consent-to-contact form located on the Child and Family Health Lab website (see Consent-to-
Contact Webpage Summary) or to call study staff to indicate their interest in learning more 
about the study. Families who complete the consent-to-contact form, can be contact by email 
or telephone to confirm their interest and schedule a time for an eligibility screen (see Phase 1 
Family Study Details Email [Opt-In Families] 5.03.2021).  
Boston University study staff will contact interested families and providers via telephone to 
provide additional details about the study and answer any questions (see Phase 1 Family 
Telephone Script and Eligibility Screen and Phase 1 Provider Telephone Script and 
Eligibility Screen). ). For youth under the age of 18, parents will answer eligibility questions 
about the family and the Child Posttraumatic Stress Scale for DSM-5 (as part of the eligibility 
screen) will be administered verbally to the youth. Young adults ages 18-30 will answer 
eligibility questions themselves and will be verbally administered the Posttraumatic 
Diagnostic Scale for DSM-5 (to assess eligibility). Eligible families and providers will then be 
scheduled to complete a qualitative interview (Phase 1). Note that, in cases where a parent or 
guardian is enrolled, that parent or guardian may or may not be a parent or guardian of the 
child with cancer, and may or may not be a parent/guardian with cancer.According to 
purposive sampling procedures that are considered the “gold standard” of qualitative research, 
we will occasionally review the characteristics of enrolled participants and target future 
recruitment activities to ensure breadth in our sample. Purposive sampling for families will be 
based on youth/young adult age, youth/young adult gender, family race/ethnicity, and cancer 
treatment status (i.e., on/off active treatment). Note that we will collect information about 
these purposive sampling variables within the phone screen and will explain to 
parents/guardians and or young adults the reason for collecting this information. 
Phase 2 (Pilot of the SibACCESS Telehealth Program) 
Families being re-contacted from past research, for whom we have email addresses, will first 
receive an emailing outlining the present study’s purpose and details regarding a pilot 
intervention trial (e.g., length of each individual session, information on the group format, etc.; 
see Phase 2 SibACCESS Family Study Details Email). Similar to recruitment procedure for 
Phase 1, it will be indicated to families that they should expect telephone outreach from the 
Boston University study staff, unless they “opt-out” of this telephone outreach by responding 
to the study details email within 1-week. Families who do not opt-out will be contacted a 
maximum of 10 times via text, telephone call, and/or email.  

 
 
 
   
 
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For families who are being re-contacted from past research, for whom we only have a 
telephone number (no email address) or for whom an email address is determined to be 
outdated we will reach out via telephone (text or call) to determine interest in the present study 
(see Phase 2 SibACCESS Family Telephone Script and Eligibility Screen).  
As with Phase 1, families recruited from the pediatric oncology service within healthcare 
centers for the pilot intervention trail (Phase 2) need to “opt-in” to be contacted by Boston 
University study staff. Families may be approached by their psychosocial provider in person at 
a clinic visit and given a brief overview of the study, or they may receive information about 
the study from newsletters, fliers, or other media. Families interested in study participation 
will be directed to independently complete an online consent-to-contact form located on the 
Child and Family Health Lab website (see Phase 2 SibACCESS Consent-to-Contact Page) 
or to call study staff to indicate their interest in learning more about the study.  
For families recruited from Alex’s Lemonade Stand foundation, we will mail and/or email an 
informational letter regarding the present study (Phase 2 ALSF Recruitment Mailer and 
Phase 2 ALSF Recruitment) to those for whom we have contact information. Approximately 
1 week after the mailing and/or emailing of the letters, Boston University study staff will 
reach out via telephone (text or call) and email to gauge family interest in hearing more about 
the student and to determine eligibility (Phase 2 Family Telephone Script and Eligibility 
Screen). 
Boston University study staff will contact interested families via telephone to provide 
additional details about the study and answer any questions (see Phase 2 SibACCESS Family 
Telephone Script and Eligibility Screen). Parents will answer eligibility questions, and the 
Child Posttraumatic Stress Scale for DSM-5 (as part of eligibility screen) will be administered 
verbally to the sibling. Eligible families will then be provided with a link from which to 
complete consent and assesnt forms,  quantitative study measures, and they will be scheduled 
to participate in the pilot intervention trial and complete a qualitative exit interview (Phase 2). 
Additional Recruitment Procedure for Phase 1 and 2 
Additionally, information regarding the present study will be shared with clinicians and 
families at healthcare centers via listings in newsletters and resource lists (see Phase 2 
SibACCESS Brief Advertisement and Phase 2 SibACCESS Website Text and Full-
Length Advertisement Document). Additional outreach may occur via fliers, emails, or other 
social media from relevant community organizations. 
Once Phase 1 and 2 of the study are closed to enrollment, contact information for families for 
whom study staff were unable to make contact will be destroyed. 
 
SECTION K:  CONSENT AND ASSENT 

 
 
 
   
 
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Please refer to the consent and assent form templates on the IRB website when creating your 
consent/assent documents. The templates include the required elements of consent and will help 
to ensure that your consent/assent form meets the requirements of the federal regulations and the 
BU CRC IRB.   
 
STUDENT RESEARCHERS must: 1) indicate in the consent form/information sheet/script that 
he/she is a student and 2) list the Faculty Advisor as a contact in the form/sheet/script. 
 
Provide a summary of the consent process, including who will consent participants, when 
and where consent will occur. The summary should include, as appropriate, any waiting 
period between informing the prospective participant about the research and obtaining 
consent, such that the prospective participant or the legally authorized representative has 
sufficient opportunity to consider whether to participate, and steps taken to minimize 
coercion or undue influence. 
 
Submit copies of all consent forms and scripts; materials should be submitted as separate 
documents in Word format. 
Phase 1 (Development of the SibACCESS Telehealth Program) 
Families and providers interested in participating in Phase 1 of the present study will be 
contacted by Boston University study staff to complete an eligibility screen. Eligible families 
and providers will then be scheduled to complete a qualitative interview. At the time of the 
interview appointment, youth/young adults, parents (if applicable) and providers will be asked 
to provide verbal consent to indicate their agreement to participate in a semi-structured 
qualitative interview and completion of background form in Qualtrics to collect cancer-related 
information, demographic information, and information posttraumatic stress symptoms in 
response to immediate family member’s cancer (see Family Background Form, Provider 
Background Form, and Phase 1 Verbal Consent Form). For youth participants under 18 
years old, parents will also be asked to provide consent to indicate their agreement for their 
participation. Youth under 18 years old will also be asked to provide verbal assent (see Phase 
1 Child Verbal Assent Form). Only Boston University study staff will be involved in 
obtaining informed consent (for parents and young adult participants) and assent (for youth 
under 18 years old) in qualitative interviews. 
Phase 2 (Pilot of the SibACCESS Telehealth Program) 
Eligible families choosing to participate in Phase 2 of the present study will be asked to 
provide informed consent indicating their agreement to participate in a pilot intervention trial 
(and its included quantitative measures, qualitative exit interview, and parent-focused 
intervention activities) via e-consent and assent forms on the REDCap platform prior to the 
pre-intervention data collection and the preliminary joining session of the intervention. Parents 
will also be asked to provide e-consent for up eligible siblings to participate in the pilot trial 
(see Phase 2 SibACCESS Altered Consent Script [REDCap]). Enrolled siblings will range 
in age from 12 to 17; therefore, siblings will be asked to provide e-assent to participate in 

 
 
 
   
 
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sessions 1 through 7 of the pilot intervention trial, pre/post-intervention quantitative measures, 
and a qualitative exit interview (see Phase 2 SibACCESS Sibling Assent Script [REDCap]). 
Should an adolescent sibling turn 18 during the pilot intervention, the sibling will be re-
consent via the REDCap platform (see Phase 2 SibACCESS Altered Consent Script) prior 
to the next pilot intervention trial session. Should the primary caregiver be unavailable for one 
or more of the program sessions involving parents, an alternate supportive adult can consent to 
participation limited to those sessions (Phase 2 Altered Consent Form – Supportive Adult). 
The supportive adult will not be asked to complete pre-program and post-program 
questionnaires, but may be asked to complete a brief exit interview.  
Only Boston University study staff will be involved in obtaining informed consent (for 
parents) and assent (for siblings) for participation in the pilot intervention trail, associated 
quantitative measures, and qualitative exit interviews via the REDCap platform.  Should a 
family require assistance completing e-consent measures, Boston University study staff will 
have access to their REDCap study files, and will be able to walk family through the consent 
form via Zoom at the family’s request. 
 
Indicate the consent and/or assent process and document(s) to be used in this study.   
Check all that apply 
Consent:  Adults (>18 years old); One of the following MUST apply                        N/A ☐ 
☐ 
Consent Form/Information Sheet 
 
☒ 
Verbal Consent (Script) 
Note:  If written consent will not be obtained, complete the ‘Waiver of Written 
Documentation Consent’ box (Box 1) located further down in this section 
☐ 
Consent will not be obtained 
Note:  If consent will not be obtained, complete the ‘Waiver or Alteration of Consent’ 
box (Box 2) located further down in this section 
 
Assent of Children (< 18 years old); One of the following MUST apply                   N/A ☐ 
☐ 
Assent Form OR Parent Consent Form/Information Sheet (older children may sign the 
parent consent form along with their parents as long as the consent form is written at the 
grade level of the subjects) 
☒ 
Verbal Assent (Script) 
☐ 
Assent will not be obtained; one of the following conditions must exist:    
 
1. ☐ The capability of some or all of the children is so limited that they cannot 
reasonably be consulted;  
 
2. ☐ The children are too young to provide assent; 
 

 
 
 
   
 
21 
Version:  November 2019 
3. ☐ The intervention or procedure involved in the research holds out the prospect of 
direct benefit to the health or well-being of the children and is available only in the 
context of the research   
 
4. ☐ The research meets the same conditions as those for waiver or alteration of 
informed consent in research involving adults, as specified in the regulations at 45 
CFR 46.116(d)*.  (Complete the ‘Waiver or Alteration of Consent’ box (Box 2) 
located further down in this section) 
 
Guidance on age requirements for obtaining assent: 
 Parental Permission for minors under 6 years old 
 Verbal assent for minors 6-11 years old 
 Written assent from minors ages 12-17 (unless verbal consent is approved for the 
parents/adult subjects 
Parental Permission; One of the following MUST apply                                           N/A ☐ 
☐ 
Parental Consent Form 
 
☒ 
Parental Verbal Consent (Script) 
Note: If written consent will not be obtained, complete the ‘Waiver of Written 
Documentation of Consent’ box (Box 1) located further down in this section 
☐ 
Parental permission will not be obtained; one of the following conditions must exist: 
 
1. ☐ The research protocol is designed to study conditions in children or a subject 
population for which parental or guardian permission is not a reasonable requirement 
to protect the subjects (for example, neglected or abused children). 
 
2. ☐ The research meets the same conditions as those for waiver or alteration of 
informed consent in research involving adults, as specified in the regulations at 45 
CFR 46.116(d)*.  (Complete the ‘Waiver or Alteration of Consent’ box (Box 2) 
located further down in this section). 
 
Consent:  Adults with Limited Decisional Capacity to Consent (>18 years old)   N/A ☒ 
 
Describe the consent and/or assent process for enrolling adults with limited decisional 
capacity to consent to research. Including how decisional capacity will determined, and who 
will serve as Legally Authorized Representative. 
 
 
 
Assent will be obtained from: 
☐ All Subjects 
☐ Some participants, specify: 
☐ No participants. If no participants will assent, provide a rationale: 
 

 
 
 
   
 
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☐ 
Consent will be obtained from the subject’s Legally Authorized Representative (LAR) 
(REQUIRED).  
Who will serve as LAR: 
 
CONSENT OF NON-ENGLISH SPEAKING SUBJECTS                            N/A ☐                     
Describe the process for obtaining consent from non-English speaking subjects.  List the 
individual who will serve as the interpreter and his/her qualifications. 
 
NOTE: A copy of the translated consent along with the Attestation Form for Translation of 
Consent must be submitted.  The Attestation Form can be located on the IRB website. 
 
 
Phase 1 (Development of the SibACCESS Telehealth Program) Only 
 
The process for obtaining consent from non-English speaking participants will be the same as 
the process indicated above for English speaking participants. A Spanish-speaking member of 
the Boston University study staff will obtain consent from Spanish-speaking participants 
verbally for Phase 1 of the study. English versions of the Phase 1 Verbal Consent Form and 
Phase 1 Child Verbal Assent Form will be translated into Spanish once approved by the IRB. 
The translated consent forms will then be submitted along with the appropriate attestation form 
to the BU-CRC IRB for approval prior to use.  
 
 
BOX 1—WAIVER OF WRITTEN DOCUMENTATION OF CONSENT 
 
WAIVER OF WRITTEN DOCUMENTATION OF CONSENT   N/A ☒      
Either Criteria 1 or 2 must be met in order to qualify                  
Yes 
No 
☐ Criteria 1 
The research is NOT FDA Regulated 
☐ 
☐ 
The only record linking the subject and the research would be the consent 
document 
☐ 
☐ 
The principal risk would be potential harm resulting from a breach of 
confidentiality 
☐ 
☐ 
Each subject will be asked whether the subject wants documentation linking 
the subject to the research and the subject’s wishes will govern 
☐ 
☐ 
A written statement/information sheet will be provided to subjects.  If NO, 
provide rationale for not providing this information:  
 
☐ 
☐ 
 ☒ Criteria 2 
The research is NOT FDA Regulated 
☒ 
☐ 
The research presents no more than minimal risk of harm to subjects 
☒ 
☐ 
The research involves no procedures for which written consent is normally 
required outside of the research context 
☒ 
☐ 

 
 
 
   
 
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A written statement/information sheet will be provided to subjects.  If NO, 
provide rationale for not providing this information: 
 
☒ 
☐ 
☐ Criteria 3 
The research is NOT FDA Regulated 
☐ 
☐ 
The research presents no more than minimal risk of harm to subjects 
☐ 
☐ 
The subjects or legally authorized representatives are members of a distinct 
cultural group or community in which signing forms is not the norm 
☐ 
☐ 
There is an appropriate mechanism for documenting that informed consent was 
obtained 
☐ 
☐ 
A written statement/information sheet will be provided to subjects.  If NO, 
provide rationale for not providing this information: 
 
☐ 
☐ 
 
 
 
BOX 2—WAIVER OR ALTERATION OF CONSENT 
 
NON-FDA REGULATED STUDIES 
WAIVER OR ALTERATION OF CONSENT                    N/A ☐                    
45 CFR 46.116 Waiver or alteration of consent. The IRB may approve a 
consent procedure which does not include, or which alters, some or all of 
the elements of informed consent set forth in this section, or waive the 
requirements to obtain informed consent provided the IRB finds and 
documents ALL of the criteria listed below: 
Yes 
No 
 
 
The research involves no more than minimal risk to the subjects; 
☒ 
☐ 
The waiver or alteration will not adversely affect the rights and welfare of the 
subjects; 
☒ 
☐ 
The research could not practicably be carried out without the waiver or 
alteration; 
☒ 
☐ 
If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using 
such information or biospecimens in an identifiable format; 
☒ 
☐ 
Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation.  If NO, provide rationale for not providing this 
information: 
 
☒ 
☐ 
Provide the justification/rationale for why this study meets the above criteria for waiving 
or altering consent (REQUIRED): 
 
Due to the current social-distancing guidelines implemented in response to the SARS-CoV-2 
pandemic, and continuation of remote operation of research activities by Boston University 
study staff, qualitative interviews for Phase 1 of the study will be completed entirely remotely 
using the telephone or the Zoom-teleconferencing platform. Additionally, the background forms 

 
 
 
   
 
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will be complete remotely using the Qualtrics survey platform (see Family Background Form 
and Provider Background Form). For this reason, the Boston University study staff are 
requesting the approval of verbal consent for young adult participants age 18 and older, for 
parents and for psychosocial providers, and verbal assent for youth  participants in Phase 1 (see 
Phase 1 Verbal Consent and Phase 1 Child Verbal Assent Form). Please note that in-person 
contact in the context of COVID-19 can be particularly risky for families who have a member 
with cancer due that individual’s immunocompromised state. 
 
For Phase 2 of the study, the pilot program is intentionally designed to be implemented via 
telehealth sessions in order to make the program more accessible to siblings of children with 
cancer. Boston University study staff are requesting that parental consent and sibling assent be 
obtained verbally (see Phase 2 Verbal Consent Form/Information Sheet and Phase 2 Sibling 
Assent Form/Information). 
 
FDA-REGULATED STUDIES 
Per FDA guidance issued in July 2017, the IRB may waive or alter informed 
consent requirements for certain minimal risk clinical investigations when 
the IRB finds and documents ALL of the criteria listed below: 
Yes 
No 
 
 
The clinical investigation involves no more than minimal risk (as defined in 21 
CFR 50.3(k) or 56.102(i)) to the subjects; 
☐ 
☐ 
The waiver or alteration will not adversely affect the rights and welfare of the 
subjects; 
☐ 
☐ 
The clinical investigation could not practicably be carried out without the 
waiver or alteration 
☐ 
☐ 
Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation.  If NO, provide rationale for not providing this 
information: 
 
☐ 
☐ 
Additional Comments: 
 
 
 
 
SECTION L:  STUDY PROCEDURES 
In the box below provide a detailed description of the study procedures to be performed 
(preferably in sequential order). Be sure to specify which procedures are for research 
purposes and which procedures are part of standard of care, if applicable. Be sure to 
include the following information: 
 Methods of data collection  
 Details regarding research activities/procedures/interventions 
 Number, frequency, duration and types of subject contacts (visits, phone calls, internet 
surveys, mailings, etc.) 
 Time required from each subject 
 Use of equipment (eye-tracker, treadmill, sensors, etc.). Provide a brief description of 
equipment that will be used in the study.* 

 
 
 
   
 
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*Note: The IRB may request more information about the equipment (including equipment 
manuals) and/or request that you submit Appendix C: Device Form. 
 
Submit copies of all surveys, interview questions, assessments, screening scripts, etc. that 
will be used during the conduct of this study; materials should be submitted as separate 
documents in either Word or PDF format. 
 
Phase 1 (Development of the Sibling Telehealth Program) 
Potentially eligible families and providers will be contacted by Boston University study staff to 
complete a 15 to 30-minute eligibility screen (see Phase 1 Family Telephone Script and 
Eligibility Screen and Phase 1 Provider Telephone Script and Eligibility Screen). If a family 
is found to be eligible, the youth/young adults and parent(s) (if applicable) each will be 
scheduled to complete a qualitative interview. Participants will participate in a 60 to 75-minute 
remote qualitative interview via the Zoom platform (audio-recording only). Young adults, 
parents and providers will also complete a brief background form via Qualtrics to collect cancer-
related information, demographic information, and information about posttraumatic stress 
symptoms in response to immediate family member’s cancer (see Family Background Form 
and Provider Background Form). Qualitative data collection and interim analyses will be 
iterative, with findings from earlier interviews incorporated into the evolving interview guide 
(see Sample Interview Questions) and SibACCESS program description until thematic 
saturation is reached (i.e., when interviews no longer yield new information). 
For providers re-contacted from the 5019E study: Responses to the following demographic 
interview questions will be shared with study staff of protocol 5870E, if a provider is re-
contacted, consented (including a question on whether they agree to their information being 
shared across studies), and enrolled in the new study. The sharing of this information across 
studies will prevent this specific group of providers from needing to answer demographic 
questions for which they have answered in the past 2 years. Additionally, if a provider does not 
consent to this demographic information being shared across the 5019E and 5870E studies, they 
will be re-asked demographic questions such as those listed below as part of semi-structured 
qualitative interview procedures. 
 
1. Tell me a little bit about the role you play in the provision of psychosocial support 
to families of individuals with cancer.  
a. What is your professional title?   
b. What is your discipline (e.g., child life specialist, social worker, psychologist, 
psychiatrist, nurse, oncologist)?    
 
2. Tell me about your center.   
a. Is your center located within a free-standing children’s hospital or a university 
medical center?   
b. Do you have trainees (e.g., child life specialist trainees?)   

 
 
 
   
 
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Version:  November 2019 
c. How many new childhood cancer patients does your center serve annually?  
d. Does your center care for hematopoietic cell transplant patients and their families?   
e. What percentage of patients travel >50 miles to receive care? 
f. How many psychosocial providers do you employ (full or part-time)? 
g. How are psychosocial providers supported – e.g., are they salaried? Do they bill for 
services? 
h. How would describe your patient demographics?  
ii. (E.g., primarily rural/urban, largely international, large/small percentage of 
racial/ethnic minority families, high/low percentage of non-English speakers, 
low/high-SES, (not) very religious)? 
 
Interviews will be recorded and transcribed verbatim in one of two ways: 1) using a password 
protected account on Amazon Transcribe or 2) by undergraduate or graduate student researchers 
with training in research ethics. Only approved study staff will have access to the Amazon 
Transcribe account. Audio recordings will be temporarily uploaded to the account for 
transcription (a process that takes approximately an hour) and then deleted from the account 
immediately following transcription. All transcripts (whether transcribed by an approved study 
staff member or Amazon Transcribe) will be reviewed a second time by a study staff member to 
check for accuracy and ensure that all potentially identifying information has been removed. All 
transcripts will be labeled with unique participant ID numbers. Audio recordings will be moved 
to the limited-access folder after transcription is complete. Audio recordings will be kept until 
data analysis is complete in case it is necessary to reference the original recording to clarify 
information during analysis. Study data will be retained for 7 years. Identifying information 
about families who are not eligible or decline participation will be destroyed. Spanish transcripts 
will be translated into English. All transcripts will be entered into a qualitative software 
program, NVivo to facilitate coding and analysis. Information from the interviews will be used 
to inform content, formatting, and feasibility of the  telehealth pilot program to address cancer-
related trauma symptoms. 
Phase 2 (Pilot of the SibACCESS Telehealth Program) 
Please Note: While multiple eligible siblings can be enrolled from each family in the present 
study, only one sibling per family will be enrolled in each cohort of the pilot intervention trial 
(e.g., one sibling per cohort of the SibACCESS pilot program). 
Potentially eligible families will be contacted to complete a 15 to 30-minute eligibility screen 
(see Phase 2 SibACCESS Family Telephone and Eligibility Screen). Eligible families (one 
parent and an eligible) will be enrolled to participate in a sibling-focused pilot telehealth group 
program focusing on increasing siblings’ exposure to cancer-related cues and opportunities to 
process those cues. The program will consist of 1 preliminary family joining session, a parent-
focused educational webinar, and 9 sibling intervention sessions (7 group sessions, 1 individual 
session, and 1 parent check-in). Group sessions will include between 3 and 10 sibling 
participants. The aim of this pilot program is to decrease the onset or intensity post-traumatic 

 
 
 
   
 
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stress for siblings of children with cancer. Sessions will be held over the HIPAA-compliant 
version of the Zoom video-teleconferencing platform. Each session of the pilot program will be 
video-recorded in order to assess program fidelity. Parents and siblings will also be asked to 
complete brief post-session surveys after each program session (Phase 2 Post-Session Survey 
03.06.2023) Parents and siblings will complete a battery of quantitative measures pre- and post-
intervention. Should a parent/sibling need assistance in completing measures, a member of the 
study staff will have access to their study record in REDCap and can assist the family in 
completion of measures via Zoom at the family’s request. Should the primary caregiver be 
unavailable for one or more of the program sessions involving parents, an alternate supportive 
adult can consent to participation limited to those sessions. A supportive adult who has 
consented to limited participation (participation limited only to sessions where parent 
involvement is needed), may be asked to complete brief exit interview 30-45 minutes regarding 
their experience with the program. The potential for exit interview will be based on the number 
of sessions the alternate supportive adult attended in support of the enrolled sibling.  
Upon completion of the program, enrolled members of families (parents and siblings) also will 
complete 30-45 minute exit interviews (Sample Exit Interview Questions). Interviews will be 
recorded and transcribed verbatim using one of two methods described above 
Phase 2: Measures 
Measures for SibACCESS Pilot Trial  (S = Sibling, P = Parent) 
 
Upon IRB Approval: REDCap will be set-up to 
calculate time 
to complete EACH proposed measure 
 
Construct 
Time to 
Complet
e 
Description 
Background (Pre Only) 
Background 
Information 
(P) 
 
A background form will include 
questions that assess family 
composition & income; family 
members’ age, gender, 
race/ethnicity, native language, 
immigration, education, & 
employment; sibling’s medical, 
mental health, or developmental 
conditions and psychotherapy 
treatment history; & information 
about cancer (specific cancer 
diagnosis, date of diagnosis, 
treatment type, relapse status). 
 
Emotional 
Avoidance (S) 
 
The Emotional Avoidance 
Strategy Inventory for 
Adolescents [86] is a 17-item 
measure of emotional avoidance 
with acceptable psychometrics 
in English [86] and Spanish [87] 
versions. 
Coping (S, P) 
 
One of the following (not both):  
1) Coping self-efficacy 
scale (26 items) 

 
 
 
   
 
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Version:  November 2019 
2) Responses to Stress 
Questionnaire (57 + 13 
= 70 items) 
 
Communicatio
n (S) 
 
The 4-item Communication 
scale of the Sibling Perception 
Questionnaire [91] is specific to 
cancer and has adequate 
reliability [92] and a Spanish 
translation [93].  
Interpersonal 
Functioning 
(S) 
 
One of the following (not both): 
1) The Interpersonal 
Relationships scale of 
the Sibling Perception 
Questionnaire [91] is 
specific to cancer and 
has adequate reliability 
[92] and a Spanish 
translation [93]. 
2) PFSES 
Outcomes (Pre & Post) 
Posttraumatic 
Stress (S) 
 
The Child PTSD Symptom Scale 
for DSM-5 [80] is a 27-item 
measure of posttraumatic stress. 
Strong test-retest reliability, 
internal consistency, and 
convergent validity with other 
child PTSD measures have 
been established [80], and a 
validated Spanish translation of 
the CPSS-5 exists [95]. 
Emotional & 
Behavioral 
Functioning 
(S, P) 
 
The Strengths & Difficulties 
Questionnaire [96, 97] is a 25-
item measure of children’s 
psychosocial adjustment. It has 
five scales: Emotional 
Symptoms, Conduct Symptoms, 
Hyperactivity/ Inattention 
Symptoms, Peer Relationship 
Problems, and Prosocial 
Behavior. It has adequate 
construct validity, internal 
consistency, and test-retest 
reliability [98] and a validated 
Spanish translation [99].  
Unmet needs 
(S) 
 
The Sibling Cancer Needs 
Inventory [32] is a 45-item 
measure with seven domains: 
information, practical assistance, 
recreation, feelings, support, 
understanding from my family, 
and sibling relationship. It has 
adequate construct validity, 

 
 
 
   
 
29 
Version:  November 2019 
internal consistency, and test-
retest reliability [100]. 
Acceptability 
of program (S, 
P) – Post 
Only 
 
The Client Satisfaction 
Questionnaire – 8 [101] is an 
established measure of client 
satisfaction with English and 
Spanish versions [102]. 
Feedback on acceptability also 
will be included in the post-
program survey. 
Global 
Assessment 
Ratings (S, P) 
– Post Only 
 
A one-item global assessment 
rating of parents’/siblings’ beliefs 
that the program led to 
improvement, decline, or no 
change in siblings’ functioning 
will be used. This will serve as 
the anchor-based method for 
determining clinical 
significance.93, 94 
 
Phase 2: SibACCESS Program Description 
SibACCESS (Acceptance, Coping, Communication, Engagement, and Social Support) targets 
the proposed mechanisms of sibling difficulties. The primary goal is to increase siblings’ 
exposure and opportunities to process cancer-related cues to decrease the onset or intensification 
of posttraumatic stress (PTS). Treatment targets include emotion awareness, emotional 
acceptance / distress tolerance, adaptive thinking, family communication (via between-session 
assignments), and social support (fostered by the group format).  
 
SibACCESS is based on acceptance-based cognitive-behavioral frameworks, drawing primarily 
on trauma-focused CBT (TF-CBT). TF-CBT is a structured, short-term treatment that 
incorporates cognitive-behavioral approaches to promote recovery from trauma. It is a logical 
starting point for the present study for multiple reasons: (a) TF-CBT was developed specifically 
for children and adolescents; parent participation is recommended but not required; (b) it has 
been tested in a group format  and using telehealth; (c) it has demonstrated effectiveness across 
cultural groups; and (d) it is appropriate for youth who meet diagnostic criteria for PTSD and 
those with sub-clinical PTS. TF-CBT has not yet been evaluated in the context of childhood 
cancer. To better match the needs of siblings of youth with cancer specifically, we also 
incorporated skills from Dialectical and Behavioral Therapy (i.e., self-validation of emotions,  
mindfulness, radical acceptance) to better address distress tolerance and acceptance of the 
aspects of cancer that are beyond siblings’ control.  
 
SibACCESS group sessions will be facilitated remotely using Zoom. The intervention includes a 
preliminary joining session, one parent-focused educational webinar, seven group sibling 

 
 
 
   
 
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sessions, one individual sibling session, and one parent check-in. The parent webinar will 
provide a program overview, psychoeducation about sibling functioning in the context of cancer, 
and brief skills training. Parents will be given “discussion starter” questions to facilitate 
communication throughout the program. Sibling group sessions are approximately 75 minutes 
and will include an ice breaker, review of last week’s homework, introduction of new topics, 
interactive practice of new skills, and assignment of home practice. Exposure to cancer-related 
emotions and cues will be emphasized across all program sessions; in addition to emotion 
exposures and cancer-related sibling narratives, siblings will confront information about cancer, 
uncomfortable thoughts and feelings, and communication about cancer throughout the program.  
 
 
 
 

 
 
 
   
 
31 
Version:  November 2019 
 
Objectives of SibACCESS Program Sessions 
 
*Starred items indicate objectives that involve exposure to cancer-related thoughts, emotions, or 
situations 
Shaded sessions indicate parent involvement 
 
Joining Session 
Brief 
Individual 
Family 
Meeting (30 
min.) 
Parents will be able to: 
 
Provide information for the facilitator about the family’s specific cancer 
context (e.g., child with cancer’s diagnosis, prognosis, treatment status) 
 
Express initial questions or concerns about involvement in the program, and 
receive individualized feedback from facilitators 
 
Siblings will be able to: 
 
Begin to build rapport with facilitators 
 
Express initial questions or concerns about involvement in the program, and 
receive individualized feedback from facilitators 
Parent Pre-session: 
Supporting siblings 
Pre-recorded 
caregiver 
webinar  
Parents will be able to: 
 
Identify the goals and structure of the SibACCESS program 
 
Recognize common sibling emotional and behavioral responses to a cancer 
diagnosis 
 
Acquire key foundational skills to support sibling through the program (e.g., 
validation, emotion self-management) 
Session 1: Program 
introduction  
Sibling group 
(75 min.) 
Siblings will be able to: 
 
Identify the goals and structure of the SibACCESS program 
 
Begin to build rapport and connection with facilitators and other sibling 
group members 
 
Establish a high-level understanding of what cancer is and types of 
treatments 
 
Practice sharing factual information about sibling’s cancer with peers* 
Session 2: Understanding 
Emotions  
Sibling group 
(75 min.) 
Siblings will be able to: 
 
Name primary emotions, their functions, and associated action urges 
 
Map the “before” (antecedent), “during” (response), and “after” 
(consequences) of a recent cancer-related emotional experience* 
 
Reflect on the thoughts, physical sensations, and behavioral urges that came 
with recent cancer-related emotional experience* 
 
Practice sharing with peers about one recent cancer-related emotion 
(including the before, during, and after, and thoughts, physical sensations, 
and action urges)* 
Session 3: Adaptive 
thinking  
Sibling group 
(75 min.) 
Siblings will be able to: 
 
Define automatic thoughts and articulate how these relate to strong emotions 
 
Identify common “thinking traps” and reflect on which ones come up most 
often for them 
 
Practice sharing one cancer-related automatic thought with peers* 
 
Apply the steps of cognitive restructuring to engage with and challenge the 
thought* 
Session 4: Distress 
tolerance: Mindfulness 
and  Radical Acceptance  
Sibling group 
(75 min.)  
Siblings will be able to: 
 
Articulate the goal of mindfulness 
 
Practice one mindfulness skill for nonjudgmentally experiencing emotions, 
without pushing them away or holding on to them* 
 
Define radical acceptance and how it is different from “liking” 
 
Reflect on one aspect of cancer siblings would like to work to radically 
accept* 

 
 
 
   
 
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SECTION M:  RISKS 
Describe any expected risks to subjects. Consider physical, psychological, social, political, 
legal, economic, or other risks that are related to the study.   
Risks are considered minimal for the present study. In Phase 1, the qualitative interview 
methodology used in this study has been used routinely in minimal risk research. Families 
Session 5: Introduction to 
Exposures 
Sibling Group 
(75 min.) 
Siblings will be able to: 
 
Describe the avoidance cycle and its consequences 
 
Articulate the rationale for confronting cancer-related thoughts, situations, 
and emotions that siblings might typically avoid 
 
Enhance self-efficacy and motivation through identifying exposures siblings 
have already completed to counter avoidance  
 
Begin to create an individualized list of exposure tasks that siblings can 
continue to work towards* 
 
Select one exposure to attempt for homework and share this exposure goal 
with a peer* 
Session 6: Introduction to 
Sibling Narrative and 
Exposure Goals 
Individual 
Sibling 
Session (45-60 
min.) 
Siblings will be able to: 
 
Reflect on exposure practices to date, including successes and difficulties 
 
In consultation with the facilitator, continue to develop 2-3 individualized 
exposure goals* 
 
Identify at least one exposure goal that will involve sharing an emotion-
based narrative of their cancer experience 
 
Describe the modality (e.g., song, picture, poem, story, letter, video) of their 
sibling narrative to the facilitator and begin to identify thoughts and 
emotions in narrative* 
 
Articulate a plan for when, how, and with whom siblings will practice these 
exposures and share this sibling narrative 
Session 7:   Exposures / 
Narrative Follow-Up and 
Problem-Solving Skills 
Sibling group 
Siblings will be able to: 
 
Reflect on successes and challenges in practicing exposures, and identify 
trouble-shooting strategies to facilitate ongoing practice 
 
Identify emotions that arose with exposure practices and how siblings 
responded to these emotions* 
 
Refine a near-complete sibling narrative 
 
Share about the thoughts and emotions included in their narrative with peer*  
Session 8: Parent Skill-
Building and Check-In 
Brief 
Individual 
Parent Session 
(45 min.)  
Parents will be able to: 
 
Discuss siblings’ treatment gains and areas for continued growth with 
facilitators 
 
Describe effective strategies for communicating about cancer and cancer-
related emotions within the family 
 
Identify at least one way they can support siblings in continuing to develop 
their narratives and practice exposures 
 
Session 9: Wrap-up 
Siblings & 
caregivers 
(caregivers 
join for second 
half of the 
session) 
Siblings will be able to: 
 
Share with peers about what they learned through exposure practices and 
creation of the sibling narrative* 
 
Reflect on and share treatment gains, as well as areas for continued practice 
 
Identify skills that siblings would like to practice in the future, and develop a 
practice plan 
Parents will be able to: 
 
Reflect on and share treatment gains that they have observed 
 
Identify strategies to support siblings’ continued skill practice 

 
 
 
   
 
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Version:  November 2019 
participating may experience emotional discomfort answering questions and discussing their 
family’s experience with cancer. Providers may also experience emotional discomfort in 
discussing the experience of families they have treated and interacted with in the context of 
cancer. In Phase 2, families participating will likely experience some emotional distress during 
pilot intervention sessions, which is an expected and intentional aspect of the intervention. 
 
There is also a small risk for breach of confidentiality. 
 
Describe the plan to minimize risks. Include in the description the availability of any 
medical or psychological resources.  
Boston University study staff who conduct the qualitative interviews (Phase 1 and Phase 2) will 
work to minimize the emotional distress experienced by youth/young adults, parents and 
providers pertaining to discussion surrounding family and professional experiences in the 
context of cancer. Interviewers will assure participants that they are not required to answer 
questions that make them uncomfortable. Regarding completion of the screening items (Phase 1 
and Phase 2) and quantitative measures (Phase 2), study staff will monitor completion of 
questionnaires. In particular, staff will immediately check the response to the youth/young adult 
screening question regarding active suicidal ideation; if active suicidal ideation is endorsed by 
the youth/young adult, study staff will contact Dr. Long (PI and licensed psychologist) and will 
ask follow-up questions to determine the level of risk. If imminent risk is discovered, staff will 
be in contact with parents (in the case of youth under the age of 18) or with the young adult 
directly (in the case of young adults age 18 or above) and will provide referrals for mental health 
care. (Individuals with active suicidal ideation will not be enrolled in the study).  
 
Study staff leading the pilot intervention will also be trained in how to manage parent and youth 
emotional discomfort, including how to assess clinical risk and deescalate emotional situations. 
Should parent or sibling participants endorse mental health risk to Boston University study staff, 
Kristin Long PhD (principal investigator and licensed clinical psychologist) will be on call to 
provide guidance to address imminent risk discovered during study activities (i.e., qualitative 
interviews, pilot program sessions, exit interviews, etc.). With parent written consent, a formal 
mental health referral may be made as indicated. 
 
SECTION N:  BENEFITS 
Describe the potential benefits to subjects related to the study.  State if there are no direct 
benefits. NOTE: Compensation and/or course credit are not considered benefits. 
There are no direct benefits to participating in this study, though it is possible participants may 
perceive a benefit of research contributing to development of more comprehensive services to 
address the needs of siblings of children with cancer. 
Describe the potential benefits to society and/or others related to the study 
 
The needs of siblings and children of immediate family members with cancer are not often met 
within oncology programs.  The present study works to develop a telehealth-based support 
program targeting posttraumatic stress symptoms of siblings of children with cancer that is 
culturally sensitive and meets the logistic and clinical needs of families. This is expected to 
improve trajectories of siblings’ functioning and reduce the overall burden of cancer on families. 
 

 
 
 
   
 
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Version:  November 2019 
SECTION O:  COSTS/PAYMENTS 
YES* 
NO 
 
☐ 
☒ 
Are there any costs to subjects as a result of participating in this study?  
If YES, provide a description of the costs: 
☒ 
☐ 
Will subjects be compensated for participating in the study?  Compensation may 
include cash, checks, gift cards, lotteries, course credit, etc. Payments should be 
prorated to compensate subjects for time and procedures completed 
If YES, provide a description of the compensation:  
Phase 1 (Development of the SibACCESS Telehealth Program) 
Participants (parents, siblings, and providers) will each receive a $30 gift card. 
Phase 2 (Pilot of the SibACCESS Telehealth Program) 
Participants (parents and siblings) each will receive a $30 gift card after 
completion of pre-intervention questionnaires (for a total of $60 per 
parent/sibling dyad). Participants will receive a $100 gift card after completion 
of post-intervention questionnaires and exit interviews (for a total of $200 per 
parent/sibling dyad). Alternate supportive adults, whose level of participation 
necessitates an exit interview, will receive a $30 gift card for their participation 
in the brief exit interview.  
Families will NOT be compensated for their involvement in intervention 
sessions. 
☐ 
☒ 
Will identifiable information be sent to Central University departments (e.g. 
Accounts Payable, Post Award Financial Operations, etc.) for payment 
purposes? If YES, this information must be disclosed in the consent form. 
 
SECTION P:  CONFIDENTIALITY OF DATA 
Describe how data will be stored (e.g. paper, electronic database, etc.) 
Phase 1 (Pertaining to Qualtrics Data, Qualitative Interview, and Exit Interviews) 
 
Interviews for Phase 1 and 2 of the present study will be audio recorded using digital recorders 
for telephone interviews. For interviews completed using the Zoom platform, interviews will be 
audio-recorded using both the record function on the Zoom-platform and a digital audio recorder 
as back-up. Audio recordings will be transferred from digital audio recorders to a limited access 
network drive for the Child and Family Health Lab. Audio recordings will then be deleted from 
the audio recorder once moved to the limited access network drive. While interviewing 
remotely, recordings will also be saved on secure cloud storage (i.e., SharePoint) only accessible 
by approved study staff, to minimize for loss of data. 
 
Should any participant opt-out of recordings but still wish to participate, the data will be 
collected in the form of notes taken by the interviewer. These notes will be typed and saved in a 
password-protected files on the limited access network drive for the Child and Family Health 

 
 
 
   
 
35 
Version:  November 2019 
Lab. For data collected from the brief background forms, data will be stored in the Qualtrics 
platform, and will only be accessible to the Boston University study staff approved in Section E 
of this protocol. When Qualtrics data is downloaded to the limited-access network drive, 
identifiers will be removed, and the file will be password protected.  
 
Phase 2 (Pilot Sessions of the SibACCESS Telehealth Program) 
 
Pilot sessions for Phase 2 of the present study will be video- and audio-recorded in order for 
Boston University study staff to assess program fidelity. Video and audio recordings collected 
from Zoom pilot sessions will be saved to the Zoom cloud storage, and will be downloaded to 
the limited access network drive for the Child and Family Health Lab.  Back-up audio 
recordings a digital audio-recorder will be transferred to a limited access network drive for the 
Child and Family Health Lab. Audio recordings from the digital audio-recorder will then be 
deleted from the audio-recorder once moved to the limited access network drive and secure 
cloud storage (i.e, SharePoint during remote operation). 
 
For data collected from pre-/post-intervention quantitative measures, data will be stored on the 
REDCap platform, and will only be accessible to the Boston University study. When REDCap 
data is downloaded to the limited-access network drive, identifiers will be removed and files will 
be password protected.  
 
Video- and/or audio-recordings of exit interviews will be collected by the Zoom-platform 
recording feature (or handheld digital audio-recorder if interview occurs via telephone only). 
Video- and/or audio-recordings will be downloaded to the limited access network drive. Audio-
recordings from the digital audio recorder will then be deleted from the audio-recorder once 
moved to the limited access network drive and/or secure cloud storage (i.e., SharePoint during 
remote operation of studies). 
 
YES* 
NO 
 
☒ 
☐ 
Will you collect identifiable information? (e.g. names, social security numbers, 
addresses, telephone numbers, etc.). If YES, complete the box below. 
Describe the coding system that will be used to protect the information including who will 
have access to the code. Coding systems are used to: 1) protect the confidentiality of the research 
data and 2) allow the investigator to link subjects to their responses. Each subject is assigned a 
unique study ID at the beginning of the study. A separate document (key) should be maintained 
that links the names of the subjects to the study ID numbers. 
 
Each participant will receive a unique identifier (e.g., SibACCESS101). The tracking document 
that connects the participant name to the information that they provide (e.g. recorded interviews, 
questionnaire data, etc.) will be kept in a password-protected computer file in a limited-access 
network drive for the Child and Family Health Lab at Boston University. Only members of the 
Boston University study staff will have access to this document. 
 
 
YES* 
NO 
 

 
 
 
   
 
36 
Version:  November 2019 
☐ 
☒ 
Will you share data with others outside of the study? If YES, complete the box 
below. 
Describe how data will be transferred and how confidentiality will be maintained (e.g. 
identifying information will not be sent outside, etc.): 
 
 
 
 
Describe how you will maintain the confidentiality of the data (e.g. locked cabinet, password-
protected files, encryption, etc.). Note: Confidentiality refers to the researcher’s agreement with 
the participant about how the subject’s identifiable private information will be handled, managed, 
and disseminated. For further assistance and/or access to resources regarding information security, 
please refer to the BU Information Security website. 
Phase 1 and 2 (Pertaining to Qualtrics Data, Qualitative Interviews, and Exit Interviews) 
 
Transcribed interviews, or interview notes for families opting out of audio or video recording, 
will be stored in a password-protected file on a limited-access network drive that can only be 
accessed by members of the Boston University study staff. All identifying information (e.g., 
participant names) will be kept in a separate file password-protected file in a limited-access 
network drive for the Child and Family Health Lab at Boston University. For data from the brief 
background forms and Phase 2 quantitative surveys in Qualtrics, data will be stored on the 
Qualtrics platform and will only be accessible by study staff approved in section E of this 
protocol. When data is downloaded to the limited-access network drive, identifiers will be 
removed and the data will be saved in a password protected-document (e.g. excel file). Only 
identification codes will be used to present data at conferences or in publications. 
 
Phase 2 (Pilot Sessions of the SibACCESS Telehealth Program) 
 
Video and audio recordings of the pilot program will be saved to Zoom cloud storage and also 
downloaded to the limited access network drive for the Child and Family Health Lab and secure 
cloud storage (i.e., SharePoint during remote operation). Video recordings will not be shared as 
part of presented data as conferences or in publications. 
Per Boston University (BU) Record Retention Policy, records concerning human subjects must be 
retained for 7 years. As the investigator, you must also adhere to all applicable requirements as 
defined by regulatory agencies (e.g. FDA, etc.) or Sponsors. 
 
SECTION Q:  CERTIFICATE OF CONFIDENTIALITY 
In 2017 the NIH updated its policy for issuing Certificates of Confidentiality. Under the policy, 
all eligible research studies funded by the NIH are automatically issued a certificate of 
confidentiality. Investigators whose research is not funded or supported by the NIH may request 
and obtain from the NIH a Certificate of Confidentiality. Investigators who request and receive 
Certificates must follow the NIH and PHS policies governing such certifications. 
 
YES 
NO 
 

 
 
 
   
 
37 
Version:  November 2019 
☒ 
☐ 
Is your research funded by the NIH and eligible for a Certificate of 
Confidentiality? 
☐ 
☒ 
If your research is not funded by the NIH, will you be applying for a Certificate 
of Confidentiality? 
 
SECTION R:  PRIVACY 
Describe how you will protect the privacy of subjects (e.g. where will consent procedures 
take place, if interviews or other interventions, where will these procedures take place) 
Storage of electronic data (i.e., audio recordings, video recordings, questionnaire data, etc.) will 
be stored on the limited access network drive and secure cloud storage (i.e., SharePoint during 
remote operation) for the PI’s (Kristin Long, PhD) research lab, the Child and Family Health 
Lab at Boston University.  
 
Only Boston University study staff  will have access to study data.  
 
Families participating in this study and engaging in qualitative interviews (Phase 1), quantitative 
data collection (Phase 2), pilot program sessions (Phase 2), and exit interviews (Phase 2) will be 
directed to complete research activities from a private location of their choosing to safeguard 
their privacy. Boston University study staff completing interviews or group pilot sessions 
remotely will conduct study activities via telephone or the Zoom video-teleconferencing 
platform from a private room or office with a door that can be closed to ensure that interviews 
and research calls are not heard by individuals not on the Boston University study staff. 
 
SECTION S:  MONITORING STUDY DATA 
How will data be monitored?  
Note: The Data and Safety Monitoring Plan should be tailored to the nature, size, and complexity 
of the research protocol, the expected risks of the research, and the type of subject population being 
studied. 
☒ 
Principal Investigator 
☐ 
Monitor/Monitoring Group 
☐ 
Data and Safety Monitoring Board (DSMB) 
Note: The DSMB Charter must be submitted with this Application.  
For more information regarding a DSMB, please refer to the NIH website.  
 
Describe the plan for monitoring study data.  This should include a description of how data 
will be collected and analyzed as the project progresses to assure the appropriateness of the 
research, its design, and subject protections. 
Data collected in the form of qualitative interviews will be analyzed according to applied 
thematic analysis methodology. This methodology includes assessment of data to build 
familiarity and create preliminary codes, creating initial codes and coding structures, combining 
codes into themes, and defining themes and the ways in which they fit together. The initial draft 
of the coding structure would be developed using a priori research questions and probes from the 

 
 
 
   
 
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semi-structured interviews. Phase 2 quantitative data will be analyzed descriptively (e.g., 
frequency of completion / missing data, mean scores on study measures). 
 
Data for Phase 1 and 2 of the study will be monitored weekly by the PI (Kristin Long, PhD) who 
will meet with the study staff to discuss data collected from interviews, pilot program sessions, 
pre- and post-intervention quantitative surveys, and exit interviews. The PI will also monitor all 
research activities to ensure the procedures are carried out according to the approved IRB 
protocol. Due to the minimal risk designation for the study, adverse events are not anticipated to 
occur. If an adverse event occurs, the PI will complete an Adverse Events Form as part of this 
IRB protocol and submit the form to the IRB within one week of the event’s occurrence. 
 
SECTION T:  HIPAA 
Health Insurance Portability and Accountability Act 
YES* 
NO 
 
☐ 
☒ 
Is this research being conducted in a covered entity?  
The following BU CRC Departments are considered covered entities:  
 Sargent College Rehabilitation Services 
o Physical Therapy Center at the Ryan Center for Sports Medicine and 
Rehabilitation 
o Sargent Choice Nutrition Center 
 The Danielsen Institute 
 Boston University Health Plan 
*If YES, contact the IRB office for assistance. 
 
SECTION U: FAMILY EDUCATIONAL RIGHTS AND PRIVACY ACT 
(FERPA): FERPA is the federal law that protects the privacy of student education records.  
Research funded by the Department of Education or research conducted in educational institutions 
that receive funds from the Department of Education (for research or other purposes) must comply 
with FERPA. 
YES* 
NO 
 
☐ 
☒ 
Does this study involve collection of information from student 
school/university records? *If YES, refer to the following websites for 
guidance on FERPA: 
 http://www.bu.edu/researchsupport/compliance/human-subjects/ 
 http://www.bu.edu/reg/general-information/ferpa/ 
 http://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html 
If FERPA applies, you must complete the box below: 
In accordance with FERPA, written consent must be obtained to access student records. The 
consent must:  
 Specify the records that may be disclosed 
 State the purpose of the disclosure 
 Identify the person or class of parties to whom the disclosure can be made 
☐ YES 
(REQUIRED) 
I confirm that I will comply with the FERPA policy that is in place at the 
educational institution where I am conducting my research.  This includes, if 
applicable, the requirements for written agreement when requesting a waiver 

 
 
 
   
 
39 
Version:  November 2019 
of consent for personally identifiable information.  If an agreement is 
required, this agreement must be submitted to the IRB. 
 
SECTION V:  PROTECTION OF PUPIL RIGHTS AMENDMENT (PPRA): 
PPRA is a federal law that affords certain rights to parents of minor students with regard to surveys 
that ask questions of a personal nature.  Research funded by the Department of Education or 
research conducted in educational institutions that receive funds (for research or other purposes) 
from the Department of Education must comply with the PPRA. 
YES* 
NO 
 
☐ 
☒ 
Does PPRA apply to this study? If YES, refer to the following websites for 
guidance:  
 http://www2.ed.gov/policy/gen/guid/fpco/ppra/index.html 
 http://www.bu.edu/researchsupport/compliance/human-subjects/ 
If PPRA applies, you must complete the box below: 
In accordance with PPRA, written parental consent must be obtained prior to subjects 
participation in the study.  
☐ YES 
(REQUIRED) 
I confirm that I will comply with the PPRA policy that is in place at the 
educational institution where I am conducting my research.   
 
SECTION W:  CLINICAL TRIALS REGISTRATION: 
The Food Drug and Administration Amendments Act (known as FDAAA 801) requires that 
“applicable clinical trials” be registered and have results reported on clinicaltrials.gov. In addition, 
the International Committee of Medical Journal Editors (ICJME) and the National Institutes of 
Health (NIH) also have requirements for registration.  Please see box below to determine if your 
study requires registration in accordance with either FDAAA 801, ICJME, or NIH. 
YES 
NO 
FDAAA 801 Requirements 
☐ 
☒ 
Does your study meet the definition of an applicable clinical trial (ACT) and 
require registration AND results submission in accordance with FDAAA 801?  
ACTs include: 
 Trials of drugs and biologics: Controlled clinical investigations, other than 
phase 1 clinical investigations, of drugs or biological products subject to 
Food and Drug Administration (FDA) regulation 
 Trials of devices (see note): 1) Controlled trials with health outcomes of 
devices subject to FDA regulation, other than small feasibility studies, and 
2) pediatric post-market surveillance required by FDA  
 
Note: If your study meets the requirement for registration and reporting, you 
must submit the National Clinical Trial (NCT) Identifier # to the IRB prior to 
IRB approval.  NCT #:  
 
YES 
NO 
ICMJE Requirements 
☒ 
☐ 
Does your study meet the definition of a clinical trial and require registration 
in accordance with ICMJE?  
 

 
 
 
   
 
40 
Version:  November 2019 
Note:  If your study meets the requirement for registration, you must submit 
the National Clinical Trial (NCT) Identifier # to the IRB prior to IRB approval. 
NCT #: 
 
YES 
NO 
NIH Requirements 
☒ 
☐ 
Does your study meet the definition of an applicable clinical trial and require 
registration AND results submission in accordance with NIH?  
For more information on this policy please refer to:   
 NIH Policy on the Dissemination of NIH-Funded Clinical Trial 
Information  
 Checklist 
Note:  If your study meets the requirement for registration and reporting, you 
must submit the National Clinical Trial (NCT) Identifier # to the IRB prior to 
IRB approval. NCT #: 
 
 
 
Certification / Signatures 
 By submitting this protocol I attest to the fact that all research activities to be implemented 
related to human subjects have been completely and accurately described herein. 
 I agree to conduct the describe research in an ethical manner.  
 I agree to comply with all institutional policies and procedures related to human subjects 
research and will not begin any human subjects research activities until I have obtained full 
approval from the IRB. 
 I agree to conduct the research as described in this protocol and not to make any changes 
(except to eliminate immediate harm to subjects) without first obtaining approval for the 
changes from the IRB.  
 I agree to immediately report any unanticipated problems involving risks to subjects or others, 
any subject complaints, and any incidents of non-compliance with the requirements of this 
protocol as soon as I become aware of them.  
 I agree to comply with any relevant HIPAA and FERPA regulations if applicable.  
 I verify that all those responsible for the design, conduct, or reporting of the proposed program, 
including at minimum, all Senior/key personnel in the grant application, have completed the 
financial 
interest 
disclosure 
forms 
and 
completed 
training 
as 
dictated 
at 
http://www.bu.edu/orc/coi/forms/, and returned the forms to   the Office for Research 
Compliance COI Unit.  NOTE: If anyone checked “yes” to any of the questions on either 
the FIND1 or NONFIND1 form, the IRB Director will contact the COI office to obtain 
the disclosure information. 
 
 
PI Printed Name: Kristin Long, PhD 
 
PI Signature:  
 
 
                               Date: 03/25/2024 

 
 
 
   
 
41 
Version:  November 2019 
Submission: This form can be completed, signed, scanned and submitted to the IRB at 
irb@bu.edu.   Faxed documents and handwritten materials are not accepted. Be sure to include all 
relevant attachments.   
 
 
 
 
 
 
 
FACULTY Research: 
 
The Department Chair signature is required: This application must be signed by the 
Department Chair for all faculty researchers.  If the PI is the Department Chair, then signature by 
the appropriate Dean is required. Department Chair signature is not required for student research.  
 
By signing this form you are indicating that you have reviewed the application, the 
faculty/staff person listed as PI on this protocol is a member of your department, hat he/she 
is qualified to serve as the PI for this study, he/she has the adequate resources, and the 
research utilizes acceptable practice for the discipline. 
 
Department Chair (print name): 
David Somers, PhD.  
 
 
 
 
 
 
 
Department/School: Psychological & Brain Sciences, CAS 
 
 
 
 
  
 
 
 
 
 
 
        
Signature: 
 
 
 
 
 
 
  
 
Date:  
1/4/2021 
 
 
 
 
  
 
 
STUDENT Research 
Student research: Student research must be signed by the faculty advisor AND the designated 
School IRB pre-reviewer (if applicable) PRIOR TO submission to the IRB.  Students should check 
with their School to determine if School IRB pre-review is required.  Students must submit a copy 
of their dissertation with the IRB Application  
 
By signing this form, you are indicating that you have reviewed the application, that you 
agree to serve as the Co-PI for this study with the student and that you will be responsible 
for the ethical conduct of this student’s human subjects research.   
 
Faculty Advisor (print name): 
 
 
 
 
 
  
 
Signature: 
 
 
 
 
 
 
  
 

 
 
 
   
 
42 
Version:  November 2019 
Date:  
 
 
 
 
  
 
IRB School Reviewer, if applicable (print name): 
 
 
 
 
 
  
 
Signature: 
 
 
 
 
 
 
  
 
Date: