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Appendix B : Institutional Review Board Documents
A S P E C T S D E V E L O P M E N T A L P R E S C H O O L
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Student Research Proposal Form for New Projects
Federal regulations and Endicott College policy require that all research involving human subjects be reviewed and approved by the Endicott College Institutional Review Board (IRB). To request review, please complete this form and upload it, along with all other documents required, to Endicott’s IRBNet portal1 that can be accessed here: https://irbnet.org/release/index.html.
Once your complete research package is on IRBNet, “share” it with your faculty sponsor(s) and any coinvestigators. In IRBNet, ONLY YOUR FACULTY SPONSOR CAN SUBMIT THE PROJECT FOR IRB REVIEW. You will need to give them permission to do so during the sharing process by granting them “full” access. Other members of the research team should only receive “read” or “write” access depending upon their roles. Applications submitted directly by a student will not be reviewed.
Please review the IRB Canvas website for submission deadlines. The length of the IRB review process varies based on the type of review required by a study (full, expedited, or exempt) and the completeness and quality of the proposal material submitted. This application form is designed to help you with the latter so please take the time needed to fully address all sections of this application. Revisions and missing documents add greatly to the time it will take to obtain approval. Written approval from the IRB must be received before conducting your research.
GENERAL STUDY INFORMATION
Protocol title of the proposed research:
How can interior architecture enhance the learning experience in early childhood education?
Planned Project Start Date (You must have IRB approval to start your project) Planned Project End Date January 24, 2022 August 2022
Research Project Personnel:
Principal Investigator (student) Marielle Cassidy
Co-Investigator (student) Department/Degree level pursued Phone
Endicott email Interior Architecture - Master of Arts (978) 960-9070 mcass436@mail.endicott.edu
Department/Degree level pursued Phone Endicott email
Co-Investigator (student) Department/Degree level pursued Phone Endicott email
Co-Investigator (student) Department/Degree level pursued Phone Endicott email
Primary Faculty Sponsor Michael Fior
Department Phone
Endicott email Interior Architecture (617) 818-8729 mfior@endicott.edu
Other Faculty Sponsor Department Phone
Endicott email Myoung Joo Chun Interior Architecture (978) 232-2545 mchun@endicott.edu
1 If you have not yet created an IRBNet account you can do that on their login page. Please use your Endicott email address (never your personal email) and select Endicott College when prompted.
Additional Research Affiliations
Grant Affiliation (if none, put N/A) N/A
Other organizations/agencies involved in the study, including those from where you are recruiting research subjects (if none, put N/A) N/A
Name of Contact Department/Position Email
☐ Check here if other organizations are involved and you have uploaded a “Researcher Agreement” document to IRBNet, indicating the document type as “Letter”.
Human Subject Research Training
Endicott College’s IRB requires all research investigators who intend to conduct research with human subjects to complete a free CITI training program on protecting human research participants. If you have not taken the course, you can visit www.citiprogram.org to complete this requirement by taking the module(s) most related to your research listed below (if you are unsure which to take, please discuss with your faculty advisor). Please note that most of you will be taking the Basic Course for Social and Behavioral Research.
(1) CITI Basic course for Biomedical and Physical Science Research (2) CITI Basic course for Social and Behavioral Research (3) CITI Good Clinical Practice (GCP) Training (Investigators and staff involved in a clinical investigation or a NIH-funded clinical trial are required to take GCP training in addition to basic human research protections training).
If you have previously completed the CITI training within the past two years or less, through Endicott or another institution, that is sufficient to meet the requirement (training needs to be renewed every three years). Any coinvestigators on your research team will also need to meet this requirement. Please enter the required training information for each member on your research team below:
Principal Investigator CITI Certificate # (Record ID) Expiration Date CITI module(s) taken
Marielle Cassidy 45038440 04-Oct-2024 490, 491, 502, 503, 504, 505, 1428, 16680, 17464
Co-Investigator (student) CITI Certificate # (Record ID) Expiration Date CITI module(s) taken
Co-Investigator (student) CITI Certificate # (Record ID) Expiration Date CITI module(s) taken
Co-Investigator (student) CITI Certificate # (Record ID) Expiration Date CITI module(s) taken
☐ Check here to affirm that your CITI Certificate is uploaded to IRBNet (this will remain available on IRBNet for any future research you might propose).
☐ If your research has co-investigators they will each need to upload their certificates to their own IRBNet account. Check here to affirm that your co-investigators’ CITI Certificates are uploaded to IRBNet.
2 | Page Institutional Review Board (IRB): – HUMAN RESEARCH STUDENT APPLICATION 2020-08-24
Section I: Project Information:
A. Human subjects from the following vulnerable populations will be involved in this study:
☐ Minors (under age 18) ☐ Individuals with impaired decision capacity ☐ Elderly ☐ Economically or educationally disadvantaged ☐ Physically disabled ☐ Non-English speakers ☐ Undocumented persons ☐ Other vulnerable population: ☐ Pregnant females ☐ Prisoners ☐ None of the above
B. The research project will be conducted and/or data will be collected through these sites2:
☐ Online – via face-to-face video-conferencing – What platform(s)?
☐ Online data collection via surveys and/or secondary data sources – Please specify:
☐ On Endicott Campus – Where?
☐ Off Campus – Where? Zoom
Wentworth Douglass Hospital Early Learning Center, Dover, NH
☐ Check here to indicate that you have secured a copy of approval from off campus sites and/or letters of support (including from entities you are recruiting from in order to do an online survey or teleconference with their employees or students). Upload this document in IRBNet and indicate the document type as “Letter”.
Please note that due to Covid, in-person research is currently discouraged and must be justified in writing if it is necessary for a particular study. Requests for in-person research may be made in writing by email to the IRB and will be considered on a case by case basis by the IRB Chair, IRB Administrator, and Provost. Requests should include: ° Justification for face to face research ° Specific details on when and where research would take place and for how long ° Specific details on participants – how many, whether they are members of the Endicott community or recruited externally ° Provisions for PPE, appropriate social distancing, and sanitation of equipment as needed
C. Has this project been approved by another Institutional Review Board? ☐ Yes ■ ☐ No
☐ If “Yes”, check here to indicate that you have secured a copy of approval from the other IRB. Upload this document in IRBNet and indicate the document type as “Letter”.
D. Will participants be: ☐ Audiotaped? ☐ Videotaped? ☐ Neither
Note: If you plan to audiotape or videotape participants, you must inform them on the consent form/statement and describe how you will protect privacy and maintain confidentiality.
E. Will you be collecting any information that identifies participants? ☐ Yes ☐ No
Note: If any of the information you collect from study participants includes identifiable information you cannot promise them anonymity. The best you can do is promise confidentiality and describe the ways you will protect their information in the consent form.
F. Is there deception involved? ☐ Yes ■ ☐ No
☐ If “Yes”, check here to indicate that you have uploaded a copy of your post-deception statement or statement (template and examples are in IRBNet library). You can label the document type as “Letter” or “Other”.
2 IMPORTANT: Endicott College requires that all researchers request and receive approval from the Endicott Research Center if they plan to survey Endicott students and faculty. 3 | Page Institutional Review Board (IRB): – HUMAN RESEARCH STUDENT APPLICATION 2020-08-24
In the next sections, please check each box as you include the relevant information in a narrative at the end of the section.
Section II: Abstract Describing Project and Purpose
In your narrative below, include:
☐ A statement of the purpose of the study and/or your research questions. ☐ A description of all research methods to be used. ☐ A description of the data/observations that will be collected in the study. ☐ A brief description and a copy of each instrument. ☐ A list of all citations/references. ☐ Check here to indicate that you have uploaded copies in IRBNet of any questionnaires, tests, or other instruments to be used in your research and indicate the document type as “Questionnaires/survey”.
The purpose of this study is to look at interior architecture design techniques that can help to enhance the learning experience of children in early education. Research methods will include a comprehensive literature review of research and studies completed in the past and present, site visits to educational facilities, interviews with those in the early education or educational design field, and lastly a detailed study of precedents and case studies within early educational facilities or projects with extensive use of biophilic and sustainable design. Written sources will be the primary origin of research where the author has had first-hand experience or the source is published in a peer reviewed journal. Interviews will be semi-formal, mostly conducted virtually to address key questions and other topics that may arise in conversations.
Section III: Protocol
How many participants will be recruited for your study?
5-8
In your narrative below, include:
☐ Who the research participants will be. ☐ How old the participants will be. ☐ How the research participants will be protected if they are from a vulnerable population. ☐ How participants will be recruited or contacted. ☐ How much time will be required of each participant. ☐ A description of the procedures to which people will be subjected. ☐ Check here to indicate that you have uploaded recruitment materials with your submission in IRBNet and indicate the document type as “Advertisement”. This could include a web posting, email or verbal description if recruiting by verbal announcement.
Research participants will include architects, designers, managers, directors and teachers within the field of educational, universal and sustainable design. All participants will be adults and their identity will only be given, if permitted by the member. No participants are expected to be of a vulnerable population. Participants will be recruited via email/phone while interviews and meetings will be conducted virtually on Zoom. However, some participants will be interviewed in-person at the site visits. The time taken from each participant will vary based on their availability and importance of their role within the research. Participants will be subjected to questions and commentary regarding early educational design, how it can improve and recent advancements within the field.
Section IV: Risks & Precautions
Do you consider your study to be ☐ Minimal Risk3 or ☐ More than Minimal Risk4
In your narrative below, include:
☐ The potential risks or discomforts to participants in your protocol and how you are minimizing such risks. ☐ The steps to be taken to ensure that each subject’s participation is voluntary. ☐ A description of any incentives/compensation that will be offered to the subjects for their participation, how and when they will be distributed, and what will be done with their incentive if a respondent chooses to leave prior to study completion.
This study presents minimal risk to all participants. As research looks at the mental and physical health of young children, it is quite likely participants will be able to recall their own childhood experiences, or more recent experiences of their own children. This could potentially bring up a touchy subject, when discussing the vulnerability of children. The study also looks at the need for the use of sustainable design elements and the environmental impact the building has on it's specific environment, which may bring about stress relating to climate change and the current state of our environment. These potential risks will be stated in the informed consent documents and those who feel inclined not to participate will have the opportunity to withdraw from the interview process at any given time. There is no incentive or compensation that will be offered to participants, however they will have access to the final research and design, as they might enjoy seeing how their time and effort has benefited the study.
Section V: Confidentiality of Data
In your narrative below, include:
☐ The names of personnel who will have access to the data, or with whom they will be shared. ☐ Whether the data already exist or are being collected for the purpose of this study. ☐ How the data will be stored. ☐ Include a description of how electronic or paper files will be protected. ☐ Whether or not you plan to include your data in an online data repository, such as “Open Science Framework”, and what sort of privacy settings you will use. ☐ Whether participants’ data can be linked to them by anyone, including the research team (i.e., anonymity). ☐ A description of the methods to be used to ensure the privacy and confidentiality of obtained data. ☐ Plans for publication of data. ☐ Plans for destruction of data. Please note: In accordance with federal guidelines, Endicott College requires that data be stored for at least 3 years after the completion of the project.
I, Marielle Cassidy, will have access to the data as I am the principal investigator. Professor Michael Fior and Myoung Joo Chun will also have minimal access when we are together and when I am sharing my findings with them, as they are my faculty supervisors. Other than these 2 internal faculty members at Endicott College, no one else will have access to the data and interview research. Also, no names or personal information will be shared without written consent from participants. Any interviews or potentially sensitive information will be kept private on a personal password-protected external hard drive, in the most secure form of collection as possible. The data I am collecting will be a combination of previously published research as well as new information for the purpose of this study The resulting book, design and project will be shared with the Interior Architecture Design Department at Endicott College for use in the CIDA accreditation process. If the paper were to be published, all participants will be notified and have another opportunity to withdraw any personal information prior to publication. However, anonymity cannot be fully insured because identities will be kept within my own files. For any participants who would like to remain anonymous, any names and affiliations will be completely removed from published work. All data, research and interview records will be stored on a personal password-protected external hard drive for a maximum of three years and will only be discussed in private meetings with Professor Michael Fior or Myoung Joo Chun. All data will be completely erased after three years from the study.
3 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. 4 More than minimal risk means that there is a minor possibility of feeling discomfort when participating in the study. You will need to let us know how you will mitigate this possibility. 5 | Page Institutional Review Board (IRB): – HUMAN RESEARCH STUDENT APPLICATION 2020-08-24
Section VI: Informed Consent
Will all participants be able to give informed consent? ☐ Yes ☐ No
Are any participants children or minors under the age of 18? ☐ Yes ■ ☐ No
If yes, please check the age categories that will be included: ☐ Under 5-years old ☐ Between 5- and 7-years-old ☐ Between 8- and 13-years-old ☐ Between 14- and 17-years-old
In your narrative below, include:
☐ A description of the consent process. How will consent be obtained? ☐ If your research includes any vulnerable populations, describe any specific concerns you anticipate they might have before or during your research and whether and how you are using the consent process to address these concerns.
In IRBNet, upload a copy of all consent documents to be signed by your research participants and/or any statements to be read to, or by the participant. Indicate the document type as “Consent Form”. Check the appropriate box below to note what kind of consent documents you are uploading.
Initial contact with participants will be made via email and those who are responsive and interested will then receive a copy of the informed consent forms. These forms will include the explanation of potential risks and benefits, a description of the interview procedure, approval to use identifiable information and of course the option to withdraw from the study/research at any given time. Once the form is signed, continuation of the interview process will continue. If there are any additional questions or concerns from participants, I will offer a time to meet and discuss any issues at hand and try to clarify any confusion. Participants can give either written or verbal consent over audio or video so that there is a record; to these forms and they will each receive a copy for their own, personal record.
Please use the Templates found in IRBNet and on the Endicott IRB Canvas website for these forms. These must be modified for your study. Use the standard Consent Form template with the exception of the following:
If the research is exempt or no risk, use the Disclosure Statement. If any research subjects are minors, use the Parental Consent form to obtain parent or legal guardian signature. If the minor participant is eight or older and can sign a written assent, also use the Child Assent form template. If they are younger and can understand (usually 7- to 5-years-old), you should prepare an oral description to read to participants and ask for verbal assent. See the Child Assent Statement for an example to help create your own.
Please check the type of consent you are including in your study below:
☐ Standard Consent Form ☐ Disclosure Statement ☐ Parental Consent Form ☐ Child Assent Form or Statement
☐ Check here to indicate you uploaded a copy of each of the consent documents in IRBNet and indicate the document type.
INSTITUTIONAL REVIEW BOARD (IRB)
Exempt Determination Criteria
☐ Please check if you believe this project meets a criterion for exemption.
Please note that these categories have been modified in the revised Common Rule. Consult the table below and indicate the criterion or criteria that you believe qualifies your study for exempt status. Describe why you believe your project is exempt. Failure to do so will result in the termination of IRB review and your application will be returned to you.
This study will look closely at early educational facilities/environments, the users within the space: children and teachers as well as learning techniques and how they relate to interior architecture and overall spatial awareness
Review the abbreviated descriptions* below and check the criterion or criteria that you believe qualifies your study for exempt status. Be sure to fill out your rationale above. Be sure to fill out your rationale above. Exempt Sub Category Criteria ☐ Educational practices 1 -☐ Tests, surveys, or observation of public behavior, no identifiers 2 i ☐ Tests, surveys, or observation of public behavior, no risk 2 ii ☐ Tests, surveys, or observation of public behavior, identifiers with limited IRB review (provisions for confidentiality/privacy) 2 iii ☐ Benign behavioral interventions, no identifiers 3 i(A) ☐ Benign behavioral interventions, no risk 3 i(B) ☐ Benign behavioral interventions with limited IRB review (provisions for confidentiality/privacy 3 i(C) ☐ Secondary research, publicly available information with identifiers 4 i ☐ Secondary research with information recoded with no identifiers 4 ii ☐ Secondary research with identifiable health information 4 iii ☐ Secondary research for a federal agency 4 iv ☐ Public benefit research and demonstration projects 5 -☐ Taste and food quality studies 6 -* See complete description of Exempt criteria on the Endicott IRB Canvas website or at https://www.ecfr.gov/cgibin/retrieveECFR?gp=&SID=b19da247520d4163d09a2ca47ab0032f&mc=true&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1104
INSTITUTIONAL REVIEW BOARD (IRB)
Responsibilities of the Principal Investigator:
Please check to acknowledge that you have read and accept the following policies:
☐ As one engaged in investigation utilizing human participants, I acknowledge the rights and welfare of the human participants involved.
☐ I acknowledge my responsibility as a researcher to secure the informed consent of the participant by explaining the procedures, in so far as possible, and by describing the risks as weighed against the potential benefits of the investigation.
☐ The principal investigator or the faculty sponsor is responsible for retaining informed consent documents for a period of at least three years after the project.
☐ Any additions or changes in procedures in the protocol will be submitted to the IRB for written approval prior to these changes being implemented (except in case of immediate hazards to the subject).
☐ Any problems connected with the use of human subjects once the project has begun must be communicated to the IRB Chair.
☐ In IRBNet, once you have “created” your “project” you will need to “share” it with your faculty sponsor and co-investigators, if any. ONLY YOUR FACULTY SPONSOR CAN SUBMIT THE PROJECT FOR IRB
REVIEW IN IRBNET. You will need to give them permission to do so during the sharing process by granting them “full” access. Faculty submission serves as an alternative to their signature and confirms they have reviewed the submission and approved it. Other members of the research team should only receive “read” or
“write” access depending upon their roles. Applications submitted directly by a student will not be
reviewed.
☐ If the IRB requires modifications in the project prior to approval, the IRB will notify the PI who can make the changes and their Faculty sponsor who can review the requested changes and resubmit application for final approval.
☐ Faculty sponsors have linked their CITI training to their IRBNet profile.
☐ Student investigator’s certificates of CITI training are uploaded with this Project in IRBNet.
Endicott College Institutional Review Board (IRB) Disclosure Statement How can interior architecture enhance the learning experience for children with Autism Spectrum Disorder (ASD) within the early childhood educational setting?
INTRODUCTION:
This research will ask you questions about interior architecture design techniques that can help to enhance the learning experience of children with Autism in early education. The purpose of the study is to incorporate several immersive design elements that can help enhance the overall learning environment and experience of the child, to ease them from transitioning from school to life outside of the built environment. A combination of a “Neuro-typical” design approach as well as sustainable environments and bioclimatic design will be used to create an eco-friendly, green building that is well-suited and beneficial to its surrounding environment. The purpose is to explore learning techniques that universally satisfy and exceed the normal learning experience to create a healing, learning environment that evokes several creative and intuitive feelings for the students, while universally designed to ensure equality and inclusivity
PARTICIPATION:
Taking part in this survey is completely voluntary. You may stop your participation at any time. You are free to decline to answer any question you do not wish to answer. There are no right or wrong answers. All answers will remain completely confidential.
RISKS:
Some of the survey questions ask about childhood as well as sustainability in interior architecture and may be distressing to you as you think about your past experiences.
In order to mitigate these risks, the research team will slightly touch upon the topic before asking any questions
BENEFITS:
The benefits of your participation in this survey are going to include the opportunity to have access to the final design and project as well as the ability to reach out to the principal investigator at any time. The benefits of this study in general are learning the different types of educational environments and the positive and negative effects that it has on the developing brain, and how it can be more beneficial.
For concerns about your treatment as a research participant, please contact:
Institutional Review Board (IRB)
Endicott College 376 Hale St, Beverly, MA 01915 nsaltiko@endicott.edu
This research project has been reviewed by the Institutional Review Board at Endicott College in accordance with US Department of Health and
Human Services Office of Human Research Protections 45 CFR part 46 and does not constitute approval by the host institution.
Endicott College Institutional Review Board (IRB) Disclosure Statement How can interior architecture enhance the learning experience for children with Autism Spectrum Disorder (ASD) within the early childhood educational setting?
ANONYMITY/CONFIDENTIALITY:
Your name or identity will not be used in reports or presentations of the findings of this research. Information provided to the researchers will be kept confidential with the exception of information which must be reported under Massachusetts and Federal law such as cases of child or elder abuse. This research project has been approved by the Institutional Review Board at Endicott College. Thank you for your help.
An analysis of the results and an explanation of the study will be available in the Endicott College Interior Architecture Department located in the Visual and Performing Arts Building on campus in Beverly, Massachusetts when results are finalized and available.
CONTACT:
For questions or concerns about the research, please contact myself, Marielle Cassidy by phone or email: (978) 960-9070, mcass436@mail.endicott.edu; or faculty investigators, Professor Michael Fior (mfior@endicott.edu) and Myoung Joo Chun (mchun@endicott.edu).
ELECTRONIC CONSENT:
Continuing with this survey indicates that you have read the above information, that you are voluntarily agreeing to participate and that you are 18 years of age or older.
For concerns about your treatment as a research participant, please contact:
Institutional Review Board (IRB)
Endicott College 376 Hale St, Beverly, MA 01915 nsaltiko@endicott.edu
This research project has been reviewed by the Institutional Review Board at Endicott College in accordance with US Department of Health and
Human Services Office of Human Research Protections 45 CFR part 46 and does not constitute approval by the host institution.
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