Protocol Number 5852 You will need to have a title for the project

NORTH CAROLINA STATE UNIVERSITY
INSTITUTIONAL REVIEW BOARD FOR THE USE OF HUMAN SUBJECTS IN RESEARCH
SUBMISSION FOR NEW STUDIES
Protocol Number 5852
This document is menat to be used for instructional purposes or as a tool
when preparing your IRB application.
Items highlighted in "yellow" are the questions asked in the eIRB
application.
Project Title
You will need to have a title for the project.
Sometimes, the questions are answered with tips and clarifying
information that may help throughout the instructional process or
application preparation
Note: This PDF serves as a instructional tool as well as a tool for preparation. Throughout this document you will see
answers to questions that will have information or tips about how to prepare your application. Many questions are
answered "yes" or "no." These questions were answered in such a way as to prompt "pop up" questions. This means
that all possible questions are present in this PDF. Based on how you respond to each question (about your research),
questions will either appear or disappear. Your application is complete when all appropriate questions are addressed
and all supplemental documentation is uploaded. Please see the PDF tutorials for how to navigate and use the eIRB
system. These tutorials are found here: http://research.ncsu.edu/sparcs/compliance/irb/submission-guidance]
IRB File Number:
Original Approval Date:
Approval Period
Source of funding (if externally funded, enter PINS or RADAR number of funding proposal via 'Add New Sponsored Project Record' button below):
You will need information about your funding
NCSU Faculty point of contact for this protocol:NB: only this person has authority to submit the protocol
Paxton, Debra: Research and Innovation
Does any investigator associated with this project have a significant financial interest in, or other conflict of interest involving, the sponsor of this
project? (Answer No if this project is not sponsored)
No
Is this conflict managed with a written management plan, and is the management plan being properly followed?
No
Preliminary Review Determination
Category:
Provide a brief synopsis of the study (limit text to 1500 characters)
You will need to have BRIEF synopsis of your research. Do not cut and paste from other info.
Briefly describe in lay language the purpose of the proposed research and why it is important.
BRIEFLY describe the purpose of your research. In Lay Language.
Is this research being conducted by a student?
Yes
Is this research for a thesis?
Yes
Is this research for a dissertatiion?
Yes
Is this independent research?
Yes
Is this research for a course?
No
Do you currently intend to use the data for any purpose beyond the fulfillment of the class assignment?
No
Please explain
If so, please explain
If you anticipate additional NCSU-affiliated investigators (other than those listed on the Title tab) may be involved in this research, list them here
indicating their name and department.
Will the investigators be collaborating with researchers at any institutions or organizations outside of NC State?
Yes
List collaborating institutions and describe the nature of the collaboration
What is NCSU's role in this research?
Describe funding flow, if any (e.g. subcontractors)
Is this international research?
Yes
Identify the countries involved in this research
An IRB equivalent review for local and cultural context may be necessary for this study. Can you recommend consultants with cultural expertise who
may be willing to provide this review?
Adults 18 - 64 in the general population?
Yes
NCSU students, faculty or staff?
Yes
Adults age 65 and older?
Yes
Minors (under age 18--be sure to include provision for parental consent and/or child assent)?
Yes
List ages or age range:
Could any of the children be "Wards of the State" (a child whose welfare is the responsibility of the state or other agency, institution, or entity)?
Yes
Please explain:
Prisoners (any individual involuntarily confined or detained in a penal institution -- can be detained pending arraignment, trial or sentencing)?
Yes
Pregnant women?
Yes
Are pregnant women the primary population or focus for this research?
Yes
Provide rationale for why they are the focus population and describe the risks associated with their involvment as participants
Fetuses?
Yes
Students?
Yes
Does the research involve normal educational practices?
Yes
Is the research being conducted in an accepted educational setting?
Yes
This question as about whether or not the research is taking place in a
classroom or something like a classroom or other accepted educational settings
Are participants in a class taught by the principal investigator?
Yes
Are the research activities part of the required course requirements?
This is getting at "if all students in a class will participate in this
activity, regardless if their data will be used for research." Example, all
students complete a reading assessment but only those who have
consented/assented will have their data used for research. OR another
example: You are using class assignments for research purposes
Yes
Will course credit be offered to participants?
Yes
Amount of credit?
No
If class credit will be given, list the amount and alternative ways to earn the same amount of credit.Note: the time it takes to gain the same amount of
credit by the alternate means should be commensurate with the study task(s)
This credit is talking about the amount of credit they would get for being in this specific research project, it does not refer
to the overall credits they get for a course.
If you are offering "credit" for participation in the research (and you are a teacher or teachers will offer this research)
then you need to make sure there is an alternative way for students to receive that same credit. The task they complete
should be equitable to being a research participant. That means it should take about the same time and effort to
complete the alternative task as it would to be a part of the research.
How will permission to conduct research be obtained from the school or district?
Will you utilize private academic records?
Yes
Explain the procedures and document permission for accessing these records.
Employees?
Yes
Describe where (in the workplace, out of the workplace) activities will be conducted.
Employees is referring to populations that may be in a compromised position because the researchers are in a
supervisory position over them, or if the study could put them in employment risk or involves their supervisor.
From whom and how will permission to conduct research on the employees be obtained?
When you talk about this, you will also need to articulate how just because their workplace says it's okay to do the
research there, the employees will be assured that it's voluntary and not a job requirement
How will potential participants be approached and informed about the research so as to reduce any perceived coercion to participate?
Is the employer involved in the research activities in any way?
Yes
Please explain:
Will the employer receive any results from the research activities (i.e. reports, recommendations, etc.)?
Yes
Please explain. How will employee identities be protected in reports provided to employers?
Impaired decision making capacity/Legally incompetent?
Yes
How will competency be assessed and from whom will you obtain consent?
Mental/emotional/developmental/psychiatric challenges?
Yes
Identify the challenge and explain the unique risks for this population.
Describe any special provisions necessary for consent and other study activities (e.g., legal guardian for those unable to consent).
People with physical challenges?
Yes
Identify the challenge and explain the unique risks for this population.
Describe any special provisions necessary for working with this population (e.g., witnesses for the visually impaired).
Economically or educationally disadvantaged?
Yes
Racial, ethnic, religious and/or other minorities?
Yes
Non-English speakers?
Yes
Describe the procedures used to overcome any language barrier.
Will a translator be used?
Yes
Provide information about the translator (who they are, relation to the community, why you have selected them for use, confidentiality measures being
utilized).
Explain the necessity for the use of the vulnerable populations listed.
State how, where, when, and by whom consent will be obtained from each participant group. Identify the type of consent (e.g., written, verbal,
electronic, etc.). Label and submit all consent forms.
How (online? paper?)
Where
When
By Whom
There should be a consent process outlined FOR EACH participant group
You will need to upload a consent form for each participant group (and sometimes each data collection method if
relevant/appropriate)
All consents should be written in lay language and they should be age appropriate.
If any participants are minors, describe the process for obtaining parental consent and minor's assent (minor's agreement to participate).
Parent Consent
Minor Assent
Are you applying for a waiver of the requirement for consent (no consent information of any kind provided to participants) for any participant group(s) in
your study?
Yes
Describe the procedures and/or participant group for which you are applying for a waiver, and justify why this waiver is needed and consent is not
feasible.
You must justify why you need a waiver.
Are you applying for an alteration (exclusion of one or more of the specific required elements) of consent for any participant group(s) in your study?
Yes
Identify which required elements of consent you are altering, describe the participant group(s) for which this waiver will apply, and justify why this
waiver is needed.
If you want to waive any of the "required elements of consent" they include:
- A statement that the study involves research
- An explanation of the purposes of the research
- Statement of the expected duration of the subject's participation
- A description of the procedures to be followed
- Identification of any procedures which are experimental
- A description of any reasonably foreseeable risks or discomforts to the subject
- A description of any benefits to the subject or to others which may reasonably be expected from the research
- Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the
subject
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as
to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further
information may be obtained
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights,
and whom to contact in the event of a research-related injury to the subject
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits
to which the subject is otherwise entitled.
The regulations further provide that the following additional information be provided to subjects, where appropriate:
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the
subject is or may become pregnant) which are currently unforeseeable
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard
to the subject's consent
- Any additional costs to the subject that may result from participation in the research
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of
participation by the subject
- A statement that significant new findings developed during the course of the research which may relate to the subject's
willingness to continue participation will be provided to the subjec
- The approximate number of subjects involved in the study.
Are you applying for a waiver of signed consent (consent information is provided, but participant signatures are not collected)? A waiver of signed
consent may be granted only if: The research involves no more than minimal riskThe research involves no procedures for which consent is normally
required outside of the research context.
Yes
Would a signed consent document be the only document or record linking the participant to the research?
Yes
Is there any deception of the human subjects involved in this study?
Yes
Describe why deception is necessary and describe the debriefing procedures.Does the deception require a waiver or alteration of informed consent
information?Describe debriefing and/or disclosure procedures and submit materials for review.Are participants given the option to destroy their data if
they do not want to be a part the study after disclosure?
If you are using debriefing information, make sure to upload that as a document.
For each participant group please indicate how many individuals from that group will be involved in the research. Estimates or ranges of the numbers
of participants are acceptable. Please be aware that participant numbers may affect study risk. If your participation totals differ by 10% from what was
originally approved, notify the IRB.
Participant Group 1: 50 subjects
Participant Group 2: 3 subjects
How will potential participants be be found and selected for inclusion in the study?
For each participant group, how will potential participants be approached about the research and invited to participate?
Outline the avenues that you are going to recruit participants. Announcements in a class? Word of Mouth? Phone Call?
Flyers? E-mails? Social media postings?
All avenues must have a corresponding document uploaded for us to review.
Describe any inclusion and exclusion criteria for your participants and describe why those criteria are necessary (If your study concentrates on a
particular population, you do not need to repeat your description of that population here.)
Is there any relationship between researcher and participants - such as teacher/student; employer/employee?
Yes
What is the justification for using this participant group instead of an unrelated participant group?
Describe any risks associated with conducting your research with a related participant group.
Describe how this relationship will be managed to reduce risk during the research.
How will risks to confidentiality be managed?
Address any concerns regarding data quality (e.g. non-candid responses) that could result from this relationship.
If there is a previous relationship, could that relationship skew the way your participant answers the questions/responds
to tasks etc? If so, please address that here.
In the following questions describe in lay terms all study procedures that will be experienced by each group of participants in this study.For each group
of participants in your study, provide a step-by-step description of what they will experience from beginning to end of the study activities.
This should be a DETAILED explanation of what ALL participants will experience from the moment they are recruited
until they are completely done with the research.
If you have multiple participant groups or multiple methods for data collection, it's okay to break this section up into
smaller chunks with subheadings. Example:
Participant Group 1 will experience ....
Participant Group 2 will experience ....
or
Data collection method 1 .... (ex: face to face interviews)
Data collection method 2 .... (ex: online surveys)
Data collection emthod 3 .... (ex: in person/paper surveys)
Please
see
our
supplemental
and
http://research.ncsu.edu/sparcs/compliance/irb/submission-guidance/
helpful
documents
here:
You must have your instruments, recruitment, consents, debriefs, info sheets, and all other study related documents
prepared and uploaded when you submit this application. They should be .docx files when possible.
Describe how, where, when, and by whom data will be collected.
This question gets at the specifics behind who is doing what data collection and when/where it will happen.
How
When
Where
By Whom
Social?
No
Psychological?
No
Financial/Employability?
No
Legal?
No
Physical?
No
Academic?
No
Employment?
No
Financial?
This starts the questions about risk. Think about what type of risk the
procedures could pose to your participants.
What type of risk is posed to participants by you having their data?
What if it's breached or printed in the news? What risk is there then?
Answer all of these questions as approprite
No
Medical?
No
Private Behavior?
No
Economic Status?
No
Sexual Issues?
No
Religious Issues/Beliefs?
No
Describe the nature and degree of risk that this study poses for each item marked "Yes" above. Describe the steps taken to minimize these risks. You
CANNOT say 'none' or 'no risks'.
Address all the risks that you answered "Yes" for above.
If you answered "no" for everything above, you can say "There is minimal risk associated with this research"
You cannot leave this blank
You cannot say "NA" or "None" or "no risks"
If you are accessing private records, describe how you are gaining access to these records, what information you need from the records, and how you
will receive/record data.
Detail how you are accessing the records
Detail what information is in the records
Detail how you will receive the data
Detail how you will record the data
Detail how you have access to the data at all (your job function? are you requesting it?)
Are you asking participants to disclose information about other individuals (e.g., friends, family, co-workers, etc.)?
Yes
Describe the data you will collect and discuss how you will protect confidentiality and the privacy of these third-party individuals.
If you are collecting information that participants might consider personal or sensitive or that if revealed might cause embarrassment, harm to
reputation or could reasonably place the subjects at risk of criminal or civil liability, what measures will you take to protect participants from those
risks?
If any of the study procedures could be considered risky in and of themselves (e.g. study procedures involving upsetting questions, stressful situations,
physical risks, etc.) what measures will you take to protect participants from those risks?
Describe the anticipated direct benefits to be gained by each group of participants in this study (compensation is not a direct benefit).
If no direct benefit is expected for participants describe any indirect benefits that may be expected, such as to the scientific community or to society.
Will you be receiving already existing data without identifiers for this study?
Yes
Will you be receiving already existing data which includes identifiers for this study?
Yes
Describe how the benefits balance out the risks of this study.
Will data be collected anonymously (meaning that you do not ever collect data in a way that would allow you to link any identifying information to a
participant)?
Yes
Will identifiers be recorded with the data?
Yes
Will you use a master list, crosswalk, or other means of linking a participant's identity to the data?
Yes
Will it be possible to identify a participant indirectly from the data collected (i.e. indirect identification from demographic information)?
Yes
Audio recordings?
Yes
Video recordings?
Yes
Images?
Yes
Digital/electronic files?
Yes
Paper documents (including notes and journals)?
Yes
Physiological Responses?
Yes
Online survey?
Yes
Restricted Computer?
Yes
Password Protected files?
Yes
Firewall System?
Yes
Locked Private Office?
Yes
Locked Filing Cabinets?
Yes
Encrypted Files?
Yes
Describe all participant identifiers that will be collected (whether they will be retained or not) and explain why they are necessary.
Participant identifier refers to a data point that could identify a participant. This can be a name, phone number, email
address, physical address, IP address, student/employee ID, job title, etc. This is not referring to a code that you
assigned the participant.
If any links between data and participants are to be retained, how will you protect the confidentiality of the data?
Links can refer to a code that you assigned to the data, that links back to a master list. It can refer to actual identifiers on
the data etc.
Talk about what the links are, how they are retained, and how you plan on protecting them.
Please see this site for helpful information: http://research.ncsu.edu/sparcs/compliance/irb/submission-guidance/
If you are collecting data electronically, what (if any) identifiable information will be collected by the host site (such as email and/or IP address) and will
this information be reported to you?
Describe any ways that participants could be identified indirectly from the data collected and describe measures taken to protect identities.
Indirect Identification means that you have enough information about an individual, that you could identify a person.
For all recordings of any type:Describe the type of recording(s) to be made Describe the safe storage of recordings Who will have access to the
recordings? Will recordings be used in publications or data reporting? Will images be altered to de-identify?Will recordings be transcribed and by
whom?
Describe how data will be reported (aggregate, individual responses, use of direct quotes) and describe how identities will be protected in study
reports.
Will anyone besides the PI or the research team have access to the data (including completed surveys) from the moment they are collected until they
are destroyed?
Describe any compensation that participants will be eligible to receive, including what the compensation is, any eligibility requirements, and how it will
be delivered.
Make sure you are clear here, about how and what you are paying participants with. If you say your research is
anonymous but then say you are paying participants, you will need to state how you will do that while maintaining
anonymity.
Make sure to talk with your advisor/supervisor/Dean/ or accountant to see if there are any pay related rules, procedures,
or restrictions.
Explain compensation provisions if the participant withdraws prior to completion of the study.
If an open ended question does not pertain to
your research, you can state "NA" unless it
says otherwise.
The IRB may send your application back to
you if they feel that you should answer that
question fully.