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Checklist for Completing IRB Request Forms
Human subjects research can occurwhen you are obtaining information through interactions with people. Those
interactions couldinclude, but are not limited to, face-to-face,by paper, on-line, formally and informally, and
through observation. Todetermine if any of your workwhere youmight be conductinghuman subjects research
needs IRB oversight, youmust submit the details to an Institutional Review Board (IRB).
When your research is collecting “aboutwhom” information, yousubmit a RequestforReview to the IRB. “About
whom” information is about the person, not about the organization. For example, if you interview a director of a
shelter forbattered women about her training and how she defines the problem of battery, then the inquiry is
about the director, not the shelter. This is “about whom” information.
When you are collecting “about what” information, you submit a RequestforDetermination instead. “About
what” information is about an organization, not about the person. For example, if you call the director of the
women’s shelter and ask her for the average length of stay of the women whouse the shelter, that inquiry is
collecting “aboutwhat” information because it is not about the director, instead it is about the shelter.
All projects that include data collectionAND analysis use this checklist. If you are only analyzing data that was
already collected by other researchers from human subjects, follow the directions foundon the Checklist for Data
Analysis Only Projectsinstead.
Requirements for both Requests for Determination and Requests for Review
Front Page:
 Contact Information - Include the Principal Investigator’s, Co-Principal Investigators’ and Faculty Advisor’s
contactinformation.
o DO include “Clinton School of Public Service” as the department for Clinton Schoolinvestigators and
faculty advisors.
o DO NOTinclude the general Clinton Schoolphone number, use direct phone numbers instead.
 Principal Investigator - List only one student as the Principal Investigator (PI).Onteam projects, the PI’s role at
UACS is to be the communicator between the IRB and the research team. All co-principal investigators listed on
the request form are responsible for conducting the research.
 Co-Principal Investigators - Co-principal investigators include all individuals who will be participating in the
recruitment of subjects, conductingthe consent process, obtaining consent from subjects, intervening with
human subjects for research purposes, and/or receiving the identifiable information about subjects.
o DO NOTlist translators as co-researchers as long as they are only translating and not also helping with
any of the activities listed above.
o DO NOTlist individuals as researches if they are “informing prospective subjects about the availability
of the research, providing prospective subjects with information about the research, and/or obtaining
prospective subjects permission for researchers to contactthem.” In other words, the organization that
you workwithmay participate in any of these activities withoutbeing CITI trained or being listed as co-
principal investigators.1
 Faculty Advisor - For Practicumand Capstone, list the faculty advisor for yourspecific project except forthose
that have Dean Rutherford or Don Ernst as faculty advisors. In those cases, Marie Lindquist is listed as your
faculty advisor forthe IRB process only. For IPSP,Marie Lindquist is listed as the faculty advisor for all IPSP
projects.
 Sponsor - Give the name of the public service organization supervising your research.
Section 1: Describe the significance of the project.
1 Adapted from the CITI Training.
2
 1.a. Briefly describe the part of your projectwhere you are obtaining information through interactions with
people. Include (1)who youwant to collectthe information from, (2) what types of information youare
obtaining from them, and (3) whatyou are hoping to determine through the information you are obtaining.
o DO make the description of the information you are collecting clear so that the IRB can determine if you
need IRB oversight and if youare collecting“about whom” information or “about what” information.
 About Whom Example: We will be talking with (1) parents at the Central Arkansas libraries
about (2) how often they read to their children as well as the reading levelof their children. We
want to (3)see if the children’s reading levels are influenced by how often they are read to by
their parents.
 About What Example: Wewill be talking with (1) small business owners in Central Arkansas.
We want to learn (2)about practices they have implemented that improve the environmental
sustainability of their business, the additional environmental sustainability practices they want
to implement, and their training needs regarding implementing new environmental
sustainability practices. This willallow us to (3) determine the progress that has been made on
environmental sustainability practices in Central Arkansas small businesses. This information
will also help us develop trainings forsmall businesses on how to implement additional
environmental sustainability practices.
o DO specifically describe any sensitive private information you are collecting (i.e., income, religious
preference, sexual behavior, illegal behavior, political beliefs, health information, and activities in
countries with political violence,police states, etc.).
o DO NOTdescribe yourentire project; only describe the aspects where you are collecting information
from people.
Section 2: Describe the methods and procedures.
 2.a. Describe the data collectionprocedures and what participants will have to do.
o Name all of the data collectionmethods and tools you will use. Options couldinclude, but are not
limited to: on-line surveys, phone interviews, focusgroups, in-person questionnaires, participant
observation,2 and community conversations.
o Example: Participants will be asked to schedule an in-person interview. If they are not available foran
in-person interview, they willbe asked if a phone interview can be scheduled instead.
o DO be specific about if it willbe in-person, on-line, over the phone, etc.
o DO include all of the data collectionprocedures that you plan to use including alternative procedures as
is shown in the example above.
 2.b. How long will this take participants to complete:
o Be specific about the amount of time it willtake for each data collection tool.
o For example: The focus group is scheduled fortwohours. The on-line survey will take approximately
15 minutes to complete.
o DO keep in mind how long you can reasonably expect your participants to commit to taking your
survey, being interviewed, etc.Are your time expectations reasonable for yourpotential participants?
 2.c. Will follow-upsor reminders be sent? If so, explain.
o Be specific about (1) the format of the reminders for example email or phone call, and (2) how often
they willbe reminded.
o Example: An email willbe sent to potential participants to remind them about the interview day/time.
Section 3: Describe the recruiting procedures.
 3.a. How will the names and contactinformation forparticipants be obtained?
o Will an organization or individual provide them to you? Will youfind names and addresses on-line?
o Example: The Sustainability Consortium will provide the names and email addresses of their members.
o Example: No contact information willbe needed.
2 For more information about participant observation as a data collection method see http://www.qualitative-
research.net/index.php/fqs/article/view/466/996
3
 3.b. How will participants be approached about participating in the study?
o Example: We will stand outside of supermarkets around Little Rockand ask people entering and exiting
if they wouldcomplete our survey.
o Example: We will send an email to potential participants asking if they would participate in an
interview.
o Example: The Director of Policy and Planning at the Arkansas Department of Health and Human
Services will send an email to potential participants on our behalf.
o DO consider the best ways to reach the participants that youwant. Are they best reached by email, mail,
door-to-door,at localbusinesses, etc.?
For Requests for Determination, you will not find sections 4-9 on your form. Skip to the
attachments section below.
For Request for Review, sections 4-9 as well as attachments are required.
Section 4: Describe compensation.
 4.a.-4.e. If you ARE NOTproviding money or incentives to participants, answer “no” to the first part and leave
the rest blank. Compensation includes both money and incentives (i.e., giveaways,gift cards, course credit,
etc.).If youARE providing money or other incentives to participants, meet with yourfaculty advisor to discuss
and complete this section.3 Youwill need to determine protocols that will fairly distribute compensation and
not unduly influence participants. Here are more specifics about that:
o Exclusion fromthe research should not keep any population from receiving equal benefits.
o Youneed to be carefulabout not unduly influencing potential participants through an offerof an
excessive or inappropriate reward or other overture in order to obtain compliance. For example, an
investigator might promise psychology students extra credit if they participate in the research. If that is
the only way a student can earn extra credit, then the investigator is unduly influencing potential
subjects. If, however,she offerscomparable alternatives forearning extra credit, the possibility of
undue influence is minimized.4
Section 5: Conflict of interest
 5.a.-5.b. If you DONOT have a conflictof interest, state that in this section. If you DOhave a conflictof interest,
describe whatthat conflictis in this section. Conflicts of interest to consider include recruiting participants
whoare your students, employees, colleagues, and/or subordinates. Italso includes receiving some type of
financial benefit because of the research. More information about conflictsof interest in research can be found
at http://www.research.umn.edu/irb/guidance/coi.html#.VDWPJvl4rYg.
 5.c. If you DOhave a conflictof interest, describe whatreasonable and appropriate actions youplan to take to
protect subjects from the influence of conflictinginterests.
Section 6: Describe benefits and risks
 6.a. Explain the benefits to participants or to others.
o Includes any benefits forthe individual participants as well as the benefits forthe larger community.
o Example: By participating, youwill be able to influence the training sessions on environmental
sustainability practices offered foryour small business. You willalso be helping the Central Arkansas
business community improve their environmental sustainability.
 6.b. Explain the risks to participants. What willbe done to minimize the risks? If there are no knownrisks, this
should be stated.
3 The Clinton School will not provide money or incentives to participants in our field projects. Either your partner organization
provides them, you obtain donations, or you find another way to provide them.
4 Information for this section came from: http://answers.hhs.gov/ohrp/questions/7250
4
o There are often risks (psychological,physical, social, legal or economic) that are associated with
participating and it is important to think about all of them. See examples and ideas forminimizing those
risks at: http://www.uwsuper.edu/irb/risks.cfm.
Section 7: Informed consent
Informed consent is the process by which a participant learns what s/he's getting him or herself into if s/he
decides to participate in yourproject. Almost always,the participant must sign, in person or electronically,an
informed consent statement saying that they agree to participate.5
 7.a. Is yourproject anonymous?
o Your projectcan only be anonymous if you, the researcher, do not know who has participated, although
you may know whowas invited to participate.
 Example: You hand out surveys but you do not collectany identifying information (i.e., names,
organization names) through the survey.This wouldallow participation to be anonymous.
 7.b. If youare requesting a waiverof signed consent, please justify.
o Signed consent may be waived “in minimal risk research involvingthe administration of online or
mailed surveys…or when anonymous sensitive information is collectedand youdo not want any
written documentation that links the participant tothe research study.”6
o In addition, a verbal consent procedure could be approved if written consent cannot be accomplished
(i.e., if phone interviews are conducted, if participants are illiterate).
 7.c. How will informed consent/assent be obtained?
o Include the consent document (i.e., written form, verbal script) foreach of your data collectiontools.
o Assent - Minors cannot give informed consent forthemselves, but they must assent. In other words, if a
mom gives "permission" forher son Johnny to participate but Johnny doesn't wantto (i.e., he does not
assent), he doesn't participate. The child assent process needs toinclude age appropriate information
that the child will use to decide if s/he wants to participate or not.7
o Example: Our electronic survey asks participants to provide their consent to participate at the
beginning of the survey.
o Example: Participants will be given a consent format the beginning of the interview.They will be given
time to review the formand decide if they would like to sign it and participate in the interview.
o Example: During carpool at the school, we willshow parents our surveys and ask them to sign a
consent form allowing their son/daughter to participate. During class, we willhand out the survey with
the assent information at the top. Students will be given 10 minutes to complete the survey. If they do
not want to complete it, they can just leave it blank.
 7.d. If subjects are under 18, have you attached consent forms fromparents or guardian? When planning
consent procedures forminors, you also need to develop a parent/guardian consent form. This form contains
the same details as a regular consent form except the language is adjusted to suit parents/guardians.
Parents/guardians must also be given the opportunity to review the data collectiontool before deciding
whether or not to let their child participate.
o If you ARE researching children, youmust answer “Yes” and attach the consent form for
parents/guardians.
o If you are NOTconducting research on anyone under the age of 18, leave blank.
Section 8: Confidentiality
In this section, be sure to distinguish between the following8:
5 Revised from: Harvard University. (June 2013). QUICK TIPS for Completing the Application Form.
http://www.fas.harvard.edu/~human subjects research/hum_sub/index.html#forms
6 From: http://www.irb.northwestern.edu/process/new-study/informed-consent/waiver-documentation-consent
7 Revised from: Harvard University. (June 2013). QUICK TIPS for Completing the Application Form.
http://www.fas.harvard.edu/~human subjects research/hum_sub/index.html#forms
8 This section is revised from: Harvard University. (June 2013). QUICK TIPS for Completing the Application Form.
http://www.fas.harvard.edu/~human subjects research/hum_sub/index.html#forms
5
 Participationis anonymous whenthe researcher does not know whohas participated, though the
researcher may know who was invited to participate.
 Participationis confidential when the researcher does know participants’ identities but will not reveal
them.
 Dataare anonymous whenno one, not even the researcher, can link the participants’ identity to the data.
 Dataare confidential when the researcher could link data to individual participants but this information
will not be revealed.
 Reportsofthe data are anonymous whenno one reading the report could determine the identity of a
participant, directly or indirectly.
 If the data are reported so that participants’ identities could be determined, directly or indirectly, the
report is neitherconfidentialnor anonymous.Itis perfectly acceptable to complete research that is neither
confidentialnor anonymous. Infactall focusgroups fall into this category because the other participants of
the focus group know whoparticipated making it impossible to keep that information confidential or
anonymous. You can, however,ask the participants to keep the information confidential and do the same in
your reports.
 8.a. How will confidentiality of records be maintained?
o Specifically describe yourprocedures forthis both during and after yourproject. Consider the
following:
 Keeping records confidential can be accomplished in various waysincluding:
 Collect data withoutidentifiers
 Remove all identifiers from the data as soon as possible after collecting it
 Substitute codes for identifiers
 Use and protect computer passwords
 Encryptdata9
 If you are using codes and/or if you are keeping participant information confidential, the codes
and signed consent forms need to be kept in a separate secure locationfrom your data.
 All paper surveys, paper consent forms, voicerecordings, notes, original survey results, and
other collected data need to be kept in a secure location during your project.After your project
workis over,they should be destroyed. For example, responses in Survey Monkey should be
downloaded and then erased fromSurvey Monkey.Paper surveys, notes, consent forms should
be turned into PDFdocuments and then shredded. Voice recordings should be transcribed and
then erased.
 8.b. Will individuals be identified?
o Often youwill want to protectyour participants from being identifiable in yourreports. Consider using
aggregate reporting, misleading identifiers or other methods. If you are keeping identities anonymous
in your reports, youanswer “No” here. Include yourprocedure fornot identifying participants.
 Example: I will know participants’ identities but I will use codes in my data and identifying
information will not be revealed in any final reports on the data.
 Example: Participants’ identities will be collectedbut the data will only be reported in aggregate
form withoutidentifying information included.
o If the data are reported so that participants’ identities could be determined, directly or indirectly, you
answer “Yes” here. This means that you are reporting your data so that participants’ identities could be
determined, directly or indirectly. For example, youare collecting information about best practices
from experts and those experts can be contactedif anyone who reads yourreport wants more
information.
o If you believe you willbe required to put limits on the confidentiality you promise, be sure to be
specific about that in this section and on your consent form. These are reasons given in your CITI
Training forwhy youmight be required to report something: the requirement to report child abuse,
specific communicable diseases, the intent to harm oneself or others, and elder abuse. Investigators
may also be compelled to release study data in response to legal action.
 8.c. Where will records be stored?
9 From the CITI Training
6
o Records include, but are not limited to, signed consent/assent forms, raw data, aggregated data,
and/or codes. If you have both paper and electronic records, include the storage locations for each type.
o It is recommended that youkeep records electronically on a password-protected computer.
o Signed consent forms can be kept in paper form in a locked office.They could also be turned into a PDF
document and then kept on a password-protected computer. In this case, the paper forms should be
shredded afterwards.
 8.d. How will data be reported?
o Be specific about the types of reports youwill be creating that will include your data. For example, will
you include it in a final public document? Willit be only used internally with the sponsoring
organization? Will yoube publishing on your results?
Section 9: Data security
 9.a. Records must be kept for three years beyond the life of the study. Who willhave access to the
records/data?
o Records include, but are not limited to, signed consent/assent forms, raw data, aggregated data,
research notes, and/or codes. Be specific about who willhave access to what. What will the co-
investigators have access to? What will the faculty advisor have access to? What willthe sponsoring
organization have access to?
 9.b. Data willbe kept in a secured location (lockedand/or password protected) by PIand advisor where?
o Data includes, but are not limited to, raw data and aggregated data.
o Be specific about this. Will yourdata be kept in someone’s locked office?Who’s office?Will your data be
kept on someone’s password protected computer? Who’s computer?
o If your data changes locations during or after the research, describe where yourdata willbe kept
during the research and where it will be kept afterwards.
Attachments
Attachments Required forboth Requests forDetermination and Requests forReview
 Attach the CITI Course Completion Records for all co-researchers and your faculty advisor. Typically your
faculty advisor will give this to you after youhave completed all of the requested edits and it is ready to submit
to UALR.
 Attach your specific recruitment materials: fliers, ads, phone scripts, press releases, emails, etc. Include
anything that you willuse to encourage people to participate in your human subjects research.
o Example: Include the email template(s) of the emails you willask the sponsoring organization to send
to potential participants.
o Example: Include the poster you will hang at the local community center to invite people to participate.
o Example: If youwill attend certain meetings or events to recruit, include a list of which
meetings/events and a script of what youwill say about your projectto recruit participants.
o Example: If youwill go door-to-door,include a list of the neighborhoods where youwill canvass and
what youwill say to those that answer the door.
o DO include in all of your recruitment materials the purpose of yourproject, the benefits of participating,
the time commitment required, and the name and specific contactinformation for the individual who
can answer any questions.
 Attach your specific data collectiontools: surveys, interview questions, focusgroup questions, etc.
o Example: If youplan to conductan on-line survey, submit a copy of the exact survey designed in the on-
line tool10 you plan to use. Include the introduction to the survey as well.
o Example: If youplan to conductinterviews, submit your exact interview questions along with any
introductory information you will share withparticipants.
o DO use open-ended questions in your interviews and focus groups to obtain richer information.
10 The school has a SurveyMonkey account that students can use for any on-line surveys. Email Hilary for the details if you
want to use it.
7
o DO use close-ended questions in yoursurveys and questionnaires to more easily analyze the large
amount of data collected.
Additional Attachments Required forRequests forReview
 Attach your specific consent/assent materials: written consent forms, written assent forms, parent or guardian
consent forms, the consent information given beforean on-line survey,the consent script read before a phone
interview, etc. Be sure that an appropriate way to consent for each of your data collectiontools. All
consent/assent materials must follow the requirements for informed consent foundon the Request for Review
form and must also include:
o Any benefits forthe individual participants as wellas the benefits for the larger community.
o A statement that participation is voluntary
o A statements that a participant willnot be penalized or lose benefits if they choose not to participate
o The level of anonymity and/or confidentiality you are promising participants, if any at all. If not
promising anonymity or confidentiality,state that.
o Full name and contactinformation for the PI.11 Include the PI’s direct phone number; the Clinton
School’s general phone number is not appropriate. If contactingparticipants though email or other on-
line tools, also include a direct email address for the PI.
o Any conflictsof interest you might have that participants would need to know about.
o This exact statement must be included:
 This study has been reviewed and approved by The University of Arkansas-Little Rock's
Institutional Review Board (IRB).The IRB has determined that this study meets the ethical
obligations required by federal law and University policies. If youhave questions or concerns
regarding this study please contactthe Principal Investigator. If youhave any questions
regarding yourrights as a human subjects research subject, please contactthe Research
Compliance Officeat501-569-8657 or irb@ualr.edu.
 Clinton Schoolstudents DONOT need to include a site letter of permission or support.
Reviewing your Document before Submission
Before submitting your documents to the IRB, checkfor the following:
 Will yoube able to easily compile and analyze the information you collect?Yourfaculty advisor will be able to
help youdetermine this.
 Are all of your documents written forthe literacy level of your participants? You should work towards writing
at an 8th grade reading level unless your population requires something different.
 Have you tested your data collectionmethods and tools with individuals who resemble yourhuman subjects?
o Are youobtaining the information that you want to obtain?
o Are they free of any errors?
o Are they easy to understand?
o Are electronic versions set up correctly?
o Note: When testing your data collectiontools that involvehuman subjects, youcannot record the
information you obtain or use it in yourfinal report. It is recommended that youask people to test your
tools who are similar to your potential participants but whoyou will not recruit to participate later.
 Have you asked someone outside yourresearch team to review your consent/assent and recruitment
materials?
o Do yourmaterials encourage participation?
o Do they contain all of the important information that they would want to know?
 Is everything clear and concise?
 Is everything that is going to potential participants written in an accessible, inviting way that would encourage
participation?
11 Subjects have a right to know whom to contactif they have second thoughts about what they agreed to, so you
need to let them know how to contactyoudirectly.
8
 Have you avoided using Clinton School jargon and terms that willnot be understood by an outside audience?
These are some of the terms to use carefully:
o Key Informants,Experts,Laypersons,Stakeholders-Whoexactly are you referring to? Specifically
describe them. Example: Rather than using the term key informant, describe them as small business
owners in Central Arkansas.
o Quantitative,Qualitative,Open-Ended,Close-Ended,Primary,Secondary -Youneed to be specific about
the exact information youare working to obtain, not the types. Example: Rather than writing that you
are collectingqualitative data using open-ended questions, write that youare collecting information
about the sustainability practices small businesses have implemented.
o Surveys - Be specific about what kind. Is it an in-person interview? A phone interview? An in-person
paper questionnaire? An on-line questionnaire? A mailed questionnaire? An in-person focusgroup?
o Practicum, IPSP, Capstone – These terms are not knownoutside the Clinton School.
o BestPractices - Exactly whatinformation are youcollecting?
o Sustainable -This term means many different things. How are you using it? Is that clear?
o Deliverable -Exactly whatare you creating? A report? A brochure? A journal article? Something else?
o Recorded - Willit be audio recorded? Video recorded? Notes taken?
o NeedsAssessment,Evaluation,AssetMap,ImpactStudy – Be specific about exactly what information you
are collectingin order to complete the needs assessment. The type of information is whatmatters to
the IRB.

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Unit 3: Research Techniques - LO3
 

Checklist for Completing IRB Request Forms

  • 1. 1 Checklist for Completing IRB Request Forms Human subjects research can occurwhen you are obtaining information through interactions with people. Those interactions couldinclude, but are not limited to, face-to-face,by paper, on-line, formally and informally, and through observation. Todetermine if any of your workwhere youmight be conductinghuman subjects research needs IRB oversight, youmust submit the details to an Institutional Review Board (IRB). When your research is collecting “aboutwhom” information, yousubmit a RequestforReview to the IRB. “About whom” information is about the person, not about the organization. For example, if you interview a director of a shelter forbattered women about her training and how she defines the problem of battery, then the inquiry is about the director, not the shelter. This is “about whom” information. When you are collecting “about what” information, you submit a RequestforDetermination instead. “About what” information is about an organization, not about the person. For example, if you call the director of the women’s shelter and ask her for the average length of stay of the women whouse the shelter, that inquiry is collecting “aboutwhat” information because it is not about the director, instead it is about the shelter. All projects that include data collectionAND analysis use this checklist. If you are only analyzing data that was already collected by other researchers from human subjects, follow the directions foundon the Checklist for Data Analysis Only Projectsinstead. Requirements for both Requests for Determination and Requests for Review Front Page:  Contact Information - Include the Principal Investigator’s, Co-Principal Investigators’ and Faculty Advisor’s contactinformation. o DO include “Clinton School of Public Service” as the department for Clinton Schoolinvestigators and faculty advisors. o DO NOTinclude the general Clinton Schoolphone number, use direct phone numbers instead.  Principal Investigator - List only one student as the Principal Investigator (PI).Onteam projects, the PI’s role at UACS is to be the communicator between the IRB and the research team. All co-principal investigators listed on the request form are responsible for conducting the research.  Co-Principal Investigators - Co-principal investigators include all individuals who will be participating in the recruitment of subjects, conductingthe consent process, obtaining consent from subjects, intervening with human subjects for research purposes, and/or receiving the identifiable information about subjects. o DO NOTlist translators as co-researchers as long as they are only translating and not also helping with any of the activities listed above. o DO NOTlist individuals as researches if they are “informing prospective subjects about the availability of the research, providing prospective subjects with information about the research, and/or obtaining prospective subjects permission for researchers to contactthem.” In other words, the organization that you workwithmay participate in any of these activities withoutbeing CITI trained or being listed as co- principal investigators.1  Faculty Advisor - For Practicumand Capstone, list the faculty advisor for yourspecific project except forthose that have Dean Rutherford or Don Ernst as faculty advisors. In those cases, Marie Lindquist is listed as your faculty advisor forthe IRB process only. For IPSP,Marie Lindquist is listed as the faculty advisor for all IPSP projects.  Sponsor - Give the name of the public service organization supervising your research. Section 1: Describe the significance of the project. 1 Adapted from the CITI Training.
  • 2. 2  1.a. Briefly describe the part of your projectwhere you are obtaining information through interactions with people. Include (1)who youwant to collectthe information from, (2) what types of information youare obtaining from them, and (3) whatyou are hoping to determine through the information you are obtaining. o DO make the description of the information you are collecting clear so that the IRB can determine if you need IRB oversight and if youare collecting“about whom” information or “about what” information.  About Whom Example: We will be talking with (1) parents at the Central Arkansas libraries about (2) how often they read to their children as well as the reading levelof their children. We want to (3)see if the children’s reading levels are influenced by how often they are read to by their parents.  About What Example: Wewill be talking with (1) small business owners in Central Arkansas. We want to learn (2)about practices they have implemented that improve the environmental sustainability of their business, the additional environmental sustainability practices they want to implement, and their training needs regarding implementing new environmental sustainability practices. This willallow us to (3) determine the progress that has been made on environmental sustainability practices in Central Arkansas small businesses. This information will also help us develop trainings forsmall businesses on how to implement additional environmental sustainability practices. o DO specifically describe any sensitive private information you are collecting (i.e., income, religious preference, sexual behavior, illegal behavior, political beliefs, health information, and activities in countries with political violence,police states, etc.). o DO NOTdescribe yourentire project; only describe the aspects where you are collecting information from people. Section 2: Describe the methods and procedures.  2.a. Describe the data collectionprocedures and what participants will have to do. o Name all of the data collectionmethods and tools you will use. Options couldinclude, but are not limited to: on-line surveys, phone interviews, focusgroups, in-person questionnaires, participant observation,2 and community conversations. o Example: Participants will be asked to schedule an in-person interview. If they are not available foran in-person interview, they willbe asked if a phone interview can be scheduled instead. o DO be specific about if it willbe in-person, on-line, over the phone, etc. o DO include all of the data collectionprocedures that you plan to use including alternative procedures as is shown in the example above.  2.b. How long will this take participants to complete: o Be specific about the amount of time it willtake for each data collection tool. o For example: The focus group is scheduled fortwohours. The on-line survey will take approximately 15 minutes to complete. o DO keep in mind how long you can reasonably expect your participants to commit to taking your survey, being interviewed, etc.Are your time expectations reasonable for yourpotential participants?  2.c. Will follow-upsor reminders be sent? If so, explain. o Be specific about (1) the format of the reminders for example email or phone call, and (2) how often they willbe reminded. o Example: An email willbe sent to potential participants to remind them about the interview day/time. Section 3: Describe the recruiting procedures.  3.a. How will the names and contactinformation forparticipants be obtained? o Will an organization or individual provide them to you? Will youfind names and addresses on-line? o Example: The Sustainability Consortium will provide the names and email addresses of their members. o Example: No contact information willbe needed. 2 For more information about participant observation as a data collection method see http://www.qualitative- research.net/index.php/fqs/article/view/466/996
  • 3. 3  3.b. How will participants be approached about participating in the study? o Example: We will stand outside of supermarkets around Little Rockand ask people entering and exiting if they wouldcomplete our survey. o Example: We will send an email to potential participants asking if they would participate in an interview. o Example: The Director of Policy and Planning at the Arkansas Department of Health and Human Services will send an email to potential participants on our behalf. o DO consider the best ways to reach the participants that youwant. Are they best reached by email, mail, door-to-door,at localbusinesses, etc.? For Requests for Determination, you will not find sections 4-9 on your form. Skip to the attachments section below. For Request for Review, sections 4-9 as well as attachments are required. Section 4: Describe compensation.  4.a.-4.e. If you ARE NOTproviding money or incentives to participants, answer “no” to the first part and leave the rest blank. Compensation includes both money and incentives (i.e., giveaways,gift cards, course credit, etc.).If youARE providing money or other incentives to participants, meet with yourfaculty advisor to discuss and complete this section.3 Youwill need to determine protocols that will fairly distribute compensation and not unduly influence participants. Here are more specifics about that: o Exclusion fromthe research should not keep any population from receiving equal benefits. o Youneed to be carefulabout not unduly influencing potential participants through an offerof an excessive or inappropriate reward or other overture in order to obtain compliance. For example, an investigator might promise psychology students extra credit if they participate in the research. If that is the only way a student can earn extra credit, then the investigator is unduly influencing potential subjects. If, however,she offerscomparable alternatives forearning extra credit, the possibility of undue influence is minimized.4 Section 5: Conflict of interest  5.a.-5.b. If you DONOT have a conflictof interest, state that in this section. If you DOhave a conflictof interest, describe whatthat conflictis in this section. Conflicts of interest to consider include recruiting participants whoare your students, employees, colleagues, and/or subordinates. Italso includes receiving some type of financial benefit because of the research. More information about conflictsof interest in research can be found at http://www.research.umn.edu/irb/guidance/coi.html#.VDWPJvl4rYg.  5.c. If you DOhave a conflictof interest, describe whatreasonable and appropriate actions youplan to take to protect subjects from the influence of conflictinginterests. Section 6: Describe benefits and risks  6.a. Explain the benefits to participants or to others. o Includes any benefits forthe individual participants as well as the benefits forthe larger community. o Example: By participating, youwill be able to influence the training sessions on environmental sustainability practices offered foryour small business. You willalso be helping the Central Arkansas business community improve their environmental sustainability.  6.b. Explain the risks to participants. What willbe done to minimize the risks? If there are no knownrisks, this should be stated. 3 The Clinton School will not provide money or incentives to participants in our field projects. Either your partner organization provides them, you obtain donations, or you find another way to provide them. 4 Information for this section came from: http://answers.hhs.gov/ohrp/questions/7250
  • 4. 4 o There are often risks (psychological,physical, social, legal or economic) that are associated with participating and it is important to think about all of them. See examples and ideas forminimizing those risks at: http://www.uwsuper.edu/irb/risks.cfm. Section 7: Informed consent Informed consent is the process by which a participant learns what s/he's getting him or herself into if s/he decides to participate in yourproject. Almost always,the participant must sign, in person or electronically,an informed consent statement saying that they agree to participate.5  7.a. Is yourproject anonymous? o Your projectcan only be anonymous if you, the researcher, do not know who has participated, although you may know whowas invited to participate.  Example: You hand out surveys but you do not collectany identifying information (i.e., names, organization names) through the survey.This wouldallow participation to be anonymous.  7.b. If youare requesting a waiverof signed consent, please justify. o Signed consent may be waived “in minimal risk research involvingthe administration of online or mailed surveys…or when anonymous sensitive information is collectedand youdo not want any written documentation that links the participant tothe research study.”6 o In addition, a verbal consent procedure could be approved if written consent cannot be accomplished (i.e., if phone interviews are conducted, if participants are illiterate).  7.c. How will informed consent/assent be obtained? o Include the consent document (i.e., written form, verbal script) foreach of your data collectiontools. o Assent - Minors cannot give informed consent forthemselves, but they must assent. In other words, if a mom gives "permission" forher son Johnny to participate but Johnny doesn't wantto (i.e., he does not assent), he doesn't participate. The child assent process needs toinclude age appropriate information that the child will use to decide if s/he wants to participate or not.7 o Example: Our electronic survey asks participants to provide their consent to participate at the beginning of the survey. o Example: Participants will be given a consent format the beginning of the interview.They will be given time to review the formand decide if they would like to sign it and participate in the interview. o Example: During carpool at the school, we willshow parents our surveys and ask them to sign a consent form allowing their son/daughter to participate. During class, we willhand out the survey with the assent information at the top. Students will be given 10 minutes to complete the survey. If they do not want to complete it, they can just leave it blank.  7.d. If subjects are under 18, have you attached consent forms fromparents or guardian? When planning consent procedures forminors, you also need to develop a parent/guardian consent form. This form contains the same details as a regular consent form except the language is adjusted to suit parents/guardians. Parents/guardians must also be given the opportunity to review the data collectiontool before deciding whether or not to let their child participate. o If you ARE researching children, youmust answer “Yes” and attach the consent form for parents/guardians. o If you are NOTconducting research on anyone under the age of 18, leave blank. Section 8: Confidentiality In this section, be sure to distinguish between the following8: 5 Revised from: Harvard University. (June 2013). QUICK TIPS for Completing the Application Form. http://www.fas.harvard.edu/~human subjects research/hum_sub/index.html#forms 6 From: http://www.irb.northwestern.edu/process/new-study/informed-consent/waiver-documentation-consent 7 Revised from: Harvard University. (June 2013). QUICK TIPS for Completing the Application Form. http://www.fas.harvard.edu/~human subjects research/hum_sub/index.html#forms 8 This section is revised from: Harvard University. (June 2013). QUICK TIPS for Completing the Application Form. http://www.fas.harvard.edu/~human subjects research/hum_sub/index.html#forms
  • 5. 5  Participationis anonymous whenthe researcher does not know whohas participated, though the researcher may know who was invited to participate.  Participationis confidential when the researcher does know participants’ identities but will not reveal them.  Dataare anonymous whenno one, not even the researcher, can link the participants’ identity to the data.  Dataare confidential when the researcher could link data to individual participants but this information will not be revealed.  Reportsofthe data are anonymous whenno one reading the report could determine the identity of a participant, directly or indirectly.  If the data are reported so that participants’ identities could be determined, directly or indirectly, the report is neitherconfidentialnor anonymous.Itis perfectly acceptable to complete research that is neither confidentialnor anonymous. Infactall focusgroups fall into this category because the other participants of the focus group know whoparticipated making it impossible to keep that information confidential or anonymous. You can, however,ask the participants to keep the information confidential and do the same in your reports.  8.a. How will confidentiality of records be maintained? o Specifically describe yourprocedures forthis both during and after yourproject. Consider the following:  Keeping records confidential can be accomplished in various waysincluding:  Collect data withoutidentifiers  Remove all identifiers from the data as soon as possible after collecting it  Substitute codes for identifiers  Use and protect computer passwords  Encryptdata9  If you are using codes and/or if you are keeping participant information confidential, the codes and signed consent forms need to be kept in a separate secure locationfrom your data.  All paper surveys, paper consent forms, voicerecordings, notes, original survey results, and other collected data need to be kept in a secure location during your project.After your project workis over,they should be destroyed. For example, responses in Survey Monkey should be downloaded and then erased fromSurvey Monkey.Paper surveys, notes, consent forms should be turned into PDFdocuments and then shredded. Voice recordings should be transcribed and then erased.  8.b. Will individuals be identified? o Often youwill want to protectyour participants from being identifiable in yourreports. Consider using aggregate reporting, misleading identifiers or other methods. If you are keeping identities anonymous in your reports, youanswer “No” here. Include yourprocedure fornot identifying participants.  Example: I will know participants’ identities but I will use codes in my data and identifying information will not be revealed in any final reports on the data.  Example: Participants’ identities will be collectedbut the data will only be reported in aggregate form withoutidentifying information included. o If the data are reported so that participants’ identities could be determined, directly or indirectly, you answer “Yes” here. This means that you are reporting your data so that participants’ identities could be determined, directly or indirectly. For example, youare collecting information about best practices from experts and those experts can be contactedif anyone who reads yourreport wants more information. o If you believe you willbe required to put limits on the confidentiality you promise, be sure to be specific about that in this section and on your consent form. These are reasons given in your CITI Training forwhy youmight be required to report something: the requirement to report child abuse, specific communicable diseases, the intent to harm oneself or others, and elder abuse. Investigators may also be compelled to release study data in response to legal action.  8.c. Where will records be stored? 9 From the CITI Training
  • 6. 6 o Records include, but are not limited to, signed consent/assent forms, raw data, aggregated data, and/or codes. If you have both paper and electronic records, include the storage locations for each type. o It is recommended that youkeep records electronically on a password-protected computer. o Signed consent forms can be kept in paper form in a locked office.They could also be turned into a PDF document and then kept on a password-protected computer. In this case, the paper forms should be shredded afterwards.  8.d. How will data be reported? o Be specific about the types of reports youwill be creating that will include your data. For example, will you include it in a final public document? Willit be only used internally with the sponsoring organization? Will yoube publishing on your results? Section 9: Data security  9.a. Records must be kept for three years beyond the life of the study. Who willhave access to the records/data? o Records include, but are not limited to, signed consent/assent forms, raw data, aggregated data, research notes, and/or codes. Be specific about who willhave access to what. What will the co- investigators have access to? What will the faculty advisor have access to? What willthe sponsoring organization have access to?  9.b. Data willbe kept in a secured location (lockedand/or password protected) by PIand advisor where? o Data includes, but are not limited to, raw data and aggregated data. o Be specific about this. Will yourdata be kept in someone’s locked office?Who’s office?Will your data be kept on someone’s password protected computer? Who’s computer? o If your data changes locations during or after the research, describe where yourdata willbe kept during the research and where it will be kept afterwards. Attachments Attachments Required forboth Requests forDetermination and Requests forReview  Attach the CITI Course Completion Records for all co-researchers and your faculty advisor. Typically your faculty advisor will give this to you after youhave completed all of the requested edits and it is ready to submit to UALR.  Attach your specific recruitment materials: fliers, ads, phone scripts, press releases, emails, etc. Include anything that you willuse to encourage people to participate in your human subjects research. o Example: Include the email template(s) of the emails you willask the sponsoring organization to send to potential participants. o Example: Include the poster you will hang at the local community center to invite people to participate. o Example: If youwill attend certain meetings or events to recruit, include a list of which meetings/events and a script of what youwill say about your projectto recruit participants. o Example: If youwill go door-to-door,include a list of the neighborhoods where youwill canvass and what youwill say to those that answer the door. o DO include in all of your recruitment materials the purpose of yourproject, the benefits of participating, the time commitment required, and the name and specific contactinformation for the individual who can answer any questions.  Attach your specific data collectiontools: surveys, interview questions, focusgroup questions, etc. o Example: If youplan to conductan on-line survey, submit a copy of the exact survey designed in the on- line tool10 you plan to use. Include the introduction to the survey as well. o Example: If youplan to conductinterviews, submit your exact interview questions along with any introductory information you will share withparticipants. o DO use open-ended questions in your interviews and focus groups to obtain richer information. 10 The school has a SurveyMonkey account that students can use for any on-line surveys. Email Hilary for the details if you want to use it.
  • 7. 7 o DO use close-ended questions in yoursurveys and questionnaires to more easily analyze the large amount of data collected. Additional Attachments Required forRequests forReview  Attach your specific consent/assent materials: written consent forms, written assent forms, parent or guardian consent forms, the consent information given beforean on-line survey,the consent script read before a phone interview, etc. Be sure that an appropriate way to consent for each of your data collectiontools. All consent/assent materials must follow the requirements for informed consent foundon the Request for Review form and must also include: o Any benefits forthe individual participants as wellas the benefits for the larger community. o A statement that participation is voluntary o A statements that a participant willnot be penalized or lose benefits if they choose not to participate o The level of anonymity and/or confidentiality you are promising participants, if any at all. If not promising anonymity or confidentiality,state that. o Full name and contactinformation for the PI.11 Include the PI’s direct phone number; the Clinton School’s general phone number is not appropriate. If contactingparticipants though email or other on- line tools, also include a direct email address for the PI. o Any conflictsof interest you might have that participants would need to know about. o This exact statement must be included:  This study has been reviewed and approved by The University of Arkansas-Little Rock's Institutional Review Board (IRB).The IRB has determined that this study meets the ethical obligations required by federal law and University policies. If youhave questions or concerns regarding this study please contactthe Principal Investigator. If youhave any questions regarding yourrights as a human subjects research subject, please contactthe Research Compliance Officeat501-569-8657 or irb@ualr.edu.  Clinton Schoolstudents DONOT need to include a site letter of permission or support. Reviewing your Document before Submission Before submitting your documents to the IRB, checkfor the following:  Will yoube able to easily compile and analyze the information you collect?Yourfaculty advisor will be able to help youdetermine this.  Are all of your documents written forthe literacy level of your participants? You should work towards writing at an 8th grade reading level unless your population requires something different.  Have you tested your data collectionmethods and tools with individuals who resemble yourhuman subjects? o Are youobtaining the information that you want to obtain? o Are they free of any errors? o Are they easy to understand? o Are electronic versions set up correctly? o Note: When testing your data collectiontools that involvehuman subjects, youcannot record the information you obtain or use it in yourfinal report. It is recommended that youask people to test your tools who are similar to your potential participants but whoyou will not recruit to participate later.  Have you asked someone outside yourresearch team to review your consent/assent and recruitment materials? o Do yourmaterials encourage participation? o Do they contain all of the important information that they would want to know?  Is everything clear and concise?  Is everything that is going to potential participants written in an accessible, inviting way that would encourage participation? 11 Subjects have a right to know whom to contactif they have second thoughts about what they agreed to, so you need to let them know how to contactyoudirectly.
  • 8. 8  Have you avoided using Clinton School jargon and terms that willnot be understood by an outside audience? These are some of the terms to use carefully: o Key Informants,Experts,Laypersons,Stakeholders-Whoexactly are you referring to? Specifically describe them. Example: Rather than using the term key informant, describe them as small business owners in Central Arkansas. o Quantitative,Qualitative,Open-Ended,Close-Ended,Primary,Secondary -Youneed to be specific about the exact information youare working to obtain, not the types. Example: Rather than writing that you are collectingqualitative data using open-ended questions, write that youare collecting information about the sustainability practices small businesses have implemented. o Surveys - Be specific about what kind. Is it an in-person interview? A phone interview? An in-person paper questionnaire? An on-line questionnaire? A mailed questionnaire? An in-person focusgroup? o Practicum, IPSP, Capstone – These terms are not knownoutside the Clinton School. o BestPractices - Exactly whatinformation are youcollecting? o Sustainable -This term means many different things. How are you using it? Is that clear? o Deliverable -Exactly whatare you creating? A report? A brochure? A journal article? Something else? o Recorded - Willit be audio recorded? Video recorded? Notes taken? o NeedsAssessment,Evaluation,AssetMap,ImpactStudy – Be specific about exactly what information you are collectingin order to complete the needs assessment. The type of information is whatmatters to the IRB.