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IRBEXPEDITEDapplicationFINALRULE

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Gettysburg College IRB Application for Expedited Review Page 1 of 10
*THIS FORM SHOULD BE DOWNLOADED AND THEN OPENED IN ADOBE ACROBAT BEFORE BEING FILLED OUT. FILLING IT OUT IN A
BROWSER WINDOW OR IN ANOTHER PROGRAM MAY RESULT IN DATA LOSS
.
Section 1: Inves
tigator(s) Information
Name(s) of Primary Investigator(s) at Gettysburg College:
Department or Program:
College Status/Position:
Name of Faculty Sponsor (if student):
Name(s) and institution(s) of co-researcher(s) at other
institution(s) or collaborator(s) at local organization(s), if
this is community-based participatory research:
CITI Training Date: (w/in past 5 years)
Proposal Submission Date:
Approximate Start Date for Research:
Approximate End Date for Research:
Have you received, or do you hope to receive, funding to conduct this research?
For external funding, name the (potential) granting institution:
Section 2: Request for Expedited Review
I have read through the IRB review types in full on the IRB webpages before making this request for Expedited
review. I understand that IRB guidelines were revised in January 2019 to accord with new federal guidelines,
introducing procedural changes while opening up new Exempt categories.
My proposal qualifies f
or expedited review under the category indicated below (check the one that applies):
Category 1: Clinical studies of drugs and medical devices (click to read more).
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture (click to read more).
Category 3: Prospective collection of biological specimens for research purposes by noninvasive means (click to
read more).
Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving x-rays or microwaves (click to read more).
Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or
will be collected solely for nonresearch purposes (such as medical treatment or diagnosis), when not exempt.
Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.
enter mm/dd/yyy
select:
Gettysburg College IRB Application for Expedited Review Page 2 of 10
Cat
egory 7: Research on individual or group characteristics or behavior (including, but not limited to, research
on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social
behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies, when not exempt.
Additional Information for Determination of Expedited Review
A. In
dicate which of the following best describes this research:
This re
search poses "no more than minimal risk," which 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"
This r
esearch poses some risk to the research subject, in the sense that identification of the subjects
and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to
the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing. However, I
have implemented reasonable and appropriate protections so that risks related to invasion of privacy
and breach of confidentiality are no greater than minimal.
*No
te: reviewers retain the right to refer this proposal to the full committee for review
B. Pleas
e affirm the following by checking the box:
I understand that regardless of the protections that I will implement, research on the following
populations and topics will generally require Full board review. I hereby certify that I am not
conducting research on the any of these populations or topics:
Populations
● Pregnant women
● Children (individuals under the age of eighteen)
● Prisoners
● Cognitively impaired persons
● Seriously ill individuals
● Refugees, if targeted or questioned about their experiences as refugees
● Victims of domestic abuse, if targeted and if questioned about their experiences as victims of abuse
● Stigmatized populations, if targeted or if questioned about bias, discrimination, or harassment
● Individuals involved in illegal activities, if targeted for such behaviors or questioned about them
● Undocumented immigrants, if targeted or questioned about their status or experience as
undocumented immigrants
Topics
● The research focuses on stigmatizing or illegal aspects of the subjects’ behavior if this topic is
central to the research objective and if research is more extensive than a brief survey question.
● Th
e research involves requests for information that might be considered offensive, threatening, or
degrading by the respondents.
Gettysburg College IRB Application for Expedited Review Page 3 of 10
S
ection 3: Project Information
A. Pr
oject Title
:
B
. Research question: BRIEFLY describe the objective of your research in language that a non-expert can understand:
C
. Research locale: Where will the research take place (what country(ies), state(s), and town(s))?
Will your research take place in a particular institution or organization (Gettysburg College, or a school, prison,
business, government agency or NGO)?
I
f yes, specify what institution or organization:
If yes, and if the research is not at Gettysburg College, check here to confirm that you have attached a
letter or email from an authority in the institution granting you permission to conduct research on their
premises or at institutionally-sponsored events.
D. R
esearch Subjects (RSs): Describe the population that will participate in your study. How many individuals w
ill
participate? Break down participants into categories, if appropriate.
E. Methodology: Describe all of the methods that you will use to collect data from your research subjects (RSs) in order
t
o answer your research question. Include a discussion of all activities that RSs will engage in and all ways in which they
will be observed (describing the events and the settings of observation). Estimate how much time each task will take,
and describe any equipment or procedures used.
select:
Gettysburg College IRB Application for Expedited Review Page 4 of 10
Che
ck here to confirm that you have attached copies of all stimulus materials, questionnaires, protocols, and
interview guides to be used (if you plan to conduct informal, unstructured interviews, provide a guide that
includes the topics that you will address).
Section 4: Deception
Will it be necessary to deceive or withhold information about the research objectives from RSs?
Note: withholding minor details about one's hypothesis does not constitute deception. However, misleading participants
about the central question(s) you will expl
ore or about the types of tasks that they will complete does.
If yes, please detail how deception or incomplete information fits into the research process, justify why it is necessary,
and describe your debriefing procedure (include a discussion of how during the debriefing, you will provide RSs with an
opportunity to ask new questions that they have about the research).
If yes, check here to confirm that you have attached a debriefing form or script (click here to see sample
).
Section 5: Soliciting Participation
A. Ho
w will you target the individuals who will participate in your research? Be specific about the groups, communities,
institutions, or organizations that your RSs are associated with, and how you will identify them (through review of
institutional records, class rosters, or through referral, canvassing, advertisement, mass emails, participation in group
activities, contact with group leaders, etc.)?
In y
our response above, did you indicate that you will solicit the participation of RSs connected to a particular
institution aside from Gettysburg College (schools, prisons, corporations, government agencies or NGOs)?
If y
es, check here to confirm that you have obtained permission from an authority figure in the
institution granting you permission to use institutional records or gatherings to identify potential
research participants (this can be included in the same letter/email granting permission to conduct
research on their premises or at institutionally-sponsored events; see above).
select:
select:
Gettysburg College IRB Application for Expedited Review Page 5 of 10
B
. How will you make initial contact with potential RSs to solicit participation in your research (through ads, flyers,
posters, telephone, mail, email, or personal contact)? Note that material recruiting Gettysburg College students must
stipulate that subjects must be at least eighteen years of age.
Check here to confirm that you have attached copies of any recruitment materials that you will use.
C
. Will participants receive inducements before or rewards after the study?
i.
If yes, explain what these inducements will be:
ii. If
yes, under what conditions will RSs receive partial or no payment?
S
ection 6: Privacy Considerations
This section will assess privacy in soliciting participation, privacy in data collection and storage, and privacy in reporting
of research results.
A. P
rivacy in soliciting participation: Will you use individually identifiable information (for example, a list of names o
r a
s
et of email addresses) to contact and recruit participants?
I
f yes, describe the identifiers and explain what will happen to them after the recruitment process is complete:
B
. Privacy in data collection and storage: Do you plan to collect and/or store individually identifiable information
?
Note: This would include names and images, as well as indirect identifiers (emails, IP addresses, or ID numbers)
that are associated with the RSs’. If you create a key giving RSs a code, the data are considered identifiable.
Images of RSs’ faces are considered direct identifiers, although audio-recordings are not.
select:
select:
Gettysburg College IRB Application for Expedited Review Page 6 of 10
I
f yes, answer all of the questions below:
i. Describe the direct and/or indirect identifiers other than images that will be associated with RSs’ data
(collection of images is covered below). Explain why it is necessary to collect these identifiers.
ii.
Who else, if anyone, will know the names of RSs? Explain why. If someone other than the researcher w
ill
c
ollect data directly from RSs or analyze data with identifiers, explain who this individual is (or describe th
e
institution with which (s)he is affiliated). Give assurance that this third party is aware of the privacy
considerations outlined in this proposal and trained in U.S. research norms regarding confidentiality.
iii. Data protection plan: Explain the security controls that you will employ to ensure that nobody, aside from the
i
ndividual(s) mentioned above, will have access to the identities of your RSs.
If yes, answer the questions below that are applicable to your research:
iv. If RSs will be photographed or video-recorded, explain why the collection of images is required. Note that the
IRB will only approve the collection of photographs or videos if they are essential to meeting your resear
ch
o
bjectives or if making a visual record is a common research method within your discipline.
v
. If the collected data will subsequently be de-identified, explain your plan for de-identifying data (at what point
and by whom).
Gettysburg College IRB Application for Expedited Review Page 7 of 10
vi. If
you believe that your data should be destroyed, what is your plan for doing so?
C. Pr
ivacy in reporting: Will you use RSs’ names or images (including video-recordings or photographs) in your final
presentations, publications, reports, webpages or creative works?
If ye
s, explain your decision to do so:
If yo
ur research involves photographs or video-recordings, check here to confirm that you have attached
a photo or video release form, to be administered at the time you take the photographs/make the
video-recordings, or (if you included permission to photograph or video-record in the original consent
form/script) when you are preparing the work for public dissemination (click here to see sample
)
Sec
tion 7: Risks
This section will assess three types of risks: risks associated with the research topic, risks of physical or bodily harm or
discomfort, and risks associated with the release of RS identities.
A. Ri
sks associated with the research topic: Could the research questions possibly upset or distress participants?
Note that expedited review is permissible for research on sensitive aspects of the RS’s behavior if the researcher
can offer full assurance of confidentiality.
If yes, answer all of the questions below:
i. Describe the specific emotional harm or discomfort that RSs might experience, and how serious this may be.
ii. Exp
lain any strategies that you will use to screen participants or mitigate risks.
B. Risks of physical or bodily harm or discomfort: Could the research procedure(s) pose any risks of physical harm or
discomfort?
select:
select:
select:
Gettysburg College IRB Application for Expedited Review Page 8 of 10
If yes, answer all of the questions below:
i. Describe these risks.
ii. Explain any strategies you will use to screen participants or mitigate risks.
C: Risks associated with the release of RS identities: Could the inadvertent disclosure of identifiable data place a
participant at risk of harm?
If yes, answer all of the questions below:
i. Describe the kinds of situations that could lead to harm, and elucidate the type of harm that the RS could
suffer.
ii. D
escribe the likelihood of this occurring, given your data protection plan (described above)
iii. Explain any strategies that you will use to mitigate such risk.
select:
IRB Application for Expedited Review
Gettysburg College
Section 8: Informed Consent
A. How will you obtain consent?*
Check here to indicate that you have attached a copy of one of the following: a) consent form, b) implied consent text
and informational hand-out, or c) verbal consent script and informational hand-out. If research will be conducted in
another language, provide both English and translated copies.
Clarification and Proviso: There are three methods to obtain informed consent, each with stipulations:
a) through a signed consent form or an electronic signature given by a RS after a consent form is
received (this is the most common option used by researchers; records must be kept)
b) through implied consent (When a survey is used in low-risk research, the researcher may include at
the beginning of the survey a full explanation of the nature of the research. If the subject proceeds to
answer the survey questions, consent is implied. The implied consent text must ask RSs to print or
download a copy of the consent text that they can keep for their records.)
c) through verbal consent (When conducting low-risk research in which RSs are members of a distinct
cultural group or community in which signing forms is not the norm, or when the only record linking the
subject and the research would be the consent form and potential harm would result from a breach of
confidentiality. In either case, there must be a mechanism for documenting that informed consent was
obtained, and an info-sheet on the research must be provided.)
Researchers may use the Sample Consent Form or construct their own consent forms/scripts/text. In all cases,
the researcher must provide RSs with key information about the research (click here to see the "Components of
Consent Forms, Texts, and Scripts”).
B. Are there any p
ower dynamics (eg., instructor-student, supervisor-employee) that could potentially hinder RSs’ ability
to freely accept or decline to participate in the study?
If yes, e
xplain the efforts you will make to assure the RSs that their participation is entirely voluntary.
Section 9: Projects Involving Translators or Field Assistants who are Foreign-Born
A. If your res
earch will be conducted in a language other than English, will you require the assistance of a translator
when collecting or analyzing data?
B. Will your res
earch involve the administration of surveys or questionnaires by a research assistant or field worker who
lives outside of the U.S.?
Page 9 of 10
*Note that in making your selection, you
commit to abiding by the terms in the
"Clarification and Proviso," below.
select:
select:
select:
select:
Gettysburg College IRB Application for Expedited Review Page 10 of 10
If you replied yes to either of the above, describe the nationality, language proficiency, and status of the third-
party individual(s) who will be involved in data collection and/or analysis. Explain whether and how these
individuals have already been trained in U.S. IRB-mandated research ethics or discuss your plan to train them to
adhere to the ethical assurances given in this proposal.
Note: you must provide the IRB with
both non-English and English copies of all consent texts.
Section 10: Final Submission
A. If you are a student, has your faculty sponsor reviewed and approved this application?
Stude
nts must ask their faculty sponsor to email the IRB (irb@gettysburg.edu
) on their behalf with the following
statement: “I assume responsibility for ensuring that [student’s(s’) name(s)] is/are aware of their
responsibilities as researcher(s). I have mentored him/her/them in filling out this proposal and have reviewed
the final draft, which I approve. I will oversee this research in its entirety.”
B. Will yo
u contact the IRB if a substantive change occurs in the research methods and ethical measures
proposed here?
C. Have
you included all supporting documents (recruitment materials, informed consent materials,
questionnaires/surveys/research instruments, debriefing scripts, letters of permission to conduct research in
institutional settings, and photo or video release forms)?
**********************************************************************************************
Once you have answered all of the above questions and verified that you have completed this form fully and
accurately, email this application and all necessary attachments, converted to PDF, to the IRB
(irb@gettysburg.edu). Note that the IRB will not review any proposal unless all required fields (lined in red) are
checked off or filled in and all supporting material is attached.
select:
select:
select:
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Completed 10 February 2020

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