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C rC 0 C G@ jI ! jI 4 A jI A D $ GC GC ]# C jI r B : LIST OF REQUIRED APPLICATION MATERIALS
INSTITUTIONAL REVIEW BOARD
HENNEPIN TECHNICAL COLLEGE
Cover page
Summary of proposed research
Participant population
Recruitment of participants
Informed consent process
Confidentiality of data
Risks and benefits
Consent form
Supplementary form for student researchers (if applicable)
Instructions
鶹Ƶ policies and federal regulations require that each project involving research with human participants be reviewed to consider whether:
Risks to participants are minimized,
Risks to participants are reasonable in relation to anticipated benefits,
Informed consent is sought from each prospective participant or legally authorized representative,
Adequate preparation is taken to protect the anonymity and confidentiality of participants,
Participants are debriefed on their involvement, and
Adequate safeguards are included if participants are in some way vulnerable.
Human subject is defined in U.S. Federal Policy as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (45 C.F.R. 46.102[f]).
The term research here refers to systematic data collection done with the intent to communicate findings to the community in some fashion (for example, in a publication or conference presentation).
In general, the Institutional Review Board (IRB) aims to accomplish these goals by assisting researchers in anticipating circumstances that may put research participants at risk and helping them to remedy such problems. However, the ultimate responsibility for treatment of research participants rests with the researchers involved.
IRB review is specifically required when
Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects. (46.101b 2i)
If any disclosure of the human subjects responses outside the research could reasonably place the subjects at risk of criminal or civic liability or be damaging to the subjects financial standing, employability, or reputation. (46.101b 2ii)
Research involving elected or appointed public officials or candidates for office.
(46.101b 3i)
Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. (46.101b 3ii)
Given this, several types of activities are not intended to fall under IRB review. These include:
Research in common educational settings, involving normal or special educational practices. (46.101b 1)
Research involving educational tests, surveys, interviews, or observations unless confidentiality cannot be maintained or disclosure places the participants at risk.
(46.101b 2)
Research involving the study of existing data either publicly available or recorded by the researcher(s) in a manner that maintains confidentiality. (46.101b 4)
Institutional or organizational research designed to improve service or benefits when approved by the agencys head. (46.101b 5)
To have your research reviewed, complete each of the components in the following checklist. Applications should be sent via electronic mail to irea@hennepintech.edu.
Please allow four weeks for review. No research may be initiated prior to formal written approval from the IRB.
Checklist for Submitting A Complete Application
____ 1. All questions on the application have been completed in a thorough fashion.
____2. All supporting documents have been attached. This includes consent forms, survey
instruments, interview questions, solicitation letters, flyers, advertisements, etc. Supporting documents must be in final form as you intend to use them. Your
application will be returned if these documents are in outline or draft form.
____3. If individuals under the age of 18 are participating, a consent form adapted for parents
is provided. This must include a line for parents to indicate their consent.
____4. If a student is conducting the research, the supplementary form for student researchers
has been included.
____5. If this study requires approval of another Committee or cooperating agency,
documentation of approval or notice of application has been attached.
____6. Appropriate signatures have been provided.
APPLICATION FORM
INSTITUTIONAL REVIEW BOARD
HENNEPIN TECHNICAL COLLEGE
Cover Page
1. Project Title (use same title as grant title/application, if applicable):
2. Faculty Contact Information
a. Name: b. Department: c. Mailing address: d. Phone number: e. E-mail address:
3. Inclusive Dates of Project:
4. Institutional Oversight:Is this research subject to review by another internal
committee at 鶹Ƶ?
No Yes
Is this research being conducted at another location or
with a cooperating organization (for example:
schools, clinics, community agencies, etc)?
No Yes
c. If you answered yes to either 5a or 5b, please provide more details (as well as written
documentation of approval from the relevant committee and/or organization):
Summary of Proposed Research
Please use lay language to answer the following questions.
1. Describe your rationale and hypotheses for this proposed research. Include enough
background information to understand your rationale and hypotheses at a basic level.
2. Describe the methods you propose to use in this research (including the frequency and
duration of procedures, tests, and experiments). As a part of this, clearly describe the
tasks participants will be asked to perform. Make sure to attach all surveys, instruments,
interview questions, focus group questions, etc. that you intend to use. These must be in
final form as you intend to use them.
Participant Population
1. Expected Number of Participants:2. Expected Age Range (check all that apply)
0 17 years (include parental consent form) 18 years and older
3. Describe the location(s) from which you will be recruiting participants. As a part of
this, describe any criteria that you have for participants to be included or excluded.
Recruitment of Participants
1. Describe how participants will be identified and recruited. As a part of this,
describe any incentives that will be used to motivate participation and how you will
handle those who decline to participate. Attach a copy of all recruitment materials to
be used (such as advertisements, bulletin board notices, e-mails, scripts, and URLs).
2. Describe who will approach potential participants to take part in the proposed
research and their position (for example, principal investigator, student research
assistant, instructor in the course):
3. Use of Records:
a. Will participants be identified from records of some kind?
_____ No _____ Yes
b. If yes, are records private medical or student records?
_____ No _____ Yes
If your answer to 3a is yes, make sure to include written approval for the use of
records in this research. If your answer to 3B is yes, provide the protocol, consent
forms, letters, etc. for securing consent from the record holders.
Informed Consent Process
1. In relation to the actual data gathering, when will consent be discussed and
obtained? Be specific. How will this process be modified if you are involving
individuals under the age of 17 to obtain the consent of parents?
2. Who will be securing informed consent? Name all of the individuals and their
positions (for example, primary investigator, student research assistant, instructor in
the course).
3. Describe what specifically will be said to potential participants to explain the research.
4. What specific questions will be asked to assess participants understanding of the risks
and benefits of participation?
Confidentiality of Data
1. Will you record any direct identifiers (names, student identification numbers, social security numbers, addresses, telephone numbers, etc.) along with the data?
_____ No _____ Yes
2. Will you retain a link between study code numbers and direct identifiers after the data
collection is complete?
_____ No _____ Yes
3. Will you provide identifiers or links to anyone outside the research team?
_____ No _____ Yes
4. If you answered yes to any of the above three questions, please explain why this is
necessary and what you will do to ensure the confidentiality of your participants.
5. Describe where, how long, and in what format you intend to keep the data (such as
paper, digital or electronic media, video, audio, etc.). Also, describe what security
provisions will be taken to protect these data (for example, password protection,
encryption, etc.).
Risks and Benefits
1. Does this research involve any of the following possible risks or harms to participants?
(Check all that apply)
a._____ Use of deception
b. _____ Use of private records (agency, educational, or medical)
c. _____ Manipulation of psychological or social variables such as sensory
deprivation, social isolation, or psychological stress
d. _____ Any probing for personal or sensitive information in surveys or interviews
e. _____ Presentation of materials that participants might consider sensitive,
offensive, threatening, or degrading
f. _____ Possible invasion of privacy for participants or their families
g. _____ Social or economic risk
h. _____ Physically intrusive procedures
i. _____ Other, please specify ___________________________________________
2. Describe the nature and the extent of the risk or harm check above. The described
risks/harms must be disclosed in the consent form.
3. Explain what steps will be taken to minimize risks or harms and to protect
participants welfare.
4. Describe how participation in this research may benefit participants directly (for
example, course credit of some kind) or indirectly (for example, contribution to
knowledge in the field, improved self-knowledge).
5. Describe how this research may benefit society and how these benefits outweigh the
risk for the participants.
Signatures for Approval
Director of Institutional Research, Effectiveness, and Assessment Date
Vice President of Academic Affairs Date
Vice President of Student Affairs Date
College President Date
Institutional Review Board Application
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