THE UNIVERSITY OF NORTH CAROLINA AT GREENSBORO

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					                         THE UNIVERSITY OF NORTH CAROLINA AT GREENSBORO

                                    Instructions for Completing the Application
                                   For the Use of Human Participants in Research

All research with human participants conducted by students, faculty, or staff at UNCG must be reviewed initially by
a member of the University's Institutional Review Board, whether or not requests for outside funding are involved.
To initiate this review, the principal investigator must complete this application and submit it to the Office of
Research Compliance (ORC). An IRB Reviewer determines the category of review appropriate for the study and
reviews the application for completeness and compliance with federal regulations, University policy, and IRB
procedures. If Full Committee Review is necessary, the University IRB considers the application at a regularly
scheduled meeting. Criteria for expedited and full committee review are available at:

                          http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm

Principal Investigators must submit the original and one copy of the IRB application to the ORC at least one month
prior to the date that data collection is planned. Principal Investigators are advised to keep a copy of the application for
their records. NO DATA CAN BE COLLECTED OR PARTICIPANTS RECRUITED PRIOR TO RECEIVING
AN APPROVAL FORM FROM THE IRB.

Researchers should use the attached forms to provide information about the application. The application is provided in
Word format, and researchers should insert their responses to the Application Prompts in the cells provided. Researchers
should create additional space for their responses as necessary. Templates for other forms, including Consent Forms, are
available on the Office of Research Compliance website:

                                                 http://www.uncg.edu/orc


The Office of Research Compliance will inform faculty members regarding the disposition of their applications.
Students may not serve as Principal Investigators and do not receive direct notification of IRB disposition of
proposals on which they are listed as Student Researchers. Instead, communication regarding the project will be
addressed to the Faculty Principal Investigator who is supervising the research. Any changes in research protocol
that affect human participants must be approved by the IRB prior to implementation, unless the changes are
necessary to eliminate apparent immediate hazards to the participant. Any unanticipated problems involving risks to
participants or others must be promptly reported to the Office of Research Compliance.

Recommendations for Facilitating IRB Approval:

         1. Attach all supplementary materials specified in the application. Do NOT submit additional appendices
         (proposals, summaries, and abstracts) not specified in the application;
         2. Allow for sufficient time for the approval process;
         3. Be sure to sign and date your application where required.




Page 1 of 27                                                                                  Version 6-8-09
                                Application For the Use of Human Participants in Research
                                             2009-2010 Application*
                                                      Part I

Date Submitted to ORC:           /         /

Project Title:

Principal Investigator:

Email Address of Principal Investigator:

Telephone Number of Principal Investigator:

Address of Principal Investigator:

Relationship to the University (specify): ____ Faculty ____ Staff

Other Faculty Investigators:

Email Address(es) of Other Faculty Investigators:

Telephone Number(s) of Other Faculty Investigators:

Address(es) of Other Investigator(s):

If student research, name of Student Researcher:

Type of student research: ____ Thesis           ____ Dissertation ____ Other

Student Researcher Campus Address:

Student Researcher e-mail address:

School/College:                         Department:

Funding Agency/Sponsor (if applicable):

Does any research team member receive ANY federally funded salary support? Yes                  No

Projected data collection dates**: From          /      /       To         /      /

Is the starting date of data collection at least one month after date of submission to ORC?
____ Yes             ____ No (Provide justification/explanation and reiterate any special arrangements you have made for
review):

*IRB applications are updated annually. This application will not be accepted for review during academic years
subsequent to the one for which it was issued.
**The beginning data collection date must be at least one month after review of the IRB application by the
departmental reviewer. Data collection cannot begin before IRB approval is received.


IRB Initial Reviewer’s Signature                                                      Date Reviewed


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    “This investigation involves human participants. I am submitting this form in accordance with the policies of
UNCG for the protection of human participants participating in research. I certify that I have a valid certificate
of IRB education, and have read UNCG’s policy on Research with Human Participants. I understand the
University’s policies concerning research involving human participants and agree to:

 a. Obtain the voluntary informed consent of participants (or of participants’ legally authorized
    representatives) to the extent required by federal regulations and by the determinations of the IRB;

 b. Report to the IRB any serious or unexpected on-site or off-site adverse events or unanticipated problems
    within the appropriate reporting period;

 c. Obtain prior approval from the IRB before amending or altering this research project or implementing
    changes in the informed consent document;

 d. Maintain informed consent documents and progress reports as required by institutional and federal
    policies; and

 e. Accept the responsibility for the conduct, supervision, and surveillance of this research and the protection
    of human participants as required by state and federal law and regulation, and as documented in the UNCG
    Federal Wide Assurance, UNCG IRB guidelines, and UNCG policies and procedures.”

  f. Maintain confidentiality in accordance with procedures outlined in this protocol as the UNCG IRB has
     approved.




     Signatures of All Principal Investigators                           Date

     Signature of Student Researcher (if applicable)                     Date


                                                 IMPORTANT

       This is the 2009-2010 Version of the UNCG IRB Application. It will not be accepted for
                              review during subsequent academic years




     Page 3 of 27                                                                   Version 6-8-09
                                       THIS PAGE IS FOR IRB USE ONLY

(IRB Representative: Indicate appropriate category of review: expedited or full review. Note: the standard requirements
for informed consent apply regardless of the type of review utilized by the IRB.)


                                          Part 2 - Expedited or Full Review

   This proposed project has been reviewed and was found to require:

              Expedited Review (63 FR 60364-60367, November 9, 1998)

                  Expedited category. Check all that apply:
                      1. (a)                              6.
                      1. (b)                              7.
                      2. (a)                              8. (a)
                      2. (b)                              8. (b)
                      3.                                  8. (c)
                      4.                                  9.
                      5.

              Full IRB Review.    Please explain below:




I certify that this project has been reviewed by me as an IRB member and that the research was not proposed by me or by
a student working under my supervision.
                                                                 ____________________________________
                                                                  IRB Signature             Date
                                                                 ____________________________________
                                                                 Print Name                 Dept. /School

Send this application package to: IRB, Office of Research Compliance, 2718 MHHRA.


Part 3 - IRB Action

            Expedited Review         (Date:     /     /     )

            Full Review              (Date:     /     /     )

Comments:



IRB Chairperson/ Designee


Page 4 of 27                                                                             Version 6-8-09
                                         IRB Application and Checklist
                                                    Part 4
Please provide responses to the following Application Prompts.

                                                                              Initial by      Initial by IRB
                         Application Prompts                                  Principal       Departmental
           The Principal Investigator completes this column.                 Investigator       Reviewer

1.    At any time, will members of the research team or their immediate
     family members have financial interest in, receive personal
     compensation from, or hold a position in an industry sponsoring
     this study or otherwise have a potential conflict of interest
     regarding the conduct of this study?

___ YES       ___ NO         ___ N/A (no industry sponsors)

If YES, the Potential Conflict of Interest in Research must be attached
to this application.
2. Will this project also need to be reviewed by any of these
     additional committees?


___ YES       ___ NO Radiation Safety Committee


If the answer to any of the above is YES, have you submitted an
application to the relevant committee(s)?

___ YES       ___ NO

3.   Why is doing this research important and how will this research
     project positively impact your profession/discipline?



4.   As part of this study, will you obtain personally identifiable health
     information (PHI) from a hospital, health care provider, or other
     HIPAA-defined Covered Entity?

___ YES       ___ NO

If YES, attach the Application to Use PHI in Research to this
application.
5. Is the funding agency for this application a federal entity following
    under the umbrella of the Department for Health and Human
    Services?
___ YES       ___ NO


If YES, attach the full grant proposal and follow instructions for
referencing the grant proposal within this application. Click here.



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6.    Have you attached approved evidence of training in the protection
      of human participants in research for all principal investigators?
      Click Here

___ YES        ___ NO

7.    If the proposed project is student research, have you also attached
      approved evidence of training in the protection of human
      participants in research for the student investigator?

___ YES        ___ NO       ___ Not Applicable

8.    Will persons who are NOT principal investigators or student
      researchers have access to research DATA (e.g., data entry,
      transcription)?

     ____YES      ____NO

     If YES, investigator(s) must agree to keep Certificates of
     Confidentiality on file by checking the statement below.

     ____Certificates of Confidentiality will be kept on file with the
     Principal Investigator’s research records.

     Will persons who are NOT principal investigators or student
     researchers interact with research PARTICIPANTS (e.g., data
     collection)?
     ____YES ____NO

     If YES, investigator(s) must also agree to keep current (within the
     past 5 years) evidence of training in the protection of human
     participants in research on file for each such person by checking the
     statement below.

     ____Evidence of training in the protection of human participants
     will be kept on file with the Principal Investigator’s research
     records.

     ____Certificates of Confidentiality will be kept on file with the
     Principal Investigator’s research records.

9.    Provide an overview of the purpose of the project. Do not exceed
      one paragraph. Do not include a review of literature.




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10. Describe data collection procedures. If data collection tool(s) are
    used please attach copy(s) to this application.




11. List all types of data to be collected and how each will be recorded
    (written, electronic, audiotaped, videotaped, other).




12. Indicate how many persons will participate in the study and
    provide a description of how you arrived at this number.




13. List all inclusion and exclusion criteria for participants in this
    study.



14. Will you exclude any persons from participating in the study on the
    basis of race, gender, or ethnicity?

 ___ YES       ___ NO

 If YES, what is your justification for excluding persons on the basis of
 race, gender, or ethnicity?




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15. Will some or all participants be likely to be vulnerable to coercion
    or undue influence?

 _____ Yes     ______ No

 If YES, please describe any additional safeguards to protect these
 participants’ rights and welfare.




16. How much time will participating in the study require for
    participants?




17. Is there a relationship between the researcher and participants
    and/or participating institutions/agencies?

 ___ YES       ___ NO

 If YES, describe the relationship and how you will disclose this
 information to participants and ensure that participants do not
 experience coercion due to this relationship.


18. Is there any need for deception or less than full disclosure?

 ___ YES       ___ NO

 If YES, describe and justify the deception or need for less than full
 disclosure. Attach to this application a copy of your debriefing script
 or handout explaining to participants the true purpose of the study and
 need for deception.

19. Will the research be conducted in class?

 ___ YES       ___ NO

 If YES, what will students do if they are not participating?

20. Describe the setting in which the research will be conducted.




21. Indicate which of the following procedures will be used to recruit
    participants into this study (at least one option must be selected and
Page 8 of 27                                                                 Version 6-8-09
    appropriate documentation attached):

 Will recruitment materials be used (e.g., advertisements, brochures,
 recruitment letters, flyers, PowerPoint materials)?

 ___ YES       ___ NO

 If YES, include copies with this application. Please note required
 elements for recruitment materials. Required elements click here

 Will recruitment be oral?

 ___ YES       ___ NO

 If YES, provide a brief description of the information that will be
 communicated to potential participants. This information must include
 all required elements for recruitment materials listed in the preceding
 link.

 Will recruitment involve providing participants with copies of consent
 forms without accompanying written or oral material?

 ___ YES       ___ NO

22. Will any agencies, schools, or organizations be involved with
    recruitment of or access to participants, access to participant
    contact information, or data collection?

 ____YES      ____NO

 If YES, attach a copy of a letter of support from each agency, school,
 or organization.

    *If working with Moses Cone Hospital you should not have to
    submit to their IRB. Please view the contract for details. Data
    collection cannot begin at a site until a letter of support is received
    by ORC. Recruitment of participants from a UNCG class requires
    an agency letter from an instructor or department chair unaffiliated
    with the research project. Research conducted in collaboration with
    other institutions requires a copy of their IRB approval
    notification(s).
23. What, if any, are the benefits to individual participants from this
    research study? Do not list compensation, reimbursement, or
    benefits of programs that would accrue to individuals who did not
    consent to participate in the research.




24. What are the benefits to society from this research study?




Page 9 of 27                                                                  Version 6-8-09
25. What is the level of risk for participants in this study?

 ____NONE        ____ MINIMAL         ____ MORE THAN MINIMAL

26. If MINIMAL or MORE THAN MINIMAL risk, describe the risks
    to the participants in this study.



27. If MINIMAL or MORE THAN MINIMAL risk, what precautions
    are being taken to minimize risks to participants?




28. What, if any, compensation will participants in this study receive
    and how will it be dispersed?


29. Will there be any compensation for injury directly associated with
    the research?

30. You are required to have a plan in place for stopping the study if it
     is apparent that there is increased risk(s) above that which is
     expected now in this protocol
Please describe below at what point you will stop your study. (i.e.
students with a high probability of failing a class in which the
curriculum is experimental, physical harm to participant, or
overwhelming emotional/psychological trauma directly associated with
your study)



31. How will privacy for participants be maintained while you are
    collecting your data?



32. How will you maintain confidentiality (seclusion from the presence
    or view of others) of your research data?


33. Federal law requires that consent forms be kept for a minimum of
    three years following closure of the project. With this in mind,
    how many years after the closure of the project will you keep
    signed consent forms?

     _________ Years


34. When will you dispose of identified data other than consent forms?




Page 10 of 27                                                               Version 6-8-09
35. Where will you store identified data and consent forms and how
    will they be secured at this location? Please be sure that your
    response specifies whether this location is on or off the UNCG
    campus.



36. How will identified data and consent forms eventually be
    destroyed?




37. Are you recruiting participants or collecting data in a foreign
    country?

 ___ YES       ___ NO

 If YES, please consult the CITI module on International Research
 (Click Here) and attach to this application answers to the questions
 listed under “Additional Information for IRB Review”

   Have you attached to this application answers to the questions listed
  under the “Additional Information for IRB Review”?

 ___ YES       ___ NO


                                          Consent Procedures and Forms

                                                                            Initial by     Check by IRB
                          Application Prompts                               Principal      Dept. Reviewer
                                                                           Investigator
38. Please describe your informed consent process including the
    following criteria:
The person who will conduct the consent interview.

o The person who will provide consent or permission.




o Any waiting period between informing the prospective participant
and obtaining consent.




Page 11 of 27                                                                       Version 6-8-09
o Steps taken to minimize the possibility of coercion or undue
influence.




o The language to be used by those obtaining consent.




o The language understood by the prospective participant or the legally
authorized representative.




39. Check all of the following you will use to obtain consent/assent
    from participants:

    Long form consent _____

    Short form consent with oral presentation _____

    Assent form*** _____

    Requesting waiver of documentation of informed consent under 45
    CFR 46.117(c) _____ (provide rationale below that meets these
    CFR criteria). Do not cut and paste the regulations.




   Requesting waiver of all or some required elements of informed
   consent under 45 CFR 46.116(c) or (d) _____ (provide rationale
   below that meets these CFR criteria).
   Do not cut and paste the regulations.




40. How old will participants be?
Page 12 of 27                                                             Version 6-8-09
Ages: _________________________

***Any participant under the age of 18 must have written parental
consent, and the participant must give assent, which requires a separate
consent form. If you are recruiting participants from a college
campus community, some may be under the age of 18. Is there any
possibility that some or all participants will be under the age of 18?

___ YES      ___ NO

If YES, what arrangements are you making to obtain both parental
consent and child/participant assent?

41. Will participants potentially have any cognitive limitations or
    impairments that will prevent them from fully understanding
    research procedures and/or the consent process?

 _____YES _____NO

 If YES, describe limitations or impairments below with your plan to
 make sure participants understand the research procedures and
 consent process and are legally able to consent to participation.

42. Provide an elaboration of how you know all participants in this
    study will be able to read and understand consent forms in the
    format and language in which they are presented. If there is a
    possibility that some participants will not be able to read and
    understand consent forms in their presented format (due to
    illiteracy, disability, or language spoken/read), provide an
    elaboration of how you will identify these participants and ensure
    their ability to access and understand consent information.

 ***Parents of some children attending U.S. schools do not read
 English. The UNCG IRB will not approve research involving sending
 home English consent forms to parents of children enrolled in a U.S.
 school without the researcher having provided a manner for
 identifying such parents and ensuring their ability to access and
 understand consent information.***”

43. Participants need to be provided copies of all consent/assent
    documents for their own records. What procedures will you use to
    provide a copy of these documents to participants?


44. Is a clear explanation of the purpose of the research included on the
    Consent Form?

____ Yes    ____ No


45. Is a clear explanation of the procedures to be used included on the
    Consent Form?


Page 13 of 27                                                               Version 6-8-09
____ Yes     ____ No

46. If applicable, is a description of the benefits of the study to
    PARTICIPANTS provided on the Consent Form?

____ Yes     ____ No


47. Is a description of the benefits of the study to SOCIETY provided
    on the Consent Form?

____ Yes     ____ No

48. If applicable, are the risks of participation described on the
    Consent Form?

____ Yes     ____ No

If the study entails more than minimal risk, the Consent Form must
include a statement regarding compensation, availability of treatment,
and directions for contacting the Research Compliance Officer.

49. On the Consent Form, are participants given the opportunity to ask
    questions about the study?

    ____ Yes      ____ No

50. On the Consent Form, are participants given the opportunity to
    withdraw from the research without penalty?

     ____ Yes     ____ No

51. Is the amount of time required of participants for participation in
    the study described on the Consent Form?

  ____ Yes      ____ No

52. Is a description of how confidentiality will be maintained included
    on the Consent Form?

    ____ Yes     ____ No


53. Will IDENTIFIED data will be stored OFF the UNCG campus?

    ____ Yes     ____ No

   If YES, does the consent form specify (a) the location of off-campus
   data storage, (b) how data will be stored securely, and (c) how long
   data will be stored at this location?

   ____ Yes     ____ No



Page 14 of 27                                                             Version 6-8-09
54. Are the researchers’ name, phone number or email if applicable for
    questions about the study included on the Consent Form?

   ____ Yes      ____ No


55. Does the Consent Form include the Research Compliance Officer’s
    name and phone number for questions about the rights of human
    participants in research?

    ____ Yes     ____ No

56. Is a space for the signature of a witness to the oral presentation
    provided on the Consent Form, when the short form with oral
    presentation is used?

   ____ Yes      ____ No     ____ Not Applicable

57. Is a script for the oral presentation provided with the application,
    when the short form with oral presentation is used?

   ____ Yes     ____ No     ____ Not Applicable

58. Is a separate form for the assent of minors provided, if necessary?

    ____ Yes     ____ No     ____ Not Applicable

59. If research participants are non-English speakers, have the consent
    documents been provided in the appropriate language?

   ____ Yes      ____ No     ____ Not Applicable

60. UNCG now requires that participants sign copies of the
    consent/assent forms that have been stamped as approved by the
    IRB Chair or the ORC. Are you requesting a waiver of this
    requirement?

   ___ YES (provide justification for waiver below)        ___ NO




Page 15 of 27                                                              Version 6-8-09
                           INSTRUCTIONS FOR DEVELOPING CONSENT FORMS
                  DO NOT INCLUDE THESE INSTRUCTIONS WITH YOUR APPLICATION.

1.   Consent forms must be written in simple language that is understandable to the participants. A reading level of 4-7th
     grade is recommended for most populations.

2.   Consent forms should NOT be written in the first person (e.g. they should NOT say “I understand the procedures
     and risks and agree to participate in this study....”). Sections of the consent form may be in the third person (e.g.,
     “Subjects in this study will be interviewed.....”) and the actual agreements to participate should be in the second
     person (e.g., “By signing this consent form, you are agreeing that you understand the procedures and risks...”). (See
     attached consent form template.)

3.   When research involves minors (persons under the age of 18) or those who are not legally competent, informed
     consent must be obtained from the parent or guardian. Assent must also be obtained from the participant, if s/he is
     able to understand the research process and/or is able to make a judgment about their willingness to participate.

4.   A copy of the consent form must be provided to each participant and a signed copy retained by the principal
     investigator. EXCEPTION: A letter containing all aspects of informed consent may be used for data collected by
     mailed survey or with some web-based data collection procedures. Participants may not need to sign a consent
     form, if they have been fully informed of their rights pertaining to the research study and if returning these data
     collection tools can be assumed to reflect their informed consent.

5.   Informed consent must be acquired in the language of the participant or the household of participants when children
     or other vulnerable populations are members of the participant pool. Researchers must make provisions for
     translators and for translation of consent documents into participants’ language, including sign language and/or
     Braille when applicable.

6.   Consent may be obtained through EITHER the Long Form or the Short Form with Oral Presentation. The Long
     Form for Informed Consent should be used whenever appropriate. Either format must ensure that participants are
     apprised of all aspects of informed consent (see list below).




Page 16 of 27                                                                                Version 6-8-09
                                     ASPECTS OF INFORMED CONSENT
                                            (required in all studies)

               1.  Explanation of research purpose and procedures (including participant selection)
               2.  Benefits of the study to participants AND society
               3.  Risks of participation in the study (If participating in the study poses more than
                   minimal risk, the Consent Form must include a statement regarding
                   compensation/treatment for injury, and directions to contact the UNCG Office of
                   Research Compliance at (336) 256-1482 about any research-related injuries)
               4. The opportunity to ask questions
               5. The opportunity to withdraw without penalty
               6. The amount of time required of the participants
               7. Confidentiality of data and final disposition of data, including provisions for
                   maintaining the security of data and research records
               8. Phone number and name for questions on research
               9. If you have any concerns about your rights, how you are being treated or if you have
                   questions, want more information or have suggestions, please contact Eric Allen in the
                   Office of Research Compliance at UNCG at (336) 256-1482.
               10. If identified data will be stored off the UNCG campus, the UNCG IRB requires that
                   this be communicated to participants on the Consent Form along with provisions for
                   storing data securely and a statement of how long data will be stored at this
                   location.
               11. A statement that the study involves research
               12. Identification of any procedures that are experimental

      A. Long Form: The long form should be used whenever possible. The long form must be used when
         research procedures are complicated or when the researcher will have no direct contact with the
         participants. Information should be included in the spaces provided on the form. N/A should be inserted for
         sections not applicable to a specific study. THE FORM MAY BE REVISED TO FIT THE NEEDS OF
         THE STUDY, BUT IT MUST INCLUDE ALL ASPECTS OF INFORMED CONSENT. Some
         research requires that other information be included in the consent document. Your IRB Departmental
         Reviewer will inform you if additional information is needed for your study.

       B. Short Form with Oral Presentation: A short form with an oral presentation may be used when consent is
          administered in a group setting. The oral presentation must include the aspects of informed consent. A
          witness unaffiliated with the study must sign the oral presentation. The witness can be another participant,
          but the witness CANNOT be a member of the research team. RESEARCHERS SHOULD USE THE
          LONG FORM IF THEY ARE NOT CONFIDENT THAT A THIRD PARTY WHO IS NOT A
          MEMBER OF THE RESEARCH TEAM WILL BE AVAILABLE TO WITNESS THE ORAL
          PRESENTATION.


               The Oral Presentation must include:

               1.   Explanation of research purpose and procedures (including participant selection)
               2.   Benefits of the study to participants AND society
               3.   Risks of participation in the study (If participating in the study poses more than
                    minimal risk, the Consent Form must include a statement regarding
                    compensation/treatment for injury, and directions to contact the UNCG Office of
                    Research Compliance at (336) 256-1482 about any research-related injuries)
               4.   The opportunity to ask questions
               5.   The opportunity to withdraw without penalty
               6.   The amount of time required of the participants
               7.   Confidentiality of data and final disposition of data, including provisions for

Page 17 of 27                                                                           Version 6-8-09
                      maintaining the security of data and research records
                 8.   If identified data will be stored off the UNCG campus, the UNCG IRB requires that
                      this be communicated to participants in the oral presentation along with provisions
                      for storing data securely and a statement of how long data will be stored at this
                      location.

             The oral presentation does not require the participants' signatures but must include
             the date on which it was read to participants.

                 IF AN ORAL PRESENTATION IS PLANNED, THE CONTENT OF THE
                 PRESENTATION MUST BE INCLUDED IN THE APPLICATION AS A SCRIPT
                 ON THE TEMPLATE FORM, WHICH IS ATTACHED.

Templates for consent forms appear on the following pages. ATTACH ONLY THE FORMS THAT YOU PLAN TO
USE. For special situations in obtaining consent, please see your IRB Departmental Reviewer or call the Office of
Research Compliance (336-256-1482).




Page 18 of 27                                                                           Version 6-8-09
                       UNIVERSITY OF NORTH CAROLINA AT GREENSBORO

  THIS IS A TEMPLATE FOR THE LONG FORM FOR OBTAINING INFORMED CONSENT FOR
     PARTICIPATION IN RESEARCH. IT MUST BE ADAPTED TO INCLUDE ALL OF THE
INFORMATION REQUIRED (RED TEXTINDICATES REQUIRED LANGUAGE) FOR INFORMED
CONSENT. IF AN ITEM IS NOT APPROPRIATE FOR THE STUDY, PLEASE DELETE IT FROM THE
                                     FORM.

                    CONSENT TO ACT AS A HUMAN PARTICIPANT: LONG FORM

Project Title:

Project Director:

Participant's Name:

What is the study about?
This is a research project. This section should include a statement that the study involves research and the
purpose of the study.

Why are you asking me?
The reason for selecting the participant; inclusion/exclusion criteria

What will you ask me to do if I agree to be in the study?
The procedures to be used and identification of any procedures which are experimental, the expected
duration (time) of the participant’s participation, and any anticipated follow-up should be discussed. Any
procedure which is likely to cause stress, pain (physical, psychological or emotional), or any other
unpleasant reaction should be described, and a number with a contact person answer questions so that the
person understands fully to what they are consenting. Also include any procedures that are experimental
in this section.

Is there any audio/video recording?
This section should describe any plans to use audio/video recording if it is applicable to the project
proposed. It should include the statement “Because your voice will be potentially identifiable by anyone
who hears the tape, your confidentiality for things you say on the tape cannot be guaranteed although the
researcher will try to limit access to the tape as described below.”

What are the dangers to me?
If there are no risks to participants, include the following statement: “The Institutional Review Board at
the University of North Carolina at Greensboro has determined that participation in this study poses no
risk to participants.” If there are minimal risks or more than minimal risks, describe the risks. Research
involving more than minimal risk must also include an explanation as to whether compensation, medical,
psychological or other types of treatments are available if injury or a stressful situation occurs.

If you have any concerns about your rights, how you are being treated or if you have questions, want more information
or have suggestions, please contact Eric Allen in the Office of Research Compliance at UNCG at (336) 256-1482
Questions, concerns or complaints about this project or benefits or risks associated with being in this study can be
answered by [name of principal investigator] who may be contacted at (333) 333-3333 (you can also include your
email address if you like).

Page 19 of 27                                                                             Version 6-8-09
Are there any benefits to me for taking part in this research study?
Participants should be informed about direct or indirect potential benefits to them or others or the absence
of benefits. Be sure that your language does not guarantee any benefits (use the word “may”). Elements
related to payment (remuneration) are not considered “benefits” to a participant and should be discussed
within the Costs/Payments section. If there are no direct benefits, indicate, “There are no direct benefits
to participants in this study.”

Are there any benefits to society as a result of me taking part in this research?
Describe any benefits to society that may result from this study. Be sure that your language does not
guarantee any benefits (use the word “may”).

Will I get paid for being in the study? Will it cost me anything?
Costs and Payments to the Participant should be addressed explicitly, including a statement that payments
will not be given if that is the case. Describe how payments will be made if the participant elects to
discontinue participation during the study. If there are no costs or payments involved you may state,
“There are no costs to you or payments made for participating in this study.”

How will you keep my information confidential?
Describe how information will be kept confidential. For example: stored in a locked file cabinet,
password protection, encryption, not identifying participants by name when data are disseminated,
anonymous data collection procedures. Include a statement that reads "all information obtained in this
study is strictly confidential unless disclosure is required by law." If applicable, the researcher must add a
description of any legal duty to report abuse that might supersede these confidentiality promises.

For Internet Research, include this wording: “Absolute confidentiality of data provided through the
Internet cannot be guaranteed due to the limited protections of Internet access. Please be sure to
close your browser when finished so no one will be able to see what you have been doing."
Alternatively, add security statement from commercial survey tool used for the study.
What if I want to leave the study?
“You have the right to refuse to participate or to withdraw at any time, without penalty. If you do
withdraw, it will not affect you in any way. If you choose to withdraw, you may request that any of your
data which has been collected be destroyed unless it is in a de-identifiable state.”

What about new information/changes in the study?
“If significant new information relating to the study becomes available which may relate to your
willingness to continue to participate, this information will be provided to you.”

Voluntary Consent by Participant:
By signing this consent form you are agreeing that you read, or it has been read to you, and you fully
understand the contents of this document and are openly willing consent to take part in this study. All of
your questions concerning this study have been answered. By signing this form, you are agreeing that you
are 18 years of age or older and are agreeing to participate, or have the individual specified above as a
participant participate, in this study described to you by        .

Signature: ________________________ Date: ________________

 THIS IS A TEMPLATE FOR THE SHORT FORM FOR OBTAINING INFORMED CONSENT
        FOR PARTICIPATION IN RESEARCH. THIS TEMPLATE AND THE ORAL
   PRESENTATION MUST BE ADAPTED TO INCLUDE ALL OF THE INFORMATION
Page 20 of 27                                          Version 6-8-09
    REQUIRED FOR INFORMED CONSENT. RED TEXT IS REQUIRED LANGUAGE. A
    SCRIPT FOR THE ORAL PRESENTATION MUST ALSO BE ATTACHED TO THE IRB
                               APPLICATION.

Project Title:

Project Director:

Participant's Name:

What this study is about
       has explained in the earlier verbal discussion the procedures involved in this research study. These include
the purpose and what will be required of you. Any new information that comes up during the study will be provided
to you if the information might affect your willingness to continue participation in the project.

Possible good things that may come out of this study
Reiterate that any benefits to the individual and or society were discussed in the earlier discussion.

Possible risks that may occur in this study
Reiterate that any risks were discussed in the oral discussion.

All of my questions
       has answered all of your current questions about you being in this study. Any other questions concerns or
complaints about this project or benefits or risks associated with being in this study can be answered by [name of
principal investigator] who may be contacted at (333) 333-3333 (you can also include your email address if you
like).

Leaving the study
You are free to refuse to participate or to withdraw your consent to be in this study at any time. There will be no
penalty or unfair treatment if you choose not to be in the study. Being in this study is completely voluntary.

My personal information
Your privacy will be protected. You will not be identified by name or other identifiable information as being part of
this project. If privacy will not be protected or has limited protection please explain her and replace the previous
statement.

Study approval
The University of North Carolina at Greensboro Institutional Review Board makes sure that studies with people
follows federal rules. They have approved this study, its consent form, and the earlier verbal discussion.

My rights while in this study
If you have any concerns about your rights, how you are being treated or if you have questions, want more information
or have suggestions, please contact Eric Allen in the Office of Research Compliance at UNCG at (336) 256-1482

By signing this form, you are agreeing that you are 18 years of age or older. You also agree to participate in the
study described to you by      .

_______________________________________                           ______________
Participant's Signature                                                  Date


_______________________________________
Witness* to Oral Presentation
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and Participant's Signature

*Investigators and data collectors may not serve as witnesses. Participants, family members, and persons unaffiliated
with the study may serve as witnesses.



Signature of person obtaining consent on behalf of
The University of North Carolina at Greensboro

________________________________________
Date




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Sample Script:

      You are being asked if want to be in a research study. We are trying to find out about (insert the
       purpose of the study in nontechnical language)
      You have been picked for this study because (Include inclusion/exclusion criteria)
      This discussion and the piece of paper (short form) given to you will tell you about the study to
       help you decide if you want to be part of the study
      You will be asked to (list what will be required of the participants including the commitment of
       time, any costs to the participant, and number of visits/follow ups)
      You will get paid $1 for every survey or interview you complete which can amount to $20 at the
       end of the study. If there is no payment to participants “There are no payments made for
       participating in this study” (include whichever statement work for your study)
      You will be audio/video recorded throughout the course of this study (include if applicable)
      The benefits to (you and or society) being in this study include (insert all benefits but no
       compensation or reimbursements)
      The risks involved in this study include (insert all foreseen risks)
      Your privacy will be protected by (insert measures taken to ensure privacy/confidentiality locked
       file cabinet, password protection, or encryption) “all information obtained in this study is strictly
       confidential unless disclosure is required by law”. In addition the investigator must add a
       description of any legal duty to report abuse that might supersede these confidentiality promises.
      You should ask any questions you have before making up your mind. You can think about it and
       talk to your family or friends before you decide if you want to be in the study
      If you decide you want to be in the study you will need to sign the piece of paper (short form)
       given to your earlier. A family member, friend, or someone next to you will also need to sign this
       piece of paper as the witness.
      If you decide you do not want to be in the study later you are free to leave when ever you like
       without penalty or unfair treatment.




                 UNIVERSITY OF NORTH CAROLINA AT GREENSBORO

Page 23 of 27                                                                    Version 6-8-09
 THIS IS A TEMPLATE FOR THE LONG FORM FOR OBTAINING INFORMED CONSENT
  FROM A PARENT/GUARDIAN FOR A CHILD’S PARTICIPATION IN RESEARCH. IT
MUST BE ADAPTED TO INCLUDE ALL OF THE INFORMATION REQUIRED (RED TEXT
INDICATES REQUIRED LANGUAGE) FOR INFORMED CONSENT. IF AN ITEM IS NOT
       APPROPRIATE FOR THE STUDY, PLEASE DELETE IT FROM THE FORM.

     CONSENT FOR A MINOR TO ACT AS A HUMAN PARTICIPANT: LONG FORM

Project Title:

Project Director:

Participant's Name:

What is the study about?
This section should include a statement that the study involves research, the purpose of the study,
and how their child will be involved.

Why are you asking my child?
The reason for selecting their child; inclusion/exclusion criteria

What will you ask my child to do if I agree to let him or her be in the study?
The procedures to be used and identification of any procedures which are experimental, the
expected duration (time) of the child’s participation, and any anticipated follow-up should be
discussed. Any procedure which is likely to cause stress, pain (physical, psychological, or
emotional), or any other unpleasant reaction should be described so that the parent/guardian
understands fully to what they are consenting.

Is there any audio/video recording of my child?
This section should describe any plans to use audio/video recording if it is applicable to the
project proposed (section should be omitted if there will be no audio/video recording). It should
include the statement “Because your child’s voice will be potentially identifiable by anyone who
hears the tape, confidentiality for things said on the tape cannot be guaranteed although the
researcher will try to limit access to the tape as described below.”

What are the dangers to my child?
If there are no risks to the child in this study, include the following statement: “The Institutional
Review Board at the University of North Carolina at Greensboro has determined that
participation in this study poses no risk to participants.” If there are minimal risks or more than
minimal risks, describe the risks. Research involving more than minimal risk must also include
an explanation as to whether compensation, medical, psychological or other types of treatments
are available if injury or a stressful situation occurs.

If you have any concerns about your child’s rights, how they are being treated or if you have questions, want more

Page 24 of 27                                                                              Version 6-8-09
information or have suggestions, please contact Eric Allen in the Office of Research Compliance at UNCG at (336) 256-
1482 Questions about this project or benefits or risks associated with being in this study can be
answered by [name of principal investigator] who may be contacted at (333) 333-3333 (you can
also include your email address if you like).

Are there any benefits to my child as a result of participation in this research study?
Parents should be informed about direct or indirect potential benefits to their children or the
absence of benefits. Be sure that your language does not guarantee any benefits (use the word
“may”). Payment and incentives are not considered “benefits” to a participant and should be
discussed within this section. If there are no direct benefits, state “There are no direct benefits to
participants in this study.”

Are there any benefits to society as a result of my child taking part in this research?
Describe any benefits to society that may result from this study. Be sure that your language does
not guarantee any benefits (use the word “may”).

Will my child get paid for being in the study? Will it cost me anything for my kid to be in
this study?
Costs and payments/incentives should be described explicitly, including conditions under which
payments will not be given if that is the case. Describe how payments will be made if the
participant elects to discontinue participation part way through the study. If there are no costs or
payments involved, you may state, “There are no costs to you or payments to you or your child
as a result of participation in this study.”

How will my child’s information be kept confidential?
Describe how information will be kept confidential. For example: stored in a locked file cabinet,
password protection, encryption, not identifying participants by name when data are
disseminated, anonymous data collection procedures. Include a statement that reads "all
information obtained in this study is strictly confidential unless disclosure is required by law." If
applicable, the researcher must add a description of any legal duty to report abuse that might
supersede these confidentiality promises. For Internet Research, include this wording:
“Absolute confidentiality of data provided through the Internet cannot be guaranteed due
to the limited protections of Internet access. Please be sure to close your browser when
finished so no one will be able to see what you have been doing." Alternatively, add
security statement from commercial survey tool used for the study.

What if my child wants to leave the study or I want him/her to leave the study?

“You have the right to refuse to allow your child to participate or to withdraw him or her at any
time, without penalty. If your child does withdraw, it will not affect you or your child in any
way. If you or your child chooses to withdraw, you may request that any data which has been
collected be destroyed unless it is in a de-identifiable state.”


What about new information/changes in the study?

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“If significant new information relating to the study becomes available which may relate to your
willingness allow your child to continue to participate, this information will be provided to you.”

Voluntary Consent by Participant:
By signing this consent form, you are agreeing that you have read it or it has been read to you,
You fully understand the contents of this document and consent to your child taking part in this
study. All of your questions concerning this study have been answered. By signing this form,
you are agreeing that you are the legal parent or guardian of the child who wishes to participate
in this study described to you by       .

____________________________________                    Date: ________________
Participant's Parent/Legal Guardian’s Signature

____________________________________                    Date: ________________
Participant's Parent/Legal Guardian’s Signature




This example can be used as a model for developing Assent Forms for use with children. Please note that
1) the language in the Assent Form must be age appropriate and contain the elements of informed
consent and 2) a Long Form OR Short Form with Oral Presentation must be used to gain consent from
parents/guardians for their children to participate in research activities.

Page 26 of 27                                                                 Version 6-8-09
Study Title:

My name is         .

What is this about?
I would like to talk to you about        (enter the subject of your project). I want to learn about        (enter
the objective of the study feelings, thoughts, therapies, or etc).

Did my parents say it was ok?
Your parent(s) said it was ok for you to be in this study and have signed a form like this one. (if appropriate,
include a sentence that indicates if the kid’s parent will be present during their participation in the research)

Why me?
We would like you to take part because you have or are           (enter participant inclusion/exclusion
information).

What if I want to stop?
You do not have to say “yes”, if you do not want to take part. We will not punish you if you say “no”. Even
if you say “yes” now and change your mind after you start doing this study, you can stop and no one will be
mad at you.

What will I have to do?
     (Include a brief explanation of the procedures and duration)

Will anything bad happen to me?
      (List any risks, discomforts, or state that there is nothing bad that will happen to them)

Will anything good happen to me?
      (List any benefits to the participant and or society)

Do I get anything for being in this study?
      (List any incentives or reimbursements)

What if I have questions?
You are free to ask questions at any time.

If you understand this study and want to be in it, please write your name below.
_____________________                        _______
Signature of child                             Date




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