Attached please find the forms you need to use for the W9 assignment (IRB application and Consent letter).

Attached please find the forms you need to use for the W9 assignment (IRB application and Consent letter). Informed Consent Form
By the due date assigned, submit the Informed Consent Letter to the Submissions Area (please note that this is only an example and no data may be collected).
Informed Consent Letter
•Procedure section is clear, described in detail, specific, and all inclusive. Written in lay language (as documented by reading level score). Includes risks and benefits relevant to study. Address assent (if applicable).
nsg6101_irb_application__6_.doc

informed_consent_letter_example__5_.docx

Don't use plagiarized sources. Get Your Custom Essay on
Attached please find the forms you need to use for the W9 assignment (IRB application and Consent letter).
Just from $13/Page
Order Essay

Unformatted Attachment Preview

THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
INSTITUTIONAL REVIEW BOARD
FOR THE PROTECTION OF HUMAN SUBJECTS IN
RESEARCH
This form is to be used for requesting IRB review for exempt,
expedited and full board studies
Please note that handwritten and/or incomplete forms will be returned to you.
CHECKLIST FOR IRB APPLICATION SUBMISSION
(to be completed by PI before submission to IRB)
Application Form with Signatures/ Confidentiality Agreements
NIH Training Certificate(s)
Protocol or Attached Research Proposal and/ or Contract/ Grant
Solicitation Announcements/Recruitment Flyers
Data Collection Instruments/Research Questions/Questionnaires/Surveys
Informed Consent Documents
Parental/Legal Guardian Permission Form (if applicable)
Child Assent Form (if applicable)
Approval from Study Sites (if applicable)
Medical Screening Instrument (if applicable)
Debriefing Plan (if applicable)
Student as Principal Investigator Worksheet (if applicable)
Page 1 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
Project Title
PART I – INVESTIGATOR and RESEARCH PERSONNEL
1) PRINCIPAL INVESTIGATOR
(Undergraduate students cannot serve as Principal Investigator, but may be listed as a Co-Investigator.)
Name:
Dr.
Mr.
Ms.
Professor
Dr.
Mr.
Ms.
Professor
Highest Degree Completed:
Investigator Status:
Faculty
Graduate Student
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
2) CO-INVESTIGATOR – 1 (if applicable)
Name:
Highest Degree Completed:
Investigator Status:
Faculty
Other
Graduate Student
Undergraduate
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
3) CO-INVESTIGATOR – 2 (if applicable)
Dr.
Name:
Mr.
Ms.
Professor
Highest Degree Completed:
Investigator Status:
Faculty
Other
Graduate Student
Undergraduate
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
4) FACULTY SPONSOR (if applicable)
Name:
Highest Degree Completed:
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
Page 2 of 15
Dr.
Mr.
Ms.
Professor
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS (if applicable)
Name:
E-mail:
Phone:
Name:
E-mail:
Phone:
Name:
E-mail:
Phone:
Name:
E-mail:
Phone:
Name:
E-mail:
Phone:
PART II – FUNDING INFORMATION
1) Check all of the appropriate boxes for funding sources for this research. Include pending
funding source(s).
Extramural
College
Department
Other:
P.I. of Grant or Contract:
Sponsor:
Contract/Grant No.
(if available):
Contract/Grant Title:
***Please provide one complete copy of the proposal submitted to the sponsor with this application.
Please note that submission of your grant application is a regulatory requirement and will be
maintained for the record with your application. The IRB will not utilize the grant during the review
process other than to confirm that the grant proposal is consistent with the IRB proposal. You must
submit all necessary documentation for the application in addition to the copy of the grant.
PART III – EDUCATION AND TRAINING
All research personnel (faculty, staff, graduate students working on a thesis or dissertation, anyone
using data for purposes of independent research, students involved in data collection, faculty
sponsors, persons receiving grant monies for human subject research or those personnel with
management responsibilities) must complete this section.
1) Have all key research personnel completed the required NIH training? No
Yes
***If No, DO NOT submit this application. Your application will not be considered until you have
completed the IRB training and can provide a copy of your NIH course completion certificate.
(Please include a copy/copies of all certificate(s) with each application.)
***Please note that this NIH training is a mandatory requirement to be completed every three years.
***If you have not completed the NIH training, but have completed a comparable course (e.g. CITI
training), please include documentation of those courses.
2) If other necessary training/education is required for completion of this study, please attach copies
of certificates or other documentation (e.g., HIPAA training, phlebotomy training).
Page 3 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
PART IV – INVESTIGATOR ASSURANCE
1)
•
•
•
•
•
•
•
•
•
•
•
Institutional Review Board Policy Compliance Agreement
I certify that the information provided in this application is complete and correct.
I understand that as Principal Investigator, I have the responsibility for the conduct of the study,
the ethical performance of the project and the protection of the rights and welfare of human
participants.
I agree to comply and to assure that all affiliated personnel comply with all South University
IRB policies and procedures, as well as with all applicable federal, state and local laws
regarding the protection of human participants in research.
I agree that I have the appropriate expertise to conduct this study.
I assure that this study is performed by qualified personnel adhering to the South University
IRB approved protocol. Student PI’s must attach student PI worksheet (see appendix A).
I assure that no modification to the approved protocol and consent materials will be made
without first submitting for review and approval by the South University IRB an amendment to
the approved protocol.
I agree to obtain legally effective informed consent from the research participants as applicable
to this research and as prescribed in the approved protocol.
I will promptly report unanticipated problems to the South University IRB by using the
Notification Form provided on the IRB website.
I will adhere to all requirements for continuing review and will complete a Continuance
Request form if my research extends beyond one year.
I will advise the South University IRB of any change of address or contact information as long
as this protocol remains active.
I assure that I have obtained all necessary approvals from entities other than South University
IRB that are necessary to conduct this research (e.g., cooperation letters or approvals from other
institutions).
My signature below certifies that I am knowledgeable about the regulations and policies governing
research with human subjects and have sufficient training and experience to conduct this particular
study in accordance with the research protocol.
Principal Investigator
Date (mm/dd/yyyy)
Co-Investigator
Date (mm/dd/yyyy)
Faculty Sponsor
Date (mm/dd/yyyy)
Page 4 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
2)
•
•
•
•
Confidentiality Agreement
I have agreed to assist with the research project described in this application.
I agree not to discuss or disclose any of the content or personal information contained within the
data, tapes, transcriptions, or other research records with anyone other than the Principal
Investigator, Co-Investigator, or in the context of the research team.
I agree to maintain confidentiality at all times and to abide by the South University IRB Policy
and Procedures Manual.
If I am aware of any breach in confidentiality, I am required to report violations of
confidentiality to the IRB Committee Director, who will report this information to the College
Dean and the Vice Chancellor of Academic Affairs.
Principal Investigator
Date (mm/dd/yyyy)
Co-Investigator
Date (mm/dd/yyyy)
Faculty Sponsor
Date (mm/dd/yyyy)
Student Investigator
Date (mm/dd/yyyy)
Student Investigator
Date (mm/dd/yyyy)
Student Investigator
Date (mm/dd/yyyy)
Page 5 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
PART V – ADMINISTRATIVE DATA
1) Proposed duration of data collection/analysis
Start date:
End date:
***South University IRB policy dictates that project approvals may be granted for a maximum of one
year, although the exact approval term will be determined based on the level of participant risk
inherent in the proposal. Should the PIs need an extension beyond the proposed duration, they can
apply by completing the Continuance Request Form.
2) If this research will result in a thesis or dissertation, please check the appropriate box.
Undergraduate Level Project
(Thesis, Capstone)
Masters Level Project
(Thesis, Capstone)
Doctoral Level Project
(Dissertation, Capstone)
3) Conflict of Interest
Is there any potential or perceived conflict of interest between the researcher, sponsor and/or
South University associated with this study?
No
Yes
***If yes, please explain, including any and all possible conflicts:
4) Study population
a. Maximum Number of Participants Proposed:
b. Age Range:
c. Gender:
to
Males
(include low/high age range)
Females
d. Site of Subject Recruitment:
***Please note that if recruitment will be conducted at any physical site other than South University,
you will need to include a letter from management of the proposed site indicating their approval of
your use of the facility.
e. Will medical clearance or medical screening be necessary for participants to
participate because of tissue or blood sampling, administration of substances such as
food or drugs, or physical exercise conditioning?
No
Yes
***If yes, explain how clearance will be obtained. If a screening instrument will be used, please
attach a copy to the application.
Page 6 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
5) Potentially Vulnerable Populations. Please check any groups included in the study.
Children (under 18 years of age)
Pregnant Women
Elderly (65 & older)
Psychologically Impaired
Cognitively Impaired
Prisoners
Native American Tribes and/or Tribal
Organizations
Students currently enrolled in a class
instructed by the investigator
*** If you checked any of the above groups, your proposal will require full board review.
6) Study Site:
***Please note that if research will be conducted at any physical site other than South University, you
will need to include a letter from management of the proposed site indicating their approval of your
use of the facility.
PART VI – SUMMARY OF STUDY ACTIVITIES
***Submission of a copy of a grant application or project proposal does not replace completion of
this form. If additional space is required, you may attach a separate document, but please respond to
each item in this section and label your responses accordingly. Incomplete proposals will be returned
to you.
1) Provide background information for the study including the objective of the proposed
research, purpose, research question, hypothesis and other information deemed relevant.
2) Describe the research design of the study (i.e., state whether the study is correlational,
experimental, etc. and define the variables).
Page 7 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
3) Describe the tasks that participants will be asked to perform including a step-by-step
description of the procedures you plan to use with your subjects. Provide the approximate
duration of subject participation for each procedure/ instrument and the frequency and setting
of each administration. Identify any personnel who will assist with data collection.
***You must submit a copy of each study instrument, including all questionnaires, surveys,
protocols for interviews, etc.
***If someone will be assisting with data collection, but is not indicated as a co-investigator or
research assistant in this application (i.e. they will be accessing archival data for you) you must
submit a letter of approval indicating that they are willing and capable to assist.
4) Describe the recruitment procedures. Explain who will approach potential participants and
take part in the research study and what will be done to protect the individual’s privacy in this
process.
***You must submit a copy of any material used to recruit subjects (e.g., informed consent forms,
advertisement, flyers, telephone scripts, verbal recruitment scripts, cover letters, etc.)
5) Describe how participants will be debriefed.
***If deception is used, the principal investigator should offer the participant the opportunity to
withdraw his/her data after being debriefed, and this information should be included in the debriefing
script.
Page 8 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
PART VII – PRIVACY PROCEDURES
1) Will data be recorded by audiotape?
Will data be recorded by videotape?
Will photographs be taken?
No
No
No
Yes
Yes
Yes
a. How will subjects be identified in these recordings?
b. Explain your plan for disposal of tapes/photographs/negatives, including when this
disposal will occur (i.e. after transcription/development or at the conclusion of the
study).
***If you wish to retain the tapes/photographs/negatives beyond transcription/development, you must
provide justification.
***Subjects must be informed of the collection and disposal of the tapes/photographs/negatives via
the informed consent process.
2) Will you record any direct identifiers (e.g.,, names, social security numbers, addresses,
telephone numbers, etc)?
No
Yes
a. Explain why it is necessary to record these identifiers.
Page 9 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
b. Describe the coding system you will use to protect against disclosure of these
identifiers.
c. Describe how subject identifiers will be maintained or destroyed after the study is
completed.
***If you will retain a link between the study code numbers and direct identifiers after the data
collection is complete, explain why this is necessary and state how long you will keep this link.
d. Will you provide a link or identifier to anyone outside the research team?
No
Yes
***If yes, explain why and to whom.
3) Where, how long, and in what format (such as paper, digital or electronic media, video, audio
or photographic) will data be kept? In addition, describe what security provisions will be
taken to protect these data (password protection, encryption, etc).
Page 10 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
4) Will you place a copy of the consent form or other research study information in the
participant’s record such as medical, personal or educational record? No
Yes
***If yes, explain why this is necessary.
***This information should be clearly explained in the consent document and/or process.
5) Will any record of the subject’s participation in this study be made available to his or her
supervisor, teacher, or employer?
No
Yes
***If yes, please explain why this is necessary
.
6) Will you obtain a Federal Certificate of Confidentiality for this research? No
Yes
***If yes, submit documentation of application (and a copy of the Certificate of Confidentiality award
if granted) with this application form. If the data collected contain information about illegal
behavior, visit the NIH Certificates of Confidentiality Kiosk http://grants1.nih.gov/grants/policy/coc
for information about obtaining a Federal Certificate of Confidentiality.
PART VIII – INFORMED CONSENT INFORMATION
1) Informed Consent: Please attach, as an appendix, an informed consent document to this
application. South University IRB requires that all activity involving human subjects be
carried out only AFTER obtaining proper consent from the participants of the research. Thus
an information sheet or cover letter that contains all required elements of informed consent
must be attached to this application. You may access a template for this form on the South
University IRB website. (Please attach an assent form for children/youth participation and
permission forms for parents/legal guardians; or consent forms for adult participation).
2) Request for Waiver of Informed Consent: Are you requesting a waiver of informed consent?
No
Yes
Page 11 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
***If yes, provide a written justification for a waiver of informed consent according to Section 46.116
of 45 CFR 46 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116).
3) Request for Waiver of Documentation of Consent (applies to studies that do not wish to have
signatures of the participants, i.e. internet research): Are you requesting a waiver of
documentation of consent?
No
Yes
***If yes, provide a written justification for a waiver of documentation of consent according to
Section 46.117 of 45 CFR 46
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117).
PART IX – RISKS AND BENEFITS
1) Does the research involve any of the possible risks or harms to subjects listed below?
No
Yes
***If Yes, independent scientific review may be required to determine if scientific merit
justifies this risk.
Check all that apply:
Use of deception
***If deception is used, describe in detail here, including the debriefing process and script.
***If deception is used, the principal investigator should offer the participant the opportunity to
withdraw his/her data after being debriefed, and this information should be included in the debriefing
script.
Page 12 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
Use of confidential records (e.g. educational or medical records)
Manipulation of psychological or social variables such as sensory deprivation, social
isolation, psychological stressors
Presentation of materials which subjects might consider sensitive, offensive,
threatening or degrading
Possible invasion of privacy of subject or family
Social, legal, or economic risk
Employment/occupational risk
Students of the researcher
Subordinates and colleagues of the researcher
Residents of any facility (i.e., prison)
Pregnant women
Children and minors
Elderly subjects (65+ years of age)
Wards of the state
Mentally and emotionally disability
Individuals who are not fluent in English
Other risks (specify):
2) Describe the nature and degree of the risk or harm checked above.
***The described risks/harms must be disclosed in the consent form.
Page 13 of 15
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
3) Explain what steps will be taken to minimize risks or harms and to protect subjects’ welfare.
If the research include protected populations (See Part V, Item 5 above), please identify each
group and answer this question for each group.
4) Describe the anticipated benefits of this research for individual participants in each subject
group. If none, state “none”.
5) Describe the anticipated benefits of this research for society, and explain how the benefits
outweigh the risks.
PART X – COMPENSATION INFORMATION
1) Will any compensation or inducements, i.e. course credit, be offered to the subjects for their
participation?
No
Yes
If yes, describe those inducements and include a statement in the informed consent document explaining how
compensation will be handled in the event the participant withdraws from the stu …
Purchase answer to see full
attachment

Order a unique copy of this paper
(550 words)

Approximate price: $22

Basic features
  • Free title page and bibliography
  • Unlimited revisions
  • Plagiarism-free guarantee
  • Money-back guarantee
  • 24/7 support
On-demand options
  • Writer’s samples
  • Part-by-part delivery
  • Overnight delivery
  • Copies of used sources
  • Expert Proofreading
Paper format
  • 275 words per page
  • 12 pt Arial/Times New Roman
  • Double line spacing
  • Any citation style (APA, MLA, Chicago/Turabian, Harvard)

Our guarantees

Delivering a high-quality product at a reasonable price is not enough anymore.
That’s why we have developed 5 beneficial guarantees that will make your experience with our service enjoyable, easy, and safe.

Money-back guarantee

You have to be 100% sure of the quality of your product to give a money-back guarantee. This describes us perfectly. Make sure that this guarantee is totally transparent.

Read more

Zero-plagiarism guarantee

Each paper is composed from scratch, according to your instructions. It is then checked by our plagiarism-detection software. There is no gap where plagiarism could squeeze in.

Read more

Free-revision policy

Thanks to our free revisions, there is no way for you to be unsatisfied. We will work on your paper until you are completely happy with the result.

Read more

Privacy policy

Your email is safe, as we store it according to international data protection rules. Your bank details are secure, as we use only reliable payment systems.

Read more

Fair-cooperation guarantee

By sending us your money, you buy the service we provide. Check out our terms and conditions if you prefer business talks to be laid out in official language.

Read more

Calculate the price of your order

550 words
We'll send you the first draft for approval by September 11, 2018 at 10:52 AM
Total price:
$26
The price is based on these factors:
Academic level
Number of pages
Urgency

Order your essay today and save 15% with the discount code ESSAYHELP