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).
Informed Consent Letter Example
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THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S INFORMED CONSENT LETTER AND IS ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101
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For Official Use Only |
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Date received: |
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Date reviewed: |
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End date: |
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File #: |
SELF CONSENT
I have been invited to take part in a research study titled:
This study is being conducted by , who can be contacted at:
I understand that
my participation is voluntary
and that I can refuse to participate or stop taking part any time without giving any reason and without facing any penalty. Additionally, I have the right to request the return, removal, or destruction of any information relating to me or my participation.
PURPOSE OF STUDY
I understand that the purpose of the study is to:
PROCEDURES
I understand that if I volunteer to take part in this study, I will be asked to:
BENEFITS
I understand that the benefits I may gain from participation include:
RISKS
I understand that the risks, discomforts, or stresses I may face during participation include:
CONFIDENTIALITY
I understand that the only people who will know that I am a research subject are members of the research team. No individually-identifiable information about me, or provided by me during the study will be shared with others except when necessary to protect the rights and welfare of myself and others (for example, if I am injured and need emergency care, if the provided information concerns suicide, homicide, or child abuse, or if revealing the information is required by law).
FURTHER QUESTIONS
I understand that any further questions that I have, now or during the course of the study can be directed to the researcher ( ).
Additionally, I understand that questions or problems regarding my rights as a research participant can be addressed to Dr. Jessica Hillyer, Institutional Review Board Director of Compliance and Training, South University, 7700 W. Parmer Ln., Austin, TX 78729;
jhillyer@southuniversity.edu
; 512-516-8779.
My signature below indicates that the researchers have satisfactorily answered all of my current questions about this study and that I understand the purpose, procedures, benefits, and risks described above. I have also been offered a copy of this form to keep for my own records.
Participant Printed Name
Signature of Participant Date (mm/dd/yyyy)
Signature of Principal Investigator Date (mm/dd/yyyy)
Page 1 of 2
THISIS 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)
FORMCHECKBOX
Application Form with Signatures/ Confidentiality Agreements
FORMCHECKBOX
NIH Training Certificate(s)
FORMCHECKBOX
Protocol or Attached Research Proposal and/ or Contract/ Grant
FORMCHECKBOX
Solicitation Announcements/Recruitment Flyers
FORMCHECKBOX
Data Collection Instruments/Research Questions/Questionnaires/Surveys
FORMCHECKBOX
Informed Consent Documents
FORMCHECKBOX
Parental/Legal Guardian Permission Form (if applicable)
FORMCHECKBOX
Child Assent Form (if applicable)
FORMCHECKBOX
Approval from Study Sites (if applicable)
FORMCHECKBOX
Medical Screening Instrument (if applicable)
FORMCHECKBOX
Debriefing Plan (if applicable)
FORMCHECKBOX
Student as
Principal Investigator
Worksheet (if applicable)
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:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime
Phone:
2) CO-INVESTIGATOR – 1
(if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Other
FORMCHECKBOX
Undergraduate FORMCHECKBOX
Staff
College/Department:
Daytime Phone:
3) CO-INVESTIGATOR – 2
(if applicable)
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FORMCHECKBOX |
4) FACULTY SPONSOR
(if applicable)
5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS
(if applicable)
| 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).
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FORMCHECKBOX |
FORMCHECKBOX |
FORMCHECKBOX |
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FORMCHECKBOX |
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P.I. of Grant or Contract: |
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Sponsor: |
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Contract/Grant No. (if available): |
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***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 FORMCHECKBOX
Yes FORMCHECKBOX
***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).
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) |
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| Co-Investigator |
Date (mm/dd/yyyy) |
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Faculty Sponsor |
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)
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Student Investigator |
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.
FORMCHECKBOX
Undergraduate Level Project
FORMCHECKBOX
Masters Level Project
FORMCHECKBOX
Doctoral Level Project
(Thesis, Capstone)
(Thesis, Capstone)
(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 FORMCHECKBOX
Yes FORMCHECKBOX
***If yes, please explain, including any and all possible conflicts:
4) Study population
a. Maximum Number of Participants Proposed:
b. Age Range: to (include low/high age range)
c. Gender: FORMCHECKBOX
Males FORMCHECKBOX
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 FORMCHECKBOX
Yes FORMCHECKBOX
***If yes, explain how clearance will be obtained. If a screening instrument will be used, please attach a copy to the application.
5) Potentially Vulnerable Populations. Please check any groups included in the study.
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FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX |
FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX |
*** 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).
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.
PART VII – PRIVACY PROCEDURES
1)
Will data be recorded by audiotape?
No FORMCHECKBOX
Yes FORMCHECKBOX
Will data be recorded by videotape?
No FORMCHECKBOX
Yes FORMCHECKBOX
Will photographs be taken?
No FORMCHECKBOX
Yes FORMCHECKBOX
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 FORMCHECKBOX
Yes FORMCHECKBOX
a. Explain why it is necessary to record these identifiers.
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 FORMCHECKBOX
Yes FORMCHECKBOX
***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).
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 FORMCHECKBOX
Yes FORMCHECKBOX
***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 FORMCHECKBOX
Yes FORMCHECKBOX
***If yes, please explain why this is necessary
.
6) Will you obtain a Federal Certificate of Confidentiality for this research? No FORMCHECKBOX
Yes FORMCHECKBOX
***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 FORMCHECKBOX
Yes FORMCHECKBOX
***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 FORMCHECKBOX
Yes FORMCHECKBOX
***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 FORMCHECKBOX
Yes FORMCHECKBOX
***If Yes, independent scientific review may be required to determine if scientific merit
justifies this risk.
Check all that apply:
FORMCHECKBOX
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.
FORMCHECKBOX
Use of confidential records (e.g. educational or medical records)
FORMCHECKBOX
Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological stressors
FORMCHECKBOX
Presentation of materials which subjects might consider sensitive, offensive,
threatening or degrading
FORMCHECKBOX
Possible invasion of privacy of subject or family
FORMCHECKBOX
Social, legal, or economic risk
FORMCHECKBOX
Employment/occupational risk
FORMCHECKBOX
Students of the researcher
FORMCHECKBOX
Subordinates and colleagues of the researcher
FORMCHECKBOX
Residents of any facility (i.e., prison)
FORMCHECKBOX
Pregnant women
FORMCHECKBOX
Children and minors
FORMCHECKBOX
Elderly subjects (65+ years of age)
FORMCHECKBOX
Wards of the state
FORMCHECKBOX
Mentally and emotionally disability
FORMCHECKBOX
Individuals who are not fluent in English
FORMCHECKBOX
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.
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 FORMCHECKBOX
Yes FORMCHECKBOX
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 study.
***If yes, describe those inducements.
***The informed consent document must include a statement explaining how compensation will be handled in the event that the participant withdraws from the study.
Appendix A: Student as Principal Investigator Worksheet
Level:
FORMCHECKBOX
Masters
FORMCHECKBOX
Doctorate
This project has been reviewed to determine that the scope, anticipated risks and benefits, and methodology are appropriate for this research by:
FORMCHECKBOX
Approval of thesis/dissertation proposal by faculty committee
FORMCHECKBOX
My personal review and approval of research proposal
FORMCHECKBOX
Other:
The student researcher is qualified to conduct independent research based on the following credentials (check all that apply):
FORMCHECKBOX
has completed a graduate research methods course
FORMCHECKBOX
has experience as an independent or closely supervised research assistant
FORMCHECKBOX
has completed NIH training
FORMCHECKBOX
Other:
FACULTY SPONSOR’S ASSURANCE
By my signature as sponsor on this research application, I certify that the student is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct this particular study in accordance with the research protocol. Additionally,
· I hereby confirm that I have thoroughly reviewed this IRB application, including the protocol narrative, and deem it ready for submission.
· I agree to meet with the investigator on a regular basis to monitor study progress.
· I agree to be available, personally, to assist the investigator in solving problems, should they arise during the course of the study.
· I assure that the investigator will promptly report unanticipated problems and will adhere to all requirements for continuing review.
· If I am unavailable, e.g. sabbatical leave, vacation, or resignation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence, and I will advise the South University IRB, in writing, of such changes.
· The research is appropriate in design.
Print Faculty Sponsor Name
Faculty Sponsor Signature
Date (mm/dd/yyyy)
Print PI Name
PI Signature
Date (mm/dd/yyyy)
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