MID WEEK ASSIGNMENT – Savvy Essay Writers | savvyessaywriters.net
MID WEEK ASSIGNMENT – Savvy Essay Writers | savvyessaywriters.net
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
- IRB ApplicationTHIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S INFORMED CONSENT LETTER AND IS ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101 .
For Official Use Only Date received: Date reviewed: End date: 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)
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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)
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 Highest Degree Completed: Investigator Status: FORMCHECKBOX Faculty FORMCHECKBOX Graduate Student FORMCHECKBOX Other FORMCHECKBOX Undergraduate FORMCHECKBOX Staff E-mail Address: College/Department: Campus Mailing Address: Daytime Phone: 3) CO-INVESTIGATOR – 2 (if applicable)
Name: FORMCHECKBOX Dr. FORMCHECKBOX Mr. FORMCHECKBOX Ms. FORMCHECKBOX Professor Highest Degree Completed: Investigator Status: FORMCHECKBOX Faculty FORMCHECKBOX Graduate Student FORMCHECKBOX Other FORMCHECKBOX Undergraduate FORMCHECKBOX Staff E-mail Address: College/Department: Campus Mailing Address: Daytime Phone: 4) FACULTY SPONSOR (if applicable)
Name: FORMCHECKBOX Dr. FORMCHECKBOX Mr. FORMCHECKBOX Ms. FORMCHECKBOX Professor Highest Degree Completed: E-mail Address: College/Department: Campus Mailing Address: Daytime Phone: 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).
FORMCHECKBOX Extramural FORMCHECKBOX College FORMCHECKBOX Department FORMCHECKBOX 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 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…
