Human Research ProtocolOnly Minimal Risk ConsentParental or Guardian (Without HIPAA)
Only Minimal Risk
Parental or Guardian Consent (Without HIPAA)
Principal InvestigatorClick here to enter text.
DepartmentClick here to enter text.
Protocol NumberClick here to enter text.
Study TitleClick here to enter text.
Co-Investigator(s)Click here to enter text.
Sponsor (if any)Click here to enter text.
Contact Persons
Click here to enter text.
In the event your child experiences any side effects or injury related to this research, you should contact ______at ______. (After hours contact: ______at ______. If you have any questions, concerns, or complaints about this research, you can contact ______at ______or ______at ______.
For information regarding your child’s rights as a research subject, to discuss problems, concerns, or suggestions related to the research, to obtain information or offer input about the research, contact the Office of Research Integrity and Compliance (304) 293-7073.
In addition if you would like to discuss problems, concerns, have suggestions related to research, or would like to offer input about the research, contact the Office of Research Integrity and Compliance at 304-293-7073.
Introduction
Your child, ______, has been asked to participate in this research study, which has been explained to you and your child by [use full name of person and degrees the first time used or provide a blank ______if multiple options exist]. This study is being conducted by ______[list all investigators names and degrees] in the Department of ______at West Virginia University with funding provided by ______or sponsored by ______.
This research is being conducted to fulfill the requirements for a doctoral dissertation in ______[subject] in the Department of ______at West Virginia University, under the supervision of ______[use full name and degree of Faculty Advisor].
Purpose(s) of the Study
The purpose of this study is to learn more about ______. WVU expects to enroll approximately ______subjects; a total of approximately ______subjects at all sites are expected to participate in this study.
Description of Procedures
This study involves [describe procedures in appropriate detail] and will take approximately [state how long it will take to participate in the study] for your child to complete. Your child will be asked to fill out a questionnaire regarding [state what the questionnaire is about]. This will take approximately [state how long it will take to complete the questionnaire]. Your child does not have to answer all the questions. You will have the opportunity to see the questionnaire before signing this consent form.
The study will be performed at [location]. Approximately ______subjects are expected to participate in this study.
Risks and Discomforts
There are no known or expected risks to your child from participating in this study, except for the mild frustration associated with answering the questions.
Alternatives
Your child does not have to participate in this study.
Alternatives that could be considered include:
Benefits
Your child may not receive any direct benefit from this study. The knowledge gained from this study may eventually benefit others.
Financial Considerations
No payments will be made for participating in the study.
Your child may receive ______for being in the study.
[If planning to pay participants, explain fully and clearly any fees or bonuses and how they will be paid, including proration. Unless the study is confidential, the WVU consent form must inform subjects that they will be asked to provide their Social Security Number and verification of U.S Citizenship or Permanent Resident Status to receive payment. For confidential studies only name and address are required.]
Confidentiality
Any information about your child that is obtained as a result of their participation in this research will be kept as confidential as legally possible.
Your child’s research records and test results, just like hospital records, may be subpoenaed by court order or may be inspected by the study sponsor or federal regulatory authorities without your additional consent.
Audiotapes or videotapes will be kept locked up and will be destroyed as soon as possible after the research is finished.
In any publications that result from this research, neither your child’s name nor any information from which your child might be identified will be published without your consent.
Voluntary Participation
Refusal to participate or withdrawal will not affect your child’s future care, [or your employee status at West Virginia University] and will involve no penalty to you.
Signatures
Upon signing this consent, you will receive a copy.
I willing consent to allow my child to participate in this research.
Signature of Parent or Guardian
______
Printed Name Date Time ______
Signature of Investigator or Co-Investigator
______
Printed Name Date Time ______
Fax: 304-293-3098
/ Chestnut Ridge Research Building
886 Chestnut Ridge Road
PO Box 6845
Morgantown, WV 26506-6845
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Subject’s Initials______
Date______