Research Assent Form

IRB Office Use Only

DO NOT USE TO ENROLL PARTICIPANTS
(Once approved, IRB logo goes here) / Approval date:
Approved consent IRB version No.:

INSTRUCTIONS FOR DRAFTING AN ORAL PARENTAL PERMISSION SCRIPT (WITH HIPAA AUTHORIZATION LANGUAGE, BUT NO PROVISION FOR SIGNATURE) FOR

STUDIES INVOLVING CHILDREN BASED IN A U.S. COVERED ENTITY

This template is designed for studies that do not contemplate obtaining a signature from parents of children recruited through a U.S. “covered entity”, e.g. a health provider. Using this template is only appropriate if your study involves a minimal risk procedure for which signed consent is not ordinarily obtained, such as a survey or focus group activity, or if you plan to obtain parental permission from a participant’s parent or legal guardian recruited through a covered entity over the telephone (making it impracticable to obtain a signature). In both of these cases, you must obtain a HIPAA waiver of the requirement to obtain a signature for the HIPAA Authorization.

This oral parental permission/authorization script template provides sample language for you to use. This is a Word Document; remove this instruction page after completing your form. As you draft the form, consider the following tips:

Use simple words and short sentences. It’s easier for participants to digest single concepts than multiple concepts in a string. Itemizing using bullet points or tables may also be helpful
Think about what you, or one of your family members, would like to know if he or she considered joining the study.
Fill in all the sections marked in [blue].
Use good document control practices to label each form.
Delete the title of the document at the top of the next page.
Delete this page.

JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

PARENTAL PERMISSION/HIPAA AUTHORIZATION INSTRUCTIONAL TEMPLATE FOR STUDIES

INVOLVING CHILDREN IN U.S. COVERED ENTITIES

Study Title:

Principal Investigator:

IRB No.:

PI Version Date:

[Greeting]. I am from [Johns Hopkins School/Department] and would like to talk to you about a research study on [topic of the study]. We are working to see if [hypothesis of study w/out bias as to outcome]. We are asking you for permission for your child to join this study because your child [explain why they qualify]. You do not have to give permission for your child to join, it is your choice. Your decision will not affect the care your child will receive at [name of Covered Entity; Johns Hopkins or other U.S. Based Covered Entity from which participants are recruited].

If you say yes, we will ask you to [describe the study procedures that require parental involvement (bringing the child to appointments, filling out diaries, etc.). Describe the study procedures that involve the child, who will do them, how long they will take, and where they will happen].

Your child may [be uncomfortable answering questions, get bored– describe risk]. [For questionnaires] Your child does not have to answer all the questions and may stop at any time.

[For most studies:“Your child will receive no direct benefit from this study.”] We will use the information from your child and other children to [answer our question/find out about…].

We will do our best to keep your child’s information safe by [not writing down your child’s name/using a special code/locking up the information/etc.] When we share your child’s information with other researchers, we will ask them to use the same protections.

<Always include the following sentence

People at Johns Hopkins who are involved in the study or who need to make sure the study is being done correctly will see the information.

People at Johns Hopkins may need to send your child’s information to people outside of Johns Hopkins (for example, government groups like the Office of Human Research Protections) who need to make sure the study is being done correctly.

People at Johns Hopkins may need to send your child’s information to people outside of Johns Hopkins (for example, government groups like the Food and Drug Administration) who are involved in the study or who need to make sure it is being done correctly. If the study has a sponsor, people at Johns Hopkins will send your child’s information to that sponsor.

These people will use your child’s information for the purpose of the study.

We will collect information about your child until the end of the study unless you tell us that you have changed your mind. If you change your mind and don’t want your child’s information used for the study anymore, you may call The Johns Hopkins School of Public Health Institutional Review Board (IRB) at 410-955-3193. Just remember, if we have already used your child’s information for the study, the use of that information cannot be cancelled.

We try to make sure that everyone who needs to see your child’sinformation uses it only for this study or other studies approved by the Institutional Review Board at Johns Hopkins. But we cannot guaranteethat it will be kept confidential.

[Address payment/cost to participants.] We will/will not pay you or your child to join this study. [Include as appropriate: We will pay you back for any travel costs. We will provide foodyou’re your child while your child is with us.]

Do you have any questions? You may ask me now, or contact [name and contact info] about your questions. If needed, you maycall the IRB (410-955-3193) if you have any problems with this study.

Will you permit your child to join the study?

3Oct2016