Consent template for research

Parent Notification Template : Typically used for studies in an educational setting particularly where the study is exempt but parent notification is still required , this template is a guide for creating a notification letter to send home to parents. It is more suited to non-anthropology research though anthropologists are welcome to refer to it as well.

The purpose is to educate participants about the study and to provide them with resources, particularly if the study is upsetting. Advertising Flyer Template : Recruitment materials are part of the consent process and it is important that participants are accurately informed about the study throughout the process.

You are not required to use this flyer template it is a model appropriate for a flyer posted around campus , but it is important that you follow the guide provided in Recruitment. Release signature required. Using data in this manner is beyond the scope of the study and you should seek additional permission to use the participant's data in this way. This form allows a participant to declare how they would like their materials to be used by the researcher if the researcher wants to use the materials in situations beyond the study.

Data Release Form : This form is similar to the Post-Debrief Consent Form; it is used when a participant has been recorded or photographed without their knowledge. Post-Debrief Consent Form : This form is used in a deception study after the deception is revealed to the participant. The participant is given an opportunity to decide if they still want to participate after the true purpose of the study is revealed.

The title of protocol must match the title on all consent forms. The title must be relevant, appropriate, and easy to understand. Include the project title on all pages of the consent form. List the page numbers on all pages of the consent form in the standard format: Page 1. Delete all colored text from the final copy of your form.

The examples should serve as a starting point and should be edited as necessary to match the requirements of the specific study. Those rewriting model consent forms to fit the CHOP consent form templates often make them worse rather than better. The IRB will accept and approve an ICF that differs from the templates, provided that the document contains all of the required and any applicable optional elements and it is well written. Writing a consent form requires substantial effort to take the consent template and add the required information using plain language, brevity and clarity.

However, making the effort at the time of the initial submission will greatly speed up the approval of the study. To get your consent form approved quickly, it is incumbent on the investigative staff to create clear, simple consent documents.

The toolkit recommends using the Flesh-Kincaid reading tool included in Microsoft Word. Studies have shown that the Flesh-Kincaid can underestimate the difficulty of text related to medical information by 1 - 2 grades.

Pictographs that present a graphical representation of the frequency of study risks, such as the meaning of likely, less likely and rare or common, occasional, and rare have been show to improve subject comprehension.

Two examples are included below so that they can be incorporated into consent documents. This can be in the form of a either. The disadvantage is that the consent form is longer and is harder to understand.

Using a stand-alone HIPAA Authorization instead of a combined document shortens and simplifies the consent document considerably. The responsibility for this form falls on the investigator. There are disadvantages, subjects will need to sign twice - once for the consent form and and once for the HIPAA Authorization - instead of a signing a just one document. In addition, the investigator will need to remember to use both forms instead of just a single form. The consent form templates include a signature page that is appropriate for studies approved under 45 CFR There are many studies that involve circumstances that require revision to the standard language, for example, studies that include both parents as subjects or only adults.

The signature pages below can be used to substitute for the standard signature page for studies where the participants differ from the most common scenarios. What is commonly known as verbal consent is in regulatory terms referred to as informed consent with waiver of documentation.

The IRB does not recommend using a "verbal script"; we recommend that the investigators develop a consent form to that will be read to the prospective subject. One of the standard consent templates can be modified for this purpose as follows:.

When using a Short Form Consent process for non-English speaking subjects, the Study Summary document replaces the standard consent form. There are two differences: 1 title changes to "Study Summary Document" and 2 there is a different signature page which is signed by the member of the investigative team obtaining consent and the witness instead of the subject or parent of the subject. This statement is only required when there is an FDA requirement for trial registration on clinicaltrials.

This new requirement applies to all new and revised consent forms subject to FDA regulations and reporting requirements as of March 7, This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph j of section of the Public Health Service Act. The statement is:. This Web site will not include information that can identify you.

At most, the Web site will include a summary of the results. You can search this Web site at any time. Skip to main content. This form contains all the necessary information when borrowing a laptop from the company. Get this easy to understand simple informed consent form template for your informed consent form needs. Just copy this template to your Jotform account and manage everything in your account. Use these features here for free. Only in Jotform! Build your form from this template and have your personal training informed consent form instantly!

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