Format For Signed Informed Consent Document printable pdf download

Template 1 Format for Signed Informed Consent Document

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Northeastern University, Department

Investigator Name

Title of Project

Informed Consent to Participate in a Research Study

We are inviting you [or your child] to take part in a research study. This form will tell

you about the study, but the researcher will explain it to you first. You may ask this

person any questions that you have. When you are ready to make a decision, you may

tell the researcher if you want to participate or not. You do not have to participate if you

do not want to. If you decide to participate, the researcher will ask you to sign this

statement and will give you a copy to keep.

Why am I being asked to take part in this research study?

Explain if the person is being recruited because of special or clinical characteristics.

Ex: We are asking you to be in this study because you are a Gulf War veteran.

Why is this research study being done?

State the purpose of the study in lay language.

Ex: The purpose of this research is to develop a survey that will be useful in

measuring whether people with arthritis are doing better or worse after

treatment.

Is preferable to:

The purpose of this research is to develop a psychometrically valid and reliable

instrument that will provide quantitative data that can be analyzed to support

treatment and management decisions for people with arthritis.

What will I be asked to do?

If you decide to take part in this study, we will ask you to _________________.

Describe all the tasks that the person will be asked to do, or describe what will be done to

them. Provide sufficient detail so the person understands what his/her role entails. If it

involves questionnaires, provide a brief description. If it involves unfamiliar equipment,

explain how it will be used. Use lay language rather than technical/professional terms.

Use bullets or timetables for research that has multiple visits or tasks.

Identify and describe any procedures that are experimental.

If applicable, differentiate between research procedures and routine procedures. For

example, if you wish to add a research component to a regularly scheduled (non-research)

program, clearly identify the tasks that are program-related and those that are research-

related. Be clear that the person may continue with the regular program even if they

decide not to participate in the research component.

If the study is randomized, explain randomization.

NU HSRP Rev. 1/4/2010

TEMPLATE 1 - FORMAT FOR SIGNED INFORMED CONSENT DOCUMENT

Format For Signed Informed Consent Document