Participation Is Voluntary

[This is an example of a consent form that could be used for interview research that is not exempt (in this case, because sensitive information about grant funding is obtained). It is posted to illustrate acceptable wording. Check the CUHS web site to be sure you have the most recent version of this document.]

Participation is voluntary

It is your choice whether or not to participate in this research. If you choose to participate, you may change your mind and leave the study at any time. Refusal to participate or stopping your participation will involve no penalty or loss of benefits to which you are otherwise entitled.

What is the purpose of this research?

The purpose of this research is to investigate the opinions of faculty about the ESTR protocol and consent form templates as they start to use them in Summer, 2013. We are asking you to take part because you will be using the templates to submit research to CUHS.

How long will I take part in this research?

Your participation will last up to 12 months. You will be interviewed now (before you use the templates), a second time (after you have submitted your application using the templates), and possibly a third time if you submit another application using the templates within one year from your first interview. Each interview will last about 30 minutes.

I may be interested in re-contacting you for additional information or clarifications after the last interview. If I do, your participation would be completely up to you. If you would prefer that we refrain from re-contacting you, please intital below:

Please do not re-contact me following the study: ______

What can I expect if I take part in this research?

As a participant, you will be interviewed on two or three occasions. Each interview will be at a time and place convenient to you. The interviews will ask about your experience with using the templates and your opinions on their quality and usefulness. It will also ask about your experience and plans for applying for and obtaining funding for your research. With your permission, I will make an audio recording of the interview.

What are the risks and possible discomforts?

If you choose to participate, there is a chance that the confidentiality protections for the information about your funding could be compromised.

Are there any benefits from being in this research study?

Wedo not expect any direct benefits to you from your taking part in this research.

Will I be compensated for participating in this research?

You will not be compensated for participating in this research.

If I take part in this research, how will my privacy be protected? What happens to the information you collect?

The data we collect will be kept in a locked office. All paper files with your identifiable information will be kept in a locked filing cabinet. All electronic data will be stored on a password-protected, encrypted computer system and only encrypted communication channels will be used to transfer the files. Reports of the results will remove any information that could allow someone to identify you.

The information with your name on it will be analyzed by the researcher(s) and may be reviewed by people checking to see that the research is done properly.

If I have any questions, concerns or complaints about this research study, who can I talk to?

The researcher for this study is Sam Smith, who can be reached at 617-495-5000,

• If you have questions, concerns, or complaints,
• If you would like to talk to the research team,
• If you think the research has harmed you,or
• If you wish to withdraw from the study.

This research has been reviewed by the Committee on the Use of Human Subjectsin Research at Harvard University. They can be reached at 617-496-2847, 1414 Massachusetts Avenue, Second Floor, Cambridge, MA 02138, or for any of the following:

• If your questions, concerns, or complaints are not being answered by the research team,
• If you cannot reach the research team,
• If you want to talk to someone besides the research team, or
• If you have questions about your rights as a research participant.

Statement of Consent

I have read the information in this consent form. All my questions about the research have been answeredto my satisfaction.

SIGNATURE

Your signature below indicates your permission to take part in this research. You will be provided with a copy of this consent form.

______

Printed name of participant

______

Signature of participantDate

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