Informed Consent Form

Informed Consent

This study is being conducted by . If study is being conducted by a graduate student, the PI (advisor) should also be listed here.

Key Information about this study

This consent form is designed to inform you about the study in which you are being asked to participate. Following is a brief summary about the study; however, you can find more detailed information later on in the form.

• List key pieces of information designed to assist the participant in deciding whether or not they would like to participate in the study.

• This information should include:

○ Any relevant inclusion or exclusion criteria,

○ Risks/Benefits,

○ Time commitment,

○ Compensation,

○ Privacy concerns.

• This section is designed to be a concise and focused presentation of key information that is mostly likely to assist in understanding the reasons why one might or might not want to participate in research.

You are being asked to participate in this study because

As a participant in this study, you will

This study will take place and should take you about to complete.

As a participant in this study,

Individual benefits of this study will include Additionally, societal benefits

Your participation in this research is your choice. If you decide to participate in the study, you may change your mind and stop participating at any time without penalty or loss of benefits to which you are already entitled.

You will not incur any costs for participating in this study.

If there are alternative treatments, ways to earn extra/course credit, etc. these should be described here.

Your will be collected during the course of the research.

Research collecting identifiable private information and/or identifiable biospecimens must state that:

• Collected samples/data may be given to another investigator for future research without additional consent, OR

• Collected samples/data will not be used or distributed for future research, even if de-identified.

When applicable, describe whether clinically relevant research results will be given to the participant, and under what conditions

If biospecimens (even after they are de-identified) will be used for commercial profit, this must be disclosed to participants, including whether or not that profit will be shared.

In addition, describe whether the research will or might include whole genome or exome sequencing.

In the event of you will be removed from this study.

If applicable, if you are injured during the course of this study, you should contact the .

Before you decide whether you’d like to participate in this study, please ask any questions that come to mind now. Later, if you have questions about the study, you can contact .

You have rights as a research participant. All research with human participants is reviewed by a committee called the Institutional Review Board (IRB) which works to protect your rights and welfare. If you have questions about your rights, an unresolved question, a concern or complaint about this research you may contact the IRB chair at .

Documentation of Informed Consent:

You are freely making a decision whether to be in this research study. Signing this form means that

1. you have read and understood this consent form

2. you have had your questions answered, and

3. you have decided to be in the study.

You will be given a copy of this consent form to keep.

DELETE this page if not applicable:

If study involves the investigation of a drug (Phase I-IV), non-approved use of a drug or substance, or investigation of a medical device or substance that is subject to FDA regulations, following statement is required:

If applicable, add the statement:

[The Certificate of Confidentiality section below is required for all NIH funded research, and any other research with a Certificate of Confidentiality. Delete if not applicable.]

Certificate of Confidentiality [include if applicable]

The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to further protect your privacy. With this Certificate, the investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use. Research information protected by this Certificate cannot be disclosed to anyone else who is not connected with the research unless:

1. there is a law that requires disclosure (such as to report child abuse or communicable diseases but not for legal proceedings);

2. you have consented to the disclosure, including for your medical treatment; or

3. the research information is used for other scientific research, as allowed by federal regulations protecting research subjects.

Disclosure is required, however, for audit or program evaluation requested by the agency that is funding this project or for information that is required by the Food and Drug Administration (FDA).

You should understand that a Confidentiality Certificate does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it. This means that you and your family must also actively protect your own privacy.

Finally, you should understand that the investigator is not prevented from taking steps, including reporting to authorities, to prevent serious harm to yourself or others.