Addendum

Permission to Take Part in a Research Study

[Insert Study Title]

Whom can I talk to?

If you have questions, concerns, or complaints or think the research has hurt you, talk to the investigator [Insert name of the Palmetto Health investigator] or research team at [Insert contact information for the local research team]

Palmetto Health has agreed to accept the [Insert the Lead Institution] Institutional Review Board review, approval and continuing oversight of this research. Information concerning your rights as a research subject can be obtained by contacting (803) 434-2884 or for any of the following:

·  Your questions, concerns, or complaints are not being answered by the research team.

·  You cannot reach the research team.

·  You want to talk to someone besides the research team.

·  You have questions about your rights as a research subject.

·  You want to get information or provide input about this research.

How many people will be studied at Palmetto Health?

We expect about _____ people at Palmetto Health will be in this research study.

What else do I need to know?

[Include for research involving more than minimal risk. Otherwise delete.] If you need medical care because of taking part in this research study, contact the investigator, and medical care will be made available. Generally, the financial costs this care will continue to be your responsibility and will be billed to you or to your insurance. Palmetto Health has no program to pay for medical care for research-related injuries. [In the event the research sponsor is assuming responsibility for payment of research-related injury, the above paragraph may be revised as appropriate, but in no case can imply that the Palmetto Health will assume any financial responsibility. The language should be as identical as possible to that on the clinical trial agreement while incorporating the above paragraph as closely as possible.]

What happens to the information we collect?

Organizations that may inspect and copy your information include the Palmetto Health IRB and other representatives of Palmetto Health.

[There are three signature pages attached to this template consent. Use the signature page or pages appropriate for your study. The IRB recommends that you make separate consent documents for each signature page to be used.]

[Omit the signature page if there is no written documentation of consent.]

Signature Block for Capable Adult

I have read this consent form or had it read to me. I have discussed it with the investigator and my questions have been answered. I will be given a signed copy of this form. By my signature I agree to take part in the study.
Signature of subject / Date
Printed name of subject
Signature of person obtaining consent / Date
Printed name of person obtaining consent / Date

Witness Signature

Witness / q  My signature below documents my physical presence at the time the consent was signed by the subject.
q  My signature below documents that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the subject, and that consent was freely given by the subject. (Required when the subject is illiterate)
Signature of witness / Date
Printed name of witness

Signature Block for Adult Unable to Consent

I have read this consent form or had it read to me. I have discussed it with the investigator and my questions have been answered. I will be given a signed copy of this form. By my signature, I agree for the named subject to take part in the study.
Printed name of subject
Signature of legally authorized representative / Date
Printed name of legally authorized representative
Signature of person obtaining consent / Date
Printed name of person obtaining consent / Date

[Add the following block if you will document assent of the subject.]

Assent / q  Obtained
q  Not obtained because the capability of the subject is so limited that the subject cannot reasonably be consulted.

Witness Signature

Witness / q  My signature below documents my physical presence at the time the consent was signed by the legally authorized representative of the subject.
q  My signature below documents that the information in the consent document and any other written information was accurately explained to, and apparently understood by, by the legally authorized representative of the subject, and that consent was freely given by the legally authorized representative of the subject. (Required when the legally authorized representative is illiterate)
Signature of witness / Date
Printed name of witness

Signature Block for Children

I have read this consent form or had it read to me. I have discussed it with the investigator and my questions have been answered. I will be given a signed copy of this form. By my signature, I agree for the named child to take part in the study.
Printed name of child
Signature of parent or guardian / Date
q  Parent
q  Guardian (See note below)
Printed name of parent or guardian
Note on permission by guardians: An individual may provide permission for a child only if that individual is legally authorized to consent to the child’s general medical care.
Signature of parent / Date
Printed name of parent
If signature of second parent not obtained, indicate why: (select one)
q  The IRB determined that the permission of one parent is sufficient. [Delete if the IRB did not make this determination]
q  Second parent is deceased
q  Second parent is unknown / q  Second parent is incompetent
q  Second parent is not reasonably available
q  Only one parent has legal responsibility for the care and custody of the child

[Add the following block if you will document assent of children]

Assent / q  Obtained
q  Not obtained because the capability of the child is so limited that the child cannot reasonably be consulted.

[Add the following block to all consents]

Signature of person obtaining consent and assent / Date
Printed name of person obtaining consent / Date

Witness Signature

Witness / q  My signature below documents my physical presence at the time the consent was signed by the parent or guardian of the subject.
q  My signature below documents that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the parent or guardian of the subject, and that consent was freely given by the parent or guardian of the subject. (Required when the parent or guardian is illiterate)
Signature of witness / Date
Printed name of witness

Document Version Date: March 31, 2014

Page 2 of 5 Initials ______