Include preferred number for participants to use

Initiate discussion filling in the '[ ]' (brackets) with appropriate information.

-Hello I am [ ]

-I obtained your contact information from [ ]

-Can I proceed? IF 'NO' you must end discussion

-Now I will tell you everything you need to know and consider before you decide whether or not to join this study. The decision to join the study is entirely yours. If you decide to join the study you may change your mind at any point and withdraw your consent to participate.

-The name of the study is [ ]

-[ ] is the principal investigator in charge of how the study will be conducted.

See script key #1 below and enter here. If not applicable, please so indicate

See script key #2 below and enter here. If not applicable, please so indicate.

See script key #3 below and enter here.

See script key #4 below and enter here.

You may or may not benefit from study participation or your condition may worsen. It is hoped that the knowledge gained from your participation may help others. Also, See script key #5 below.

List the major standard of care options and/or possibility of other research studies

List as appropriate. Examples are:

•    United States Food and Drug Administration (FDA),

•    The Office of Human Research Protections (OHRP), the

•    Piedmont Healthcare Institutional Review Board (IRB), etc…

(during discussion complete blanks with appropriate information)

You may choose not to be in this study. If you agree to be in the study you may withdraw from the study at any time without penalty or loss of benefits to which you are entitled. Your access to health care at Piedmont ___________and from your doctor will not be affected by the withdrawal.

You may revoke your authorization for use of data at any time by calling the Principal Investigator and by completing the revocation form you will be provided. If identifiers (like your name, address, and telephone number) are removed from your PHI, then the remaining information will not be subject to the Privacy Rules. This means that the information may be used or disclosed with other people or organizations, and/or for other purposes.

It is also possible that your being part of the study may be stopped at any time without asking you. This might happen if you do not follow the instructions given by the study doctor or if the study is stopped for administrative, medical, or other reasons as determined by the Sponsor Piedmont ______________, the United States Food and Drug Administration (FDA), or other regulatory authorities. In addition, your doctor may remove you from this study, if it is believed to be in your best interest.

__________________________________________________

_______________________________________________________

________________________________________________________

______________________________________________________

_____________________________

_____________________________________________________

1)    ‘______________, the sponsor of the study, is paying Piedmont Healthcare [and Dr. ________] to perform this research.

2)    Dr. _________ also: { serves on the board, serves as a consultant for, has an ownership in, etc}

3)    Describe what is asked of the participant. Describe procedures and identify which are experimental and which are standard of care, specimen collection, blood draws, etc. If a drug trial, discuss study phase and explain terms (blind, placebo, randomized, sham, etc…) as appropriate. If a comparison study, explain why the comparison is being done. Indicate expected duration of participation, scheduling, logs, diaries, etc…

4)    This section should explain: A) All reasonably foreseeable risks and discomforts associated with participation in the study. B) A quantification of risk, if possible (e.g. less common risks are those experienced by 10% or less of subjects). C) Whether this study could involve a loss of confidentiality that may affect employability, insurability, or social standing. D) Whether this study may cause discomfort through the recall of traumatic or uncomfortable experiences. E) Risks that are shared by multiple drugs can be grouped together in one heading. Those risks that are unique to a drug or device must be itemized separately. F) Consider necessity of pregnancy language for females and males.

Note: There are risks in any study. This section should never state "there are no risks." Breach of confidentiality may be the only risk, but it should always be listed.

5)    If there are any definite benefits to participation it should be discussed. NOTE: remuneration is not a benefit to participation.