Consent Form Checklist (Page 2 of 4) in pdf

___ 8. Benefits: Study benefits to subjects or to others (societal benefits) which may reasonably

be expected are stated.

___ 9. Risks/Discomforts: You must, at a minimum, state there is no known risk! Any potential

for physical harm (e.g., risks associated with having blood drawn); potential for

psychological harm (eg: distress at being asked sensitive questions of a very personal

nature); and potential for social harm (e.g., collection of information such as drug or

alcohol use or abuse, which if inadvertently released, could be damaging). It is helpful to

include measures to reduce risk (e.g. use of trained personnel, safety procedures,

measures to assure confidentiality).

___ 10. Right to Refuse: It is stated that participation in the study is voluntary and that subjects

may change their mind and withdraw from the study at any time without penalty or loss

of any benefit to which they may otherwise be entitled.

___ 11. Privacy: It is specified whether the study is Anonymous or Confidential (An anonymous

study is one in which the data cannot be linked to the identity of the subject directly or

indirectly – either because the name/identity of the subject is never obtained by the

investigator, or because there is no code linking data to the subject's identity.) If the

study is not anonymous, i.e., if there is a code linking data to identity, describe the

extent, if any, to which confidentiality of records identifying the subject will be

maintained. Confidentiality cannot be absolute: always state 'data will be kept

confidential unless release is legally compelled'.

____ 12. Financial Information: Any compensation for participating and any uncompensated

costs incurred by subjects are specified. (State when incentives will be delivered).

Numbers 13-16 must be included in a consent form when a subject enters an

experimental medical or behavioral treatment program. To explore the potential to

remedy a condition from which he/she suffers.

___ Check here if not applicable and skip to #17. (otherwise, answer each question with yes or

no. "No" indicates a consent form deficiency Which must be remedied before the IRB

application can be approved.)

___ 13. Alternatives: It is specified whether there are proven, established treatment options

available that may be advantageous to the subject (in lieu of the study treatment).

___ 14. Unforeseeable Risks: It is specified that the treatment or procedure may involve risks to

the subject (or the embryo or fetus, if the subject is or may become pregnant) which are

currently unforeseeable.

15. Study-associated injury or illness:

___ A. Any compensation or medical care which will be arranged for or provided by the

investigators is described

___ B. Subjects are informed what to do and whom they are to notify in the event of a

study-related illness or injury.

LSU Institutional Review Board

Consent Form Checklist

Consent Form Checklist Page 2