Informed Consent

OMB #0912-0620 Attachment 8

CDC Guidance to WISEWOMAN Grantees

Consent to Participate in the Program
Requirements

State/Tribal programs must have a process in place to obtain consent from
participants to participate in the WISEWOMAN Program.

Guidance

State/Tribal programs should consider combining the National Breast and
Cervical Cancer Early Detection Program (NBCCEDP) and
WISEWOMAN consent forms to reduce burden on participants.
The following table includes items that the CDC WISEWOMAN Program
has determined should be included on the WISEWOMAN consent form
with examples of how some of the items might be worded on the forms.
Item to Include
Purpose and
Procedures of Program

List of Screening Tests

Side
Effects/Discomfort of
Lab Tests
Return for Rescreening

Examples from the Field
I agree to be in the (name of) program. This
program has been designed to help women
reduce their risk for heart disease, stroke, and
other chronic diseases. This program
provides free screening tests and a coach
who will contact me to talk about easy ways
to eat smart, be fit, and live well.
I agree to have my height, weight, blood
pressure, cholesterol, and glucose
measured/tested. In addition, I understand
that I will be asked some personal and family
medical history and health behavior
questions.
The screening tests and possible side effects
or discomfort have been explained to me.
I understand that I will be asked to participate
in WISEWOMAN when I return in 12-18
months for my breast and cervical annual
exam appointment. The same screening tests
and paperwork will be completed at that
appointment. It is very important that I
return for this appointment because I will
learn if there are any changes in my heart
disease and stroke risk and will help (name
of) program learn if this program was useful.

Item to Include
Examples from the Field
Obligation to Refer
The (name of) program is required to refer
Women with Abnormal you to a health care provider for medical
Screening Results
follow up if your screening values are not
normal.
Physical Activity
Physical activity clearance may be needed
1
Clearance
from a health care provider before you will
be referred to participate in physical activity.
Dropping out of
I may drop out of this program at any time.
Program
Confidentiality
I understand that any information about me
Statement
obtained as a result of my participation in
program will be kept as confidential as
legally possible.
Contact information for For more information about this program, I
Questions
can contact (name and phone number of
program contact).
Other information programs might want to include on the consent form
includes, but is not limited to:

Eligibility Criteria

Billing Responsibility

A statement about sharing information with the participant’s health
care provider, the state health department, and CDC
The consent form must be approved by CDC staff members before
implementation of program direct services can occur.
Monitoring

CDC staff members will review the consent form to determine if the
State/Tribal program is using a consent form that meets all CDC
WISEWOMAN Program requirements.

References

1

Programs might want to consider using the Physical Activity Readiness
Questionnaire (PAR-Q) as a tool to clear women for physical activity. The
tool was developed by the British Columbia Ministry of Health and an
Expert Advisory Committee of the Canadian Society for Exercise
Physiology revised the questionnaire in 2002. The PAR-Q can be found at
http://uwfitness.uwaterloo.ca/PDF/par-q.pdf.