PROCEDURE
Blood will be drawn by a healthcare professional for a PSA test (and if applicable, other men's health tests listed above). You will be informed of your blood test results at a later date, via US mail and/or email, because the labs will require analysis at a laboratory. You should receive your test results within 2-6 weeks after this event. If applicable, the Digital Rectal Exam will be performed by a trained Healthcare Professional by inserting a gloved finger into the rectum and gently pressing against the prostate gland. The DRE results will be included in the same letter as the lab results. If your PSA and or DRE results are abnormal, we recommend that you contact your personal physician. Please share all results, normal or abnormal with a Physician. Your lab results will be reviewed by a Physician and will come from the Prostate Conditions Education Council. You may be contacted by PCEC patient navigator to discuss your results or Center for African American Health to connect futher.
RISKS
Collection of the blood specimen may cause minor discomfort, or occasionally an infection may result and a swelling containing blood (a hematoma) may develop.
PARTICIPATION
Participation is voluntary. By receiving a screening, you recognize, understand, and accept all risks and responsibilities associated with and resulting from it. This program will only screen for abnormalities in the prostate using a PSA test and does not constitute a complete medical examination or diagnosis. Test results do not represent or imply that you DO or DO NOT have prostate cancer. Although PSA tests can not definitively diagnose prostate cancer, they may indicate levels of probability of having, or not having prostate cancer. An abnormal PSA test can also be an indicator of other prostate health issues, such as an Enlarged Prostate (BPH) and Prostatitis (infection in the prostate). For diagnosis of a medical condition such as prostate cancer, you acknowledge, understand, and accept that you must see a physician for a complete medical examination.
CONFIDENTIALITY
As part of this program, you allow the release of all information from your medical records with regard to prostate disease and treatment to the PCEC and its agents. You allow PCEC to contact you regarding prostate cancer screening and your participation in this program. You also authorize the PCEC to use this information, including the results of your screening tests for statistical evaluation, scientific research and publication. You will not be individually identified in any recognizable way. The results of these screening tests will be released to you and, aside from the names above, the confidentiality of all of your medical records will be maintained within legal limits. Please note that while your anonymity will be guaranteed by signing this consent you do realize that your responses on this questionnaire as well as your blood sample could be used for future analysis, and in/for future studies. PCEC may contact you based on your tests results and responses.
SUBJECT AGREEMENT WAIVER
I have read, understand, and accept this informed consent and waiver. I have had the opportunity to ask questions, have been informed as to the purpose of the Screening and the potential risks, and freely consent to be a participant in the Screening. I understand and assume all risks associated with my participation in this program and the Screening. I understand that the program will only screen for abnormalities in the prostate area and does not constitute a complete medical exam or diagnosis. I understand that abnormal test results do not represent or imply that I DO have prostate cancer. For a diagnosis of a medical problem, I acknowledge that I must see a physician for a complete medical examination. I understand that I am responsible for my own health. The responsibility for any follow-up examinations to check abnormalities found during this screening lies solely with me and not with any participating organization, physician, or other health care volunteer. I understand that I will receive a copy of this informed consent and release upon request. I understand and agree to the use of information from my medical records in accordance with the limitations set forth in this consent form. Having read this informed consent and waiver, and in consideration of PCEC accepting me for participation in this prostate cancer screening program, I, for myself and for anyone entitled to act on my behalf, waive and release PCEC and its agents and sponsors from all claims of any kind arising out of my participation in the program and Screening.
PLEASE NOTE:
A screening is NOT a diagnosis; it is important to evaluate the risks and benefits of diagnosis and screening. Please be sure to contact a physician if you have any questions.