NCI CIRB Protocol Version Date: [Version date listed on NCI model consent] / Page 1 of 4
DVAHCS PI Version Date: [to be updated by DVAMC PI]
Participant Name: / Date:
Study Title:
DVAHCSPrincipal Investigator: / VAHCS: Durham VAMC
[Required Text:Study Title for Study Participants:[enter title here]
[Required Text:INSTITUTIONAL REVIEW BOARD INFORMATION:
All research studies taking place within the Durham Veterans Health Care System (VAHSC) are typically reviewed by the Durham Veterans Affairs Medical Center (DVAMC) Institutional Review Board (IRB) with respect to risks and benefits in participating in research and the protection of human subjects in research.
For this research study, the Durham VAMC IRB has agreed to rely on the National Cancer Institute Central Institutional Review Board (NCI CIRB) for review and oversight of this study. If you have any questions about the IRB, please contact the NCI CIRB at 888-657-3711.]
[INSERT NCI MODEL CONSENT DOCUMENT]
[If APPLICABLE, this section should be added to the end of the risk section of the model consent] RADIATION RISK INFORMATION
[Include the following paragraph if the study involves research scans or x-rays.]Cancer research often includes x-rays and scans that are provided as part of routine care. The following information describes potential side effects of x-rays and scans done only for research purposes.[only include the below radiation risk statements if applicable to the study]
Risks Associated X-Rays:
Risks Associated with Echocardiogram (Echo):
Risk Associated with Computerized Tomography (CT)Scan:You will have a CT scan of your lungs. This will occur before you start therapy and each time you complete two cycles of therapy and at your post-therapy follow-up visit. A CT scan is a specialized x-ray test involving an effective radiation dose equivalent of about six months of naturally occurring radiation. If you participate throughout the three years, you will have up to 14 CT scans if clinically necessary. This would result in an effective radiation dose equivalent to about 7 years of naturally occurring radiation. This estimated radiation dose does not include any exposure you might have from other tests. Extra radiation may increase the risk of developing another cancer at a later date, but the risk is very low. There is also a risk of feeling discomfort or anxiety while lying in the scanner.
Risks Associated with Positron Emission Tomography Scan, (PET):
Risks Associated with Magnetic Resonance Imaging (MRI) scan:
Risks Associated with Electrocardiogram (ECG) and/or a nuclear stress study(multigated acquisition [MUGA]) :If you have a left ventricular dysfunction, you may have a stress or nuclear electrocardiogram study to determine if the study drug is affecting your heart. You can expect to have two sets of images taken of your heart, once during physical exertion, either while exercising on a treadmill or stationary bike, and another set about two hours later when the body is at rest.
During a regular stress electrocardiogram test, patients who are unable to exercise are given a stress medicine like dobutamine, a drug that increases the heart rate without exercise. The stress medicine can be immediately stopped if there are problems. However, patients who cannot exercise and also cannot take dobutamine because of an arrhythmia (irregular heartbeat) will need to take a nuclear stress test, which uses the drug adenosine instead. Adenosine dilates coronary vessels unless they vessels have a reduced coronary flow reserve and cannot further dilate in response to adenosine. You may experience flushing, chest discomfort, shortness of breath, throat/neck/jaw discomfort, abdominal pain or discomfort, lightheadedness, dizziness, nausea, headache, upset stomach, pain at injection site, discomfort of the arms and hands, weakness, low blood pressure, nervousness and irregular heartbeat.
Also, while a stress electrocardiogram uses an ultrasound to produce images of the heart, a nuclear stress study uses a radioactive dye that is injected into the bloodstream. A special scanner that detects the radioactive material takes pictures of the heart. Light spots on the images indicate that not enough radioactive material is getting to the heart – evidence that there is inadequate blood flow going to the muscle. The images can also highlight areas of heart damage.
There is also a risk of feeling discomfort or anxiety during the test. If IV contrast is given to you during the scan, you have a small risk of developing an allergic reaction. However, most reactions are mild and can be easily controlled with medication. Symptoms of an allergic reaction could include trouble breathing or low blood pressure.
[Insert thissectionat end of ‘What are the costs of taking part in this study?’ of the model consent]VAHCS INFORMATION ON COSTS ASSOCIATED WITH THIS STUDY:
You will not be charged for any treatments or procedures that are part of this study. If you usually pay co-payments for VA care and medications, these co-payment requirements will continue to apply to medical care and services provided by VA that are not part of this study.
[If APPLICABLE, include some or all of the following text (avoid redundancy with model consent)]You will not be paid for taking part in this study. However, you may be reimbursed for your reasonable expenses. Eligible out-of-pocket expenses include travel and other costs associated with clinic visits required for this study. This may include expenses such as parking, tolls, meals, and bus and taxi fare, or overnight lodging at a hotel. You must provide receipts in order to be reimbursed. If you use a privately owned vehicle, you will be reimbursed at the IRS rate which is currently 57½ cents a mile. We will calculate the round-trip mileage using a web-based mapping program such as Google Maps.
[Insert this at the end of ‘What happens if I am injured or hurt because I took part in this study?’ of the model consent]DVHCS INJURY INFORMATION:
[Required text:The VA will provide necessary medical treatment should you be injured by being in this study. You will be treated for the injury at no cost to you. This care may be provided by the Durham VAHCS or arrangements may be made for contracted care at another facility. You have not released this institution from liability for negligence. In case of research related injury resulting from this study, you should contact your study team. If you have questions about compensation and medical treatment for any study related injuries, you can call the medical administration service at this VA Medical Center at 919-286-6957.
If you want to speak to someone who is not a member of the study to discuss problems, ask questions or voice concerns, you can call (919) 286-0411, extension 7632.]
[Insert this section at the end of ‘Who will see my medical information’ of the model consent] DVAHCS PRIVACY INFORMATION
[Required Text:Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. The researchers will do their best to make sure that any information that is released will not identify you. All electronic research data stored at Durham VAHCS will be kept on a password protected computer on a secure Durham VAHCS network that is only available to the cancer researchers and his/her team. All hard copy study related files will be stored in a locked office of the Durham VAHCS investigators and his/her team.]
[Required Text:Your research records may be reviewed by Durham VA staff who are responsible for the safe conduct of this research. We may also provide your research records to federal agencies such as the Office for Human Research Protections (OHRP), the VA Office of the Inspector General (OIG), the VA Office of Research Oversight (ORO), and the Food and Drug Administration. We may also disclose your information to [insert names and/or agencies such as pharmaceutical companies, CROs or clinical monitors, Institute for Medical Research (IMR), sponsors, etc., including those who may receive information for reimbursement].We will not share any information with these groups outside the VHA unless they agree to keep the information confidential and use it only for the purposes related to the study. Any information shared with these outside groups may no longer be protected under federal law. These groups may disclose your information to other groups. If the sponsor receives identified information, it is then the sponsor, and not the VA, who is responsible for the security of the information.]
[Include as Applicable:]
Duke University Health System (DUHS)—Durham VAHCS affiliate health care system
Duke Cancer Institute—Durham VAHCS affiliate institution
Institute for Medical Research (IMR)-- for study reimbursement purposes
Representatives, including monitors and auditors, of Alliance for Clinical Trials in Oncology
[If APPLICABLE, add this section]VHA Policy on Genetic Information:
VA has no policies that would deny benefits based on genetic information.
[Insert this section after ‘ARE THERE ANY COSTS OR PAYMENTS FOR THE ADDITIONAL, OPTIONAL RESEARCH STUDIES? of the model consent]DVHCS FINANCIAL INTEREST RELATED TO THIS RESEARCH STUDY
[Required text][Sponsor Name/National Cancer Institute (NCI)] is the sponsor of this study. Some of the study funds will be used to pay the salary of research staff, but not the salary of the DVAMC principal investigator.[*If any real or apparent conflict of interest is associated with an investigator, note the COI in the ICF and contact to research office.]