ATTACHMENT 6
Informed Consent
REDS-II Donor Iron Status Evaluation (RISE) Study
You are asked to participate in a research study, called the REDS-II Donor Iron Status Evaluation (RISE) Study, which is being conducted at the <BLOOD CENTER NAME> under the supervision of Dr. <NAME>. This study is part of a larger program conducting blood safety and availability research called REDS (Retrovirus Epidemiology Donor Study) funded by the National Heart, Lung, and Blood Institute.
Overview of the Study
The RISE Study will assess how blood donation and personal characteristics may affect levels of iron and hemoglobin in a person’s blood. Information from the study will help us evaluate which laboratory tests are best for monitoring donors’ iron and hemoglobin levels, the best frequency for blood donation, and how some personal characteristics such as diet, use of mineral supplements, or smoking may influence iron levels and the ability to donate blood. We will also assess in women donors how menstrual periods affect their iron levels and ability to donate blood.
Why was I asked to participate?
We are asking for your participation in this study because: [One box below to be checked by Research staff]
______You are new to blood donation and have never donated blood.
______You have not donated blood in the last two years before today.
______You are a man who has donated at least 3 times in the last 12 months (not including today). Double red cell donations count as two donations.
______You are a woman who has donated at least 2 times in the last 12 months (not including today). Double red cell donations count as two donations.
What do I need to do to participate?
If your hemoglobin level is high enough today for you to donate, we are asking you to participate in this study for approximately 2 years during which time we will assess your hemoglobin and/or iron levels each time you come to donate.
For the study to accomplish its goals, it is important that you understand we would like you to donate blood to the <BLOOD CENTER NAME> as frequently as you can over the next two years. You will receive reminders from the research staff at <BLOOD CENTER NAME> to donate blood while you are enrolled in the study. You will also receive routine recruitment calls from the blood center.
We would like you to donate at least as often as checked below: [Research staff to check one box below]
______ If you have never donated before today, you agree to donate blood at least twice a year for the next two years (4 more donations after today over the next two years).
______ If you have not donated blood in the last two years before today, you agree to donate blood at least twice a year for the next two years (4 more donations after today over the next two years).
______ If you are a man who has donated at least 3 times in the last 12 months (not including today), you agree to continue to donate at least three times a year for the next two years (6 more donations after today over the next two years).
______ If you are a woman who has donated at least 2 times in the last 12 months (not including today), you agree to continue to donate at least two times a year for the next two years (4 more donations after today over the next two years).
If your hemoglobin level is NOT high enough today for you to donate, we will not be able to enroll you in the study.
What you can expect if you participate in this study
At each donation visit, including today, you will be evaluated as usual by blood center staff to determine if you are eligible to donate. This will include a hemoglobin screening test to check for anemia.
As part of your blood donation, an additional three teaspoons (15 ccs) of blood will be taken to check your iron and hemoglobin levels at your first and final study visits. For all other donations between the first and final study visits, only two teaspoons (10ccs) of blood will be taken. Your samples between the first and the final study visits may or may not be used to check your iron levels. The iron tests that will be done on the blood samples you provide today will include checking your genetic material (DNA) for genes that may make you likely to have either too little or too much iron. Also, at today’s donation and at your final study visit, we will check your blood cell counts.
Today you will be asked to complete a 10-minute survey about your blood donation history, diet, use of iron supplements and aspirin, smoking history, and, for women, pregnancy and menstrual history. Towards the end of the two year study period, you will be asked to complete a 5-minute survey to check if there have been any changes in your use of vitamins and iron supplements, smoking habits, and, for women, menstrual history. These are all factors that are expected to influence your body’s iron stores. Some of these questions may be sensitive, but it is important for the study that they be answered fully and accurately.
As part of the study, you are also being asked to have samples of your blood saved indefinitely in a frozen repository for future research to examine factors that affect how your body absorbs and keeps iron or sets hemoglobin levels, as well as factors that may otherwise affect the safety or benefit of regular blood donations. Samples of your blood provided at donations throughout the study would be saved for future research to address these issues.
If you are told you cannot donate blood
If you are told you cannot donate blood today because your hemoglobin level is too low, you cannot participate in the study. You should ask the Blood Center staff when you can next try to donate blood.
If you can give blood today but cannot at some point in the next two years because your hemoglobin level is too low, we will ask you at that time to provide three teaspoons of blood for the research tests. You should ask the Blood Center staff when you can next attempt to donate blood. You are still being asked to continue to participate in the study until it ends.
If you cannot donate blood for a reason other than low hemoglobin during the next two years, your participation in this study will end but you will be asked to provide a final sample of three teaspoons of blood and to complete the 5-minute survey.
Your blood test results
The research iron test results, which will not be available until late in the study, will not be medically relevant. The <BLOOD CENTER NAME> routinely informs you if your hemoglobin level is too low to donate. Therefore, we do not plan to notify you of the results of any research tests that may show expected iron loss, unless you specifically request them.
DNA test results, such as the test for iron overload (hemochromatosis), may be important to your health. You (and your physician, if you identify one) will be notified if these test results are abnormal. These results may be of potential medical concern.
Other test results, including complete blood count, will be shared with you or your physician if these are medically significant or upon your request.
Sample Repository
As previously mentioned, if you agree to participate, samples of your blood will also be saved indefinitely in a frozen repository for future research on the ability of donors to donate regularly and on the impact of multiple blood donations on donors’ health. These include studies of factors that directly and indirectly influence donor iron stores and hemoglobin levels. Future testing on these saved samples will be done only for these purposes and may include additional tests of your genetic material if new genes are identified that effect how your body absorbs and keeps iron or sets hemoglobin levels; contribute to the development of anemia; or otherwise affect the safety or benefit of regular blood donation. No other genetic tests will be done on your DNA. The testing may be done at other laboratories, but your identity (name, address) will remain coded and only be known to the research staff at the <BLOOD CENTER>. All proposed testing on saved samples will be subject to review and approval by all appropriate Institutional Review Boards responsible for protecting the rights of research study subjects. The results of tests which will be conducted on your stored blood specimens will not be made available to you. If you agree to participate in the repository, the blood center may contact you in the future to request additional blood samples. You are free to donate these additional samples or not, and your decision will not affect your relationship with the blood center.
What are the risks and benefits of participating in this study?
Risks: Other than the known risks of blood donation that you have been informed of upon registering to donate, the only additional risks of participating in this research study are:
1) If a blood draw is necessary for study purposes, you may experience pain, bruising, and rarely infection.
2) Small additional blood loss: Rarely, the extra 2-3 teaspoons of blood drawn for the study at each blood donation could aggravate iron loss.
3) Information risk: If you request your results or are notified of a serious health implication from the testing, this information could be upsetting, although it could also represent a benefit to you.
4) Genetic testing: Knowing that you have a genetic or inherited abnormality in how your body absorbs iron could cause distress to you and your family, although it could also represent a benefit to you or your family.
5) Confidentiality: Participation in research may involve loss of privacy, but information about you will be handled as confidentially as possible by the investigators. Your name and address will be kept in a locked file at the blood center. Other study data will have a code number instead of your name. Your name will not be used in any published report about this study.
To further protect your privacy, the study investigators have obtained a Certificate of Confidentiality from the Department of Health and Human Services (DHHS). With this certificate, the investigators may not disclose information (for example by court order or subpoena) that may identify you in any federal, state or local civil, criminal, administrative, legislative, or other proceedings. Disclosure will be necessary, however, upon request of DHHS for audit or program evaluation purposes. A Certificate of Confidentiality does not prevent you, however, from voluntarily releasing information about yourself or your involvement in this research.
Benefits: Although you will not directly benefit from participating in this study, this study may benefit other donors like you in the future, by helping <BLOOD CENTER NAME> develop donor-specific guidelines on how often one can safely donate blood. You will not be paid to participate in the study.
What are my rights as a study subject?
Your decision whether or not to take part in this study is voluntary. It will not change your future relationship with <BLOOD CENTER NAME> in any way. If you decide to participate, you will be given a copy of this form to keep. You are free to end your participation at any time without harm to your rights or your future relationship with < BLOOD CENTER NAME>. If you decide to participate in the RISE Study, but change your mind later you may withdraw at any time or elect not to provide a study blood sample or complete one of the questionnaires. In the case that you are unwilling to provide samples or complete surveys as outlined in this consent, we may decide to withdraw you from the study. You may also request to have your samples withdrawn from the sample repository. Withdrawal from the research study will not affect your relationship with <BLOOD CENTER NAME> or your previous or future blood donations.
In the event that you suffer physical injury as a direct result of your participation in this research activity, the <BLOOD CENTER NAME> will assume responsibility for making immediate medical care available to you. This care will be provided without charge if you notify Dr. <Principal Investigator’s or designee’s name> at < telephone number> within fifteen days of the date of the injury or appearance of symptoms, and consent to the care offered. There is no provision for monetary compensation to you at the expense of <BLOOD CENTER NAME> for such things as lost wages, disability, injury or discomfort resulting to you from such physical injury. Further information concerning treatment and payment of medical expenses in the event of an injury may be obtained from <Principal Investigator’s or designee’s name> and <telephone number>.
Contact Person
If you have any questions, please ask us now. If you have any additional questions later, contact Dr. <NAME> at <PHONE> who will be happy to answer them. If you have questions about your rights as a research subject, call at <PHONE> (local IRB).
Consent Authorization
I have read this form and understand the purpose of this study, procedures to be followed, and the potential risks and benefits. I have been allowed to ask questions, and my questions have been answered to my satisfaction. I understand that I may withdraw at any time after signing this form. A signed copy of this consent form has been given to me.
I agree to participate in the research in the following ways (please check all that apply).
[ ] I consent to participate in this study and to the storage of my blood samples in a repository. I also consent to future studies that may use my stored blood samples to study the ability of donors to donate regularly and the impact of multiple blood donations on donors’ health.
[ ] I consent to participate in this study but do not want my blood sample stored in a repository for future use in studies examining the ability of donors to donate regularly and the impact of multiple blood donations on donors’ health.
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Printed or Typed Name
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Signature
of the participant
Date
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Witness
Name and Signature Date
Last
Updated: November 21, 2007
| File Type | application/msword |
| File Title | Informed Consent |
| Author | Aman |
| Last Modified By | S. Mathew |
| File Modified | 2009-03-03 |
| File Created | 2009-03-03 |