Evaluation and Classification of Drug Related Problems |
Thank you for participating in this research to investigate the relationship between medicine and farm injury. Please answer the following questions reflecting on your use of medicine (prescription and non-prescription) in the past 12 months. Upon completion of this questionnaire please include your address, phone number and SSN (if applicable) so we can mail you the $25 gift card.
WAIVER OF DOCUMENTATION OF CONSENT
INVESTIGATOR'S NAME: KELLY A. COCHRAN
PROJECT #2011799
STUDY TITLE: EVALUATION OF MEDICATION - RELATED AGRICULTURAL INJURY AMONG MISSOURI FARMERS
1. I would like to ask you to participate in a study that involves research.
2. Participation is voluntary and your decision not to participate will not involve any penalty or loss of benefits.
3. For this study, we would ask that you complete a questionnaire, which should take less than 15 minutes to complete. The questionnaire asks questions related to medication use practices and adverse effects of medicines you may have experienced. If you would like to complete
the survey by phone it could take 15-60 minutes. If there are follow-up questions that investigators need to ask about your survey responses, it could take 60 minutes.
4. The purpose of our study is to identify the frequency and characterization of medicine -related problems and how they may impact farmers and result in farm injury. It is known that risk of farm injury increases with use of medication, notably with the use of specific classes of medicine. What is not yet known, is the extent to which drug-related problems are associated with farm injury. Drug-related problems are defined as any undesirable event
experienced by an individual that involves or is suspected to involve medication, interferes with achieving goals of treatment, and requires clinical judgement to resolve. Troublesome issues such as improper dose or drug selection, adverse reactions, or drug interactions may be the missing indicator that healthcare professionals could apply to develop preventive interventions.
5. We are asking approximately 173 subjects to participate in this study.
6. The study staff may withdraw you from the study at any time after explaining to you the reason for withdrawal.
7. While on the study, you are not at risk for discomforts from participation. You should discuss these with the investigator if you feel you are at risk.
8. If you agree to take part in this study, you may expect to benefit from taking part in this research to the extent that you are contributing to medical knowledge.
9. If you choose to participate, your responses to the questionnaire will be confidential and not linked with your identity. The responses will be stored in a password protected data base.
10. The information and/or samples we collect from you for this study will not be used or shared with other investigators for future research studies. This applies even if we remove all information that could identify you from the data/samples.
2. Participation is voluntary and your decision not to participate will not involve any penalty or loss of benefits.
3. For this study, we would ask that you complete a questionnaire, which should take less than 15 minutes to complete. The questionnaire asks questions related to medication use practices and adverse effects of medicines you may have experienced. If you would like to complete
the survey by phone it could take 15-60 minutes. If there are follow-up questions that investigators need to ask about your survey responses, it could take 60 minutes.
4. The purpose of our study is to identify the frequency and characterization of medicine -related problems and how they may impact farmers and result in farm injury. It is known that risk of farm injury increases with use of medication, notably with the use of specific classes of medicine. What is not yet known, is the extent to which drug-related problems are associated with farm injury. Drug-related problems are defined as any undesirable event
experienced by an individual that involves or is suspected to involve medication, interferes with achieving goals of treatment, and requires clinical judgement to resolve. Troublesome issues such as improper dose or drug selection, adverse reactions, or drug interactions may be the missing indicator that healthcare professionals could apply to develop preventive interventions.
5. We are asking approximately 173 subjects to participate in this study.
6. The study staff may withdraw you from the study at any time after explaining to you the reason for withdrawal.
7. While on the study, you are not at risk for discomforts from participation. You should discuss these with the investigator if you feel you are at risk.
8. If you agree to take part in this study, you may expect to benefit from taking part in this research to the extent that you are contributing to medical knowledge.
9. If you choose to participate, your responses to the questionnaire will be confidential and not linked with your identity. The responses will be stored in a password protected data base.
10. The information and/or samples we collect from you for this study will not be used or shared with other investigators for future research studies. This applies even if we remove all information that could identify you from the data/samples.
11. There is no cost to you to participate.
12. There is $25 gift card of compensation given to you for participation in this study. It will take about 3 months to receive the gift card. We will need your social security number in order to pay you. Any payment may need to be reported as income on your tax return. If you are not a resident/citizen (non-resident alien) of the United States, you will need to work with the MU
Nonresident Tax Specialist at 573-882-5509.
13. It is not the policy of the University of Missouri to compensate clinical research subjects in the event the research results in injury. The University of Missouri, in fulfilling its public responsibility, provides medical, professional, and general liability insurance coverage for any injury in the event such injury is caused by the negligence of the University of Missouri, its faculty or staff. The University of Missouri also will provide facilities and medical attention to subjects who suffer injuries while participating in research projects at the
University of Missouri.
14. If you have any questions regarding your rights as a participant in this research and/or concerns about the study, or if you feel under any pressure to enroll or to continue to participate in this study, you may contact the University of Missouri Health Sciences Institutional Review Board (which is a group of people who review the research studies to protect participants' rights) at (573) 882-3181.
15. "If you want to talk privately about your rights or any issues related to your participation in this study, you can contact University of Missouri Research Participant Advocacy by calling 888-280-5002 (a free call), or emailing muresearchrpa@missouri.edu."
16. If you have any problems or questions, you may contact Kelly Cochran, Principal Investigator at 573-884-9673.
17. I would be happy to answer any questions that you may have.
12. There is $25 gift card of compensation given to you for participation in this study. It will take about 3 months to receive the gift card. We will need your social security number in order to pay you. Any payment may need to be reported as income on your tax return. If you are not a resident/citizen (non-resident alien) of the United States, you will need to work with the MU
Nonresident Tax Specialist at 573-882-5509.
13. It is not the policy of the University of Missouri to compensate clinical research subjects in the event the research results in injury. The University of Missouri, in fulfilling its public responsibility, provides medical, professional, and general liability insurance coverage for any injury in the event such injury is caused by the negligence of the University of Missouri, its faculty or staff. The University of Missouri also will provide facilities and medical attention to subjects who suffer injuries while participating in research projects at the
University of Missouri.
14. If you have any questions regarding your rights as a participant in this research and/or concerns about the study, or if you feel under any pressure to enroll or to continue to participate in this study, you may contact the University of Missouri Health Sciences Institutional Review Board (which is a group of people who review the research studies to protect participants' rights) at (573) 882-3181.
15. "If you want to talk privately about your rights or any issues related to your participation in this study, you can contact University of Missouri Research Participant Advocacy by calling 888-280-5002 (a free call), or emailing muresearchrpa@missouri.edu."
16. If you have any problems or questions, you may contact Kelly Cochran, Principal Investigator at 573-884-9673.
17. I would be happy to answer any questions that you may have.
18. You may print a copy of this script for you to keep.