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MRN Urine Testing Guidelines
Urine testing (pregnancy and/or drug) must be done if specified in an IRB approved study protocol or if required by MRN policy. According to MRN policy for MRI scanning, the following populations must have a documented negative pregnancy test before entering the scanner: • All females under the age of 18 who have had their first menstrual period; • All adult females who report the possibility of being pregnant; • Any female participant who requests to be tested.
CONSIDERATIONS:
• It is the PI’s responsibility to procure for their studies all necessary pregnancy and/or drug tests, specimen cups (plastic cups are adequate), and any other materials needed for testing (e.g. latex gloves, dropper/pipette, etc.). Ordering information is provided at the end of this document. • PIs should consider having a female research team member administer urine pregnancy tests. • PIs should consider drafting a script for research team members to use to administer and disclose results
PROCEDURES:
• Provide a urine collection cup and instruct the participant to fill it to a certain line (as indicated on the package) or to provide a certain amount (e.g. ¼ cup full). • Escort the participant to a restroom close to the scanner. Restrooms that can be used for this purpose are located in rooms 1071 (near 1.5T control room), 1034 (women’s) and 1036 (men’s), 1061 (near MEG control room), and 1101A (in the genetics lab – with approval from Marilee). • Instruct the participant to leave the urine sample in the specimen cabinet (preferred, if available) or on the counter in the restroom when they are finished. • Wait outside the restroom until the participant is finished then guide him/her to an appropriate waiting area while you complete the pregnancy and/or drug test(s). • Administer the test(s) in the same restroom that the participant used. • ALWAYS wear gloves when handling urine or any biospecimen. • Depending on the type of test, either dip the testing stick into the urine or extract droplets from the cup of • Discard the remaining urine into the toilet and flush. • Discard tests and specimen cups into the waste basket in the restroom (wrap the test in a paper towel to • Record the results of the drug and/or pregnancy test(s) on the MR safety screening form, the Urine Collection Record (Attachment 1), or other data collection form, as appropriate. • All pregnancy test results need to be recorded on the MRI Safety Screening Form; indicate a positive or negative result and the initials of the research team member/MRN staff member administering the test. Any positive pregnancy test will exclude the participant from receiving an MRI scan. • On the Urine Collection Record, indicate what type of test was performed (drug and/or pregnancy), the time and date, the results (positive or negative; for drug tests also indicate for which drug they were positive), the lot # of each test (optional), and the RA’s initials who administered each test. • Inconclusive pregnancy test results require administration of another test. If the second test is inconclusive, the participant cannot be scanned. • Disclose all testing results to participants in a private area. • When delivering positive pregnancy results to minors, consider the experience level of the person administering the test. Additional protections may be necessary, such as access to a clinical psychologist, therapist and/or a Pregnancy Resources Sheet (Attachment 2). MRN policy requires that test results remain confidential so parents/legal guardians cannot be notified. When working with incarcerated participants, pregnancy/drug results should be disclosed as per HRRC and prison requirements. • For positive results on a drug screen, follow your study specific protocol procedures. Additionally, disclosure of any positive drug test results should be handled per your approved study protocol. Regardless of the drug test results, the RA and MR tech should feel that the participant is safe to enter the scanning environment. If the individual appears impaired and it is not safe to continue with the research procedures for the day, consult with your PI or the medical director before allowing the individual to leave the facility. • Remind the participant that no one involved with the study will let anyone know about the results of their pregnancy and/or drug test(s) or why they did not complete the scan. You can tell them that they are welcome to discuss what happened today with whomever they would like, but that you will strictly maintain their privacy on this issue. If applicable, let them know that the positive result will not interfere with their progress in the study; that they will be able to continue to participate, with the exception of the MRI, in the intervention and follow-ups (and receive the planned compensation). RECOMMENDED CONSENT FORM LANGUAGE FOR MINOR PREGNANCY TESTING:
Parent Consent:
• If your child is female and is pregnant or expects to become pregnant prior to participation in the study,
she will not be enrolled. If she has had her first menstrual period, she will be asked to take a urine pregnancy test before being allowed to receive an MRI scan (or participate in the study) to exclude the possibility of pregnancy. The results of the pregnancy test are private, and will not be shared with you (or juvenile justice officials). Combined Child/Adult Consent: • If you are a woman 18 years of age or older and there is a possibility that you may be pregnant, you will be asked to take a urine pregnancy test before being allowed to participate in the MRI portion of the study. If you are under the age of 18 and have already had your first menstrual period, we require that a pregnancy test is done before the MRI scan, but you are the only one that will get the results; we will not report the results of the pregnancy test to your parent or guardian.
RECOMMENDED CONSENT FORM LANGUAGE FOR MINOR DRUG TESTING:
Parent Consent:
• Your child will be asked to give us a urine sample to test for the presence of several drugs, including
cocaine, heroin, methamphetamine, and marijuana. For safety purposes, your child will take a urine drug test before being allowed to receive an MRI scan (or any study procedures or participate in the study). The results of these tests will not be shared with you or anyone else, including, police, security, prison staff, or parole officers, even if your child tests positive for a drug. Combined Child/Adult Consent: • You will be asked to give us a urine sample to test for the presence of several drugs, including cocaine, heroin, methamphetamine, and marijuana. You will also be asked to give a urine sample on the days of MRI and EEG recording. You will be able to collect this urine in a restroom without anyone watching you (IF APPLICABLE) and your therapist will not know the results of your tests. (IF APPLICABLE) If you test positive for drugs, you may be excluded or rescheduled. The results of these tests will not be shared with anyone, including police, security, prison staff, or parole officers, even if you test positive for a drug.
ORDERING INFORMATION:
• Pregnancy testing kits can be purchased in bulk by Diana South, MRI Core, through Central Supply at the hospital. To do this, e-mail the request to dsouth@mrn.org including the number of boxes need and the grant charge code. There are 25 tests/box. • Online Drug screening tests: http://www.medicaldisposables.us/home.php • Online Pregnancy tests: http://www.americanscreeningcorp.com/QUICKVUE_ONE- Attachment 1
Urine Collection Record
Urine Collection Record
STUDY TITLE
Date/Time
Type of test
Drug/Pregnancy
(optional)
Initials
Attachment 2
Pregnancy Resources Sheet
American Adoptions provides adoption services to pregnant women and couples hoping to adopt in all cities in New Mexico, including the major cities of Albuquerque, Las Cruces, Santa Fe, Rio Rancho, Roswell, Farmington, The BabyNet information and referral service (a part of the Information Center for New Mexicans) helps pregnant women and families with small children gain information to access and utilize medical and support services. BabyNet promotes baby wellness by identifying and promoting prenatal and perinatal services as well as helping to reduce the incidence and effects of disabling conditions by educating and providing information. Links to websites for general health and pregnancy information (505) 975-9667 Car Seat Assistance- Trumbull Provides $15 car seats if you come in and get car seat safety training Family Resource Center (505) 256-2005 Care Net Pregnancy Center Non-profit counseling and pregnancy resource center committed to providing up- to-date information in order to make informed decisions about pregnancy, sexual health, and relationships. Services are free of charge. Resources on all aspects of domestic and intercountry adoption, including adoption from foster care. Includes information for prospective and adoptive parents; information about searching for birth relatives; and resources for professionals on recruiting adoptive families, preparing children and youth, supporting birth parents, and providing postadoption services. Offers Pregnancy Counseling and Supplemental nutrition program to pregnant 111 Stanford NE (505) 841-4100 GRADS-Graduation, Reality, and Helps teens to understand the importance of prenatal care Teaches healthy parenting skills Provides the opportunity to earn TECH PREP credit and learn parenting skills while studying child development Prepares individuals for work or educational opportunities Helps teen mothers learn how to pursue careers and teach them life skills (505) 265-5522 info@lifeoptionsacademy.org http://www.primefi.com/loa New Futures, Inc. Allows teen mothers to bring their children to school with them, and along with their academic coursework, they learn about their parenting responsibilities. Birth Control: Pills, Condoms, Depo-Provera, etc. Breast Exam Counseling - Birth Control Counseling - Pregnancy Options Counseling - STD Emergency Contraception (EC) HIV/AIDS Testing and Counseling Male Health Services Menopause/Midlife Services Norplant Removal Post-Abortion Exam Pregnancy Testing and Counseling Sexually Transmitted Infection Testing & Treatment Urinary Tract Infection Diagnosis and Treatment Vaginal Infection Testing & Treatment Cancer Screening (Pap Test) Blood Tests Birth Control: Pills, Condoms, Depo-Provera, etc. Breast Exam Cancer Screening (Pap Test) Colposcopy Counseling - Abortion Counseling - Birth Control Counseling - Pregnancy Options Counseling - STD Counseling - Tubal Ligation Counseling - Vasectomy Emergency Contraception (EC) HIV/AIDS Testing and Counseling Male Health Services Menopause/Midlife Services Norplant Removal Birth Control without Pelvic Exam Post-Abortion Exam Pregnancy Testing and Counseling Sexually Transmitted Infection Testing & Treatment Sonogram Sterilization – Female and Male Tubal Ligation (Female Sterilization) Ultrasound Urinary Tract Infection Diagnosis and Treatment Vaginal Infection Testing & Treatment Vasectomy Birth Control: Pills, Condoms, Depo-Provera, etc. Breast Exam Cancer Screening (Pap Test) Counseling - Birth Control Counseling - Pregnancy Options Emergency Contraception (EC) HIV/AIDS Testing and Counseling Male Health Services Menopause/Midlife Services Norplant Removal Post-Abortion Exam Pregnancy Testing and Counseling Sexually Transmitted Infection Testing & Treatment Urinary Tract Infection Diagnosis and Treatment Vaginal Infection Testing & Treatment Counseling - STD Blood Tests

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