Information for Clinicians/Researchers
Forms required for New IFAR Enrollments:
Consent for IFAR participation must be obtained by designated staff at Rockefeller University, University of Minnesota, Children's Hospital Cincinnati, or Memorial Sloan Kettering Cancer Center. If you are not at one of these centers please have the patient call Jennifer Kennedy at 212-327-8612 or email at firstname.lastname@example.org for consenting purposes. If the help of an interpreter is needed to consent the family again please contact Jennifer Kennedy to make these arrangements.
- Consent form. This form is 12 pages long and details all of risks, benefits, and limitations of participation in the IFAR. Every family member participating, needs his/her own form and it is required for enrollment.
- When the participant in a minor, the parents should sign on the child's behalf. Children under age 18 do not need to sign anywhere on the consent form. The parent(s) should check one of the options on page 8, and then sign and date at the top of page 10. Having both parental signatures is preferable but not required.
- If the participant is an adult with FA, he/she should check one of the options on page 8, and then sign and date at the top of page 9.
- If the participant is an adult without FA (a parent of a child with FA for example), he/she should check one of the options on page 8, and then sign (and date), on the top of page 9 with his/her own name (not the name of the child).
- Pediatric Assent form for children ages 7-18 with FA or FA-like features. This form is 2 pages long and is a simpler version of the consent form. It should be reviewed will all children with FA between the ages of 7 and 18. If the child agrees to participate, he/she should sign and date where indicated on page 2. This form is also required for enrollment if the child is between the ages of 7 and 18.
- Pediatric Assent form for children ages 7-18 without FA or FA-like features This form is 2 pages long and is a simpler version of the consent form. It should be reviewed will all children without FA between the ages of 7 and 18. If the child agrees to participate, he/she should sign and date where indicated on page 2. This form is also required for enrollment if the child is between the ages of 7 and 18.
- HIPAA form. This is the Health Insurance Portability and Accountability Act form which is 3 pages. Again this form is required for each participant for enrollment. Individuals only need to complete page 3 of this form.
- When the participant is a minor, the parents should sign on the child's behalf. To do this, the child's name should be written on the bottom left line above "print name of participant". The parent should sign on the top left line and print his/her name on the middle right line. He/she should write in the date and indicate whether he/she is the mother, father, or other legal guardian.
- When the participant is an adult (with or without FA), he/she should sign sign and print his/her name on the left side and then date on the right. The last two lines on the bottom right can be left blank. Again parents of children with FA, are considered the participant themselves fur purposes of these forms.
- IFAR form (to be completed by MD/GC/Nurse) This is our medical history form. The referring physician, or a representative from his/her office, should complete this form as thoroughly as possible and attach any relevant test reports or medical records.
Release Forms (applicable forms needed for all new enrollments as well):
- Authorization to release research results. Since our lab is currently a research lab all results need to be confirmed in a CLIA-approved laboratory before being released. This release form is needed to facilitate this process. While it is preferable to have the participant sign this form at the time of enrollment to help expedite the process, it is not a requirement. To complete this form, the referring physician's name and information should be included where indicated. The participant's name(s) should be added, and one of the laboratories should be circled. Oregon Health and Science University and Prevention Genetics do the most confirmatory testing for FA and we would recommend one of these two labs be chosen. Lastly, the appropriate signature line should be used at the bottom depending on the age and legal guardianship status of the affected individual.
- Authorization to release clinical results. For all participants enrolled after 2009, this for does not need to be completed. This form is needed to release any results from clinical testing done in our lab before July 2009 (either DEB testing or molecular testing).
- Authorization to obtain annual records. While it is ideal to receive copies of any testing, clinic visit summaries, other medical records, after each visit, we recognize you are very busy and this may not be possible. As such, we have created this form to have more regular follow-up and better longitudinal data. If this form can be completed at the time of enrollment for all new participants with FA or FA-like symptoms that would be great. To complete this form, the referring physician's information and the participant's name should be completed where indicated. And then, the appropriate signature line should be used at the bottom depending on the age and legal guardianship status of the affected individual.
- Authorization to obtain past medical records
If you have any questions about the IFAR Enrollment Forms or Release Forms please contact Jennifer Kennedy at 212-327-8612.
Specimen Collection Instructions and Requisition Forms:
- Requisition form for all sample collection
- Instructions for collection and shipment of blood samples
- Instructions for collection and shipment of fibroblasts
- Instructions for collection and shipment of DNA or buccal swabs
If you have any questions about specimen collection please contact Francis Lach, Lab Manager, at 212-327-8862
The knowledge produced from our study is only as good as the information we receive from you. Thus regular updates are crucial. If you can send a copy of your clinic note to us after each visit that would be very helpful. It would also be very helpful to know about any major change in status such as transplant, serious illness, or death. Lastly we have completed an Annual IFAR Update Form. We will complete this as much as possible from the records sent, but may request completion of this form for more accurate patient information. Thank you for your help with this!
If you have any questions about the usage agreement please contact Agata Smogorzewska, Principal Investigator, at 212-327-7850.