SECTION 2: HUMAN STUDIES AND SAFETY

Alex Kilger RN BS
Adminstrative Director
215-349-5470
Alex.kilger@uphs.upenn.edu

PURPOSE

GUIDELINES

Facility
Scanner Safety
Facility Safety
Human Subjects Classification

Human Studies on HUP5/6
TECHDEV Studies & applications
TECHDEV volunteers
TECHDEV pregnancy issues
Research Pulse Sequences and Coils
Human Clinical Studies
IRB Review guidelines
Gadolinium Requisites
Pregnancy Issues
Consent guidelines
Stents and the 3T
Invasive vs Non-invasive definitions
Pediatric Subjects
MRI Scan Rates
Research vs Family Accounts

Animal studies on HUP 5/6
Specimen studies on HUP 5/6

CAMRIS AND INSTITUTIONAL OVERSIGHT OF RESEARCH

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PURPOSE:This document describes the guidelines that must be followed by all groups who will have access to the Research Scanners and Research Equipment. It is the policy of CAMRIS to maintain a safe environment and to promote a conscientious approach to research projects and developments. The first section will describe facility safety. The subsequent sections will describe Human and Animal safety HUP5/6

GUIDELINES

1) Facility:
CAMRIS currently operates two clinical MRI scanners fully dedicated for research protocols, a 1.5 Tesla Siemens Sonata (HUP5) and a 3.0 Tesla Siemens Trio (HUP6). CAMRIS is also responsible for two MRI Scanners that are 50% dedicated for research a 1.5T Siemens Avanto and a 3T Siemens Tim Trio, both located in the Devon MRI facility. Extensive expertise in pulse programming and radiofrequency coil design is available. Access to research scanners requires IRB regulatory approval and CAMRIS oversight approval.

2) Magnet Safety
Magnetic Resonance imaging is a diagnostic technology that uses magnetic energy and radio waves to crate cross-sectional images of the body. The magnetic force generated by MR scanners may present an unusual safety hazard to patients, visitors and staff.

The MRI magnet has a very strong attraction to ferro-magnetic items such as iron and other metals. Oxygen tanks, wheelchairs, stretchers, mop buckets and hand tools are all examples of metallic items that should never be brought into close proximity to the magnet. The magnetic attraction is so strong that items such as these can be drawn into the center, or bore, of the magnet resulting in injury to a person and damage to the magnet.There are numerous case histories in healthcare of said items being "pulled" out of the user's hand ( flying objects clause) and drawn into the magnet. It has been estimated that the weight of the item increases 100 fold as it is being pulled into the core. Thus a 15 pound item will now have a force and weight of a 1500 pound item.

Do not make assumptions about devices or equipment being safe. For example, "sandbags" can sometimes contain metallic pellets instead of sand. Err on the side of caution. Unless a device or piece of equipment has been proven to be MRI safe, do not bring it into the MRI areas.

The magnetic field is also strong enough to affect the magnetic strip on credit/debit or ATM cards rendering them useless. The magnetic field also affects pacemakers and hearing aids.

Keep in mind that these units are ALWAYS ON. Once energized, the magnetic force is always present and thus the attraction for metallic

3).Facility Safety

All groups using the facilities after-hours and weekends will have at least one member present during all scanning sessions who has been approved for operating the unit by the Manager of that facility. The approval process involves training by the facility manager or their designate.

Training will include, but not be limited to: emergency procedures - including safe machine shutdown, working within Machine and FDA limits, maintaining records of machine usage, machine performance,malfunctions and providing a safe working environment. In addition, approved users must view the relevant safety films, read and sign off that they comprehend the policies and procedures related to their research (human, animal, phantom, hardware, software, etc.). Additional training may be required in order to be authorized by a facility director to perform studies on human subjects.

The approved operator must also demonstrate to the facility manager that they are capable of initiating the following emergery responses;

In situations involving clinical emergencies or major equipment failure, patient care studies will have priority over research studies.

Under NO circumstance is the CRASH CART to be disturbed or unplugged. The red electrical outlet ouside of the HUP5 scanner is not to be used for anything other than the defibrillator.

Supplies for non-human research are not to be taken from the clinical research supplies. All cabinets used during the day will be locked during the evening and weekend hours.

All groups are responsible for ensuring that all who are present follow routine safety precautions with regard to metal objects, implanted devices, foreign bodies, etc. It is required that a trained member of the group review this with new participants prior to entering the console area. No one should enter the scanner areas without having been cleared by the responsible member of the team

4) Human Subjects Classification

The CAMRIS committe has divided research involving human subjects into four categories

Category 1: limited human scanning for testing and optimization of new experimental pulse sequences and/or coils under a global "technical development" (TECHDEV ) protocol. Not for acquisition of preliminary data. Stamped consent forms have been made available under Mitch Schnall IRB approval for use.

Category 2: studies conducted on normal volunteers for the purposes of a final "tweaking" of protocols and/or acquisition of preliminary data ( pilot studies). Investigators must provide their own "normal subjects" consent form.

Category 3: research studies carried out on patients and/or control groups. However the study design does not include the use of the MRI data to guide clinical decisions and there is no treatment component of the protocol. Investigators must provide their own consent forms

Category 4: Clinical trials: Studies are carried out on patients and/or control groups. The study results are used to guide clinical decisions and/or treatment as part of the study protocol. Investigators must provide their own consent forms

All persons, categories 1, 2, 3 and 4 must be part of a IRB approved Human Use protocol and every subject must sign an IRB approved consent before entering the Magnet.

Category 1 studies are free after-hours and on weekends.
Category 1 studies do not require use of a MR Technologist, and can be scanned by an approved user.
Category 1 volunteers/subjects do not need to be registered and entered into the IDX system.

Categories 2, 3 and 4 must have a MRI Service Center Account Code and will be billed.
Categories 2, 3 and 4 a MRI technologist must be used to ensure that all of the screening and safety procedures involved in conventional MRI scanning are followed
Categories 2, 3 and 4, all persons, whether they are healthy walk-in volunteers, normal subjects, outpatients or inpatients participating in research studies and/or clinical trials using HUP Radiology facilities must have medical record number (MRN) and be entered into the IDX system.

Human Studies on HUP 5/6

1) TECHDEV Studies

APPLICATIONS
Technical Development time is free after 7 PM and on weekends. TECHDEV's are typically phantom experiments of limited scope. Limited human scanning is allowed to further access the results of experimental pulse sequences and/or coils.

A one page written proposal must be submitted to the CAMRIS committee for review. The PI's of all approved proposals will then be added as sub-investigators to the TECHDEV protocol. The PI's will then be responsible for providing yearly updates of their research progress. A listing of all approved projects will be posted by each Scanner. Nobody is permitted to do research under the TECHDEV Protocols unless their project is on the list.

A global Human Use approval letter and consent form has been made available under Mitch Schnall's IRB approval to use for technical developments involving limited human scanning at the 1.5T and 3T Scanners. A consent form and case report form must be filled out for each scanning session. These forms are available by each scanner.

Records of all the current ongoing and approved PSD's, SAR justifications and protocols will be maintained by the HUP5/6 Technical staff and each PI must keep their own on file.

Consent forms and case report forms will also be maintained by the HUP5/6 Staff as well as by the Investigators.

All Investigators must show evidence of completing the University's Teaching Module on Human Studies Research. The certification must accompany the written proposal.

The on-line POR training modules can be accessed by visiting <www.med.upenn.edu/ohr >and clicking on the POR Certification quick link found on the right side of the screen.

2) TECHDEV Volunteers

Scanning of Volunteers under the TECHDEV protocols may be performed by CAMRIS technologists or users authorized by the Facility Manager. All volunteers imaged under this protocol must come from one of the MR labs in the University designated as "study population". Subjects must be healthy and at least 18 years of age, who are involved in MRI technique development, who are knowledgeable about MRI, and who have been scanned previously by a technologist. Note: Under the guidelines of the Human Use committee of the University of Pennsylvania, individuals who are subordinates of the investigator cannot be used as volunteers for that individual's studies. Thus, Investigators cannot use their own students, postdoctoral or clinical fellows or even medical students on rotation as subjects for any of their own studies. <NIH Guidelines>

3) TECHDEV PREGNANCY ISSUES

Technical Development questionnaire and Consent form explicitly state the need for all normal female subjects of child bearing age to take a urine pregnancy test prior to their participation. If you need access to urine pregnancy tests please let one of the Technologists know and one will be made available. As of this date the pregnancy "disclaimer" does not exist.

Research Pulse Sequences and Coils

All research pulse sequences and coils that are to be used on human subjects must be approved by the CAMRIS committee. .Research pulse sequences include those written at HUP or any other institution or corporation. The only sequences that are exempted are those provided by the manufacturer as "product" and are used within the parameters and protocols for which they were developed. Overriding the design of a product sequence using "control variables" requires CAMRIS approval. Modification of any aspect of an approved sequence requires CAMRIS re-approval. Additionally, disabling of the RF power monitor is prohibited.

Research coils include those built at HUP or other institutions. The only coils that are exempted are those provided by the Scanner Manufacturer (ex; SIEMENS / GE) as "product" and are used within the parameters and protocols for which they were developed. Overriding the design of the product coil requires CAMRIS approval. Modification of any aspect of an approved coil also requires CAMRIS approval.

Human Clinical Studies

Authorization for performing studies in categories 2, 3 and 4 must be obtained from the CAMRIS committee. You must submit an application form, along with a copy of the IRB approval letter, dated consent form, MRI Protocol, IRB Face Sheet, condensed version of the Protocol and a copy of the entire protocol. For forms and additional guidelines < Human and Animal Studies HUP5/6 >. A monitoring plan must be submitted for all NIH/NCA studies. For all category 4 uses (clinical trials) an external monitor must be part of the monitoring plan (this may include monitoring by the Cancer Center, etc.).

For all categories 2, 3 and 4, a MRI technologist must be used to ensure that all of the screening and safety procedures involved in conventional clinical MRI scanning are followed. All persons entering the instrument will be re-checked for metallic objects and provided with hearing protection. Each request should designate a board certified radiologist within the HUP Radiology department as the "contact person" for the study. A licensed physician should be in the MRI facility when the study is being performed. This need not be a member of the study team.

All persons, whether they are healthy walk-in volunteers, normal subjects, outpatients or inpatients participating in research studies and/or clinical trials using HUP Radiology facilities must have a medical record number (MRN) and be entered into the DECRAD system. Please note: TECHDEV Investigators and volunteers are exempt and do not need to be registered or entered into the DECRAD system. Limited human scanning is allowed to further access the results of experimental pulse sequences and/or coils.

All Faculty and staff involved in the conduct of human subject research - either through direct patient contact, use/development of human materials or survey research must complete the School of Medicine Patient Oriented research Training Modules. The SoM recently finalized many updates, upgrades and improvments to the system.
Those with existing School of Medicine POR certification will need to complete the new POR certification program before your current certification expires
Those without existing or expired School of Medicine POR certification must successfully complete the on-line POR certification before submitting any human research studies to CAMRIS AND the Penn IRB.
The on-line POR training modules can be accessed by visiting <www.med.upenn.edu/ohr >and clicking on the POR Certification quick link found on the right side of the screen.

All research groups using the facility for studies on humans will have at least one member of the group trained in Cardiopulmonary Resuscitation (CPR) and present during scanner sessions. The scanning technologist is considered part of the group. The CPR certification should be renewed annually. This policy is to allow skilled delivery of emergency care while the hospital code team is en route. The CAMRIS Committee will maintain a file of the certificates. It is the responsibility of the individual to maintain current status. Courses are given regularly here at the hospital and elsewhere.

STUDENTS AND fMRI's The CAMRIS committee expressly forbids giving class credits to students for participation in a fMRI scan as part of a class project. This determination falls under the same policy intent that says a PI can't coerce his own lab staff to be a scan subject. < NIH guidelines > Instructors can give extra credit for observing a fMRI scan and/or participation in other routine cognitive testings.If a student would still like to be a volunteer in an fMRI study on their own, outside of the classroom and for another investigator, they may do so.

If during a research study an unexpected abnormality is incidentally observed during the MR part of the examination, the investigator should contact the "contact" Radiologist. The Radiologist should review the results and advise the investigator on a course of action. This report should be formally documented in the radiology information system.

All groups are responsible for maintaining security and restricting unwarranted access to the facility. This includes basic safety in the scanner area during use and securing the facility when not in use. If a problem arises with an unauthorized person or persons, scanning should stop and hospital security notified.

Non-FDA approved devices can only be used following designation as non-significant risk by the IRB and approval by CAMRIS. Coils and pulse sequences must be approved according to the relevant CAMRIS policies. There must be reference in the protocol and consent forms to non significant risk investigational devices. Devices and sequences to be used for applications which exceed the FDA's guidelines must be under an IDE from the FDA as well as having approval from the IRB and CAMRIS.

No formal reports are provided for Research MRI's unless the Investigator has a Radiologist "on board" who will take responsibility for the interpretation and dictation of a report through the DECRAD information system. This Radiologist must be listed as a sub-investigator or a co-investigator of that particular protocol.

Each research group will be responsible for screening for metallic foreign bodies in subjects considered "at-risk" by their responses to clinical screening. The research group has the choice of either excluding a subject who answers yes to questions related to potential intra-ocular metal or to further evaluate by ordering orbital plain films. The research group is then responsible for obtaining and if necessary, paying for this examination. If this is done outside of the University of Pennsylvania, the films must be reviewed by a radiologist at the University of Pennsylvania prior to scanning. A second screening will take place before entering the Magnet Room by the technologist

Human Venipuncture / injection can only be performed by RN’s, PA’s, MD’s and others credentialed by the hospital for these procedures.

All MR imaging protocols utilizing one of our in-stock and pre-approved IV contrast agents must send a prescription for the contrast for each subject being scanned. The MD prescribing the contrast agent must be the Investigator, a co-investigator or a sub-investigator.

Data Analysis: Describes the investigator's plan to analyze the data such that a conclusion can be drawn. We look for no specific details, but a plan for statistical analysis of the data to correlate with the purpose of the study and/or experiment involving human subjects. For small studies of limited risk, a short description of the analysis plan is sufficient, while some of our more involved Drug studies may have up to 10 pages.

"RISK-BENEFIT" Ratio: In the beginning ( CAMRIS: 1999) , we would just review the SAFETY aspect of the study, but now within the past year ( 2002-2003) , as part of our ever growing responsibilities (see the new IRB FACE SHEET), we are now reviewing the RISKS and BENEFITS of human studies involving MRI scanners.

IRB REVIEW GUIDELINES
EXEMPT REVIEW
a) Reader studies in which the images are certified as de-identified
b) Anonymous or de-identified specimen studies

EXPEDITED REVIEW
a) Non-contrast MRI studies
b) Functional MRI studies
c) MR spectroscopy studies

FULL BOARD REVIEW
a) MRI with IV contrast studies
b) MRI with sedation
c) MRI needle locs and needle core biopsies

GADOLINIUM REQUISITES

All patients receiving a gadolium-based house stock injection for research studies must have a prescription for the Contrast Agent signed by a licensed physician. The MD prescribing the contrast agent must be either the Investigator, a Co-Investigator or a Sub-Investigator. You may use the physician's own scripts or get blank scripts from CAMRIS. No patient will have a Contrast Agent administered if a script is not completed, signed and submitted prior to the examination.

6) Pregnancy Issues

As per Joe Sherwin and new IRB guidelines, it has been deemed that "regulations require us to exclude pregnant women unless there is direct benefit and the study can not be done in any other way". For most uses of MRI in diagnostic research we have the direct benefit component. However, in low risk fMRI studies we have trouble meeting the federal requirements that there be direct benefit. Moreover, because these studies do not particularly target pregnant women we have no other option than to exclude them even though the risk to both women and fetus is minimal.

The above pregnancy excusion guidelines are applicable to all functional studies, all TECHDEV's and to all normal volunteers. All other routine noncontrast MRI studies to use the nonrestrictive pregnancy statement. ( see below)

CAMRIS POLICY STATEMENT: There are no known risks of MRI on pregnant women or the fetus.Therefore routine, non-contrast, imaging protocols at 1.5T and 3T scanners need not exclude pregnant women if there is any possibility that the women may benefit from the research. This ensures that we are not discriminating against pregnant women by denying them the potential benefit. However, these women should be informed that there is a possibility of a yet undiscovered pregnancy related risk and a pregnancy test could be made available to them to help them make an informed decision whether or not to participate.If there is no chance that pregnant women could benefit from research, current federal guidelines require that these women be excluded even if there are no established risks of MRI. As per CAMRIS policies, a negative urine pregnancy test will be mandated before a a woman of child bearing potential can be studied under a protocol that excludes pregnant women.

Updated templates for use in consents and study protocols
a) "There are no known risks of MRI on pregnant women or a fetus.Therefore routine, non-contrast, imaging protocols at 1.5T and 3T scanners need not exclude pregnant women if there is any possibility that they may benefit from the research. However, these women should be informed that there is a possibility of a yet undiscovered pregnancy related risk and a urine pregnancy test could be made available to them to help them make an informed decision whether or not to participate".

b) "Although there are no known risks of MRI on pregnant women or a fetus, there is a possibility of yet undiscovered pregnancy related risks. Since there is no direct benefit from participating in this protocol for a pregnant woman, we will exclude pregnant women. A negative urine pregnancy test will be mandated before a woman of child-bearing potential can participate in this study".

c) "Gadolinium-based IV contrast agents are not approved in pregnant women and they are to be excluded from such trials. A negative urine pregnancy test will be mandated before a house stock contrast can be administered to a woman of child bearing potential".

ADDITIONAL NOTES
Urine pregnancy tests can be obtained from Norman Butler ( HUP5/6) if you do not have access to kits from other sources. Pregnancy testing must be done within 24 hours prior to the MRI to be considered acceptable.

Criteria for "women of child bearing potential" definitions: To exclude or not to exclude from mandatory pregnancy testing clauses. Applies to all females from the ages of 11 and up.

POLICY REVIEW: CONSENTING SUBJECTS
Under no circumstances....can a TECHDEV, PRODEV, normal subject, control subject, research subject, etc. etc. be scanned in one of our research scanners without a signed consent. This is considered a serious Protocol violation

Excerpt from PennManual.
Protocol Violations:
"Serious variances to the protocol have the potential to change the risk/benefit ratio, the validity of the study results, or a subject's rights or well-being. When such a variance occurs and prospective approval was not obtained, this is then considered a Protocol Violation."

"Examples of protocol violations include: subjects enrolled who did not fulfill eligibility criteria, failing to obtain informed consent, confidential information disclosed, enrolling subjects during a lapse in IRB approval, conducting unapproved research tests or procedures, and administering investigational medications in a manner not specified in the study protocol."

"The IRB should be notified of any protocol violations promptly after the violation is discovered. The investigator should include a detailed plan of how to prevent serious protocol violations from occurring in the future. If necessary, the IRB has the authority to intervene by terminating approval for the project or suspending an investigator for extremely serious or repeated non-compliance issues."

7). Human Subjects Consent Guidelines.

A) Flying objects clause must be added to the consent form as a RISK factor. (May use a variation)

"The known risks associated with this study are minimal. The greatest risk is a metallic object flying through the air toward the magnet and hitting you. To reduce this risk we require that all people involved with the study remove all metal from their clothing and all metal objects from their pockets. No metal objects are allowed to be brought into the magnet room at any time. In addition, once you are in the magnet, the door to the room will be closed so that no one inadvertently walks into the magnet".

B) Since the upcoming Siemen's 3T is considered a "standard Clinical scanner", this does not need to be added as such on the consent form. However, if you want, you may state that this study is being performed on a "standard clinical scanner operating at 3 Tesla"

Note: if your consent form currently states that the study is being done on a 1.5 Tesla Scanner, you cannot use the 3 Tesla scanner unless you modify the consent. However, if your current consent form states this study is being done on a "Magnetic Resonance Scanner," (nonspecific) then you can use either.

C) Non-FDA approved devices can only be used following designation as non-significant risk by the IRB and approval by CAMRIS. Coils and pulse sequences must be approved according to the relevant CAMRIS policies. There must be reference in the protocol and consent forms to "non-significant risk investigational devices".

"Some of the imaging sequences and/or RF coils are not FDA approved but are considered non-significant risk investigational devices"

D) Targeted enrollments:
The number of subjects to be recruited as part of your study needs to be stated in both the consent and in the study protocol.
The number of MRI's each subject will undergo for resarch purposes needs to be stated in both the consent and in the study protocol.
The length of time each subject is to be in the study needs to be stated in both the consent and in the study protocol

E) IV Contrast Risks and Procedures Clauses
1) Updated IV Contrast RISK statement
"There is a risk that multiple needle-sticks will be necessary in order to ensure proper placement of the Intravenous line. There is a small risk of infection at the site the catheter is placed or there may be a small amount of pain or bruising associated with the placement of the Intravenous catheter. The FDA approves the Imaging agent ( Gadolinium) given for this research project for use with human participants and does not recognize any major risks asociated with its use. Some patients ( less than 3%) may experience mild nausea and/or headache after the injection: however these side effects usually resolve themselves without need for treatment. There is a very low risk of allergic reaction ( less than 1% including a reaction at the injection site, hives and/or difficulty breathing) to gadolinium.

2) Updated IV Contrast procedure statement
: "A small catheter will be placed into a vein in your forearm before your MRI. The Intravenous line will be used for the injection of Gadolinium"

F) TO GAD OR NOT TO GAD:
Investigators to decide if subjects can or can not participate their MRI study if they cannot receive gadolinium due to moderate to severe renal disease (or those with a creatinine clearance level of less than 30)

CONSENTS
a) If the investigator decides that such subjects cannot participate in the MRI study unless they can also receive contrast then you need to modify your consent by adding "moderate to severe renal disease" under the EXCLUSION criteria.

b) If the investigator decides that such subjects are still eligible to participate but only for the noncontrast MR portion of the study, then you need to modify your consent under RISKS to reflect that those with moderate to severe renal disease will not undergo the dynamic portion of the study.

"subjects with known moderate to severe renal disease will not undergo the contrast portion of this study"

STUDY PROTOCOLS
a) If the investigator decides that such subjects cannot participate in the MRI study unless they can also receive contrast then you need to modify your study protocol by adding "moderate to severe renal disease" under the EXCLUSION criteria.

b) If the investigator decides that such subjects are still eligible to participate but only for the noncontrast MR portion of the study, then you need to modify your study protocol under RISKS to reflect that those with moderate to severe renal disease will not undergo the dynamic portion of the study. ( but with a little more detail)

In light of recent reports of a possible risk of nephrogenic systemic fibrosis (NSF, also referred to as nephrogenic fibrosing dermopathy or NFD) occurring following administration of a Gadolinium-based contrast agent, subjects with known moderate to severe renal disease will not undergo the dynamic portion of this study"

G) Incidental findings clause

“There is also a risk that during the course of this study*, an unexpected abnormality may be observed in your MRI scans, even though the scans are not intended for diagnostic purposes. These abnormalities are termed “incidental findings.” Most incidental findings have no significant health consequences, but in a small percentage of cases further evaluation or treatment may be indicated. If an incidental finding is noted in your image data, you will be notified of it and given a written report describing it. It will then be up to you to pursue it with your physician. Although study personnel may be able to provide some advice, the decision of whether and how to pursue an incidental finding can only be made by your physician who has knowledge of your medical history”.

*( this includes the data analysis portion, not just the scanning portion as an abnormality would probably not be noticed at the console)

For additional information < Consent Guidelines >.

8) Stents and the 3T

CAMRIS recognizes that intraluminal stents are becoming extremely common, and that there is relatively little formal data or standards regarding the safety of these devices specifically at 3 Tesla. The safety issues raised included mechanical torque on the device and interaction with the RF pulses resulting in heating. With respect to the torque issue, it was felt that since the standards typically applied at 1.5 T to qualify a stent at MRI safe are conservative and that the torque increase linearly with field strength. Therefore there was a general consensus that devises listed as compatible at 1.5 T, can be considered safe with respect to mechanical torque at 3T unless otherwise specified. There was however concern regarding potential heating, given that some stents begin to approach sizes that are a signficiant fraction of a wavelength at 3 T.

Therefore the committee feels comfortable approving the inclusion of patients with stents that satisfy ALL 3 following conditions:
1. labeled safe at 1.5 T
2. no specific data is available indicating the device is incompatible at 3T
3. where the transmit RF field is created by a local coil and is not targeted to the anatomic location of the stent (for example a coronary stent with a head transmit coil).

All other cases will have to be reviewed on a case by case basis.

8) INVASIVE vs NON-INVASIVE DEFINITIONS (1-31-05)
a) non-invasive: Procedures which do not disrupt the intergrity of the body. A non-invasive procedure does not require the insertion of an instrument or an apparatus into the human body.
b) invasive: A procedure which disrupts the integrity of the body. An invasive procedure usually involves inserting an instrument or an apparatus into the body.

MRI procedures

10). PEDIATRIC SUBJECTS ( healthy, unsedated, ambulatory)

a. Pediatric HUP code policies

The HUP code team is responsible for responding to any emergency medial incident - both adult and pediatric. Our code boxes contain equipment necessary for neonatal, pediatric and adult codes with all available sized airways, indotracheal tubes, IV caths, etc.

When a pediatric code is called, a senior emergency room resident and EMT respond with a pediatric resuscitation box. A nurse from the ICN also responds with a pediatric resuscitation box. The senior medical resident, anesthesia, pharmacy, respiratory therapist and nursing coordinator will also respond.

Employees can call a code on any hospital phone dialing C-O-D-E or 3333 and give the location: i.e. the building, the floor, the room and anything else specific.

b) Pediatric consent issues

Consent form must reflect that a parent or guardian is the one to give and sign the consent form.
"your child is invited to participate"....etc..etc..etc.....
"I voluntarily give my consent for my child to participate in this research study. I understand that I will be given a copy of this consent form"...etc...etc...etc

For healthy, ambulatory, unsedated pediatric outpatients, will need someone from the study group to accompany each patient. Should also be accompanied by a family member or guardian (someone who can give consent).

10) MRI Scan Rates

A) HUMAN CLINICAL TRIAL STUDIES: tech support mandated
$425.00 per hour for government/non-profit sponsored studies
$425.00 per hour for investigator initiated in-house clinical trials
$575.00 per hour for private industry sponsored clinical trials
$68.00 per 20 cc vial House stock Contrast

Note: only one subject per hour permitted.

RADIOLOGY OPTIONAL SERVICES
a) Coordinator Services $50.00 per scan
Includes services by a MR Research Coordinator (i.e., scheduling, monitoring, visits/audits, database entry and documentation ) for any research clinical trial not covered or supported by a grant/sponsor.

b) Reader Services $50.00 per scan
Includes MR Radiologist clinical expertise and reader services for any research clinical trial not covered or supported by a grant/sponsor.

PROTOCOL QUALIFYING/MONITORING FEE
In our continuing efforts to keep up with the current needs of the MR system users we have come across a gap in our ability to handle patients that are qualifying and recruited based on clinical studies. In these instances it is necessary for quality control during the clinical exam to help aid investigators with the following issues:

a) Consistent MR scanner - Some protocols require a scanner to be qualified via submission of a test scan. After the scanner qualifies all studies for that specific protocol must be done on that particular scanner.
b) Protocol Adherence - Protocol parameters and standards must be maintained and any deviations documented. All of the studies parameters have been judged to meet clinical care standard, but may have specific image requirements, positional standards, and/or time related restrictions
c) Data Management - qualifying patient studies will need data handled differently than the clinical standard. copies of anonymous images may be required.

A ‘Qualifying/Protocol Monitoring Fee” of $150.00 is in effect. This charge would be a one time charge for these efforts relating to a possible subject’s qualifying scan. We would then have follow up visits done as research scans with our commonly used charges. In instances where the Investigators will be continually using data from patients and continue billing their insurance the project will need to be billed each time a session uses this service.

PRODEV ACCOUNTS
Are Radiology Department Awards for 10 one hour slots ($4250.00). These are available to investigators who need preliminary data for future grant submissions. Will need to list the type of award and funding agency for grant submissions that will support this work in the future. Indicate the status of your propossal ( in preparation or submitted) for each potential funding source. To be used within one year of approval date. If house stock IV contrast agents are to be used, PI must provide a source of funding. NO CONTRAST AGENTS ARE SUPPLIED FREE.

TECH-DEV ACCOUNTS
no tech services provided. No cost after-hours and weekends

B) ANIMAL/SPECIMEN:
1) with tech support and during "prime-time hours"
$425.00 per hour for government/non-profit sponsored groups
$575.00 per hour for private industry/pharmaceutical companies

2) without tech support and after-hours.
Must pay for the first hour via a funded account or a prodev account then subsequent hours of that same session can be "no cost".( Note: a new day is a new session).

BILLING CODES
All accounts are set up with a billing code with access to an Investigator's FIN MIS number for that particular study. At present there is no way to "bill" outside investigators even if they are collaborating with PENN Investigators. The only way an outside investigator can be billed is to "subcontract" with a Penn Investigator/Faculty. That Penn Investigator sets up a BEN 26 digit account which enables us to "bill". The Penn Investigator then "bills" the outside person.

For all questions reqarding billing practices may contact Laurie Cesaro <cesarol@uphs.upenn.edu > and/or Bill D'arcy < darcyw@uphs.upenn.edu > from our Radiology Research Business Office.

11) Research vs Family Accounts.

For clinical exams on patients (to be done on HUP 1-2-3-4, Devon and Penn Towers in which the only issue is billing, "Family" accounts can be arranged. Eligibilities include baselines and as requisites for enrollments in other clinical studies. Contact Beverly Farrar 215-662-7001 for authorization and CPT codes, Joe Paugh for discount technical fees, Betty Lou Ditz 215-662-3028 for professional discount fees. Arrangements are then made through Lorraine Spellman-Davis 215-349-8960 to set up the family account.

For special MR acquisitions (HUP 5, HUP6 and Devon 3T) to be performed as part of your Research Protocol, "Research" accounts can be arranged through Alex Kilger. Eligibilities include research pulse sequences and coils, data accumulation and transfer, spectroscopy, functional studies, etc. <alex.kilger@uphs.upenn.edu >

If there is a question of which account you qualify for, contact Alex Kilger for further details.

Service Center vs Family Account tech services:
If an investigator applies for and receives a SERVICE CENTER account for his research project involving MRI's, this allows the researcher to utilize our CAMRIS facilities and technical staff......at Discounted Research rates. Scheduling is through the SERVICE CENTER (HUP5) and scanning is done by the HUP5 techs.

All research projects/clinical trials are to be done on SIEMENS research magnets (HUP5, HUP6 and Devon 3T). Occasionally, by request of the sponsor, we allow use of a GE magnet to be substituted if this is requirement of the study protocol, When this happens, arrangements are still made through HUP5 scheduling and tech services.

An Investigator cannot use clinical techs on a clinical machine with a SERVICE CENTER account. If the investigator wishes to use clinical techs and clinical machine, he/she must cancel the SERVICE CENTER account and apply for a FAMILY ACCOUNT that will allow scheduling and services to utilize on HUP1, 2, 3, 4 and the Penn Tower Scanners.

ANIMAL STUDIES on HUP5/6

Application process:
a) completion of the 3 page CAMRIS approval form and MR protocol page.
b) copy of the study protocol
c) copy of the IACUC approval letter
d) For all animal studies a copy of the "Animal Transport Letter" which allows transport of animals within the University System (obtainable from Infection Control Office 215-662-6995 )
e) attach a list of the potential risks and the steps to avoid them

Studies involving sheep: In addition to the standard travel letter obtained from Infection Control a statement must be put in ensuring that the sheep are negative for "Q" fever.

MRI RATES:
$425.00 per hour for government/non-profit sponsored groups
$575.00 per hour for private industry/pharmaceutical companies

For funded and tech supported studies. Must pay for each hour the scanner is in use. Animals are to be scheduled after all human scanning is done (late afternoon/early evening) to prevent collisons with human subjects.

For non-tech support and after hours: Must pay for the first hour via a funded account or a prodev account then subsequent hours of that same session can be "no cost". ( note: a new day is a new session.) Experienced users and animal researchers may run their own scans.

RENEWALS:
Renewal applications are due every 1 to 3 years as per IACUC Guidelines. Notices to be sent out in a timely fashion

ANIMAL STUDIES: CAMRIS vs SAIF
All large animal investigators utilizing the 1.5T and/or the 3T scanner will continue to go through CAMRIS applications and policies. The 1.5T and the 3T are considered clinical standard magnets and CAMRIS regulates all research involving these magnets whether human, animal or specimen.

SAIF: Small Animal Imaging Facility
All small animal investigators who wish to utilize the 4.7T and/or the 9.4T scanner must now go through Sallie Livingston < sallie@mail.med.upenn.edu >for small bore applications and policies

Specimen studies on HUP5/6

SPECIMEN STUDIES REQUIREMENTS
SPECIMENS: HUMAN
a) completion of the 3 page CAMRIS approval form and MR protocol page
b) copy of the study protocol
c) copy of the "Claim of Exemption" and/or approval letter from the IRB
d) copy of the stamped consent ( if applicable)
e) attach documentation for obtaining the specimens. Note: If bringing in specimens from outside labs, a letter from Infection Control is required. Specimens coming from HUP's Pathology labs are considered "in-house" and can be scanned as such.

SPECIMENS: ANIMAL
a) completion of the 3 page CAMRIS approval form and MR protocol page
b) copy of the study protocol
c) copy of the regular animal form "A," as submitted to the IACUC, if as part of the protocol they will be euthanizing and harvesting tissues/organs/and body fluids from live animals.
d) or copy of the animal form "C,"as submitted to the IACUC, For investigators who want to use animal by-products ( fresh or frozen) obtained from other investigators. The Investigators may use tissues or individual organs of animals which were not exposed to infectious agents or chemical contaminants.
e) copy of the IACUC approval letter

MRI SCAN RATES
SPECIMEN: with tech support and during "prime-time hours"
$425.00 per hour for government/non-profit sponsored groups
$525.00 per hour for private industry/pharmaceutical companies

SPECIMEN: without tech support and after-hours.
Must pay for the first hour via a funded account or a prodev account then subsequent hours of that same session can be "no cost".( Note: a new day is a new session).

CAMRIS AND INSTITUTIONAL OVERSIGHT OF RESEARCH

The individual Facility Managers and the CAMRIS Committee will have the responsibility for seeing that the above safety procedures are carried out. If a safety problem exists, the facility director may take measures necessary including excluding a group from using the facilities and/or reporting violations of human and animal safety to the appropriate oversight committees.

updated 8-4-08 ak