Risks and Benefits listed in examples are for example purposes only. See Form C instructions to details of how to analyze risks in a research submission.
Component 5 Efficacy Assessments (MRI/MUGA)List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
Group: / Direct Benefit: [State "None" (or insert direct benefit, secondary benefit, monitoring benefit)]
All Groups / Benefit to the community(or specify population)/Benefit of knowledge to be gained (philanthropic on behalf of the individual).
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Not serious / Serious
Likely
These risks are expected to occur in more than 20 or less out of 100 subjects. / **For MRI
- Claustrophobia
- None
Not serious / Serious
Less likely
These risks are expected to occur in 5 to 10 subjects or less out of 100 subjects. /
- None
- None
Serious
Rare
These risks are expected to occur in less than 5 or less subjects out of 100 / **For MRI
- The machine itself attracts ferrous metal. Metal or metal part in his/her body might move with force inside the body, potentially causing serious physical harm.
- Radiation exposure -small amount of radiation from tracer (about the same amount as two regular chest x-rays)
- Increase risk of getting cancer exposure -small amount of radiation from tracer
Are all groups exposed to the risks listed above? Yes No N/A (There is only one group)
If No, Describe: [Describe here]
Component 5
MRI
List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
All Groups / Direct Benefit: Safety Evaluation and Tumor assessment used for clinical care
(These represent a monitoring benefit and a direct clinical benefit – this is generally only the case when you are doing some MRIs as standard (representing clinical care) and some in addition for research purposes only which represent the increased monitoring)
All Groups / Benefit to the community(or specify population)/Benefit of knowledge to be gained (philanthropic on behalf of the individual).
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Not serious / Serious
Likely
These risks are expected to occur in 5 to 10out of 100 subjects. /
- No known long-term side effects
- claustrophobia
- None
Not serious / Serious
Less Likely /
- None
- None
Serious
Rare
These risks are expected to occur in less than 1 out of 100, 000 injections. /
- The machine itself attracts ferrous metal. Metal or metal part in his/her body might move with force inside the body, potentially causing serious physical harm.
Are all groups exposed to the risks listed above? Yes No N/A (There is only one group)
If No, Describe: [Describe here]
Risks and Benefits listed in examples are for example purposes only. See Form C instructions to details of how to analyze risks in a research submission.
Procedure or component 7Tumor biopsy OPTIONAL
List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
Tumor biopsy OPTIONAL – Only subjects who agree to this procedure / No direct benefit. Hopefully the knowledge learned from this testing will better help understand how the disease affects the proteins in the body/blood.
or this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Not serious / Serious
Likely
These risks are expected to occur in more than 20 out of 100 subjects. /
- none
- none
Not serious / Serious
Less likely
These risks are expected to occur in 5-20 out of 100 subjects. /
- pain
- inflammation
- bleeding
- swelling
- infection at the site where the sample is removed
- none
Serious
Rare
These risks are expected to occur in less than 5 subjects out of 100 /
- rare possibility (about 1%) of tumor cells spreading from the tumor into the nearby area
Are all groups exposed to the risks listed above? Yes No N/A (There is only one group)
If No, Describe: N/A
Procedure 5
CT scan
List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
All subjects / Direct Benefit: Determine disease progression as part of standard care
(These represent a standard care clinical benefit – note this one did not add increased monitoring probably because no CTs were research only on the component list)
All Subjects / Benefit to the community(or specify population)/Benefit of knowledge to be gained (philanthropic on behalf of the individual).
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Not serious / Serious
Likely
These risks are expected to occur in 5 to 100 out of 100 subjects. /
- Metallic taste or warm feeling in the mouth
- None
Not serious / Serious
Less likely
These risks are expected to occur in 5 - 20 [or insert different range] subjects or less out of 100 subjects. /
- None
- None
Serious
Rare
These risks are expected to occur in less than 5 subjects out of 100 /
- Allergic reaction
- CT scan solution can cause damage to kidneys, especially if the subject is diabetic, dehydrated or elderly.
Are all groups exposed to the risks listed above? Yes No N/A (There is only one group)
If No, Describe: [Describe here]
Risks and Benefits listed in examples are for example purposes only. See Form C instructions to details of how to analyze risks in a research submission.
Efficacy AssessmentsCT Scan
And MRI Scan
List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
All Subjects / Direct Benefit: Determine disease progression as part of standard care
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Not serious / Serious
Likely
These risks are expected to occur in more than 20 out of 100 subjects. /
- None
- None
Not serious / Serious
Less likely
These risks are expected to occur in 5-20 subjects or less out of 100 subjects. /
- None
- Claustrophobia (MRI Scan and CT Scan)
- None
Serious
Rare
These risks are expected to occur in less than 5 subjects out of 100 /
- Allergic reaction to contrast (MRI Scan and CT Scan)
- Rare risk of developing a new cancer from standard care interval radiation used in this study. (CT Scan)
- Injury and/or death due to sudden movement of metals in the body (MRI Scan)
Are all groups exposed to the risks listed above? Yes No N/A (There is only one group)
If No, Describe: [Describe here]
Risks and Benefits listed in examples are for example purposes only. See Form C instructions to details of how to analyze risks in a research submission.
Procedure or component 3Safety Assessment[c1]
List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
All subjects / Direct Benefit: Increased monitoring contributing to subject safety
All Subjects / Benefit to the community(or specify population)/Benefit of knowledge to be gained (philanthropic on behalf of the individual).
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Do not delete frequency. The need to know what to report promptly later = a requirement to estimate frequency (Instructions).
[c2] / Not serious / Serious
Likely
These risks are expected to occur in more than 20 out of 100 subjects. / **From Blood Collection
- pain
- bruising
- None
Not serious / Serious
Less likely
These risks are expected to occur in 5-20 subjects or less out of 100 subjects. / From Blood Collection
- dizziness
- None
Serious
Rare
These risks are expected to occur in less than 5 subjects out of 100 / From Blood Collection
- infection
Are all groups exposed to the risks listed above? Yes No N/A (There is only one group)
If No, Describe: [Describe here]
Note that sometimes the risk of fainting is not listed as a rare but serious risk, for example if subjects are already bed bound by the study design the risk is rare and not serious so not listed.
Component 5 & 6Venipuncture
Pharmokinetics
List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
All Groups / Safety evaluations provide increased monitoring as a benefit to participation
PK testing / No direct benefit. Hopefully the knowledge learned from this testing will better help understand how the disease affects the proteins in the body/blood.
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Not serious / Serious
Likely
These risks are expected to occur in 5to 100 out of 100 subjects. /
- Pain
- Swelling
- Bruising
- Bleeding where the needle is inserted
- None
Not serious / Serious
Less likely
None /
- Dizziness
- None
Serious
Rare
These risks are expected to occur in less than 5subjects out of 100 /
- Fainting
- Infection where the needle is inserted
Are all groups exposed to the risks listed above? Yes No N/A (There is only one group)
If No, Describe: [Describe here]
Risks and Benefits listed in examples are for example purposes only. See Form C instructions to details of how to analyze risks in a research submission.
Procedure or component 2PET[i3]
List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
All study groups / None direct benefit to the individual. Benefit to future medical science is significant in allowing the use of MRI in diagnosis and monitoring treatment of disease.
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Not serious / Serious
Likely
These risks are expected to occur in more than 20 out of 100 subjects. /
- Pain during placement or arterial catheter.
- None
Not serious / Serious
Less likely
These risks are expected to occur in 5-20 subjects or less out of 100 subjects. /
- .
- Uncomfortable from lying still for 2-3 hrs for the PET procedure
- Infection at the site of IV insertion
Serious
Rare
These risks are expected to occur in less than 5 subjects out of 100 /
- cancer from the radiation dose received from the injected radioactive water (H215O)
- Obstruction in the artery during arterial catheter. Pseudoaneurysm with arterial catheter.
- PET procedure: claustrophobia, (incidence of one per 500 subjects) bruising at the site of IV catheter insertion.
Component 4
Randomization
List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
All Groups / Possible improvement of disease.
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Not serious / Serious
Likely
These risks are expected to occur in more than 5 out of 100 subjects. /
- Being randomized to an arm that is not as effective as the other.
- None
Not serious / Serious
Less likely /
- None
- None
Serious
Rare
These risks are expected to occur in less than 5 subjects out of 100 /
- none
Are all groups exposed to the risks listed above? Yes No N/A (There is only one group)
If No, Describe: [Describe here]
Note there is not always a benefit to randomization and the risk may not be present if randomizing to two different standard care drugs or procedures for example.See other Examples and explanation about Randomization as a procedure in Example 3
Risks and Benefits listed in examples are for example purposes only. See Form C instructions to details of how to analyze risks in a research submission.
Procedure or component 1MRI plus contrast (Gd-DTPA) or Gadodamide
List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
All subjects / No direct benefit to individual. Benefit to future medical science is significant in allowing the use of MRI in diagnosis and monitoring treatment of disease.
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Not serious / Serious
Likely
These risks are expected to occur in more than 20 out of 100 subjects. /
- None
- None
Not serious / Serious
Less likely
These risks are expected to occur in 1 subject or less out of 100 subjects. / The following are due to contrast agent:
- Discomfort,
- tingling or warmth in the lips,
- metallic taste in the mouth,
- tingling in the arm,
- nausea,
- headache
- anxiety
- claustrophobia.
- None
Serious
Rare
These risks are expected to occur in less than 1 subjects out of 300,000 / . /
- Allergic reaction to the contrast agent
- Harm due to metal in the body moving due to MRI. Heart pace maker damaged due to MRI
Are all groups exposed to the risks listed above? Yes No x N/A (There is only one group)
If No, Describe: [Describe here]
Risks and Benefits listed in examples are for example purposes only. See Form C instructions to details of how to analyze risks in a research submission.
Procedure or component 4Radiological exams (all subjects)
List each group exposed to this procedure on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects / For each group, list the benefits of this procedure (either the procedure or a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
MUGA, skeletal survey, CT scan, dental x-ray / MUGA – to assess heart function
Skeletal survey and CT – to assess disease and it’s affect on the bones
Dental x-ray – to assess oral health and any evident issues with regards to teeth health (possibly caused by calcium levels in the body)
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Do not delete frequency. The need to know what to report promptly later = a requirement to estimatefrequency (Instructions).
Not serious / Serious
Likely
These risks are expected to occur in more than 20 out of 100 subjects. / MUGA / CT From needle insertion:
- pain
- inflammation
- bleeding
- swelling
Not serious / Serious
Less likely
These risks are expected to occur in 5-20 subjects or less out of 100 subjects. / CT / MUGA:
None to date
Dental x-ray:
Mild discomfort from the procedures / CT / MUGA:
- Infection at blood draw site
- Allergic reaction to the contrast
Serious
Rare
These risks are expected to occur in less than 5 subjects out of 100 / CT Scan and/or MUGA:
- You may feel some discomfort or anxiety when lying inside of the scanner. The contrast material (dye) that is injected into your body may cause rare side effects, including allergic reactions or nausea.
- Rare risk of developing a cancer from standard care interval radiation used in this study. (CT Scan)
Are all groups exposed to the risks listed above? Yes No N/A (There is only one group)
If No, Describe:
Risks and Benefits listed in examples are for example purposes only. See Form C instructions to details of how to analyze risks in a research submission.