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 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
All Groups
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”.
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)
Likely
These risks are expected to occur in
more than 20 out of 100 subjects.
Less likely
These risks are expected to occur in 520 subjects or less out of 100 subjects.
Not serious
Serious
None

Being randomized to an 
arm that is not as
effective
as
the
other.(may be in any
freq/severity block)
Not serious
Serious


None
None
Serious

Rare
These risks are expected to occur in
less than 5 subjects out of 100
Are all groups exposed to the risks listed above?
If No, Describe: [Describe here]
Yes
No
none
N/A (There is only one group)
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:
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
All Groups
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”.
No direct benefit to participating in the study (i.e., no research benefit) for subjects
randomized to the standard care arm
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)
Likely
These risks are expected to occur in
more than 20 out of 100 subjects.
Less likely
These risks are expected to occur in 520 subjects or less out of 100 subjects.
Not serious

None
Serious

None
Not serious
Serious


None
None
Serious

Rare
These risks are expected to occur in
less than 5 subjects out of 100
Are all groups exposed to the risks listed above?
If No, Describe: [Describe here]
Yes
No
none
N/A (There is only one group)
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.
Note there is occasionally a potential benefit to randomization when the experiment is designed to
decrease the potential for side effects usually seen in standard care
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
Experimental arm
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”.
Directly benefit of potentially fewer/less serious side effects for those subjects
randomized to the experimental arm
Standard care arm
No direct benefit to participating in the study (i.e., no research benefit) for subjects
randomized to the standard care arm
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)
Likely
These risks are expected to occur in
more than 20 out of 100 subjects.
Less likely
These risks are expected to occur in 520 subjects or less out of 100 subjects.
Not serious

None
Serious

None
Not serious
Serious

In this case it may be necessary to describe
risks that are theoretical or disclose that risks
are unknown if first time in humans. See
“Assessing potential risk frequency and
severity” in the main instructions document for
more detailed description of how to estimate
risk in a research study.
None
Serious

Rare
These risks are expected to occur in
less than 5 subjects out of 100
Are all groups exposed to the risks listed above?
If No, Describe: [Describe here]
Yes
No
none
N/A (There is only one group)
In this case it would also benefit you to describe the risks of the standard care procedure/drug
someplace in this section for comparison. See examples below:
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.
The last 2 are examples of tables that might be added when there is a potential benefit to randomization
when the experiment is designed to decrease the potential for side effects usually seen in standard care
Component 4
Experimental arm(drug/procedure)
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
Experimental arm
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”.
Direct benefit of potentially fewer/less serious side effects for those subjects
randomized to the experimental arm
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)
Likely
These risks are expected to occur in
more than 20 out of 100 subjects.
Less likely
These risks are expected to occur in 520 subjects or less out of 100 subjects.
Not serious

None
Serious

None
Not serious
Serious

In this case it may be necessary to describe
risks that are theoretical or disclose that risks
are unknown if first time in humans. See
“Assessing potential risk frequency and
severity”
None
Serious

Rare
These risks are expected to occur in
less than 5 subjects out of 100
Are all groups exposed to the risks listed above?
If No, Describe: [Describe here]
Yes
No
none
N/A (There is only one group)
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 4
Standard care arm (drug/procedure)
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
Standard care arm
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”.
No direct benefit to participating in the study for subjects randomized to the
standard care arm
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)
Likely
These risks are expected to occur in
more than 20 out of 100 subjects.
Less likely
These risks are expected to occur in 520 subjects or less out of 100 subjects.
Not serious

rash
Serious

None
Not serious
Serious



None
Severe Headaches
Visual disturbances (immediate and temporary)
Serious


Rare
These risks are expected to occur in
less than 5 subjects out of 100
Are all groups exposed to the risks listed above?
If No, Describe: [Describe here]
Yes
No
Lactic acidosis
Permanent liver damage
N/A (There is only one group)
Other risk examples:
Risks related to MRI
Claustrophobia:
Rare but not serious (1 out of 100). Being inside the MRI scanner with the padded head holder is
an unusual experience. For some people this situation will cause feeling of fear from being confined to
a small space (i.e., claustrophobia). People often report claustrophobic symptoms in the MRI scanner
because the walls of the machine are close to the person's face (about 8 inches away). We
encourage you to talk with scanner operators and study doctors who will help to calm any fears that
you may feel. If you experience severe anxiety during this study and do not feel reassured by the
staff, you may end the session by telling the operator. One person out of 100 people is unable to
complete the scan due to claustrophobia. The procedure can be stopped immediately if you
experience anxiety and you can be rapidly removed from the scanner.
Other MRI risks.
Rare but not serious (3 out of 100). Although there are no known short or long-term side effects
associated with the use of MRI, there is the possibility of unknown risks. No X-ray or radiation
exposure will occur. People with heart pacemakers cannot enter MRI areas because the magnetic
field can interfere with the function of the pacemaker. There is the potential risk that the machine itself
attracts ferrous (iron-containing) metal. You will be asked questions about your health and accident
history to determine if there is any reason you should not undergo the MRI. The machine is a powerful
magnet and, if the person undergoing the scan has some kinds of metal in their body (e.g., pins,
plates, metal clips, pacemakers), the metal might be attracted by the machine, and potentially cause
physical harm. However, such risks are rare and, when these risks happen, they are the result of
human mistakes (e.g., failure to exclude from participation individuals having metal in their bodies or
by personnel operating the MRI equipment not following proper procedures). Occasionally a person
may experience slight dizziness or other minor sensations during a MRI scan due to the magnet or the
loud noises that are part of the MRI scan. Approximately 3 in 100 people will feel anxiety in the MRI.
If you experience discomfort or anxiety during this study, you are free to tell us to end the session.