Download FORM A - Research

Examples for IRB Forms
Table of Contents
Examples for IRB Forms ................................................................................................................ 1
Table of Contents ............................................................................................................................ 1
FORM A - 1 – Multipurpose Signature Assurance Sheet............................................................... 3
FORM A – Signature Assurance Sheet .......................................................................................... 4
FORM B – General Information ..................................................................................................... 5
FORM B-2 – Study Personnel List ................................................................................................. 6
FORM C – Research Description ................................................................................................. 10
FORM C-1 – Local Repository Description ................................................................................. 13
FORM D – - Consent Documents ................................................................................................. 14
FORM F – Waiver or Alteration of Consent ................................................................................ 16
FORM H-1 – Translation Certificate ............................................................................................ 17
FORM I – Application for Access to De-identified Data (or Specimens) .................................... 18
FORM J-1 – Assurance for Research on Decedent Information .................................................. 19
FORM J – HIPAA Waiver of Authorization ................................................................................ 20
FORM K – Pre-Notification Intent to Conduct Research at Another Institution ......................... 21
FORM N – Off-site_Research ...................................................................................................... 22
FORM O – Investigational New Drug .......................................................................................... 23
FORM O-1 – Approved Drug Unapproved Use ........................................................................... 24
FORM O-2 – Placebo ................................................................................................................... 25
FORM P – Investigational Device ................................................................................................ 26
FORM P-1 – Investigational Device............................................................................................. 27
FORM Q – Radiation Exposure Worksheet ................................................................................. 28
FORM R – Monitoring Participant Safety and Data Integrity ...................................................... 29
FORM T – Decisionally Impaired ................................................................................................ 30
FORM U – PregWomen Neonates Fetuses .................................................................................. 31
FORM V – Prisoners .................................................................................................................... 32
FORM W – Children .................................................................................................................... 33
FORM X – COI Report................................................................................................................. 34
FORM Y – Monitoring Plan - Lead PI ......................................................................................... 35
FORM A - 1 – Multipurpose Signature Assurance Sheet
FORM A – Signature Assurance Sheet
Example #1 - PI will conduct research on UTHSCSA official time, no Co-PI needed
Example #2 - PI will conduct research on VA official time and is requesting IRB approval of a Co-PI
FORM B – General Information
FORM B-2 – Study Personnel List
Examples of when individuals are “engaged” in human research
In general, individuals are considered engaged in a non-exempt human research study (and therefore
would need their institution’s designated IRB approval) when their involvement in the human subject’s
research includes any of the following activities:

Individual receives support from HHS (e.g., PI on an NIH grant) to conduct human subjects research,
even where all activities involving human subjects are carried out by individuals.

Individual intervenes for research purposes with any human subjects of the research by performing
invasive or noninvasive procedures (e.g., drawing blood; collecting buccal mucosa cells using a cotton
swab; administering individual or group psychotherapy; administering drugs or other treatments;
surgically implanting medical devices; utilizing physical sensors; and utilizing other measurement
procedures).

Individual intervenes for research purposes with any human subject of the research by manipulating
the environment (e.g., controlling environmental light, sound, or temperature; presenting sensory stimuli;
and orchestrating environmental events or social interactions).

Individual obtains for research purposes identifiable private information or identifiable biological
specimens from any source. Obtaining includes, but is not limited to: (a) observing and/or recording
private behavior; and (b) using, studying, or analyzing for research purposes identifiable private
information or identifiable specimens already in the possession of the employees or agents of the
institution. Private information or specimens is considered to be individually identifiable when they can
be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.
Examples of individuals who may have limited involvement in the research and are
Not Engaged in Research
(1) The individual performs commercial or other services for investigators provided that all of the
following conditions also are met:
(a) the services performed do not merit professional recognition or publication privileges;
(b) the services performed are typically performed by the individual for non-research purposes;
and
(c) the individual will not administer any study intervention being tested or evaluated under the
protocol.
The following are some examples, assuming the individual is not part of the research team and the
services described would not merit professional recognition or publication privileges:
• an appropriately qualified laboratory technician from UHS performs routine serum chemistry
analyses of blood samples for investigators as part of a commercial service.
• an individual transcribes research study interviews as a commercial service.
• a CTRC employee who obtains blood through a blood draw or collects urine and provides such
specimens to investigators as a service.
• a radiology technician from the Dental School performs bite-wing x-rays and sends the results to
investigators as a service.
_____________________________________________________________________________
(2) The individual is an employee of another Institution (including private practice) that is not a research
site who provides clinical trial-related medical services that are dictated by the protocol and would
typically be performed as part of routine clinical monitoring and/or follow-up of subjects enrolled at a study
site by clinical trial investigators (e.g., medical history, physical examination, assessment of adverse
events, blood test, chest X-ray, or CT scan) provided that all of the following conditions also are met:
(a) the individual will not administer the study interventions being tested or evaluated under the
protocol;
(b) the clinical trial-related medical services are typically provided by the individual’s institution for
clinical purposes;
(c) the individual does not enroll subjects or obtain the informed consent of any subject for
participation in the research; and
(d) when appropriate, investigators from an institution engaged in the research retain
responsibility for:
(i) overseeing protocol-related activities; and
(ii) ensuring appropriate arrangements are made for reporting protocol-related data to
investigators at an engaged institution, including the reporting of safety monitoring data and
adverse events as required under the IRB-approved protocol.
**Note that institutions (including private practices) not initially selected as research sites whose
employees or agents administer the interventions being tested or evaluated in the study—such as
administering either of two chemotherapy regimens as part of an oncology clinical trial evaluating the
safety and effectiveness of the two regimens—generally would be engaged in human subjects research
(see scenario (3) below for a limited exception). If such an institution does not have an FWA, its
employees or agents may be covered by the FWA of another institution that is engaged in the research
through an Individual Investigator Agreement.
____________________________________________________________________________________
(3) The individual is an employee of another Institution (including private practices) not initially selected as
a research site who administers the study interventions being tested or evaluated under the protocol
limited to a one-time or short-term basis (e.g., an oncologist at the institution administers chemotherapy to
a research subject as part of a clinical trial because the subject unexpectedly goes out of town, or is
unexpectedly hospitalized), provided that all of the following conditions also are met:
(a) an investigator from an institution engaged in the research determines that it would be in the
subject’s best interest to receive the study interventions being tested or evaluated under the
protocol;
(b) the individual will not enroll subjects or obtain the informed consent of any subject for
participation in the research;
(c) investigators from the institution engaged in the research retain responsibility for:
(i) overseeing protocol-related activities;
(ii) ensuring the study interventions are administered in accordance with the IRB-approved
protocol; and
(iii) ensuring appropriate arrangements are made for reporting protocol-related data to
investigators at the engaged institution, including the reporting of safety monitoring data and
adverse events as required under the IRB-approved protocol; and
(d) an IRB designated on the engaged institution’s FWA is informed that study interventions being
tested or evaluated under the protocol have been administered at an institution not selected as
a research site.
____________________________________________________________________________________
(4) The individual who only function is to:
(a) inform prospective subjects about the availability of the research;
(b) provide prospective subjects with information about the research (which may include a copy of
the relevant informed consent document and other IRB-approved materials) but do not obtain
subjects’ consent for the research or act as representatives of the investigators;
(c) provide prospective subjects with information about contacting investigators for information or
enrollment; and/or
(d) seek or obtain the prospective subjects’ permission for investigators to contact them.
An example of this would be a private practice clinician who provides patients with literature about a
research study at the HSC, including a copy of the informed consent document, and obtains permission
from the patient to provide the patient’s name and telephone number to investigators.
____________________________________________________________________________________
(5) An individual employed by an institution (e.g., schools, nursing homes, businesses) that permits use of
their facilities for intervention or interaction with subjects by investigators from another institution.
An example would be a teacher from a Southside ISD school that had permitted HSC investigators to
conduct or distribute a research survey in the classroom; or recruit children and parents in a diabetes
prevention study, provided the teacher did not perform any activities that would be considered engaged
in research.
____________________________________________________________________________________
(6) Individuals from one institution who release to investigators at another institution identifiable private
information or identifiable biological specimens pertaining to the subjects of the research.
**Note that in some cases the institution releasing identifiable private information or identifiable biological
specimens may have institutional requirements that would need to be satisfied before the information or
specimens may be released, and/or may need to comply with other applicable regulations or laws. In
addition, if the identifiable private information or identifiable biological specimens to be released were
collected for another research study covered by 45 CFR part 46, then the institution releasing such
information or specimens should:
(a) ensure that the release would not violate the informed consent provided by the subjects to
whom the information or biological specimens pertain (under 45 CFR 46.116), or
(b) if informed consent was waived by the IRB, ensure that the release would be consistent with
the IRB’s determinations that permitted a waiver of informed consent under 45 CFR 46.116 (c)
or (d).
Examples of institutions that might release identifiable private information or identifiable biological
specimens to investigators at another institution include:
(a) schools that release identifiable student test scores;
(b) an HHS agency that releases identifiable records about its beneficiaries; and
(c) medical centers that release identifiable human biological specimens.
**Note that, in general, the institutions whose employees or agents obtain the identifiable private
information or identifiable biological specimens from the releasing institution would be engaged in human
subjects research.
____________________________________________________________________________________
(7) Individuals who:
(a) obtain coded private information or human biological specimens from another institution
involved in the research that retains a link to individually identifying information (such as name
or social security number); and
(b) are unable to readily ascertain the identity of the subjects to whom the coded information or
specimens pertain because, for example:
•the individual and the holder of the key enter into an agreement prohibiting the release of the key
to the individual under any circumstances;
•the releasing institution has IRB-approved written policies and operating procedures applicable
to the research project that prohibit the release of the key to the individual under any
circumstances; or
•there are other legal requirements prohibiting the release of the key to the individual.
For purposes of this document, coded means that:
(a) identifying information (such as name or social security number) that would enable the
investigator to readily ascertain the identity of the individual to whom the private information or
specimens pertain has been replaced with a number, letter, symbol, and/or combination thereof
(i.e., the code); and
(b) a key to decipher the code exists, enabling linkage of the identifying information to the private
information or specimens.
____________________________________________________________________________________
(8) Individuals who access or utilize individually identifiable private information only while visiting an
institution that is engaged in the research, provided their research activities are overseen by the IRB of
the institution that is engaged in the research.
**The individual is engaged however the individual’s home institution is not.
An example would be a HSC researcher conducts a records review study at BAMC and the individual’s
research activities are approved/overseen by the BAMC IRB.
____________________________________________________________________________________
(9) Individuals who access or review identifiable private information for purposes of study auditing (e.g. a
government agency or private company will have access to individually identifiable study data for auditing
purposes).
____________________________________________________________________________________
(10) Individuals who receive identifiable private information for purposes of satisfying U.S. Food and Drug
Administration reporting requirements.
____________________________________________________________________________________
(11) Individuals who author a paper, journal article, or presentation describing a human subjects research
study.
Note: the VA does not use engaged in research to determine whether a study falls under VA research
regulations.
Examples of when a study is considered “VA Research”





sponsored by the VA
being conducted by or under the direction of any salaried or without compensation (WOC) employee
of the STVHC during her/his official duty time or in connection with her/his STVHCS responsibilities
being conducted at a STVHCS facility
recruiting subjects at the STVHCS or using the STVHCS’s records (CPRS) to identify or contact
subjects for research
being funded or managed by the STVHCS or the Biomedical Research Foundation of South Texas
FORM C – Research Description
6.c.
Study Intervention
Item 4.c.9 Describe measures taken to minimize coercion or undue influence
Coercion occurs when an overt threat of harm is intentionally presented to an individual (i.e., subject or
legally authorized representative). The threat proposes to make the individual worse off than if he or she
would have been if never asked or where the threat would violate the individual’s rights.
Examples of coercion include:
 Telling a prospective subject that continued medical care is dependent upon participation in the
research.
 Telling students that participation in a survey for the instructor’s research is a required to
complete an academic course.
The IRB will not approve research where coercion is a possibility. For that reason, all sources of coercion
must be eliminated.
Undue influence is likely through the offer of excessive, unwarranted, inappropriate or improper reward or
other overture in order to obtain compliance.
Examples of undue influence include:

“unjustifiable pressures” occur when “persons in positions of authority … urge a course of action
for a subject.”
 manipulating a prospective subject’s choice by utilizing the “influence of a close relative.”
 when judgment may be compromised by financial incentives especially when the subject is not
the recipient of the financial incentive.
The IRB will not approve research unless undue influence is minimized.
Example of study interventions being tested –
Protocol will compare a new investigational drug (drug E) to two other standard care drugs ( drug S1 and
S2)
6.b. List of the study intervention(s) being tested or evaluated under this protocol
N/A - this study does not test or evaluate an intervention.
#
Study intervention(s) being tested or evaluated under the protocol
Add or delete rows as needed
1
Drug E (100mg by mouth, four times a day)
2
Drug S1 (50 mg by mouth, four times a day)
3
Drug S2 (75 mg by mouth, daily)
Skip to item 6.d.
Local Standard
Practice
Indicate whether
the intervention is
considered
acceptable practice
locally
Delete one of the words, if you are using a table for each
procedure for example vs. deleting the word procedure if you
are listing several procedures for one component.
[Insert short label] This label should be the same terms or
terms used to describe the component in the component list. It
is allowed to add a truncated list of procedures in the
component if you prefer to remind the reader when many
procedures are involved especially when you find yourself
needing to list specific procedures separately in the risks
section below with a component.
List each group exposed to this
For each group, list the benefits of this procedure (either the procedure
procedure on a separate line.
or a monitoring procedure likely to contribute to the subject’s well being).
(e.g., experimental, control, Arm A, Arm
If there are no benefits, state “none”.
B, etc
Or state All Groups/Subjects
List benefits for each component, you can list them separately on each of these lines if you have many different
components with different benefits but the intent is that you group procedures with like benefits and like levels of risk
so hopefully this will not be necessary
Examples of benefit might include: increased monitoring if several safety labs are performed as research only in the
components list indicating they would not have been performed if the subject was not participating in the study.
It is allowed to list a potential benefit “Particular research protocols may hold out the prospect of direct medical benefit
to the subjects themselves, even though such benefit can never be assured. The potential direct medical benefits to
the subjects include health improvements which may or may not be related to the disorder responsible for the
subject's incapacity”
Payments or Free medical care should not be portrayed as a benefit of research participation or considered in the
assessment of the risk:benefit ratio. Receipt of procedures and study items may be listed as benefits to the subject if
they would not have otherwise received them as part of standard care, but not in conjunction with their being "free" or
at reduced cost.
Group: 1
Direct Benefit: [State "None" (or insert direct benefit, secondary benefit, or
monitoring benefit)]
All Groups
Benefit to the community (or specify population especially if same
population being recruited) / Knowledge gained benefit (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)
Likely
These risks are expected to occur
in more than 20 out of 100
subjects.
The Board considers the definition
of likelihood should be relatively
consistent across all components
in order to allow subjects to clearly
understand the likelihood of those
risks. If it is absolutely necessary
to change the numbers, ensure
the numbers in each of the three
levels add up and do not overlap.
Less likely
These risks are expected to occur
in 5-20 subjects or less out of 100
subjects.
Rare
These risks are expected to occur
in less than 5 subjects out of 100
Not serious
Venipunture:

Pain

Bleeding

Bruising
It is ok to list one of the
procedures in the
component separately
when it is appropriate to
single it out
Serious

If you list a risk without a header the
assumption is that the risk applies to all
procedures in the component if the table is
used to describe several procedures as one
component.
Not serious
Serious
Vomiting (though not 
frequently when it
occurs it is most
often self limiting)
Serious
This block is not to be

Vomiting (dehydration) (rarely vomiting can be
used.
severe enough to lead to dehydration and
hospitalization)

Do not delete frequency. Make an
effort to estimate. See detailed
instructions above on previous
page
Occasionally it is necessary to list the same risk in
two different boxes.
When you do this it is
necessary to offer some explanation as to why you
believe it is appropriate to do so.
Click here for other examples which include examples of risk:benefit tables: Example 1, Example 2,
Example 3 (specific for randomization as a risk)
6.d. List of ALL other research procedures or components not listed in table 6.b.
All of the research procedures for this study should be listed in either table 6.b. or 6.d.
Consider grouping similar procedures under a single component. E.g., blood work, CT = safety assessments)
(Click here for example)
#
Research component

individual procedures
example:
Eligibility Assessments

History and physical

Questionnaire

Laboratory tests
Add or delete rows as needed
1
2
3
4
Eligibility Assessments
Obtain consent
Medical hx, inclusion/exclusion
review
Physical exam
Safety Assessments
Venipuncture for blood tests
EKG
Efficacy Assessments
CT scan
Column A
Local Standard
Practice Indicate the
number of times each
procedure will be
performed as stipulated
in the research plan that
would be done as part
of standard practice.
Column B
Research Only
Indicate the number of
times each procedure will
be performed solely for
research purposes (any
performed outside
frequency or timing for
acceptable local practice)
Column C
Risks
List the reasonably expected risks
under the following categories as
appropriate:
 Serious and likely;
 Serious and less likely;
 Serious and rare;
 Not serious and likely;
 Not serious and less likely
0
0
1
1
None
None
4
1
None
4
8
2
2
Not serious and likely
- Momentary pain/discomfort
None
4
2
Insert procedure here
Insert procedure here
Insert component 4 here
Insert procedure here
Insert procedure here
Insert procedure here
FORM C-1 – Local Repository Description
Serious and rare
- cancer
FORM D – - Consent Documents
Examples of risk tables categorizing risk by probably (likelihood) and magnitude (seriousness)
Likely
(10 or more subjects out of 100)
Not Serious




Serious

Cough
Headache
Nausea
Tiredness (fatigue)
None
Less Likely
(Between 2-9 subjects out of 100)






Not Serious
Chest discomfort
Chest pain
Shortness of breath
Chills
Fever


Serious
Low red blood cells (anemia), which may make you
feel tired
Low platelets (cells that help blood clot)
(thrombocytopenia), which may increase your
chance of bleeding

Rare
(Less than 2 subjects out of 100)
Not Serious
Serious

Likely
(21-100 subjects out of 100)
Likely and Not Serious
 Nausea and vomiting
 Abnormal levels of certain salts
in the body like sodium and
potassium
Likely and Serious
 Fewer red blood cells and white
blood cells and platelets in the
blood
o A low number of red blood
cells can make you feel
tired and weak.
o A low number of white
blood cells can make it
easier to get infections.
o A low number of platelets
causes you to bruise and
bleed more easily.








Allergic reaction, which may be mild or could be
potentially life-threatening (could cause death)
Less Likely
(5-20 subjects out of 100)
Less Likely and Not Serious
Rash
Metallic taste
Numbness and tingling in the
fingers and toes
Hair loss
Constipation or diarrhea
Pain in your abdomen
Temporary changes in vision
Damage to the ear causing
hearing and balance problems


Less Likely and Serious
Allergic reactions (can be severe
and life-threatening (could cause
death), causing difficulty in
breathing and/or a drop in blood
pressure)
Rare but Serious
(Less than 5 subjects out of 100)
 Damage to the liver
 Damage to the kidney
 Leukemia later in life
FORM F – Waiver or Alteration of Consent
FORM H-1 – Translation Certificate
FORM I – Application for Access to De-identified Data (or Specimens)
FORM J-1 – Assurance for Research on Decedent Information
FORM J – HIPAA Waiver of Authorization
FORM K – Pre-Notification Intent to Conduct Research at Another Institution
FORM N – Off-site_Research
FORM O – Investigational New Drug
FORM O-1 – Approved Drug Unapproved Use
FORM O-2 – Placebo
FORM P – Investigational Device
FORM P-1 – Investigational Device
FORM Q – Radiation Exposure Worksheet
FORM R – Monitoring Participant Safety and Data Integrity
FORM T – Decisionally Impaired
FORM U – PregWomen Neonates Fetuses
FORM V – Prisoners
FORM W – Children
FORM X – COI Report
FORM Y – Monitoring Plan - Lead PI
Progress Report
Example of how to complete the detailed description of the reason for withdrawal
Detailed Description of the Reason for Withdrawal
Screening – fasting blood sugar was not within the stated inclusion parameters
AE – experienced nausea & vomiting that was expected, however was unable
to continue with oral medications and was withdrawn
AE – experienced nausea & vomiting that lead to unexpected dehydration and
hospitalization (UPIRSO reported) and was withdrawn
Personal reasons – did not like the expected side effects of the study drug and
opted out of the study
Death – natural causes, not related to study
Death – disease progression, not related to study
Death – serious adverse event, related to study (UPIRSO reported)
Total number per
reason
5
3
3
1
1
1
1