OHR-2A
Principal Investigator
11/2008
Abbreviated Title
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Thomas Jefferson University—Office of Human Research
Division of Human Subjects Protection
ADDENDUM SUMMARY OF HUMAN SUBJECTS RESEARCH
PROTOCOL
In 2008, The Office of Human Research received accreditation from the Association for Accreditation of
Human Research Protection Programs (AAHRPP). As part of accreditation standards, the OHR-2 was
substantially revised. In an effort to streamline the process for PI’s to update their OHR-2’s, the OHR-2A
addendum has been created. This form contains all new elements of the current 3/2008 version of the
OHR-2 not included in previous iterations. If your study was approved prior to implementation of the
3/2008 version of the OHR-2, you should consult the OHR-2 Submittal Guidelines to see if and in what
instances you need to complete the OHR-2A.
Please address all applicable points to create a complete and succinct synopsis of the protocol. If a point
does not apply to your study, please state “NA.” Use language, insofar as is possible, that can be
understood by a layperson, and provide meanings for all acronyms used. Please maintain all questions in
the body of the text. Form must be typewritten.
PART C- DRUGS AND DEVICES
1. List all the drugs and/or devices to be used in this study. This includes the study drugs and any
other medications specified in the protocol that the subject will receive while on this study.
2. Is this study being conducted under an IND or IDE? ____ Yes
____No
If yes, provide the information requested in the following table and submit 4 copies of the applicable Investigator
Brochure with this application. If FDA has exempted the study drug from IND requirements please submit a copy
of the FDA letter. If study is being conducted under an IDE, please provide copy of confirming letter from FDA
and copy of the signed agreement with the device manufacturer.
Name of experimental drug(s)
Name of experimental device(s)
IND #
IDE #
Name of organization or individual
holding IND or IDE #
3. When the investigator or TJU holds the IND/IDE, the investigator/TJU becomes the “sponsor”
of the research and assumes responsibility to ensure that all FDA regulatory criteria for
sponsors are met. Please provide your plan for meeting FDA regulatory criteria for sponsors.
For example:
Principal Investigator
Abbreviated Title
OHR-2A
11/2008
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


Investigator who holds an IND or IDE will assign some or all responsibilities to meet FDA sponsor
requirements to a contract research organization (CRO).
Investigator will undergo an audit by a CRO to ensure that procedures are in place so that all FDA regulatory
requirements of sponsors will be met.
Investigator will assign responsibility of compliance with some FDA regulatory requirements to a CRO and
investigator will obtain an audit from a CRO to ensure that procedures are in place so that all other FDA
regulatory requirements of sponsors will be met.
NOTE: If you intend to use someone who is in-house and who has expertise on sponsor requirements, please
justify that that person has equivalent expertise to a CRO.
DRUGS
4. If test article is a drug, provide the following information:
Class of drug (i.e., anti-hypertensive, anti-emetic, etc.)
Mechanism of action (i.e., beta-adrenergic receptor blocker, anti cytokine, monoclonal
antibody, etc.).
5. Will the study drug be dispensed by the Investigational Drug Service (IDS)?
______ Yes ______ No
NOTE: The IDS must receive, track, and dispense drugs for all in-patient clinical trials. If this
is an out-patient study and the IDS is not dispensing the study drug, please provide answers
to each of the following:
 Where drug will be stored
 Who will have access to drug
 Who will maintain drug accountability logs, and dispense drug
 What measures to maintain security of drug storage and access are in place
Please include a copy of the form you will use for documenting investigational drug receipt,
storage and dispensing.
6. Is the sponsor providing the test article free of charge? If not, who will cover costs of the drug
and its administration, if applicable?
7. If sponsor is not supplying test article, is it listed in the TJUH formulary? If not, where will it
be obtained and who will pay for it?
8. Please briefly summarize relevant human clinical data for the study drug.
9. Please list the known side effects for each study drug.
10. Does this study include an off-label use of an FDA-approved drug? If yes, please explain.
OHR-2A
Principal Investigator
11/2008
Abbreviated Title
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If you do not have an IND#, please certify that you meet all of the following FDA criteria for
waiver of this requirement for the off-label use in question:
[ ] It is not intended to be reported to FDA in support of a new indication for use or to support any
other significant change in the labeling for the drug;
[ ] It is not intended to support a significant change in the advertising for the product;
[ ] It does not involve a route of administration or dosage level, use in a subject population, or other
factor that significantly increases the risks (or decreases the acceptability of the risks) associated
with the use of the drug product;
[ ] It is conducted in compliance with the requirements for IRB review and informed consent [21
CFR parts 56 and 50, respectively];
[ ] It is conducted in compliance with the requirements concerning the promotion and sale of drugs
[21 CFR 312.7]; and
[ ] It does not intend to invoke an exception for informed consent requirements for emergency
research [21 CFR 50.24].
DEVICES
11. Will the device be purchased via Supply Chain Management? [
If no, please address the following:
] YES [
] NO
Where will the device be stored?
What security measures are in place to prevent the device from being used in a patient
who is not enrolled in the research study or by a physician not involved in the study?
Provide details as to how device will be tracked (logged in, stored, assigned to subject,
implanted, etc.)
12. Who will teach investigators how to use the device (if applicable)?
13. Who will determine competence of the research team with respect to device use?
14. Federal Regulations at 21 CFR part 812 describe two types of devices, Significant Risk (SR)
and Non-Significant Risk (NSR). The initial assessment as to a device being NSR is made by the
sponsor who then supplies the IRB with all information, including any correspondence with the
FDA, necessary to support that designation. The IRB is required to make an independent
assessment regarding device risk. With respect to this study, the device fulfills requirements for:
________ a significant risk device (requires an IDE# from the FDA and IRB approval)
________ a non-significant risk device
Principal Investigator
Abbreviated Title
OHR-2A
11/2008
Page 4 of 8
________ an abbreviated IDE or IDE exemption
15. If device is NSR, provide the rationale for the designation and any relevant correspondence
from the sponsor.
16. If a NSR device study, please document approval and risk assessments by other IRBs, if
applicable(copies of correspondence should be available from the sponsor).
17. For Device Studies, certify below that you will meet the responsibility requirements for
investigators found at 21 CFR 812 subpart E
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812&showFR=1&subpartNod
e=21:8.0.1.1.9.5)
[
[
[
[
] Study will be performed according to the signed agreement with the sponsor
] Study will not be initiated until FDA and IRB approval is obtained
] Informed consent will be obtained from all subjects after FDA and IRB approval is obtained
] Any financial conflicts of interest will be disclosed prior to starting the study and updated as
appropriate during the conduct of the study
[ ] Device will be disposed of as per sponsor directions and any remaining unused devices will be
returned to the sponsor
18. Is the sponsor providing the device free of charge? If not, who will pay for it?
19. Please briefly summarize relevant human clinical data for the study device.
20. Please list the known or potential side effects for the device.
21. Please briefly summarize relevant human clinical data for the study procedures.
PART D - RISKS, BENEFITS, AND ALTERNATIVES
1. What are the risks of the research? (please note: this is not the same as the description of the
known side effects of the test article(s)
2. Discuss measures taken to minimize risks and maximize benefits associated with this study..
3. What are the potential benefits of participation?
4. Explain how the risks of the research are justified by potential benefit to the subject or society.
5. How would you treat this patient in a non-investigational setting? Please describe the
treatment that is considered standard of care, as well as any alternative procedures or drugs or
other courses of therapy that might be used, if such alternatives exist (include palliative care).
OHR-2A
Principal Investigator
11/2008
Abbreviated Title
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6. How do the risks and side effects of the standard therapies compare to those associated with
the study therapy?
7. If this is a placebo controlled trial, please provide rationale for use of placebo.
8. If subjects will not receive standard of care, provide rationale for this and address risks of not
receiving standard of care.
9. Please address any risks associated with a “washout” period if applicable.
PART E - CHILDREN
1. Address one of the three following risk categories
A. ______ Minimal risk (risks are not greater than those ordinarily encountered in daily life or
during the performance of routine physical or psychological examinations)
Describe why this study should be considered minimal risk.
Please describe any potential benefits that justify anticipated risks.
B. ______ Greater than minimal risk
Does the study present the prospect of direct benefit to individual subjects either by
the procedure or by the type of monitoring the subject will receive?
Yes_____No____
Assess the risks/benefits of the research as opposed to available alternative
treatments/approaches.
C. _______ The research poses a minor increase over minimal risk and offers no prospect
of direct benefit to subjects
Describe what generalizeable knowledge may be gained about the subject’s
condition and how this will be applied with respect to the understanding or
amelioration of the subjects’ disorder or condition
Describe the risks inherent in the actual or expected medical, dental,
psychological, social or educational situations, and justify the minor increase in
risk with respect to the proposed treatment/intervention
Principal Investigator
Abbreviated Title
OHR-2A
11/2008
Page 6 of 8
PART F – RECRUITMENT, EQUITABLE SELECTION, AND CONSENT PROCESS
1. Discuss the recruitment plan and describe recruitment methods and materials (e.g., physician
referral, newspaper ad, radio, TV spot, e-mail, etc.). Please attach all relevant materials for
IRB review and approval.
Advertising and recruitment materials using the TJU or TJUH logo must be submitted to the
Trademark Committee for approval. Call the Office of University Counsel at 955-8585 for
information.
2. Will all qualified subject populations have adequate access to recruitment materials? Please
explain.
3. Is the location and cultural setting of the research equally accessible to all qualified subject
populations? If not, what can be done to make the location and setting more accessible?
4. If you are requesting a waiver of written consent, describe the information that will be
provided to participants.
5. Who will conduct the consent interview?
6. Who will provide consent or permission (e.g., subject, legally authorized representative,
parent, caregiver, etc.)?
7. Where will the consent interview take place?
8. Provide a step-by-step description of the consent process.
9. Describe your plan to assess a person’s capacity to consent.
10. Will you seek assent from decisionally-impaired individuals? If so, describe your plan for
obtaining assent.
11. Will the potential subject be informed of the research or be provided a copy of the consent to
review prior to the actual time of consent? If so, how much time in advance? How much time
will be available for the consent process?
12. What provisions will be made if the potential subject does not wish to proceed with the
consent interview at the first encounter?
13. If the potential subject does not understand spoken English, will an interpreter be present?
YES ______NO ______
14. Is surrogate consent involved? YES ______ NO ______
Principal Investigator
OHR-2A
Abbreviated Title
11/2008
Page 7 of 8
15. Will subjects be paid or receive any other inducements for participating? If yes, please
explain. Please note that payment of subjects must be on a pro-rated basis unless there are
compelling reasons not to prorate. There cannot be a requirement to finish all visits in order for
subjects to be paid, as this is considered coercive.
16. Describe any steps taken to minimize the possibility of coercion or undue influence.
PART H - LOCATION/COLLABORATION
1. If the investigator is the lead investigator or TJU is the lead site in a multi-site study, please
address the following:
Where is the repository for adverse events and unanticipated problems and how will
information be disseminated to other sites?
Who will tabulate and disseminate interim results?
Who will provide information to other sites concerning protocol modifications?
Describe how information that is relevant to participant safety will be managed (i.e.,
notifying site investigators of SAEs and Unanticipated Problems Involving Risks to
Subjects or Others, communicating DSMB or Interim Reports, etc.)
OHR-2A
Principal Investigator
11/2008
Abbreviated Title
Page 8 of 8
PART I - CERTIFICATION
Federal Regulations require the following responsibilities of the Principal Investigator. Please
check those items to which you have conformed, and sign.
As Principal Investigator, I certify that: (check appropriate boxes)
I have read the IRB Policy and Procedures Manual.
I understand the federally-mandated responsibilities of a research investigator in conducting
a clinical protocol.
I will conduct this clinical protocol in accordance with these responsibilities.
I will consent all subjects with an IRB-approved consent form, if applicable to the project,
and store the consent forms in a safe repository.
I will provide all subjects with a copy of their signed and dated consent form.
All personnel have been appropriately trained for their assigned roles in this research.
If this study utilizes an investigational agent(s), the dose(s) of the agent(s) cited in the IRB
internal forms and the consent form agrees with the dose(s) cited in the protocol.
_________________________________
___________
Signature of principal investigator
date