IRB REVIEWER FORM
INITIAL REVIEW
Drug(s) Study
SECTION 1: STUDY TITLE & IRB FILE #
Reviewer: /Meeting Date:
SECTION 2: PRINCIPAL INVESTIGATOR PRIMARY CONTACT INFORMATION
Principal Investigator:
/Coordinator:
Please use this checklist for reference when reviewing this protocol. Make notes in the space provided for leading the discussion with the full board. Please contact the investigator with your questions prior to the meeting date. If you see any significant problems with this study, please contact the IRB coordinator in advance of the meeting date to alert him/her of your concerns.
SECTION 3: TYPE OF REVIEW FULL BOARD EXPEDITED
SECTION 4: STUDY INFORMATION
Is this a multi-center study? Yes No
Is this institution the coordinating center for the multi-center protocol? Yes No
Check all that applies in each column:
Initiator of study: Author of protocol: Type of study: Funding source(s):**
Investigator Investigator Drug study* Industry
Sponsor Sponsor Device study Government Internally supported
Cooperative group Cooperative group Chart review Cooperative group by GHS
Other ______Other ______Specimen study Not funded HDE study Foundation
Other______Other ______
Is this an emergency use of a test article? Yes No
*Does this study involve an FDA regulated product (drug) or device, approved or unapproved? Yes No
If “Yes” be sure to complete the checklist for “Special Review Determinations for Drugs or Devices”
In order to approve research covered by 45 CFR 46.111 or 21 CFR 56.111, the convened IRB must determine that the research satisfies all the requirements set forth below. The criteria for review must be used to approve research for initial review.
SECTION 5: RISKS TO PARTICIPANTS
Is there a description of the procedures that are being performed for purposes that are solely experimental for
the study? Yes No
Is there a description of the procedures required by the prevailing standard of care? Yes No
SECTION 6: RISK/POTENTIAL BENEFIT RELATIONSHIP
Risks to participants are reasonable in relation to anticipated benefits, and the importance of the knowledge that may reasonably be expected to result is clear? Yes No
In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. [45 CFR 46.111(a)(2)]
Based on the application documents received, can the research question posed by the purpose
statement in the protocol and consent form be answered by the methodology proposed by the
investigator? Yes No
Is there scholarly or scientific rationale stated for the study? Yes No
SECTION 7: EQUITABLE SELECTION OF SUBJECTS AND THE RESEARCH SETTING
Is selection of subjects equitable? Yes No
In making this determination, take into account:
§ The purpose of the research;
§ The setting in which the research will be conducted;
§ The special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons;
§ The inclusion/exclusion criteria; and
§ The recruitment method.
SECTION 8: DATA SAFETY MONITORING
If the research involves more than minimal risk to participants are there adequate provisions for
monitoring the study data to ensure safety of the participants? Yes No
The research plan makes adequate provisions for data and safety monitoring, including:
· How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with subjects. Yes No N/A
· The frequency of data collection, including when safety data collection starts. Yes No N/A
· The plan might include establishing a data monitoring committee, and if applicable, statistical tests for analyzing the safety data to determine whether harm is occurring; Yes No N/A
· Conditions that trigger an immediate suspension of the research, if applicable. Yes No N/A
SECTION 9: SAFETY OF VULNERABLE POPULATIONS
If the study involves a vulnerable population, does the protocol include additional safeguards
required to protect the safety of these participants? Yes No N/A
SECTION 10: PRIVACY INTERESTS OF PARTICIPANTS
Are there adequate provisions to protect the privacy interests of participants? Yes No
Does the research plan make adequate provisions to maintain the confidentiality of the data? Yes No
SECTION 11: INFORMED CONSENT PROCESS
Who will conduct the consent interview and obtain consent?
List name(s) here (e.g. PI/Co-Investigator; study team member along with PI)
Circumstances of consent: All of the following are true:
The investigator will obtain the legally effective informed consent from the participant or the participant’s
legally authorized representative
The circumstances of consent provide the prospective participant or the representative sufficient
opportunity to consider whether or not to participate
When a subject withdraws from a study, the data collected on the subject to the point of withdrawal remains part of the study database and may not be removed. The consent document cannot give the option of having data removed.
An investigator may ask a subject who is withdrawing whether the subject wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the subject distinguishes between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the subject’s information.
The investigator must obtain the subject’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document). The IRB must approve the consent document.
If a subject withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the investigator must not access for purposes related to the study the subject’s medical record or other confidential records requiring the subject’s consent. However, an investigator may review study data related to the subject collected prior to the subject’s withdrawal from the study, and may consult public records, such as those establishing survival status.
The circumstances of consent minimize the possibility of coercion or undue influence
Based on the investigator’s description of how subjects will be approached, are the possibilities of
coercion or undue influence minimized? Yes No
If No, explain what is needed or add any additional comments here:
Did the investigator indicate any finder’s fee or recruitment bonuses would be paid? Yes No
If Yes, please explain:
Are the recruitment materials submitted appropriate? Yes No N/A
If No, list what changes are needed in the advertisements using the IRB advertisement checklist?
Are the following items included in any advertisements submitted with this protocol?
"Greenville Hospital System" and the department/division name of the investigator and/or research facility;
The purpose of the research and/or the condition under study;
In summary form, the inclusion/exclusion criteria that will be used to determine eligibility for the study;
A brief list of participation benefits, if any (e.g. a no-cost health examination, free parking, monetary compensation);
The time or other commitment required of the subjects; and
The person or office to contact for further information. (When a telephone number is given, if it is not dedicated
exclusively to the use of the advertised study, a contact name should also be given.)
Are any other changes required in the advertisements in order to make the ads appropriate? Yes No
If Yes, what changes are needed?
Will participants be paid to participate in the study? Yes No
If Yes, what is the payment schedule?
Does the payment constitute coercion or undue influence? Yes No
The explanation describes what the compensation consists of;
The explanation describes where further information may be obtained regarding that compensation;
The consent process will explain any medical treatments are available if injury occurs;
The explanation describes what those medical treatments consist of;
The explanation describes where further information may be obtained regarding those medical treatments.
The information that will be given to the participant or the representative will be in language understandable to the
participant or the representative.
No information will be provided to the participant or the representative that waives or appears to waive any of the
participant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents
from liability for negligence.
No information will be provided to the participant or the representative that releases or appears to release the
investigator, the sponsor, the institution, or its agents from liability for negligence.
Basic elements of consent disclosure: All the following are true:
The consent process will disclose that the study involves research
The consent process will disclose the purposes of the research
The consent process will disclose the expected duration of the participant’s participation
The consent process will disclose the procedures to be followed
The consent process will identify any procedures that are experimental
The consent process will disclose any reasonably foreseeable risks or discomforts to the participant
The consent process will disclose any benefits to the participant or to others, which may reasonably be
expected from the research
The consent process will disclose appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the participant
The consent process will disclose the extent, if any, to which confidentiality of records identifying the
participant will be maintained
One of the following is true:
The research is NOT subject to FDA regulation
The consent process discloses the possibility that the Food and Drug Administration may inspect the
records
The consent process will explain who to contact for answers to pertinent questions about research participants’ rights, give comments, express concerns, complaints or offer input.
The consent process will explain who to contact for answers to pertinent questions about the research
The consent process will explain who to contact in the event of a research-related injury to the participant, or to give comments, express concerns or complaints.
The consent process will disclose that participation is voluntary
The consent process will disclose that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled
The consent process will disclose that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled
Additional elements of consent disclosure:
One of the following is true:
The risk profile of all research-related interventions is well known and the research involves no
investigational drugs or devices
The consent process discloses that the particular treatment or procedure may involve risks to the
participant which are currently unforeseeable
One of the following is true:
The research excludes women of child bearing potential
The research excludes pregnant women
The risk profile of all research interventions or interactions on embryos and fetuses is well known.
The consent process will disclose that the particular treatment or procedure may involve risks to the
embryo or fetus, if the participant is or may become pregnant, which are currently unforeseeable
One of the following is true:
There are no anticipated circumstances under which the participant’s participation will be terminated by
the investigator without regard to the participant’s consent
The consent process will disclose anticipated circumstances under which the participant’s participation
may be terminated by the investigator without regard to the participant’s consent
One of the following is true:
There are no costs to the participant that may result from participation in the research
The consent process will disclose additional costs to the participant that may result from participation
in the research
One of the following is true:
There are no adverse consequences (physical, social, economic, legal, or psychological) of a
participant’s decision to withdraw from the research
The consent process will disclose procedures for orderly termination of participation by the participant
One of the following is true:
Significant new findings during the course of the research which may relate to the participant’s
willingness to continue participation are unlikely
The consent process will disclose that significant new findings developed during the course of the
research which may relate to the participant’s willingness to continue participation will be provided to
the participant
One of the following is true:
The appropriate number of participants involved in the study is not important to a decision to take part in
the research
The consent process will disclose the approximate number of participants involved in the study
Regulatory Criteria for the Consent Process:
The investigator will obtain the legally effective consent of the participant or the participant’s legally authorized
representative.
The circumstances of the consent process provide the prospective participant or the legally authorized representative
sufficient opportunity to consider whether to participate.
The circumstances of the consent process minimize the possibility of coercion or undue influence.
The individuals communicating information to the participant or the legally authorized representative during the
consent process provide that information in a language understandable to the participant or the participant’s legally
authorized representative.
The information to be communicated to the participant or the representative during the consent process does not
include exculpatory language through which the participant or the legally authorized representative is made to waive
or appear to waive any of the participant’s legal rights.
The information to be communicated to the participant or the legally authorized representative during the consent
process does not include exculpatory language through which the participant or the legally authorized representative
releases or appears to release the investigator, the sponsor, the organization, or its agents from liability or
negligence.
Informed consent requirements are: Met