IRB Initial Submission Reviewer Sheet for Biomedical Research

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Tulane University Human Research Protection Program
IRB Initial Submission Reviewer Sheet for Biomedical Research

IRB Study #:

Protocol Title:

Principal Investigator:

Meeting Date:

Primary Reviewer:

Secondary Reviewer:

Please be reminded of the Criteria for Approval in Section 46.111 of the Federal Regulations:

46.111 Criteria for IRB Approval of Research:

(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. 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.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by CFR 46.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by CFR 46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

General:

Yes / No / Comments
·  Is there a clearly formulated hypothesis?
·  Is the research likely to answer its proposed question?
·  Is the research practical?
·  Please Provide a Short Summary of the Research Protocol Reviewed (a few short sentences):

Research Setting:

Resources / Yes / No / Comments
·  Does the PI have access to a population that will allow recruitment of the necessary number of subjects?
·  Do you feel there is sufficient time to conduct and complete the research?
·  Is there an adequate number of qualified staff to complete the research?
·  Are the facilities adequate to complete the research?
·  Is a process in place to ensure that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions?
·  If needed, is the availability of medical or psychological resources that subjects might require as a consequence of the research adequate?
External Sites / Yes / No / Comments
Has the Investigator indicated:
·  Whether the site has an IRB?
·  If the site has an IRB, whether the IRB has approved the research or plans to defer the review to the Tulane IRB?
o  An MOU is needed for the site’s IRB to defer to Tulane’s IRB
·  Whether the site has granted permission for the research to be conducted?
·  Contact information for the site?
Multi-Site Research / Yes / No / Comments
·  If the investigator is the lead investigator of a multi-site study, or if Tulane is the lead site in a multi-site study, did the investigator provide information about the management of information obtained in multi-site research that might be relevant to the protection of subjects?
·  Additional Comments Regarding Research Setting:

Risk:

·  Based upon the evaluation, the research risks are: (Please address one or the other)
No more than Minimal
Greater than Minimal
Risks to Subjects Minimized / Yes / No / Comments
·  Is there a clear and accurate identification of risks?
Indicate whether risks to subjects are minimized by considering the following elements of the protocol:
·  Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk.
·  Risks to subjects are minimized, when appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
·  Safety Monitoring is appropriate.
·  Precautions are developed to decrease the likelihood of harm.
·  Contingencies are available to deal with harms if they occur.
Risk-Benefit Ratio / Yes / No / Comments
Indicate whether the risks of the research are reasonable by considering the following elements in the protocol:
·  Potential Benefits, if any, to subjects.
·  The importance of the knowledge that might be expected to result
·  Risks to others (Risks related to disclosure of genetic information)
·  Long-term effects of the research
·  Additional Comments Regarding Risk:

Subject Selection:

Yes / No / Comments
Indicate whether the selection of subjects is reasonable and equitable by considering the following elements of the protocol:
·  Vulnerable Populations (Such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons)
·  Inclusion and Exclusion Criteria
·  Representation of Women
·  Representation of Minorities
·  Whether prospective subjects will be vulnerable to coercion or undue influence
·  Recruitment Methods
·  The influence of payments to subjects
·  Is subject selection reasonable for scope of study?
·  Additional Comments Regarding Subject Selection:

Consent Process:

Obtaining Informed Consent / Yes / No / Comments
Indicate whether the process of obtaining informed consent is adequate by considering the following elements of the protocol:
·  Time devoted to consent process appears to be sufficient.
·  The investigator or clinical coordinator will obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.
·  The circumstances of the consent process provide the prospective subject or the legally authorized representative a sufficient opportunity to consider whether to participate, or not.
·  The circumstances of the consent process minimize the possibility of coercion or undue influence.
·  The individuals communicating information to the subject or the legally authorized representative during the consent process will provide the information in a language understandable to the subject or the representative
·  The information being communicated to the subject or the representative during the consent process will not include exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject’s legal rights
Special Populations / Yes / No / Comments
·  If Minors are involved, is an assent needed? (Generally, for children over 7 years of age enrolling in non-therapeutic trials)
·  Is parental permission obtained appropriately?
·  If adults with impaired consent capacity are involved, are there mechanisms in place obtaining informed consent from legally authorized representatives?
·  If Non-English speaking subjects are involved, are adequate translations of the consent form provided?
Obtaining Informed Consent / Yes / No / Comments
Indicate whether the informed consent process is adequate by considering whether it provides the required basic elements of information to subjects:
·  A statement that the protocol involves research and includes:
o  The purpose of the research
o  Expected duration of subject’s participation
o  Description of the procedures to be followed and identifies those that are experimental
·  Disclosure of reasonably foreseeable invasive or non-invasive risks or discomforts
·  Statement of any benefits to subjects or others that may be expected
·  Appropriate alternative procedures, if any, that might be advantageous to subjects
·  How confidentiality of records identifying the subject will be maintained and disclosure of all infringements upon privacy or confidentiality which may result from participation in the research
·  Whether compensation is available for participation.
·  Contact information of the research team to:
o  To obtain answers to questions about the research
o  To voice concern or complaints about the research
·  Contact information for a person independent of the research team:
o  To obtain answers to questions about the research
o  To voice concerns, complaints, or offer input about the research
o  In the event the research staff could not be reached
o  In the event the participant wanted to talk to someone other than the research staff
·  A statement that the research is voluntary, that there are no penalties if the subject refuses to participate, and that the subject may withdraw at any time without penalty
Yes / No / Comments
If appropriate for the research, the following statements may be needed. Indicate if the inclusion of these statements are needed:
·  That some risks to subjects might be unforeseeable
·  Outline the circumstances where a subject’s participation may be terminated by the PI without regard to the subject’s consent.
·  Whether there are costs for which subjects will be responsible
·  The consequences of a subject’s decision to withdraw (safety issues)
·  New and significant findings, which may affect the subject’s willingness to continue, will be disclosed to subjects
·  The approximate number of subjects involved in the research at the institution and nationally.
·  Additional Comments Regarding the Consent Process:

Documentation of Consent:

Indicate whether informed consent will be documented by obtaining a signed informed consent form:
·  Is a waiver of consent requested? Is it appropriate? (ALL MUST APPLY)
N/A
Research involves no more than minimal risk; AND
Waiver will not adversely affect rights and welfare of subjects; AND
Research could not practicably be conducted without waiver; AND
Whenever appropriate, subjects will be provided additional pertinent information after participation.
·  Is the PI requesting a waiver of signed consent? (EITHER MAY APPLY; PLEASE INDICATE ONE)
N/A
The only record linking subject to research would be the consent form, and principal risk to subject would be potential harm resulting from breach of confidentiality
Research presents no more than minimal risk of harm to subject and involves no procedures for which written consent is normally required outside of research context
Consent Document / Yes / No / Comments
·  Indicate whether the informed consent form is written at an 8th grade reading level.
·  Consent document embodies the basic and required additional elements of disclosure
·  Space provided for subject or the subject’s legally authorized representative to sign and date the consent document
·  A copy of the consent document is given to the subject and/or legally authorized representative signing the form.
·  The investigator or clinical coordinator will provide subject or the legally authorized representative adequate time to read the consent document, or read to them the consent document if unable to read, and answer any questions before it is signed.
·  Additional Comments Regarding the Documentation of Consent:

Data Safety Monitoring:

Yes / No / Comments
·  Is a Data Safety Monitoring Plan necessary for this research?
·  Is a DSM Board required?
·  Was a DSMP submitted for review?
If yes to either of the above, please evaluate the following aspects of the plan:
·  Is the data to be obtained adequate to draw significant conclusions?
·  Is who will monitor the data identified?
·  Is the data to be monitored identified?
·  Is how frequently the data will be monitored identified?
·  Are what analyses to be performed on the data identified?
·  Are decision rules (e.g. stopping rules) that will be considered identified?
·  Will unexpected harms be detected promptly?
·  Will an increased frequency or severity of unexpected harms be detected promptly?
·  Will the protocol be stopped once harms are proven to outweigh the benefits?
·  Additional Comments Regarding Data Safety Monitoring:

Placebos:

Yes / No / Comments
·  If subjects will receive a placebo in lieu of an approved, FDA-indicated drug, does one of the following apply?
o  If subjects are being washed out from an approved FDA-indicated drug, are procedures described?
o  Placebo in lieu of an approved drug may be justified because (at least ONE must be checked):
Standard therapy is unavailable or is efficacy unproven, OR
Standard therapy possesses unacceptable side effects, OR
Minimal harm may result from the use of the placebo (e.g. ongoing disease has little adverse effect on the patient during the course of the trial and is reversible), OR
Placebo itself may be appropriate approach, OR
The disease process is characterized by exacerbation and remission, OR
The placebo is being used for a control in a non-treatment research protocol.
·  Is rescue therapy information provided?
·  Are approved alternative treatments allowed along with placebo use?
·  Additional Comments Regarding Placebos:

Privacy and Confidentiality:

Yes / No / Comments
·  Does the research make adequate provisions to protect the privacy interests of subjects?
·  Indicate if provisions to maintain confidentiality of data and research records are adequate by considering the following elements:
o  Recording and coding of data
o  Identifiably of data
o  Storage of data
o  Sharing of data (including by electronic transmission)
·  Additional Comments Regarding Privacy and Confidentiality:

Vulnerable Populations:

Yes / No / Comments
Indicate whether any Vulnerable Populations are included in the research:
·  Inclusion of children
·  Inclusion of prisoners
·  Inclusion of pregnant women, fetuses, or neonates
·  If OTHER vulnerable populations are included, have additional safeguards been included in the study to protect the rights and welfare of these subjects?
·  Additional Comments Regarding the Use of Vulnerable Populations:
If research involves children, prisoners, or pregnant women, fetuses, or neonates, please consider the additional information below.

Research with Children: