PRIMARY REVIEW CHECKLIST FOR
AMENDMENTS
AGENDA ITEM # ______
Reviewer: / Meeting Date:IRB Protocol #: / Department:
PI: / Sponsor:
TITLE OF STUDY
[ ] As the Primary Reviewer, I have no conflicting interest related to this research as defined by the DUHS IRB policy entitled “Policy Statement Regarding Conflict of Interest Pertaining to DUHS IRB Members and Consultants”.
I.STUDY OBJECTIVES
Primary:Secondary:
II.STUDY DESIGN
1.
Please provide a brief synopsisof the study:2. Will the investigator use procedures that are consistent with sound research design? Yes No
3. Will the investigator use procedures that do not unnecessarily expose subjects to risk? Yes No
4. Will the research design permit the investigator to answer the research question? Yes No
5. What is the importance of the knowledge expected to result from the research?
III. AMENDMENT AFFECTS: (check all that apply)
Study Design(protocol/summary)
Study Drug/Device/Biologic composition
Administration of Study Drug/Device/Biologic (dose, dosing schedule, method of administration, etc.)
Consent form(s)
Advertisement(s)
Inclusion/Exclusion Criteria
Ascertainment/Recruitment
Data Analysis
Safety Monitoring
Other: ______
IV. DESCRIPTION OF AMENDMENT (Using the format below, please list the changes and reasons for each.)
The purpose of this amendment is to:
Change:Reason:
1. Has the study changed from a single site study to a multi-site study?
Yes No
a. If yes, is the Duke PI the lead investigator?
Yes No
b. If yes to (a) above, is the investigator’s plan to manage information obtained in this multi-site research adequate, so that information that might be relevant to the protection of subjects will promptly be given to all sites? This would include the investigator’s plan for how all sites will promptly learn of:
o Unanticipated problems involving risks to subjects or others.
o Interim results.
o Protocol modifications.
Yes No
V. RISK/BENEFIT ASSESSMENT
1. As a result of this amendment:
Risks to subjects have: increased decreased remained unchanged
Benefits to subjects have: increased decreased remained unchanged
Please describe how risks/benefits have increased/decreased:2. Is the study design (including target enrollment, method of data analysis) sufficient to achieve study objective(s)?
___Yes ___No
Comments:3. Will the investigator minimize risks to subjects by using procedures that are consistent with soundresearch design?
Yes No
4. Will the investigator minimize risks to subjects, whenever appropriate, by using procedures already being performed on subjects for diagnostic or treatment purposes?
___Yes ___No
5. Will the investigator use study procedures that do not unnecessarily expose subjects to risk?
___Yes ___No
6. Will the research design permit the investigator to answer the research question? Yes No
7. Has the importance of the knowledge expected to result from the research changed? Yes No
If Yes, please explain:
8. Are the risks to subjects reasonable in relation to the anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result?
Yes No
If No, please explain:9. For Pediatric Studies, the Pediatric Risk Level as a result of this amendment is
1 2 3 4 (Choose one)
The greatest risk to the child is:This risk is minimized by:
The potential benefit to the child is:
45 CFR 46.111, 21 CFR 56.111
[ ] Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk.
[ ] Risks to subjects are minimized, when appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.[ ] 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.
VI. SELECTION OF SUBJECTS
Does this amendment change the inclusion/exclusion of pregnant women in the study, or does it change the pregnancy testing or contraception requirements?
Yes __No
If Yes, then:
1. Are pregnant women excluded from the study?
Yes __No
If pregnant women are excluded, how will pregnancy status be determined?
____ self-report ____ blood/serum pregnancy testing ____ urine pregnancy testing
2. If pregnancy testing is required, does the plan for pregnancy testing follow the DUHS IRB POLICY STATEMENT REGARDING PREGNANCY TESTING including:
Yes __No -concordance with the definition for childbearing potential?
Yes __No -timing of pregnancy testing at study entry and during study conduct?
3. Is contraception required for sexually active female participants?
Yes __No
If so, is the language in the consent form regarding female contraception:
Yes __No -consistent with the study protocol requirements?
Yes __No -medically appropriate to the underlying disease process or study
drug/intervention?
Yes __No -consistent with the protocol’s requirement for duration of use before
and after completion of study drug/intervention? Is the duration of
use appropriate?
4. Is contraception required for sexually active male participants?
Yes __No
If so, is the language in the consent form regarding contraception:
Yes __No -consistent with the study protocol requirements?
Yes __No -medically appropriate to the underlying disease process or study
drug/intervention?
Yes __No -consistent with the protocol’s requirement for duration of use before
and after completion of study drug/intervention? Is the duration of
use appropriate?
5. As a result of this Amendment: Does the study protocol and/or consent include language regarding reporting of pregnancy outcome information if a female partner of a male study participant becomes pregnant?
Yes __No
If Yes, is a Pregnant Partner Information Form Included? Yes __No
[ ] Selection of subjects is equitable45 CFR 46.111, 21 CFR 56.111
- taking into account the purposes of the research and the setting in which the research will be conducted and being particularly cognizant of the special problems of research involving subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
45 CFR 46.111, 21 CFR 56.111
[ ] When some or all of the subjects, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects. [ ] Not Applicable
VII. CONSENT PROCESS(if the amendment does not affect the consent process, skip this section.)
1. Is there any new information that needs to be provided to participants because it may affect their willingness to continue to take part in the research?
Yes No
If no, please move to the next section.
2. Does this amendment include a plan to re-consent subjects?
Yes No
If no, should re-consent be required?
Yes No
If yes, please explain:3. Will informed consent be sought in an appropriate manner taking steps to minimize coercion or undue
influence? Yes No
4. Please discuss any concerns regarding the consent process:
45 CFR 46.111, 21 CFR 56.111
[ ] 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 45 CFR §46.116
and for FDA-regulated research in accordance with and to the extent required by 21 CFR §50 as follows:
OR
(All items in the box below must be true)
VIII. CONSENT FORM(if the amendment does not affect the consent form, skip this section.)
- Does the consent form begin with a concise and focused presentation of the key information most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research?*
Yes No
(*Items denoted with an asterisk only apply to studies governed by the 2018 Common Rule)
2. Does the consent form contain an adequate description of the Required Elements and the Additional Elements listed in the Consent Disclosure Checklist below?
Yes No
As you use the checklist below, identify which item(s) are missing or inadequately addressed.
Consent Disclosure Checklist
Required Elements:
• A statement that the study involves research. ___Yes ___No
• An explanation of the purposes of the research. ___Yes ___No
• The duration of subject’s participation in study. Yes No
• A description of the procedures to be followed. ___Yes ___No
• Identification of any procedures that are experimental. (May be
omitted if there are none.) ___Yes ___No
• A description of any reasonably foreseeable risks or discomforts to the
participant.___Yes ___No
• A description of any benefits to the participant or to others, which may
reasonably be expected from the research.___Yes ___No
• A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the participant. (May
be omitted if there are none.) ___Yes ___No
• A statement describing the extent, if any, to which confidentiality of
records identifying the participant will be maintained. ___Yes ___No
• A statement that notes the possibility that the Food and Drug
Administration may inspect the records. (May be omitted for research
that is not FDA-regulated.) ___Yes ___No
• An explanation as to whether compensation is available if injury
occurs. (May be omitted if the research involves no more than minimal risk.)___Yes ___No
• If compensation is available when injury occurs, an explanation as to
what it consists of or where further information may be obtained. (May
be omitted if the research involves no more than minimal risk.)___Yes ___No
• An explanation as to whether any medical treatments are available if
injury occurs. (May be omitted if the research involves no more than
minimal risk.) ___Yes ___No
• If medical treatments are available when injury occurs, an explanation
as to what it consists of or where further information may be obtained.
(May be omitted if the research involves no more than minimal risk.)___Yes ___No
• An explanation of whom to contact for answers to pertinent questions
about the research. (Contact (PI) for questions/problems, complaints, concerns
or suggestions, including 24-hour contact information)___Yes ___No
• An explanation of whom to contact for answers to pertinent questions
about the research participants’ rights. (Contact (IRB) for questions about
research rights, to discussproblems, concerns, or suggestions, or to offer input)___Yes ___No
• An explanation of whom to contact in the event of a research-related
injury to the participant. (Note: May not be omitted just because the
research involves no more than minimal risk.) ___Yes ___No
• A statement that participation is voluntary. ___Yes ___No
• A statement that refusal to participate will involve no penalty or loss of
benefits to which the participant is otherwise entitled. ___Yes ___No
• A statement that the participant can discontinue participation at any
time without penalty or loss of benefits to which the participant is
otherwise entitled. ___Yes ___No
• One of the following statements about any research that
involves the collection of identifiable private information or
identifiable biospecimens:*
(i) A statement that identifiers might be removed from the
identifiable private information or identifiable biospecimens and that,
after such removal, the information or biospecimens could be used for
future research studies or distributed to another investigator for
future research studies without additional informed consent from the
subject or the legally authorized representative, if this might be a
possibility; OR___Yes ___No
(ii) A statement that the subject's information or biospecimens
collected as part of the research, even if identifiers are removed,
will not be used or distributed for future research studies.___Yes ___No
Additional Elements
• A statement that the particular treatment or procedure may involve
risks to the participant, which are currently unforeseeable. ___Yes ___No
• A statement that if the participant is or becomes pregnant, the
particular treatment or procedure may involve risks to the embryo or
fetus, which are currently unforeseeable. ___Yes ___No
• Anticipated circumstances under which the participant’s participation
may be terminated by the investigator without regard to the
participant’s consent. ___Yes ___No
• Any additional costs to the participant that may result from
participation in the research. ___Yes ___No
• The consequences of a participant’s decision to withdraw from the research. ___Yes ___No
• Procedures for orderly termination of participation by the participant.___Yes ___No
• A statement 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. ___Yes ___No
• The approximate number of participants involved in the study. ___Yes ___No
• The amount and schedule of all payments to the participant. ___Yes ___No
• A statement that the subject's biospecimens (even if
identifiers are removed) may be used for commercial profit and whether
the subject will or will not share in this commercial profit.*___Yes ___No
• A statement regarding whether clinically relevant research
results, including individual research results, will be disclosed to
subjects, and if so, under what conditions.*___Yes ___No
• For research involving biospecimens, whether the research will
(if known) or might include whole genome sequencing (i.e., sequencing
of a human germline or somatic specimen with the intent to generate the
genome or exome sequence of that specimen).*___Yes ___No
3. If the study involves the use or disclosure of protected health information (PHI), does the consent form contain an adequate description of the required elements of Authorization listed in the Authorization Checklist below? (Note that the elements may be integrated within the consent document.)
• A specific and meaningful description of what will be used or disclosed.___Yes ___No
• Who may use or disclose the information___Yes ___No
• To whom the information will be disclosed___Yes ___No
• The purpose of the disclosure___Yes ___No
• The expiration date or expiration event related to the consent/authorization___Yes ___No
• The subject’s signature and date___Yes ___No
• The right to revoke the consent/authorization___Yes ___No
• The right to refuse to sign the consent/authorization___Yes ___No
• If treatment, payment, enrollment or eligibility for benefits will be dependent
on signing the consent/authorization document, a statement to that effect___Yes ___No
• Information disclosed to others not covered by the Privacy Rule may be
re-disclosed by them and the re-disclosure will not be protected by the Privacy Rule___Yes ___No
• The consent/authorization is written in plain language___Yes ___No
• The subject will be provided a copy of his/her signed and dated
authorization form___Yes ___No
• The subject has the right to access his/her own PHI___Yes ___No
• This right to access may be temporarily denied
(for example, for a “blinded” study)___Yes ___No
4. Is the consent form understandable to the population? Yes No
5. Is the consent form accurate and complete? Yes No
6. If the long form of the consent document (as above) is not to be used for some subjects (such as those who are not able to give legally effective informed consent in English), use of the Short Form of the consent document is permissible. In this case, determine that the investigator is following all of the applicable steps described in the DUHS IRB policy titled: “Policy on Research Involving Non-English-Speaking Subjects”, which is found on the IRB website under “IRB Policies”.
45 CFR 46.111, 21 CFR 56.111
IX.Data Monitoring(if the amendment does not affect data monitoring, skip this section.)
1. Is a data monitoring plan presented in the protocol? (Required for research involving more than minimal risk to subjects)
Yes No N/A
If yes, is it adequate to ensure the safety of subjects?
Yes No N/A
If no, please explain:[ ] The research plan makes adequate provision for monitoring the data collected to ensure the
safety of subjects 45 CFR 46.111, 21 CFR 56.111
X. PRIVACY INTERESTS OF SUBJECTS & CONFIDENTIALITY OF DATA(if the amendment does not affect privacy interests of subjects or confidentiality of data, skip this section.)
1. Is an adequate plan in the protocol for protecting the confidentiality of subject PHI and study data?
Yes No
If no, please explain:2. Does this study require a Certificate of Confidentiality?
Yes No
If yes, why?All NIH-funded research has automatically been issued a Certificate of Confidentiality by NIH. If the study is NIH-funded, does Certificate of Confidentiality standard language appear in the consent form?
Yes No Not NIH-funded
3. Is an adequate plan described for protecting the privacy interests of the subject? (for example, will “cold calling” occur, will recruitment and the consent process occur in private setting)
Yes No
If no, please explain:45 CFR 46.111, 21 CFR 56.111
[ ] There are adequate provisions to protect the privacy interests of subjects.
“Privacy interests” refer to the interest of individuals in being left alone, limiting access to themselves, and limiting access to their information.[ ] There are adequate provisions to maintain the confidentiality of data.
“Confidentiality” refers to the agreement between the investigator and the subject regarding the use, handling, and management of data, and data disclosures.
XI. DRUGS/DEVICES/BIOLOGICS AND ASSOCIATED COSTS (if the amendment does not affect an investigational drug/device/biologic or other investigational chemical, metabolite, nutritional substance or other substance being used in this study, skip this section.)
1. Is an investigational drug/device/biologic or other chemical, metabolite, nutritional substance or other substance being evaluated in this study?
Yes No
[If “No”, proceed to the next section.]
2. What is the drug/device/biologic or other chemical, metabolite, nutritional substance or other substance being evaluatedin this study?
3. Has an IND/IDE number been provided?
Yes NoIf yes, please answer the following:
a. What is the IND/IDE number?
b. Who is the holder of the IND/IDE?
c. The drug/device has anIND/IDE number and the IND/IDE number is supported by one of the following (The Investigator’s Brochure may not be used for this purpose.):
?Sponsor protocol imprinted with the IND/IDE number.
?Written communication from the sponsor documenting the IND/IDE number.
?Written communication from the FDA documenting the IND/IDE number. (Required if the investigator holds the IND/IDE.)
4. If no IND/IDE number is provided, please answer the following:
For drugs/BIOLOGICS or other chemical, metabolite, nutritional substance or other substance: (Use the Checklist to Determine if an Investigational New Drug (IND) Application is Required Where an IND Number is Not Provided which is available on the IRB web site)
Have the criteria for exemption* from the requirement for an IND submission been satisfied?
___Yes ___No
For devices: (Use the Checklist to Determine if an Investigational Device Exemption (IDE) is Required Where an IDE Number is Not Provided which is available on the IRB web site)
Have the criteria for an abbreviated IDE been satisfied?
___Yes ___No
Have the criteria for exemption* from the requirement for an IDE submission been satisfied?