The purpose of this checklist is to provide support for IRB members reviewing research. This checklistis used for amendments reviewed at the convened IRB. For amendments that are included with the continuing review, use CHECKLIST: Continuing Review Criteria for Approval.
Contact the IRB Chair and/or IRB Office Staff immediately if you have questions while completing this checklist. IRB Office Tel. #: (617) 636-7512
Describe any issues or concerns in Section 12.Comments/Points to discuss at the meeting.
The Reviewer is also encouraged to contact the PI or research team directly to resolve issues before the meeting.
Meeting Date: / IRB #: / Principal Investigator: / IRB Reviewer:
Study Title:
Purpose of the amendment:
Amendment changes:
1General Considerations (Check if “Yes”. Both must be checked)
Assigned Reviewer has the adequate expertise to review this study.
If you disagree, or if you believe a content expert should also review this study, do not check this box; contact the IRB office staff immediately.
During pre-review, it was confirmed that study materials are complete and this study can proceed to the convened IRB for review.
If you determine additional materials are necessary or documents require revisions, list these in Section 12.Comments/Points to discuss at the meeting.
2Criteria for Approval of Research: (Check if “Yes” orcheck“N/A” if the amendment does not affect the criterion.)
If any of the boxes below cannot be checked, describe the changes that need to be made to the protocol and/or informed consent form (ICF)in order to meet these criteria in Section 12.Comments/Points to discuss at the meeting.
Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk.N/A:
Risks to subjects are minimized by using procedures already being performed on the subjects for other purposes, whenever appropriate. N/A:
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.N/A:
Selection of subjects is equitable. (Consider the purpose and setting of the research, involvement of vulnerable subjects, selection criteria, and recruitment, enrollment, and payment procedures.)N/A:
The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. N/A:
There are adequate provisions to protect the privacy of subjects.N/A:
There are adequate provisions to maintain the confidentiality of data.N/A:
The resources necessary to protect subjects,as described in the submission, are adequate and appropriate for the study.
(Time to conduct and complete the research; adequate facilities; appropriate subject pool, medical and psychosocial resources; qualified investigators and research staff; appropriate qualifications for international research.)N/A:
Per the protocol, all research team members are adequately informed about the protocol, the investigational product(s), and their study-related duties and functions.N/A:
As a result of this amendment, new information is to be provided to subjects because it might affect their willingness to continue participation. Describe this new information (and whether this applies to all previously enrolled subjects, active subjects, and/or future subjects) in Section 12. Comments/Points to discuss at the meeting. N/A:
The plan for communication among sites is adequate to protect subjects.
(Check “N/A” if this is not a multicenter study where Tufts is the sponsor, primary grant recipient, or coordinating site) N/A:
Additional safeguards have been included in the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence, such as children, prisoners, mentally disabled persons, or economically or educationally disadvantaged persons.
(Check “N/A” if no vulnerable subjects will be enrolled.) N/A:
Additional applicable criteria[1] are met.
(Check “N/A” if none of the checklists/worksheets are applicable) N/A:
3Additional Considerations (Check all that apply.)
The amendment involves no more than minimal risk[2]to subjects.
The amendment involves the safety or efficacy of the current study drug or an additional drug – refer to IRB Form 2 (if provided) and complete Worksheet: Drugs.
The amendment involves the safety or efficacy of the current study device or an additional study device – refer to IRB Form 3 and complete Worksheet: Devices.
The amendment involves changes to or the addition of research-related radiation (Check all that apply):
Form 4, signed by the Radiation Safety Officer (RSO) is included with the submission
Changes to the protocol and ICF were made as required by the RSO
4Funding (Check all that apply.)
If there is no federal funding for the study or if the amendment has no effect on funding, then check “N/A” and go to the next section: N/A:
Federal (NIH) grant
There are no inconsistencies between the grant and the protocol.
The research proposed in the protocol is within the scope of the grant.
5Informed Consent (Check if “Yes” orcheck“N/A”if the amendment does not include a new or revised ICF or affect consent findings) N/A:
If any of the boxes below cannot be checked, describe the changes that need to be made to the protocol / Site-Specific Appendix, and/or ICF to meet these criteria in Section 12. Comments/Points to discuss at the meeting.
This amendment includes revisions to the ICF:
Previously enrolled subjects must be re-consented to the new information contained in the revised ICF.
The PI’s proposed plan to re-consent previously enrolled subjects is acceptable.
The PI’s and/or sponsor’s assessment that previously enrolled subjects do not need to be re-consented is acceptable.
Reconsenting is not required because (choose all that apply):
The new information would not affect the subject’s willingness to continue to participate in this research study.
The new information is not applicable to previously enrolled subjects.
No subjects are currently enrolled or currently being followed.
The PI or a Co-I will obtain the legally effective informed consent of the subject or legally authorized representative (LAR).
If the submission proposes a research team member other than the PI (or a Co-I with equivalent experience) obtain consent, consider whether this is appropriate, evaluating the description of the research team member’s training, supervision, and experienceand raise this issue in Section 12. Comments/Points to discuss at the meeting.
The circumstances of consent provide the prospective subject or LAR sufficient opportunity and time to consider whether or not to participate.
The circumstances of consent minimize the possibility of coercion or undue influence.
If this study proposes enrollment of adults unable to consent or children, the consent includes an LAR or parent signature line.
(Check “N/A” if these subject populations are not being enrolled in the study) N/A:
6HIPAA Findings (Check all that apply.)
If the amendment does not require new or affect previously made HIPAA findings, check N/A and go to the next section:N/A:
This study is closed to enrollment. HIPAA authorization has already been provided.
Research authorization language is included in the ICF.
Separate Research Authorization Form (RAF) is being used.
HIPAA is Not Applicable –the research does not involve protected health information (PHI).
HIPAA Exempt –the research is not being conducted in a covered entity.
HIPAA Waiver – A Waiver of Authorization for the entire study (HRP-441) is being requested.
HIPAA Waiver for Screening Component – A Waiver of Authorization limited to the following is needed (Check all that apply.):
Identification of potential participants from existing records or databases.
Telephone screening.
Fasting beforethe first study visit.
Other (describe):
7Non-English Speaking Subjects (Check all that apply.)
If none can be checked, describe why in Section 12.Comments/Points to discuss at the meeting.
If the amendment does not affect the enrollment of non-English speakers, check N/A and go to the next section:N/A:
If non-English speaking subjects are excluded, the ethical and scientific justification for their exclusion is acceptable.
Non-English speaking subjects will be enrolled in this study.
The plan to enroll non-English speaking subjects is adequately detailed in the protocol or Site-Specific Appendix
Tufts Health Sciences IRB-approved short forms will be used for enrollment, and use of IRB approved short forms is acceptable.
English ICF will be translated into non-English speaking subjects’ native language
8Overall Scientific and Scholarly Validity (Check “Yes” if a specific item continues to apply.)If you are unable to assess each of these points, or if you question whether or not one of these boxes can be checked, contact the IRB office staff or the IRB Chair before the meeting and/or raise this issue as a point to discuss in Section 12.Comments/Points to discuss at the meeting.
Explain why any given box was left unchecked in Section12. Comments/Points to discuss at the meeting.
If the amendment does not affect the overall scientific and scholarly validity of the study, check N/A and go to the next section:N/A:
The protocol accurately describe the research in a clear and detailed manner relative to the points below:
- Objectives
- Background
- Setting
- Procedures
- Data and safety monitoring plan
- Risks
- Potential benefits
- Alternatives to participation
The research design adequately reduces risks to subjects and is feasible given the scientific design.
The monitoring procedures sufficiently reduce risks to subjects and do not affect the science. (If additional monitoring is recommended, describe in Section 12.Comments/Points to discuss at the meeting.)
The research is likely to answer its proposed question.
The protocol fairly portrays the knowledge expected to result.
9Clinical Trials[3] Complete this section if the study is a Clinical Trial. (Check if “Yes” or check “N/A” if the amendment does not affect the criteria below. All must be checked).
If you are unable to assess each of these points, or if you question whether or not one of these boxes can be checked, contact the IRB office staff or the IRB Chair before the meeting and/or raise this issue in Section 12.Comments/Points to discuss at the meeting. Explain why any given box was left unchecked in Section 12.Comments/Points to discuss at the meeting.
If the study is not a clinical trial or the amendment does not affect these points in the study, check N/A and go to the next section:N/A:
The available nonclinical and clinical information about an investigational product is adequate to support the proposed clinical trial.N/A:
A qualified physician (or dentist) who is a PI or Co-Investigator will be responsible for all study-related medical (or dental) decisions.N/A:
10Payment Complete this section if the amendment affects study payment (Check if “Yes.” All must be checked).
If you are unable to assess each of these points, or if you question whether or not one of these boxes can be checked, contact the IRB office staff or the IRB Chair before the meeting and/or raise this issue in Section 12.Comments/Points to discuss at the meeting. Explain why any given box was left unchecked in Section 12.Comments/Points to discuss at the meeting.
Refer to the Tufts Health Sciences IRB website information about use of Greenphire ClinCard at Tufts Medical Center.
If the amendment does not affect study payment, check N/A and go to the next section:N/A:
Payment information is described in the protocol (or Site-Specific Appendix) including:
Amount
Method
Recipient
Payment Schedule (including conditions under which a subject would receive partial or no payment, for example, if the subject withdraws part way through the research or is withdrawn by the Investigator).
Payment information is described in the ICF including:
Amount
Method
Recipient
Payment Schedule (including conditions under which a subject would receive partial or no payment, for example, if the subject withdraws part way through the research or is withdrawn by the Investigator).
Payment amount, method of payment, and payment schedule are neither coercive1 nor present undue influence2.
1.Coercionoccurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance. For example, an investigator might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research.
2.Undue influence, by contrast, often occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance. For example, an investigator might promise psychology students extra credit if they participate in the research. If that is the only way a student can earn extra credit, then the investigator is unduly influencing potential subjects. If, however, she offers comparable non-research alternatives for earning extra credit, the possibility of undue influence is minimized.
Payment is prorated, if applicable
In studies of considerable duration or that involve multiple interactions or interventions, OHRP recommends that payment be prorated for the time of participation in the study rather than delayed until study completion, because the latter could unduly influence a subject’s decision to withdraw at any time. For example, if the study is conducted over a period of 6 months, there might be a monthly or bi-monthly payment. Or, if the study involves 12 sessions, there might be payment after every two sessions.
The payment recipient is the subject. (If the payment recipient is not the subject, consider and note whether the proposed payment recipient is appropriate in Section 12. Comments/Points to discuss at the meeting.)
Payment is not contingent upon completing the entire study unless the entire study consists of only one visit.
Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn.
Compensation does not include a coupon good for a discount on the purchase price of the test article once it has been FDA-approved.
11Advertisements Complete this section if the amendment affects advertisements.
If you are unable to assess each of these points, or if you question whether or not one of these boxes can be checked, contact the IRB office staff or the IRB Chair before the meeting and/or raise this issue in Section 12.Comments/Points to discuss at the meeting. Explain why any given box was left unchecked in Section 12.Comments/Points to discuss at the meeting.
If the amendment does not affect advertisements, check N/A and go to the next section:N/A:
The submission describes the mode and location/site of communication of the advertisement.
Does NOT state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the ICF and protocol.
Does NOT promise “free treatment” when the intent is only to say subjects will not be charged for taking part in the research.
Does NOT include exculpatory language.
Does NOT emphasize the payment or the amount to be paid, by such means as larger or bold type or brightly colored text.
The advertisement is limited to the information prospective subjects need to determine their eligibility and interest, such as:
- The name and address of the investigator or research facility.
- The condition under study or the purpose of the research.
- In summary form, the criteria that will be used to determine eligibility for the study.
- A brief list of participation benefits, if any.
- The time or other commitment required of the subjects.
- The location of the research and the person or office to contact for further information.
For FDA-Regulated research, the advertisement: (Check if “Yes.” All must be checked.)
If the study is not FDA-Regulated then check N/A and go to the next section:N/A:
Does NOT make claims, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation.
Does NOT make claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic or device.
Does NOT use terms, such as “new treatment,” “new medication” or “new drug”.
Does NOT include a coupon good for a discount on the purchase price of the product once it has been FDA-approved for marketing.
12. Comments/Points to discuss at the meeting:
1.
13. Stipulations Required for Approval (Provide a reason for each stipulation. If you cannot provide the reason, note this in Section 12. Comments/Points to discuss at the meeting, so the Committee can discuss it.):
Stipulation Required / Reason for Stipulation
Are any of the required stipulations substantive?
No, the revised documentation/clarifications/changes may be reviewed and approved via expeditedreview procedures.
Only when the convened IRB stipulates specific revisions requiring simple concurrence by the PI, may the revisions be reviewed and approved via expedited review procedures.
Yes, the revised documentation/clarifications/changes must be reviewed and approved by the convened IRB.
When the convened IRB requests substantive clarifications or stipulations regarding the protocol or informed consent documents that are directly relevant to the determinations required by the IRB under HHS regulations at 45 CFR 46.111, IRB approval of the proposed research should be deferred, pending subsequent review by the convened IRB of responsive material.
Example reasons for stipulations:
Risks:
- Removing XX will minimize risks to subjects. If XX cannot be removed, subjects must be made aware of the risk of self-injury in participation.
- Risks of XX is a currently unaddressed risk of participation in the study; this risk requires minimization.
- Revising XX will clarify the risks to confidentiality.
- Subjects must be informed of all potential risks to participation.
- Resources to minimize risks should be extended to all subject populations.
- To minimize the risks of participation and maximize the scientific merit of the study, the eligibility criteria must be clear to the research team and participants. This is particularly true if exclusion criteria are meant to disqualify subjects who may be at higher risk in the study.
Consent Process
- The application and the consent form must be reconciled to each other for consistency.
- Providing the study consent materials earlier in the process and performing the screening prior to the experiment day will provide subjects with additional time to consider participation and eliminate inconvenience for subjects who are ultimately ineligible to participate.
- Consent forms should be written in language understandable to the subjects.
Other