Checklist of Items to be Submitted to the IRB for Continuing Review:
All documents must be submitted as a hardcopy to the IRB Office (15 Kneeland Street, Tupper 1) or by interoffice mail to Box #817. This checklist is for your use and does not need to be submitted to the IRB.
Open to Enrollment / Closed to EnrollmentForm 5 (Continuing Review): Submit for all continuing reviews.
Form 2 (Drug): Submit when the research includes testing the safety and/or efficacy of a drug. Submit a copy of the Investigator’s Brochure and/or study drug information as applicable.
Form 3 (Device): Submit when the research includes testing the safety and/or efficacy of a medical device. Submit a copy of the Operator’s Manual and/or Device Manual as applicable.
Form 4 (Radiation): Submit when the research includes research-related radiation. Submit the most recent version reviewed and signed by the Radiation Safety Officer (This can be a previously submitted signed Form 4 if no changes have been made to research-related radiation).
Form 6 (Tissue Banking): Submit when the research includes tissue banking, which is defined as storage of any specimens for unspecified future use. Submit a copy of the tissue bank’s policies or answer questions 14a –14d.
Form 7 (Chart Review): Required for retrospective medical record/chart/electronic database/specimen review and databases created for research purposes. When submitting a Form 7, there is no need to submit a separate protocol.
Site-Specific Appendix: Submit if the protocol does not already contain site-specific details such as recruitment and consent (typically multi-center protocols are not tailored to this site).
Protocol: Required at every continuing review except for studies that are closed to enrollment and conducting data analysis only.
Informed Consent Forms:
Submit a copy of the last (most recent) lCF that has been signed by a subject. All identifiers should be blacked out on this ICF prior to submission.
Submit a clean, unvalidated copy of the ICF currently in use for new validation. If any revisions are being made to the ICF with this continuing review, submit a tracked copy highlighting the changes and a clean/updated copy for validation.
If a DSMB exists for the study, submit a copy of sponsor’s, DSMB/DMC, and/or coordinating statistical center, progress report, or annual report, or DSMB/DMC report if available. This report should include the following:
· A statement indicating what information (for example, study-wide adverse events, interim findings, and any recent literature that may be relevant to the research) was reviewed;
· The date of the review; and
· An assessment of the information reviewed.
Subject Materials: Submit any materials that will be provided to, seen or heard by subjects (e.g. questionnaires, scripts, instruction sheet, etc.)
Recruitment Materials: Submit all advertisements and recruitment material, such as flyers, recruitment e-mails or letters, newspaper advertisements, radio advertisements, social media postings, etc.
Tufts MC Clinical Research Recruitment Website form: Submit for all Tufts MC studies that utilize an Informed Consent Form. This is a Tufts MC institutional requirement and must be submitted in order to receive IRB approval. The form for posting studies on this recruitment website is optional for Tufts University studies.
Research COI form: Submit the completed PI’s research COI form as well as COI forms from research team members who have indicated a “YES” response in any field on the form. / Form 5 (Continuing Review)
Protocol
Site-Specific Appendix
Research COI form
Submit applicable additional documents if subjects are still participating in active study intervention:
Form 2 (Drug)
Form 3 (Device)
Form 4 (Radiation)
Form 6 (Tissue Banking).
Subject Materials:
Closed to Enrollment and in Data Analysis Only
Research COI form
Form 5 (Continuing Review)
IRB Authorization Agreement (IAA)
Where Tufts Health Sciences IRB is the IRB of Record
If a continuing review for a study with a previously executed IAA is being submitted, a Form 5 should be completed for each site and submitted with this continuing review.
If an IAA request is being submitted with this continuing review, submit a completed Form 10 with this continuing review.
/ Form 5: Continuing Review
Submit this completed typed form (with original PI signature) to the IRB office (Box 817 or 15 Kneeland St, 1st floor).
On your cover letter, provide a list of each document being submitted for review and approval, categorizing each as follows:
· New Documents
· Revised Previously Approved Documents
· Unchanged Previously Approved Documents
The name and version of each listed document should match the name and version on the document itself.
If amendments are being requested, use the Amendment Cover Letter Template as your cover letter for this continuing review.
IRB Number: / Study Title:
Principal Investigator: / PI Telephone:
PI Email:
Research Coordinator: / Research Coordinator Telephone:
Research Coordinator Email:
Institution: / Department/Division:
Mailing Address or Box #:
A. Current Study Status
This refers to the status of the protocol under the supervision of the investigator, not the status of the protocol at all centers. If this will be the last continuing review, complete the entirety of the form. Check all that are applicable.
1. The study is permanently closed to enrollment at this site (specify below):
Specify date study closed to enrollment:
a. Study remains active for Study Intervention and/ or Active Follow-Up consisting of the following activities:
b. All subjects have completed all research-related interventions, and study remains active only for Long-Term Follow-Up*
c. Remaining study activity is limited to data analysis only
*Long-Term Follow-Up includes researchinteractionsthat involve no more than minimal risk to subjects (e.g., quality of life surveys); or collection of follow-up data from procedures or interventions that would have been done as part of routine clinical practice to monitor a subject for disease progression or recurrence, regardless of whether the procedures or interventions are described in the research protocol. Long-Term Follow-Up does NOT include research interventions that would not have been performed for clinical purposes, even if the research interventions involve no more than minimal risk.
2. All study related interventions and interactions with subjects have been completed at this site, including interventions and interactions related to collection of long-term follow-up data.
3. No additional identifiable private information* about the subjects is being obtained by this site’s PI or research team.
4. Analysis of identifiable private information* at this site has been completed. (This can be checked even if a statistical center at another institution will analyze identifiable private information from subjects enrolled at this site.)
*Private information is individually identifiable when the identity of the subject is or may readily be ascertained by the investigator or associated with the information. Obtaining identifiable private information includes an investigator’s use, study, or analysis of identifiable private information. With respect to obtaining identifiable private information, this includes obtaining identifiable biological specimens from living individuals.
a. The remaining study activity is limited to simply maintaining individually identifiable private information without using, studying, or analyzing such information.
b. The remaining study activity involves only the analysis of aggregate data sets without individual subject identifiers.
If 1c, 2, 3, and 4 (a or b) are all checked, then this is the last continuing review of this study, and the study will be closed with the IRB (proceed to section B. Enrollment Status and continue completing the rest of the form).
If, based on the information you provide, this will be the last continuing review of this study, but you would still like to keep the study active with the IRB, contact the IRB Office Staff to discuss.
If neither 4a nor 4b are checked, continuing review will still be required on an annual basis.
5. Open to enrollment
6. This is a General Certification for a grant that might involve multiple projects. Submit a list of all studies funded by the grant; include: PI name, IRB number, and the last IRB approval date for each study. Include a copy of the grant progress report, if available.
7. Medical record/chart review. Enter the number of medical records/charts reviewed to date:
8. Sample or secondary analysis research only (This does not apply to studies that have closed to enrollment and are conducting data/sample analysis only.)
B. Enrollment Status
Specify number of:
Complete each field; do not leave fields blank. Indicate 0 or N/A as applicable. / Total / In the past year (since the most recent continuing review or initial review) / The IRB counts every subject who signs any informed consent form (ICF) as enrolled in the study. Potential subjects who are screened to determine eligibility are counted as enrolled if and only if they sign a screening ICF.
1. Subjects enrolled at this investigator’s site since study started:
2. Screen Failures: / *A subject is considered to have withdrawn from the research when the subject either stopped participation or the research team stopped the subject’s participation early for reasons other than reaching a study endpoint (including subject deaths). Screen failures should not be counted as withdrawals.
3. Withdrawals/Discontinuations*:
4. Subjects who completed the study:
5. Subjects remaining in study:
If you would like to request an increase in subject enrollment, submit the Amendment Cover Letter Template with this request as your cover letter for this continuing review
C. Current Funding
Check all that apply
Federal1 / Secured Pending / Agency Name:
Industry2 / Secured Pending / Company Name:
Foundation / Secured Pending / Foundation Name:
Institutional / Secured Pending / Describe:
Departmental / Secured Pending / Describe:
Other / Secured Pending / Describe:
None
Grant title:
Specify the primary award recipient of the grant:
This is a federal award where Tufts MC/TUHS is receiving direct federal funding and a 310 form is required1
This is a sub-award/contract or service agreement where Tufts MC/TUHS will receive grant funds from the above institution2, 3
This study is funded by another Tufts Medical Center/TUHS IRB approved study (sub-study or ancillary study).
Specify IRB #:
1 If Tufts is the grant recipient, attach Funding/Grant Progress Report. If the most recent progress report is not available, please submit a copy of the grant. documentation that concerns this study (i.e. the research methods and procedures of this study as described in the grant)
2 Industry funding requires a contract is executed with the Tufts Medical Center Clinical Trials Office or the Tufts Office for Technology and Industry Collaboration prior to the commencement of an IRB approved research study.
3 Sub-contract may also include sub recipient, cooperating institution, and other terms sub-award.
D. Location of Research Study
1. Specify and describe the location of the research procedures:
2. Other Institutions (specify institutions & attach a copy of each current IRB approval):
List other institutions only when Tufts is the Sponsor, primary grant recipient, or coordinating site, otherwise indicate not applicable “N/A”.
3. International Sites (specify sites & attach a copy of each current IRB approval):
List international sites only when Tufts is engaged in research at those sites OR is the Sponsor, primary grant recipient, or coordinating site, otherwise indicate not applicable “N/A”.
4. Outside Institutions where Tufts Health Sciences IRB is the designated IRB of record (specify institutions):
E. Study-Specific Disclosure of Financial Interest†
Conflict of Interest (COI)
Check to confirm the PI and each research team member have completed the Research COI form and copies of the completed forms have been retained in the study files.
Check to confirm that the following COI forms are included with this continuing review submission:
1. The PI’s completed COI form (this needs to be submitted regardless of the responses on the form).
2. COI forms from research team members who have indicated a “YES” response in any field on the form.
† Contact the Tufts MC Office of the Vice President of Research or the TUHS Office of the Vice Provost for Research with questions about this COI policy.
F. Blood-borne Pathogen Training
Annual training is required by the Occupational Safety and Health Administration (OSHA) and the International Air Transit Association (IATA) for any research team member who will collect, handle, and/or process human samples capable of transmitting blood borne pathogens.
This does not apply to this research.
This does apply to this research and all research personnel who may come in contact with blood borne pathogens have completed or will complete the required training and, as applicable, annual updates before conducting research.
Documentation attesting to completed training is subject to audit. Contact the Tufts MC/TUHS Biosafety Officer at (617) 636-0964 with any BBP training related questions.
G. Amendment
Provide a summary of any amendments to the research approved and/or pending approval by the IRB since the IRB’s initial review or the most recent continuing review:
There have been NO amendments to the research since the IRB’s initial review or the last continuing review.
For NIH funded research, please note on 30 July 2015, the NIH released the Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval. Per this guidance, if a study is funded by the NIH, the PI must ensure that any change in research procedures in an active award that would result in an increased risk to human subjects receives NIH approval before implementation.
Study modifications are being submitted with this continuing review. If so, use the Amendment Cover Letter Template as your cover letter for this continuing review to describe modifications and provide additional necessary information.
Revisions have been made to documents submitted with this continuing review. Submit a list describing which documents have been revised, which are newly submitted, and which remain unchanged.
H. Mandatory Human Subjects Protection Education
PLEASE NOTE: If additional spaces are needed in this section, please attach an additional piece of paper
List the PI and Research Team Members This includes those responsible for the design, conduct, or reporting of the research, such as the PI & Co-Is, research nurses and coordinators, project managers, etc. / Individual’s Role
(For example, list PI, Co-I,
Research Coordinator. Do not list any research team member as a “Co-PI;” only one person may be listed as PI for a study.) / Institutional Affiliation