IRB ANNUAL/CONTINUING REVIEW FORM (Progress Report Form)

IRB ANNUAL/CONTINUING REVIEW FORM (Progress Report Form)

This form should be submitted 30 days prior to the anniversary date for projects exceeding one year in duration. Report activities that occurred over the past year and minor changes to an approved protocol. Other changes require filing an amendment. Training certification must be current before approval is granted. (Exempt status projects do not require Annual Review.)

A. Protocol Information

B. Study Staff

Insert the name of all personnel currently involved with human subjects and their role. Check the type and date of training completed for each. (Training certificates must be renewed every 3 years and on file with the IRB office.):

Name: enter text. Role: enter text. Email: enter text. Training: ( ) NIH ( ) CITI Date: enter a date.

Name: enter text. Role: enter text. Email: enter text. Training: ( ) NIH ( ) CITI Date: enter a date.

Name: enter text. Role: enter text. Email: enter text. Training: ( ) NIH ( ) CITI Date: enter a date.

Name: enter text. Role: enter text. Email: enter text. Training: ( ) NIH ( ) CITI Date: enter a date.

Name: enter text. Role: enter text. Email: enter text. Training: ( ) NIH ( ) CITI Date: enter a date.

Additional Staff or Comments: Click here to enter text.

C. Funding Source

( ) No Funding.

( ) Federal funding, list agency: Click here to enter text.

( ) UML funding, describe: Click here to enter text.

( ) Other, describe: Click here to enter text.

( ) Funding completed, date: Click here to enter a date.

D. Study Status (check all that apply)

( ) Project is proceeding on schedule.

( ) Subject recruitment-no subjects enrolled to date.

( ) Subject recruitment- is ongoing with projected end date of: Click here to enter a date.

( ) Subject recruitment- completed as of (date): Click here to enter a date.

( ) Subject recruitment- needs expanded: Request increase from original approved of Click here to enter text to Click here to enter text.

( ) Intervention & data collection- completed as of (date): Click here to enter a date.

( ) Data analysis- is ongoing: expected end date of: Click here to enter a date.

( ) Data analysis- is complete as of (date): Click here to enter a date.

( ) Other: Click here to enter text.

E. Study Information

1. Study Abstract (Provide a brief abstract of the study): Click here to enter text.

2. Summary of activities during past approval period: Click here to enter text.

3. Were any manuscripts, publications, or conference presentations related to this study completed during the past approval period? ( ) Yes or ( ) No If yes, list here: Click here to enter text.

F. Research Procedures

( ) Protocol has not been altered since original approval or last continuing review.

( ) Protocol has been modified and a summary of the changes are provided. (Provide a brief description of the research procedures, incorporating elements of all approved amendments to date for the research.): Click here to enter text.

G. Subject Numbers (Enter N/A for questions that are not applicable.)

1. Number of subjects proposed and approved by the IRB: Click here to enter text.

2. Number of subjects screened: Click here to enter text.

3. Number of subjects enrolled (consented to participate): Click here to enter text.

4. Number of subjects who voluntarily withdrew: Click here to enter text.

5. Number of subjects excluded by PI: Click here to enter text.

a. Reasons for exclusion: Click here to enter text.

H. Subject Safety (check at least one)

( ) Not applicable – there is nothing to report.

( ) Describe any problems encountered that involved risk or harm to subjects or others since last annual review: Click here to enter text.

( ) Describe any unexpected benefits to subjects or others since the last annual review: Click here to enter text.

( ) Are you aware of new information, from other sources, that affect risks/benefits from participating in this study? ( ) Yes or ( ) No If yes, provide the following:

1. Attach copies of any literature that provide new information on this study's risk/benefit ratio.

2. Summarize how this new information or experience impacts the risk/benefit ratio for this study: Click here to enter text.

3. Summarize any modifications proposed to the approved research based on these new results (an amendment form should also be submitted separately): Click here to enter text.

I. Amendments

( ) None requested at this time.

( ) Minor changes requested (such as personnel changes, elimination of a tool, etc.)

( ) New amendment(s) requested (list type of change below and submit a separate Amendment Form for approval):

1. Click here to enter text.

2. Click here to enter text.

3. Click here to enter text.

Additional: Click here to enter text.

J. Study Materials

1. Informed Consent (Check all that apply)

( ) Only the date has changed on the form.

( ) Form has minor revisions and the date changed.

( ) Waiver of documentation of informed consent was approved.

( ) Waiver of informed consent was approved.

( ) Translated forms were required and the only change is to the date

( ) Translated forms were required. The forms and the date have been revised, and are being submitted with the Translation Certification form and the Back Translated document(s).

( ) Data collection is complete, so the form does not need to be updated.

2. If Informed Consent forms were used, are they are on file and available upon request for the IRB for all subjects who agreed to participate in the research? ( ) Yes ( ) No ( ) N/A

3. Other materials to be submitted for Annual Review:

( ) Recruitment materials, such as brochures or flyers that are updated.

( ) Informed Consent documents or scripts. List titles of each: Click here to enter text.

( ) Survey/interview tools. List titles of each: Click here to enter text.

( ) Other, list name of form or document: Click here to enter text.

K. PI Assurance:

( ) I certify the accuracy of the information provided and I agree to abide by UMass Lowell policies and procedures governing research with human subjects. This form has been submitted electronically from my email account.

IRB Continuing Review form rev.9-13-12.docx1