SAMPLE FORM Application for Continuation of Approval of Research
Institutional Review Board – New YorkState Psychiatric Institute
1. IRB # 6. Date current approval expires:
2. Study Title: 7. Date of first approval:
3. Principal Investigator :
4. e-mail address:
5. Telephone:
8. Are you proposing a study amendment/modification with this application? Yes No
- Please attach request as a separate memo
9. Current Status of Study: (check one of the following seven options and follow directions)
a. Subject enrollment has not yet begun
- Complete items 13, 15-19 below.
- Enclose one unstamped copy of the most recently approved informed consent documents with required revisions.
- Enclose copies of all recruitment materials to be used in the upcoming year.
- Enclose an updated protocol summary form (PSF).
b. Subject enrollment and/or procedures are ongoing:
- Complete items 10-19 below.
- Enclose one unstamped copy of the most recently approved informed consent documents with required revisions.
- Enclose copies of all recruitment materials to be used in the upcoming year.
- Enclose an updated protocol summary form (PSF).
c. Enrollment of new subjects is closed. Research procedures and/or interventions are ongoing for subjects
currently enrolled :
- Complete items 10-19 below.
d. All research interventions are completed. Only data analysis is ongoing.
- Complete items 10-19 below.
e. All Research interventions and data analysis were completed at all study sites within past year. Study is
terminated.
- Indicate date study was terminated:
- Complete items 10-19 below.
f. Study involves secondary data collection.
- Complete items 11-19 below.
g. Study only involves data analysis/chart review.
- Complete items 11-19 below.
h. Protocol covers a grant for multiple projects. Each project receives separate IRB approval.
- Attach a list of all NYSPI-IRB protocols covered by the grant. Indicate NYSPI-IRB protocol number, titles of protocols, name of Principal Investigator, date of most recent IRB approval, and CUMC-IRB number (if applicable).
- Complete items 15 and 19 below.
10. Study enrollment and drop-out during the approval period:
a. Number of participants who signed consent in the past year:
(Do not include subjects who signed only screening consent forms)
b. Past year: number of participants who discontinued study involvement
(who withdrew consent) after protocol procedures were initiated:
- Describe circumstances of participants’ study discontinuation:
c. Past year: number of participants dropped from the research by the investigator.
(Do not include participants who failed to meet inclusion criteria during screening.)
- Describe circumstances of subject’s study removal:
11. Sample characteristics and progress toward enrollment goals
a. Sample size approved for recruitment:
b. Number of participants currently enrolled in the study:
c. Total number of participants who have completed the study since it was first approved:
d. Explain any significant departures from anticipated study retention of completion rates and any actions taken to correct them: (E.g., Were drop-out rates higher than you expected?)
e. Complete the table below to describe the sample who have entered the study to date:
(The sum of the lower right hand boxes should reflect the number of individuals who gave their informed consent. Do not include subjects who signed only screening consent forms.)
Adults
White not of Hispanic origin / Black not of Hispanic origin / Hispanic / Asian or Pacific Islander / American Indian or Alaskan Native / Other or unknown / TotalFemale
Male
Total
Children
White not of Hispanic origin / Black not of Hispanic origin / Hispanic / Asian or Pacific Islander / American Indian or Alaskan Native / Other or unknown / TotalFemale
Male
Total
12. Briefly summarize any significant findings which have arisen from the research, and list papers authored by the Principal Investigator or co-Investigators published or accepted for publication in the past year
(or indicate None):
13. Describe any study findings, recent literature, or untoward events occurring here or at other sites in the past year which might affect the analysis of the safety, risks or benefits of study participation (or indicate None):
14. Please describe any serious adverse events (serious and/or unanticipated problems involving risks to subjects or others at this site which occurred in the past year and describe any resultant protocol modifications made (or indicate None):
15. Funding: No external funding
Title of grant:
a. Principal Investigator (if different from item #3):
b. Source of funding:
c. Grants office: RFMH Columbia University Other (specify):
16. Have the principal investigator and other investigators made all required disclosures of financial interest in the study sponsor/product? Yes No Not applicable
17. I confirm that all study staff with a significant role in the design or implementation of the human subject components of this study have completed CITI training in human research subject protections. Associated documentation is in my files. Yes No
18. Is the study covered by a certificate of confidentiality? No Yes, expiration date:
19. “I hereby certify that no changes will be initiated by me without notification to and approval by the Psychiatric Institute – Columbia University Department of Psychiatry Institutional Review Board. I will also notify the IRB and the Department of Quality Assurance regarding any adverse reactions.”
This will confirm that protocol and consent procedures conform to current Institute and IRB policies including procedures to ensure confidentiality of electronically stored/transmitted data.
Principal Investigator Signature: ______Date: ______
IRB Use: (V.) 1/2007
Exp. Date: ___/___/___
LOR: FB E
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