Continuing Review Subject Information Questions

Robert Hood

08/21/2008 03:25 pm

Examples of how to answer Continuing Review, Subject Information questions. The IRB needs to know how many participants have been enrolled in total, or during the past review period, and to know how many have withdrawn or been screening failures to conduct substantive and meaningful continuing review.

As part of continuing review, the IRB needs to assess enrollment, and the number of, and reasons, for withdrawals.

Continuing Review Subject Information Questions	Sample Answers and Examples
A) Maximum number of participants previously approved by the DOH IRB to be consented by this PI for the life of the study.	Enter the number of participants the IRB approved at time of initial review (or last amendment, if the amendment was to change enrollment). If the study is sponsored, this is the number of participants the sponsor indicated and the IRB approved the site to recruit). Example: If the initial application proposed 28 participants, and the IRB approved 28, and there have been no amendments to change enrollment, then the answer to Question A in this example is 28. Example: Secondary analysis of existing data. If the investigator is analyzing data, then the investigator would list the number of records as the enrollment. For example, if the initial application proposed to analyze 4000 records from the Florida Cancer Registry, and the IRB approved, and there have been no amendments to change the enrollment, then the answer to Question A in this example would be 4000. Example: An investigator proposes to link other data to the Florida Cancer Registry. If the only part of the study that falls under the jurisdiction of the DOH IRB is the linkage with the Florida Cancer Registry, then the number of participants would be the number of records provided by the Florida Cancer Registry.
B) Total number of participants consented by this PI to participate to date (including any withdrawals by participant, PI or sponsor OR consented screen failures).	Enter the total number of participants who have provided informed consent at DOH sites. Example: If the IRB approved 28 at the time of the initial application, and the study has been open for less than one year, then at the time of the initial continuing review application, the investigator would report the number of participants who have given consent during the first approval period. If only 18 had provided consent, and 1 had been a withdrawal, and 1 had been a screening failure after consent, then the total would be 20. Example: If a study is in its third year at the local site, and the investigator is completing continuing review prior to the end of the third year, then the investigator would provide the number of of participants who have provided consent so far (years 1, 2, and 3) Example: For a data study, if the investigator was requesting 4000 participants from the Cancer Registry, but only 2700 were provided by the Cancer Registry, because only this number met the investigator's criteria) then the investigator would answer 2700.
C) How many of the total number of consented participants were withdrawals?	Enter the total number of withdrawals during the life of the study at the local site. If the study is in its first year, the investigator would report the number who withdrew during the first year. Example: If the study has been open for three years, then at continuing review the investigator would report the total number of participants who withdrew during all years the study has been open (years 1, 2, and 3) Example: The investigator conducting secondary analysis of existing data (for example, involving the Cancer Registry or Vital Records) has provided participants the opportunity to withdraw permission to use their data. Suppose the study has been open for two years; 11 withdrew during the first year, and an additional 7 withdrew the second year. A continuing review prior to the end of the second year, the investigator would report the total for years 1 and 2, or in this example, 18.
D) Total number of participants consented by this PI since the previous IRB continuing review approval (including any withdrawals by participant, PI or sponsor OR consented screen failures)	Enter the total number who have provided consent during the previous approval period, including withdrawals after consent. Example: If then the total since the previous review would be the total since the study began (if the study has only been open one year, then the answer to this question should be the same as question B) Example: If the study has been ongoing and continuing to enroll for 4 years, then for continuing review prior to the end of the fourth year, the investigator would report the number consented since the end of year three (regardless of whether the participants withdrew or were screening failures)
E) How many of these participants completed the study (participated in the study beyond screening)?	Enter the number of participants who have completed the study, if any, during the previous approval period. Example: If the study is open for followup, and 4 participants have completed during the past year or past approval period, then the answer is 4.
F) How many of these participants consented were withdrawals (describe below)?	If at continuing review prior to the end of the second year of a multi-year study, the site had obtained consent during the past year or past approval period from 9 patients, but 4 withdrew, then the investigator would indicate that 4 participants withdrew during the previous approval period.

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