Request for Protocol Approval For

Request for Protocol Approval for

Secondary Analysis of Existing Data

Adapted from DukeUniversity

Existing Datais inexistence at the time the research is proposed. The data may be in the form of data sets, but may also be in the form of interview notes or audio- or video tapes.

Identifying Information:

There are two types of identifying information: direct and indirect.

Direct Identifiers:

Direct identifiers include names, addresses, phone numbers, images, and other obvious identifiers. Direct identification can occur when identifiers are written on survey instruments, participants’ addresses are put in your notes, or when the researcher creates a key that can be used to link surveys to individuals.

Indirect Identifiers:

Indirect identifiers are bits of information that could be combined by someone outside the research team to identify participants. For example, if a researcher described a participant as a freshman forward from Oregon on the SMC men’s basketball team, someone who knew the team could identify the participant.

If you are going to use names, the question of indirect identifiers is irrelevant. Indirect identifiers are of concern when you prepare a report: will others be able to deduce who your participants were? This can be a problem especially in a small population. You may need to create misleading identifiers, report data in aggregate only, or depict identifiers in more general terms (e.g. use age ranges rather than specific ages; use a broader group identity such as “trades-people” rather than a carpenter, a roofer, etc.).

Data are identifiable if they include direct or indirect identifiers. Coded data are also considered identifiable.

The data in this study are: Identifiable (direct) ___ Identifiable (indirect)___ Not Identifiable ___

There are three parts to this request:

A. Investigator and Project Information

B. Investigator, Advisor, and Department/School Assurances

C. Project Description

A. Investigator and Project Information

Investigator: ______

Status: [ ] Faculty [ ] Graduate Student [ ] Undergraduate[ ] Staff

[ ] Other______

Department/School: ______

e-mail:______Phone: ______Campus PO Box No. ______

Faculty Advisor for Graduate and Undergraduate Students:

______

e-mail:______Phone: ______Campus PO Box No. ______

Project Title: ______

B. Assurances

(Original signatures are required for final approval.)

Investigator(s) Assurance:

I certify to the following:

1. The research will not be initiated until written approval is secured from the IRB.
2. I will conduct this study as described in the approved protocol. If any changes are anticipated, I will contact the IRB staff prior to implementing the changes. I will contact the IRB staff immediately if any of the following events occur: unanticipated risks, findings during the study that would affect the risks or benefits, and adverse events.

______

InvestigatorDate

______

InvestigatorDate

Faculty Advisor Assurance (Required for Graduate or Undergraduate Student Research):

I certify that I have reviewed and approved the student(s) research plan. I assume responsibility for 1) ensuring that the student(s) conducting research are aware of their responsibilities as researchers, and 2) that the IRB will be immediately informed in the event of unanticipated risk, adverse events, or findings during the study that would affect the risks or benefits of participation.

______

AdvisorDate

______

AdvisorDate

APPROVAL: ______Date ______

IRB Chair

APPROVAL: ______Date ______

IRB Member

C: Project Description

Please prepare a narrative that addresses the following topics.

1. The purpose of the research
2. A description of the data
3. The source of the data
4. Requirements of the data supplier, if any. If these data are external to St. Mary’s, you need to provide written permission on official letterhead with original signatures from that site to examine and analyze them.
5. A description of confidentiality procedures, if needed, which will be used to protect data that are identifiable, either directly or indirectly.

If informed consent must be secured, for example for the use of video tapes, identify the subject populations, describe the consent process, and attach the proposed Informed Consent form. For more information on informed consent, please see the IRB website.