IRB – Review of Data Collection/Retention for Protocol Development

Principal Investigator for the project:

Full Title of the Study:

SP Code:

List Departments associated with this study:

Additional Investigators:

Research Support Staff (include research activities performed by the individual such as identify/recruit study participants, obtain informed consent, intervene or interact with study participants (e.g., administer survey, conduct or oversee physical intervention), obtain individually identifiable private information about study participants, other):

Complete this application for collecting and retaining data that is needed in the process of writing/developing a research protocol. It is not intended for pilot studies or any other research activity - please submit application "IRB - Review of a New Study" instead.

Indicate all sources of the data:

Marshfield Clinic electronic health record

Marshfield Clinic paper record

Marshfield Clinic Database

Other Source – please specify:

Describe the data to be collected:

What question do you seek to answer with these data?

Describe any potential risks to participants (whose data will be used) posed by this research activity:

How will you minimize these risks?

How will this research activity potentially benefit participants or society in general?

Why do you believe the potential benefits offered by this research activity outweigh the potential risks?

Describe how confidentiality of data will be maintained:

In order to justify a waiver of informed consent, explain how this research activity satisfies each of the following (If your request is to waive both parental permission and children’s assent, please address both cases in your responses):

The research involves no more than minimal risk to the participants:

The waiver will not adversely affect the rights and welfare of the participants:

The research could not practicably be carried out without the waiver:

Whenever appropriate, the participants will be given additional, pertinent information after their participation:

In order to justify a waiver of the requirement to obtain HIPAA authorization, explain how this research activity satisfies each of the following:

The use and/or disclosure of PHI involves no more than minimal risk to privacy:

Describe your plan to protect the identifiers from improper use or disclosure:

Describe your plan to destroy identifiers at the earliest opportunity or justify why you plan to retain identifiers:

How will you make sure the PHI will not be re-used or shared improperly?

The research could not practicably be conducted without access to and use of PHI:

Describe the specific PHI to be used and/or disclosed:

Why is use and/or disclosure of PHI necessary for this research?

The research could not practicably be conducted without the waiver:

Please explain in detail why this research could not be conducted without a waiver of the requirement to obtain authorization:

Will this feasibility data be shared with anyone outside of Marshfield Clinic?

No - Complete Signature and Certification

Yes, aggregate data only - Complete Signature and Certification

Yes, individual-level data – Please complete Appendix - Sharing of Individual-Level Data

SIGNATURE AND CERTIFICATION

Principal Investigator Attestation

I certify that the information provided herein and attached is true and complete to the best of my knowledge, and that research staff are qualified (e.g., credentials and when relevant, privileges) to perform procedures assigned to them during the study.

Comments:

_______________________________________________

Signature of Principal Investigator	Date

Printed Name of Principal Investigator	Routing Location

Printed Name of Person Completing Report	Routing Location

Submit completed paperwork to: Office of Research Integrity & Protections – 1R4

APPENDIX

Sharing of Individual-Level Data

Complete this Appendix for each data recipient

With whom will the material be shared:

In general terms, describe the data to be shared (For example,” medical information about participants collected as a part of study (SP Code and Title) that contains no direct or indirect identifiers”):

Describe the intended use by the recipient:

Does the recipient plan to share the data with others not under his/her supervision (i.e., other institutions, labs, scientists) now or in the future?

No

Yes - describe plans for use, and with whom data will be shared:

Indicate the level of identifiers to be shared:

No identifiers
(data will not include: name, address, phone#, fax, email, SSN, MHN, health plan#, account #’s, certificate/license #’s, device ID#’s and serial #’s, URL, IP address, biometric ID’s, facial photos or comparable images, any unique identifying number, characteristic or code, town, city, state, county, precinct, zip code, dates {except year} directly related to a subject (e.g., dates of collection, dates of service, DOB), ages over 89 and all elements of dates {including year} indicative of such age)

Indirect identifiers only

Direct identifiers or a code that can be linked to direct identifiers

What will be shared?

Code that can be linked to direct identifiers

Direct identifiers
Explain why recipient needs direct identifiers:

How will data be secured during transfer?

Encryption of electronic data set

Other (explain):

Version – June 1, 2014

Version – May 20, 2014

IRB – Review of Data Collection/Retention for Protocol Development	Page 3 of 3

Institutional Review Board

Baer, Patricia E

2014-06-02

Hubing, Melissa E.

Marshfield Clinic