Previous Page Home PageSearch Engine IndexNext Page

Research Protocol Approval

Introduction

Date of Last Review 4/08/10
Date of Last Review 12/15/2011
SME: Director of Research


Effective communication is important between medical staff and hospital administration especially when conducting research at UTHCPC.

Who approves research

The UTHCPC Research Committee coordinates research activities to benefit patients, researchers, and staff within the goal of providing quality patient care.

Committee members

The Hospital Administrator appoints members of the UTHCPC Research Committee from appropriate leadership, clinical, research and financial areas.

Research Committee responsibilities

The primary responsibilities of the Research Committee are the following:

Reviews

Proposed research in relation to the hospital's mission, values, guidelines, and procedures

The impact of proposed research on the functions at UTHCPC

Quarterly reports from the Research Department

Assurances

That staff is fully informed of their responsibilities prior to commencement of a study

That the research is carried out expeditiously

That patient rights are being assured

Other responsibilities

Investigate problems encountered during the progress of the research

Communicate to UTHCPC staff the results of any research conducted at the hospital

Approval process:
Prospective studies

This table describes the process of approving the research protocol for prospective studies:

Stage

Description

  

1

The researcher submits the documentation to the UTHCPC Research Committee.

2

The Research Committee reviews proposed research to ensure that it complies with various UTHCPC policies and procedures.

Any research protocols that have the potential to result in an increased hospital stay, and do not have an identified funding source, will be monitored for referral to peer review if the length of stay is longer than normal.

3

The Research Committee negotiates changing the research protocol and consent form as needed.

Protocol changes: The Committee for the Protection of Human Subjects (CPHS) approves the protocol changes prior to any research approval.
4

 

Did the committee approve the protocol?

If yes, the nursing staff places a copy of the protocol on the units where the researcher will conduct research. The copy will be placed in a binder, which is housed in the medication room. If it is a pharmaceutical study, the research assistant will make an additional binder providing detailed information for that study. These also are housed in the medication room.

If no, the investigator is notified

5

The PI forwards a copy of the approval memo received from the UTHCPC Research Committee to the CPHS. The PI also is responsible for providing the UT-HCPC Research Committee with a copy of the stamped approval received from the CPHS.

Approval process:
Retrospective studies

This table describes the process of approving the research protocol for retrospective studies:

Step

Action

1

The researcher develops a design for a research project

2

The researcher sends a memo to the CPHS requesting approval to conduct the study. This memo includes information about:

The design of the study

How the data will be protected

How confidentiality will be ensured

3

 The researcher completes the relevant HIPAA forms and attaches them to the memo
4

The researcher sends a similar memo to the Research Committee at UTHCPC, informing the committee that IRB approval has been requested and explaining how any costs incurred will be covered
The memo also needs to explain if any patient identifiers will be required in the dataset and, if so, where the dataset will be stored

Any approval from the committee will be granted pending CPHS approval

(NOTE: approval is required for all studies involving UTHCPC patient data)
5

After receiving copies of approval memos from CPHS and the UTHCPC Research Committee, the researcher may request the dataset that is needed in order to conduct the study

.The researcher may make this request either to the MIS department or the Research and Program Evaluation department
6
 All research conducted at UTHCPC is subject to HIPAA procedures, as outlined by CPHS AND UTHCPC policies and procedures, including Release of Information for Researchers, Research Information Requests, Waiver of Authorization and Accounting for Disclosures of Protected Health Information.

Related Standard

The Joint Commission: Rights and Responsibilities of the Individual

 

Previous PageTop Of PageSearch Engine IndexNext Page

If you have questions regarding the content of this site please contact the Policy and Procedure Committee. If you experience any technical problems please contact the MIS Department.

Harris County Psychiatric Center University of Texas Health Science Center