COMPLETING A PROTOCOL APPLICATION

A complete CPHS protocol application package consists of submitting the following information in the iRIS system:

1. Completed CPHS Application Form (and MHHS application when applicable)
2. Complete protocol (and entire grant application if applicable)
3. Appropriate Consent Forms
4. Conflict of interest certification form [done through routing in iRIS]
5. Letters of Approval/Cooperation
6. Recruitment Letters, Bulletin Board Announcements and Advertisements
7. When applicable:
   • Appropriate HIPAA form(s)/authorization (now required for all new protocol submissions)
   • Investigator's Brochure
   • Pediatric Risk Assessment Form
   • Entire Grant Application
   • Approval for Research Use of Radioactive Drugs, Isotopes, or Ionizing Radiation
   • Questionnaires, Survey forms, Rating Scales and Data Collection forms
   • Translations (can be done after the language in the English version has been approved)

Protocol (research proposal):

At a minimum the following elements are expected to be included in your research protocol:

• Specific aims and research questions
• Background and Significance
• Research design and methods: Describe the research design and the procedures to be used to accomplish the specific aim of the project. Describe all treatments, interventions, and procedures that will involve subjects and controls. When appropriate, differentiate between standard care (treatments, interventions, procedures) and research provided to research participants. Describe study population and rationale for its choice. Provide inclusion and exclusion criteria for potential study participants. Include rationale for the number (sample size) of subjects required for the proposal, providing, where possible, an assessment of the statistical power of the design selected. Provide a description of data collection and quality assurance procedures and statistical analysis plan. For clinical trials indicate if interim statistical analyses will be done.
• Human subjects: Human subjects include all individuals participating in the proposed research. Provide a detailed description of the involvement of human subjects in the work outlined in the Research Design and Methods section. Describe recruitment methods, why a particular subject population was chosen and any special considerations for vulnerable populations (prisoners, children, mentally disabled, physically disabled, fetuses, and non-consenting subjects).
• If a clinical trial is proposed, describe if an independent Data Safety Monitoring Board will be appointed to oversee the scientific, ethical, and safety conduct of the trial.
• Describe any procedures, materials, or situations that may pose hazards to research staff and precautions to be exercised.
• Gender and Minority Inclusion/Exclusion Criteria: Women and members of minority groups, regardless of age, must be included in biomedical and behavioral research projects unless a clear and compelling rationale shows that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made based on a compelling rationale and justification. Cost or investigator convenience are not acceptable reasons except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research.
• References: List all references cited in the proposal.
• Investigator's Brochure: Provide a copy of the investigator's brochure of a new drug or device or new use of a drug or device (or summary of the relevant pre-clinical/animal data or other pertinent clinical data).
• Surveys and questionnaires: Provide copies of all survey forms and questionnaires to be used in the study. Indicate if these have been validated.
• You must include in your submission a full research proposal that amplifies all of these points (e.g. your grant application, a drug company protocol, a thesis proposal).

Informed Consent Documents

• Must conform to the "Elements of Informed Consent"

Letters of Approval/Cooperation necessary to:

• Recruit subjects other than patients of investigators
• Use records, data or specimens other than those controlled by the investigators
• Use facilities or personnel from another department or agency separate from UTHSC-H

Note: letters not received by the submission deadline may be forwarded to CPHS when received, but approval will not be granted until received.

For Memorial Hermann Hospital Approval:

• Memorial Hermann Hospital forms can also be completed through the iRIS system.
• Please note that letters of approval must be received by the investigator from both CPHS and the Memorial Hermann Hospital administration before research may begin in any hospital in the Memorial Hermann Hospital System.

For LBJ Hospital Approval:

• In addition to CPHS approval, approval from the Harris County Hospital District must be obtained prior to implementation of any research protocol. You may contact Mary Frances Fabrizio at 713-566-4646 for further details.

Recruitment Letters, Bulletin Board Announcements and Advertisements

Materials for recruitment of subjects or controls must be approved by CPHS before they are used and should describe where the research will take place, the purpose of the research and the person to contact for further information. Monetary compensation may be stated but not the amount. At no time may a "finders fee" be paid for physician referral. This is considered by legal counsel to be a violation of the Texas Medical Practice Act.

When applicable, also include:

Grants
All grants that involve human subjects, human derived data, or human derived specimens must be submitted in their entirety and reviewed by the CPHS. The committee will use a primary reviewer process with additional expert consultants in specialized areas under review, as needed.

**Important Note Regarding Human Subjects Education**
As per UTHSC-H policy HOOP 23.11: Human Subjects Education, certificates of completion for all investigators, key study personnel (including coordinators) must be on record PRIOR to their protocol approval for review by the Committee for the Protection of Human Subjects (CPHS).