Submitting a Research Protocol for CPHS Review in iRIS

Researchers proposing research that involves human subjects and/or human derived data/tissue submit their protocols for CPHS review and approval via iRIS, a web-based protocol management system (HRP PP VII.03 Information Submitted to CPHS for Initial Review iRIS is used to: submit protocols; report adverse events and protocol deviations; file IND safety reports; complete continuing reviews; and submit change and study closure/inactivation requests.

The initial protocol submitted for review includes:

• CPHS protocol and grant application
  
• informed consent documents, releases, and translations
  
• letters of support/approval – letters of approval and cooperation used to recruit subjects, to use records, data, and specimens not controlled by the investigator, and to use facilities and personnel of another department
  
• letters, bulletins, board announcements, and advertisements to be used in recruitment; questionnaires, surveys, and rating scales; and case report forms
  
• MHHS forms (available thru iRIS) if research involves Memorial Hermann Hospital facilities
  
• Clinical Research Unit application form, if applicable

The iRIS (https://iris.uth.tmc.edu/) system will guide you through the above checklist of materials needed. Please refer to the Table of Contents in this Handbook for details on each component.

Enter/Submit the Protocol and Grant Application though iRIS

The CPHS application submitted through iRIS includes at a minimum the following elements:

• 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 usual care (treatments, interventions, procedures) and research procedures to be experienced by research subjects. Describe study population and rationale for its choice. Provide inclusion and exclusion criteria for potential study subjects. 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 whether 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, children 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).

Attach Informed Consent Documents, Releases and Translations

Informed consent is a person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic or experimental procedure. Informed consent is essential for studies involving humans. Research subjects need to understand why the research is being performed, what procedures and time commitments are involved, and the potential risks and benefits; therefore lay language at a sixth grade reading level of a summary of the research is required.

If children are to be enrolled, a child’s assent form and a parental permission form must be submitted.

If there are non-English speakers as human research subjects, a translation must be provided.

These Informed Consent Documents must conform to the Elements of Informed Consent, found in Chapter 4, and the CPHS must review and approve informed consent documents, releases, and translations. The final versions approved by the CPHS and used in the study must have a CPHS stamp which shows the approval and expiration dates.

Attach Letters of Support/Approval

PIs must also submit letters of approval/cooperation when the research involves:

• Recruitment of subjects who are patients or clients in or from clinics, hospital units, or facilities administered by individuals external to the investigative team.
  
• Use of records, data or specimens other than those controlled by the investigators;
  
• Use of facilities or personnel from non- UTHSC-H facilities/entities.

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 the Director of Research and Sponsored Programs for Harris County Hospital District at 713-566-6473 for further information.

Attach all Educational and/or Recruitment Material

Materials for recruitment of subjects 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 "finder’s fee" be paid for physician referral. This is considered by legal counsel to be a violation of the Texas Medical Practice Act. Education materials and/or all other materials provided to the subjects must be submitted for review and approval prior to distribution.