Investigator Handbook
Chapter 4: THE CPHS REVIEW

Research Necessitating CPHSReview

• CPHS must review research protocols that involve human subjects, human-derived materials, data from humans, and tissues from deceased humans (HRP PP IV.01 Research Requiring Review by the CPHS http://www.uth.tmc.edu/orsc/policies/IV.1.htm). 

• As defined by Federal regulations, research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. A systematic investigation involves a predetermined method for studying a specific topic, answering a specific question, testing a hypothesis, or developing a theory.

• Activities that develop or contribute to generalizable knowledge are such that the activity is intended to be extended beyond the institution through publication or presentation, or could otherwise influence current theory or practice.

Research that does not involve humans (e.g. literature reviews, testing new assays on yeast cultures) does not require CPHS  review. 

Research requiring CPHS  review may not be initiated until it is approved.  Both funded and unfunded studies must be reviewed and approved. 

The Review Process

The CPHS review process conforms to Federal regulations, and is supplemented by institutional policies. Primary regulatory codes are in "Federal Policy for Protection of Human Subjects: Common Rule" (HHS), 45 CFR 46 and Food & Drug Administration 21 CFR 50 and 21 CFR 56. The review process is the same for all research involving human subjects or human derived materials, whether funded or non-funded.

All modifications to approved research protocols must be submitted to the CPHS  for review and approval prior to implementation.

Ongoing monitoring by the CPHS  is also required with the frequency dependent on the level of risk involved, but in every instance an annual review is required. 

The CPHS  is empowered to approve, modify or disapprove a research project.  The Committee is empowered to terminate approval for any research activity that is not conducted in accordance with the methodologies approved or that is associated with unexpected serious harm to subjects. 

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 eventsand 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  (http://www.uth.tmc.edu/orsc/iris/index.htm) 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 (HRP PP I.09 Data Safety Monitoring Boards and Plans - http://www.uth.tmc.edu/orsc/policies/I.9.htm).
• 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 (HRP PP V.02 The Process of Informed Consent http://www.uth.tmc.edu/orsc/policies/V.2.htm).  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 "finders 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.

Determining Exempt Status from CPHS Review

In iRIS, the PI may request exempt status in the section labeled “Information to be submitted to CPHS for its initial review of research protocols”.  The following human research activities are considered exempt from review by the CPHS.  Please note:  These exemptions DO NOT APPLY when deception of human subjects may be an element of the research, when the activity might expose the human subjects to discomfort or harassment beyond levels encountered in daily life, or when fetuses, pregnant women, human in vitro fertilization, or individuals involuntarily confined or detained in penal institutions are subjects of the activity.

CATEGORY #1: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

1. research on regular and special education instructional strategies,
2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

CATEGORY #2: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND ,
2. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects\' financial standing, employability, or reputation.

(NOTE: The exemption under Category 2 DOES NOT APPLY to research involving survey or interview procedures or observation of public behavior when individuals under the age of 18 are subjects of the activity except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.)

CATEGORY #3: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Category 2, if:

1. the human subjects are elected or appointed public officials or candidates for public office, OR
2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

CATEGORY #4: Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.

To qualify for this exemption, data, documents, records, or specimens must have been collected before the research project begins.  Under this exemption, an investigator (with proper HIPAA Waiver or Alteration authorization) may inspect private, identifiable records, but may only record information in a non-identifiable manner.  The data must be permanently and completely de-linked at the time of extraction.  A code may be used to organize data as it is collected.  However the code may not be a means of re-linking the data set to the original data source.

CATEGORY #5: Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:

1. public benefit or service programs;
2. procedures for obtaining benefits or services under those programs;
3. possible changes in or alternatives to those programs or procedures; or
4. possible changes in methods or levels of payment for benefits or services under those programs.

CATEGORY #6: Taste and food quality evaluation and consumer acceptance studies,

1. if wholesome foods without additives are consumed, or
2. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

The determination of exemption will be documented in the iRIS system, with notation of the category under which exemption is granted.  The PI will be notified by the iRIS system in the form of a letter.

Determining Expedited Review Status

Research is reviewed by the CPHS at convened meetings unless it is “minimal risk” and qualifies for “expedited” review.  An expedited review procedure consists of a review of research involving human participants by the CPHS Executive Chairperson, Panel Chairperson, or by one or more experienced CPHS members (Reviewer) designated by the Executive Chairperson from among the members of the CPHS

To qualify for expedited review, research must meet all of the following criteria (HRP PP IV.06 Expedited Review of Research http://www.uth.tmc.edu/orsc/policies/IV.6.htm). 

• The research presents no more than minimal risk to human participants. These risks include the probability and severity of possible harm to the subjects’ physical, psychological, social, legal or economic welfare.
  
  
• Identification of the participants and/or their responses does not reasonably place them at risk of criminal or civil liability or be damaging to the participants financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
• The research is not classified,

In addition to the above criteria, research eligible for expedited review must involve procedures listed in one or more of the following categories.

Category 1: Clinical studies of drugs and medical devices only when condition (1) or (2) is met.

• Research on drugs for which an investigational new drug application is not required. (Note: research on marketed drugs that significantly increase the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
• Research on medical devices for which;
• An investigational device exemption application is not required; or
• The medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

• From healthy, non-pregnant adults who weigh at least 50 kg. For these participants, the amounts drawn may not exceed 1 pint or 500 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
• From other adults and children, considering the age, weight and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected.  For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Category 3: Prospective collection of biological specimens for research purposes by noninvasive means. Examples include:

• Hair and nail clippings in a non-disfiguring manner;
• Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
• Permanent teeth if routine patient care indicates a need for extraction;
• Excreta and external secretions (including sweat);
• Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
• Placenta removed at delivery;
• Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
• Supra- and sub-gingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
• Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
• Sputum collected after saline mist nebulization.

Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.  Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications).

• Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant’s privacy.
• Weighing or testing sensory acuity.
• Magnetic resonance imaging.
• Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography.
• Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate, given the age, weight, and health of the individual.

Category 5: Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.

Category 7: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior) or research employing survey, interview, oral history, focus groups, program evaluation, or quality assurance methodologies.  

Continuing review of research may undergo expedited review if it meets the following criteria:

• The research is not classified and
• Category 1-7 as defined above still apply; or
• Category 8a
• The research is permanently closed to the enrollment of new participants.
• All participants have completed all research-related interventions; and
• the research remains active only for long-term follow-up of participants; or
• Category 8b:
• No participants have been enrolled (at this site)
• No additional risks have been identified (neither the investigator nor the CPHS at this site has identified any additional risks from any site or other relevant source)
• The remaining research activities are limited to data analysis; or
• Category 9:
• The research is not conducted under an investigational new drug application or investigational device exemption.
• Categories two (2) through eight (8) do not apply, but the CPHS has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Risk/Benefit Analysis

Risk
Minimal risk, according to 45 CFR 46.102 (i), means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

New protocols are reviewed on an individual basis by the CPHS to determine if risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of knowledge that may reasonably be expected to result. Pediatric protocols will be assessed into one of the following risk categories:

1. The research involves no more than minimal risk to subjects.
2. The research involves more than minimal risk to subjects:

(i) The risk(s) represents a minor increase over minimal risk,
OR
(ii) The risk(s) represents more than a minor increase over minimal risk.

Benefit
A research benefit is considered something of health-related, psychosocial, or other value to an individual research subject, or something that will contribute to the acquisition of generalizable knowledge. Money or other compensation for participation in research is not considered a benefit, but rather compensation for research-related inconveniences.

During the CPHS review, new protocols are assessed in one of the following benefit categories:

1. The research involves no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subject's disorder or condition.
2. The research involves the prospect of direct benefit to individual subjects.  Both potential risk and potential benefit shall be considered when identifying study populations. 

Risk/Benefit Assessment
In early clinical trials of new drugs, devices and procedures, risk assessment must be based solely on animal toxicity data or known risk from similar interventions.  Reevaluation of the risk/benefit ratio must be an ongoing process as investigation proceeds.  Investigators and pharmaceutical and device manufacturers sponsoring clinical trials shall be responsible for providing CPHS reviewers with detailed, current reports on toxicology and adverse effects.

The Full Board Review

When human subjects research does not qualify for review under the exempt or expedited categories, it must undergo a full review by the CPHS (HRP PPIV.04 Initial Review of Research by Full Committee http://www.uth.tmc.edu/orsc/policies/IV.4.htm).  UTHSC-H has three CPHS panels which each meet monthly, and protocols are assigned to a Committee based on when they are received through iRIS.

Protocols undergo an initial review by a Subcommittee that subsequently makes recommendations to the full Committee. The following are considered in the review process.   

1. Scientific and academic merits to the protocol, determined prior to the meeting by evidence of a signed verification of merit by the PI’s supervisor or departmental scientific review committee. 
2. Certificate of Confidentiality may be suggested for certain sensitive protocols.
3. Need for Other Organizational Review if the research involves radiation, drugs, biologics, medical or electronic devices, biohazards, or potentially harmful laboratory procedures.
4. Possible harms or anticipated benefits.  CPHS will consider all the possible harms and benefits to be experienced by the research subjects and weigh the risks with the benefits. Adequate provisions for the safety of the research subjects will be considered and may include additional requirements such as a Data Safety Monitoring Board (HRP PP I.09 Data Safety Monitoring Boards and Plans - http://www.uth.tmc.edu/orsc/policies/I.9.htm).
5. Recruiting subjects in an equitable selection process.  This takes into account the purpose of the research, awareness of the vulnerable populations (see chapter 5), and assurance that the targeted populations reflect those who may benefit most from the study.
6. Informed Consent
7. Safeguards for Vulnerable Populations against coercion or undue influence in the study procedures.
8. Need for Additional Care such as ancillary care, additional monitoring, counseling, or social support.
9. Level of Risk between minimal risk and greater than minimal risk.
10. Review Interval for next review depending upon the level of risk, but not longer than a year.
11. Criteria regarding compensation of human subjects including absence of coercion, clear dollar amount and schedules, the payment is not contingent upon the subject completing the study, does not include a coupon for the product from the study, and that all information regarding payment and schedule of payment is included in the informed consent.
12. Recruitment of human subjects and all appropriate advertising involved in the recruitment
13. Conflict of Interest Management Plan if the PI has significant financial interests in the research (HOOP 23.10 Research Conflicts of Interest: http://legal.uth.tmc.edu/hoop/23/23_10.html).

After discussing subcommittee reviews, the full Committee recommends one of the following actions.

1. Approval – When the research meets the criteria for approval as defined in FDA Code of Federal Regulations, and no changes to the submission are recommended.
2. Approval pending – When the research meets the criteria as in above, but with modifications and/or clarifications to be made before final approval.  This approval can be given after the CPHS convenes if modifications have been made by the investigator and confirmed by the Chair or his/her designee (Subcommittee Chair).
3. Deferral – When the convened CPHS requests substantive clarifications or modifications regarding the protocol or informed consent documents that are directly relevant to the determinations required by the CPHS.  Subsequent review of any responsive material will return to the convened CPHS Committee that performed the initial review.
4. Disapproval – When the research does not meet the criteria for approval.  The investigator may appeal this determination in writing to the Executive Chair of CPHS and the Chair of the Committee that made the determination, by way of iRIS.  At the discretion of the Chairs, a previously disapproved protocol may be brought back for full board reconsideration.  This motion may not be made during an expedited review; it must be sent for the full board review.
5. Tabled – A discussion or motion may be tabled temporarily in order to provide for further information, clarification or consultation; however one of the determinations above should be voted on and made before adjournment, whenever possible.  In the event of a loss of quorum, all incomplete agenda items shall be considered tabled until quorum can be reconstituted in a convened meeting.  (Quorum is more than half of the voting members or alternates in attendance.)  This motion may not be made during the expedited review process.
   
   PIs are notified via iRIS as to the result of the CPHS review.

Continuing Review

The CPHS reviews active protocols every 12 months unless it is determined that the research involves potential harm to human subjects that requires more frequent review (HRP PP IV.07 Continuing Review of Research http://www.uth.tmc.edu/orsc/policies/IV.7.htm).  Note: Reviews must continue as long as identifiable data is being analyzed, even if subjects are no longer in contact with the study and all follow-up visits have ended.

PIs are notified via email when the next continuing review is due (due dates are also available in the protocol information in iRIS).  Continuing review applications must be submitted by the fifteenth of the month prior to the expiration month of the protocol. If the continuing review materials are not submitted by this date, the PI is notified the protocol will expire and all enrollment and research activity must stop.  There are exceptions in the event that stopping a study would be harmful to the human subjects enrolled, but the CPHS must approve any exceptions.

The continuing review considers the same criteria as in the initial full review as well as any modifications to the protocol, and they include the following. 

1. Current risk-benefit assessment based on research results, including a review of all reported unanticipated problems and serious adverse events. A determination will be made whether the level of this assessment has changed from the last review.
2. Selection of subjects, and if it continues to be reasonable and impartial.
3. Informed consent process, and whether:
1. currently approved informed consent document is still accurate and complete;
2. any significant new findings that may relate to the subject’s willingness to continue participation are provided to the subject.
4. Adequacy of provisions to protect the privacy of subjects and to maintain the confidentiality of data.
5. Adequacy of provisions for monitoring the data collected to ensure the continued safety of the subjects.
6. Appropriateness of safeguards for vulnerable populations
7. DSMB - when the research is part of a multi-center trial and is subject to oversight by a Data Safety Monitoring Board (DSMB), the CPHS may rely on a current statement from the DSMB or sponsor indicating that it has reviewed protocol-wide adverse events, interim findings, and any recent literature that may be relevant to the research, in lieu of requiring that this information be submitted directly to the CPHS (HRP PP I.09 Data Safety Monitoring Boards and Plans - http://www.uth.tmc.edu/orsc/policies/I.9.htm). The CPHS must still receive and review reports of local, on-site adverse events and unanticipated problems involving risks to subjects or others and any other information needed to ensure that its continuing review is substantive and meaningful.
8. Review of complete protocol and any modifications previously approved
9. Any Additional information for continuing review the CPHS deems necessary.

PIs are notified via iRIS as to the result of the CPHS review.

A PI may not implement any changes to the protocol without first receiving CPHS approval unless it was necessary in order to avert or minimize apparent immediate hazard to subject(s) (HRP PP IV.12 Review of Modifications/Amendments to Previously Approved Research http://www.uth.tmc.edu/orsc/policies/IV.12.htm).  In the event of any immediate necessary changes, the PI has five business days to contact CPHS via iRIS to inform them of such change. 

Making your change in iRIS

• Revise the protocol or document with the exact text changes and resubmit in iRIS
• Submit the Change Request Form and describe the necessary changes and their rationale.
• Changes to the protocol may need to be reflected in revisions to the the informed consent form which should accompany the change request form.

How changes to your research are processed

• Modifications to research are reviewed by the same CPHS panel that reviewed the original protocol.
• If the research was previously deemed as exempt, the changed protocol must be approved by CPHS prior to the initiation of the research.  CPHS will then decide the appropriate review (exempt, expedited, or full)
• If the research was previously sent for expedited review, the modifications will be sent to the expedited reviewer assigned to the research. The reviewer will either approve the changes or approve pending modifications.  However, the reviewer may determine that the research is not eligible for expedited review, and forward for Full Board Review.
• If the Informed Consent form must be changed, the CPHS may request that the research subjects be re-consented.

Review of Deviations or Violations to Your Protocol

If there is an unapproved change, a violation to the conduct of the protocol, or deviation from the written protocol, a protocol deviation report must be submitted to the CPHS via iRIS no later than 10 business days from when the investigator learned of the deviation.  This can be found under Submission Forms in iRIS (HRP PP IV.13 Review of Protocol Deviations/Violations http://www.uth.tmc.edu/orsc/policies/IV.13.htm).  The protocol deviation report is sent to the CPHS Chair only if there is a serious consequence to the deviation or violation.  The Chair decides if any further action is warranted, and, together with the subcommittee or full committee and the investigator, decide on a plan to prevent any protocol deviations in the future.  It will also be decided if the PI and research team need to undergo further education on the conduct of research with human subjects.