It is the policy of UTHSC-H that all research involving human participants and deceased persons must be reviewed and approved by the Committee for Protection of Human Subjects if it falls in one of the following categories:
Research conducted by any UTHSC-H employee (faculty, staff, administrative and professional), student, or resident in any facility/location (including Memorial Hermann Healthcare System, Harris County Psychiatric Hospital, Thomas Street Clinic, LBJ General Hospital).
Research conducted by non-UTHSC-H investigators that involves subjects/patients from any UTHSC-facility (including Harris County Psychiatric Hospital). In such instances, a University faculty member must be identified who will agree to assume co-responsibility for the conduct of the research.
The definition of research under Department of Health and Human Services (DHHS):
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subject means a living individual about whom an investigator conducting research obtains data (including tissue, specimens, and cognitive phenomena) through intervention or interaction, whether identifiable or not, or private information.
Intervention includes both physical procedures by which data are gathered and manipulations of the participant or participant’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and participant.
Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may be readily ascertained by the investigator or associated with the information) in order for obtaining information to constitute research involving human subjects.
The definition of research under United States Food and Drug Administration (FDA):
Clinical Investigation is any experiment that involves a test article and one or more human participants and that is one of the following:
Subject to requirements for prior submission to Food and Drug Administration; or
Not subject to requirements for prior submission to Food and Drug Administration, but the results of which are intended to be submitted later to, or held for inspection by Food and Drug Administration as part of an application for a research or marketing permit.
Human Subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or patient.
Test Article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA regulation.
The definition of human subject under the FDA IDE regulations is a human who participates in an investigation either as an individual on whom or on whose specimen an investigational device is used or as a control.
If an activity meets the definition of research involving human subjects, the Principal Investigator must submit an application for CPHS review and approval. When in doubt whether an activity requires CPHS review and approval, the Principal Investigator must communicate to the ORSC Staff with a summary of the proposal. The ORSC Staff will review the information and make a determination whether or not the described activity meets the definition of research involving human subjects. The Principal Investigator may request written notification with the final determination from ORSC Staff.
EXAMPLES OF HUMAN SUBJECTS RESEARCH AND RESEARCH LIKE ACTIVITIES
Activities that involve systematic investigation and are designed to develop or contribute to generalizable knowledge are considered research. When such activities involve human participants, they will require review and approval by CPHS. Some examples of research involving human subjects are clinical trials, epidemiological research, retrospective medical records review research, and genetic research. However, we do recognize that it is not always easy to determine whether an activity is research involving human participants. The purpose of this guidance is to give some examples to help make this determination.
When in doubt whether an activity requires CPHS review and approval, the Principal Investigator must write to the ORSC Director with a summary of the proposal. The ORSC Director or designated ORSC staff will review the information and make a determination whether or not the described activity meets the definition of research involving human subjects. The ORSC Director or designated staff will send a written notification to the researcher with the final determination.
Case Reports – Case reports do not involve systematic investigation; however the intent is to contribute to generalizable knowledge. Case reports are not considered to be research involving human subjects and do not require prior CPHS review and approval. However, a series of 3 or more subjects qualifies as a research project and hence should be submitted for review and approval by CPHS prior to initiation.
Retrospective Medical Records Review - All retrospective medical record reviews to be conducted at LBJ Hospital, Harris County Psychiatric Hospital, Thomas Street Clinic, or at a hospital within the Memorial Hermann Healthcare System for the purposes of research must be approved by CPHS. This may be accomplished by submitting a request through the iRIS system, which will be reviewed and approved administratively. Retrospective medical chart reviews also require approval by the Memorial Hermann Research Office when using Memorial Hermann Hospital or one of the MHHS community hospitals.
Tissue Repositories - Operation of Human Tissue Repositories and data management centers are subject to oversight by CPHS. CPHS will review and approve protocols specifying the conditions under which data and specimens may be accepted and shared, and ensure adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. CPHS will also review and approve a biological sample collection protocol and consent document.
Research involving biological materials – Research involving biological materials or data from individually identifiable living persons must be reviewed by CPHS. Researchers who are uncertain whether an activity is human research must contact CPHS. Below is a list of human derived materials and whether they require CPHS approval.
Examples of material not needing CPHS approval, include but are not limited to:
anonymized nucleic acid
human cells or cell lines from established external repositories and tissue banks (such as ATCC)
anonymized commercially available blood
anonymized commercially available macrophage cell lines
anonymized cell lines, cell products, or material purified from cells, tumor cells or cultured cell lines
Examples of material that do require CPHS approval, include but are not limited to:
embryonic or fetal tissue, including the placenta, amniotic fluid, umbilical cord blood and stem cells
tumor tissue
tissues from individual donors
material from cadavers
diagnostic specimens collected for or being used for research purposes
deciduous teeth at time of exfoliation or permanent teeth extracted for clinical purposes
saliva, supra-and subgingival dental plaque, and calculus
mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
Research Involving Coded Data or Specimens – Research involving coded private information or biological specimens, that were not collected for the current research proposal do not need IRB review as long as the investigator cannot link the coded data/specimens back to individual subjects. Note: At UTHSC-H, such projects may qualify for exemption. Investigators must submit an application to CPHS for review.
Publicly Available Data – Research involving publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the CPHS if they are not sure whether the data qualifies as “publicly available”.
Quality Assurance and Improvement Projects (QA / QI) – Activities designed to determine if aspects of any practice are in line with established standards are called quality assurance. When an activity is designed to improve the performance of any practice in relation to an established standard, it is called quality improvement. When these QA / QI Projects involve systematic investigation and contribute to generalizable knowledge they must be reviewed and approved by CPHS. Additionally, any QA or QI activity where participants are subjected to additional risks or burdens beyond standard practice must be reviewed and approved by CPHS. If there is uncertainty whether an activity is human subjects research, CPHS must be contacted.
Research involving deceased individuals – Research involving deceased individuals does not meet the DHHS definition of human subjects research, but at UTHSC-H, such research must be reviewed and approved by the CPHS.
Outbreak investigations – Outbreak investigations are important activities that benefit public health. Such activities are not considered to be research and do not require CPHS review. However any interventional studies conducted during an outbreak would require review and approval by CPHS. CPHS will make an effort to expedite the review and approval process for such protocols.
Infection control – Rapid investigations to reduce the current or future spread of disease or infection carried out as part of an infection control program are not considered as research and these do not require review by CPHS. Planned research conducted by an Infection Control department requires review and approval by CPHS.
Compassionate / Emergency Use of Investigational Drug - When a physician wishes to use an investigational drug for treatment of an individual patient for a single use or a single course of treatment, and the use is not covered by an existing CPHS approved protocol, contact CPHS office with the request and justification. The Executive Chairperson will advise if the justification for such use is sufficient for approval. This is discussed in greater detail in the Policy and Procedure on Emergency Use of an Investigational Drug.
Compassionate / Emergency Use of Unapproved Medical Device - If an emergency arises where an unapproved medical device may offer the only possible life-saving alternative, but an Investigational Device Exemption (IDE) for the device does not exist, or the proposed use is not approved under an existing IDE, a physician may use the device if each of the following conditions exist: 1) the patient is in a life-threatening condition requiring immediate treatment; 2) no generally acceptable alternative is available; and 3) there is no time to use existing procedures to get FDA approval for the use. This is discussed in greater detail in Policy and Procedure on Emergency Use of an Unapproved Medical Device
Off-Label Use Of Marketed Drugs, Biologics, and Medical Devices - Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).
Investigational Use of Marketed Drugs, Biologics and Medical Devices - Investigational use suggests the use of an approved product in the context of a clinical study protocol. When the principal intent of the investigational use of a test article is to develop information about the product's safety or efficacy, submission of an IND or IDE may be required. All such activities require prior CPHS review and approval.
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 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.
Determining Exempt Status from CPHS Review
There are times when the research being submitted by the PI is exempt from CPHS Review (HRP PP IV.02 Determine Research Exempt from Full Committee Review. The PI will submit the research to the committee by way of iRIS, at which time a Chair-appointed designee will review the submission and allow or disallow the exemption. It is, therefore, not the decision of the PI if the research involving human subjects is exempt from CPHS Review or not.
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:
a. research on regular and special education instructional strategies,
b. 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:
a. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND ,
b. 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:
a. the human subjects are elected or appointed public officials or candidates for public office, OR
b. 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:
a. public benefit or service programs;
b. procedures for obtaining benefits or services under those programs;
c. possible changes in or alternatives to those programs or procedures; or
d. 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,
a. if wholesome foods without additives are consumed, or
b. 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. 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.
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:
1. 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.
2. 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.
3. 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.
1. 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.)
2. 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:
1. 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
2. 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:
1. Hair and nail clippings in a non-disfiguring manner;
2. Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
3. Permanent teeth if routine patient care indicates a need for extraction;
4. Excreta and external secretions (including sweat);
5. 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;
6. Placenta removed at delivery;
7. Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
8. 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;
9. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
10. 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.
Expedited Continuting Review Status
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.
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. 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.
Criteria for Approval
Protocols undergo an initial review by a Subcommittee that subsequently makes recommendations to the full Committee. The following are considered in the review process.
Risks to subjects are minimized by using procedures which are:
a. consistent with sound research design ,
b. do not unnecessarily expose subjects to risk, and
c. when appropriate, already being performed for diagnostic or treatment purposes.
Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. 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. Some research may offer direct potential benefit to individual subjects but most research studies are likely to yield generalizable knowledge about the subject's disorder or condition. In early clinical trials of new drugs, devices and procedures, risk assessment is 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.
Selection of Subjects is Equitable – In making this assessment, CPHS will take into account:
a. the purposes of the research,
b. the setting in which the research will be conducted, and
c. special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
Informed consent will be sought from each prospective subject or the subject's legally acceptable representative.
Informed consent will be appropriately documented.
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects as outlined in policies and procedures XXX.
Outcome of Review
After discussing subcommittee reviews, the full Committee recommends one of the following actions.
Approve - An approval is granted if the research activity meets the criteria for approval as stated above in Item 4 and no changes are recommended to the research proposal.
Approve Pending – CPHS may approve a protocol pending specific non substantive modifications. The Principal Investigator’s response may be reviewed through an expedited procedure.
Defer - When the convened board requests substantive modifications or clarifications directly relevant to the criteria of approval stated above in Item 4, IRB approval of the proposed research is deferred to review of the Principal Investigator’s responses by the Full Board.
Disapproval - CPHS may disapprove a research proposal if the proposal does not meet the criteria for approval as stated above in Item X. If the IRB decides to disapprove a research activity, the ORSC staff will include in a written notification a statement of the reasons for the CPHS decision via iRIS and give the investigator an opportunity to respond in person or in writing.
Tabled – In the event of lack of time or 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.)
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. 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.
A current risk-benefit assessment is made based on study results, including a review of all reported unanticipated problems and serious adverse events. CPHS shall determine whether the level of risk has changed from the last review.
Selection of subjects continues to be reasonable and impartial.
When reviewing the current informed consent document(s) the CPHS shall ensure the following:
a. Whether the currently approved informed consent document is still accurate and complete;
b. Any significant new findings that may relate to the participant’s willingness to continue participation are provided to the participant.
Adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data are provided, when appropriate.
There continues to be adequate provision for monitoring the data collected to ensure the continued safety of the participants, when appropriate.
Appropriate safeguards for vulnerable populations are provided.
PIs are notified via iRIS as to the result of the CPHS review.
If Your Approval for Research Needs Modification
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). 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.
As always, the investigator will be notified of the outcome of the review via iRIS.
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. 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.
Office of Research Support Committees (713) 500-7942
