The Committee for the Protection of Human Subjects (CPHS) will review research involving human subjects to assure that the protocol meets with federal, state and institutional regulations. Activity involving human subjects (identification of prospective subjects, recruitment, etc.) may not be initiated until the study has been reviewed and approved by the CPHS. The CPHS determines whether the proposed research exceeds minimal risk on a case-by-case basis with consideration to the procedures proposed and subject population to be involved in the research.
There are three different avenues for review an protocol: Exempt (Level I), Expedited (Level II) and Full Board or Convened Meeting Review (Level III). The appropriate review procedure is determined by federal regulations and applied based on how human subjects are involved in the research. The type of review is based on risk associated with participation in the research, the study intervention/interaction and how informed consent is obtained and documented. A research protocol, informed consent statement and additional supporting documents are required for all research projects submitted for review.
For approval of a any research protocol, the following federal requirements must be satisfied (45 CFR 46.111):
Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects 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. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the 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 authorized representative, in accordance with, and to the extent required by §46.116.
Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
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.
The majority of studies that involve data collection from adults using a survey or interview format are reviewed as Exempt (Level I) protocols unless the questions deal with a sensitive aspect of a subject's behavior such as illegal conduct, drug use, sexual behavior, or the use of alcohol. Surveys and interviews of children are not Exempt (Level I); however, unless the research meets the criteria of category one described in 45 CFR 46.101. Research involving pregnant women and/or fetuses, prisoners, or the institutionalized mentally disabled cannot be Exempt (Level I).
Research may be Exempt (Level I) if identifying information is not recorded (anonymous) and/or the interview/survey questions are considered non-sensitive.
The researcher will provide information about the research to potential subjects so that an informed decision can be made regarding participation. In research that meets the criteria for Exempt (Level I), the researcher can deliver this information verbally or both verbally and in writing based on a CPHS approved script or consent statement.
The following criteria are used to determine if research is Exempt (Level I) (45 CFR 46.101).
Exempt (Level I) Research Categories:
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.
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 paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
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 researcher in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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.
(c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy.
(d) Department or agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the department or agency but not otherwise covered by this policy, comply with some or all of the requirements of this policy.
(e) Compliance with this policy requires compliance with pertinent federal laws or regulations which provide additional protections for human subjects.
(f) This policy does not affect any state or local laws or regulations which may otherwise be applicable and which provide additional protections for human subjects.
(g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and which provide additional protections to human subjects of research.
(h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. [An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the FEDERAL REGISTER or will be otherwise published as provided in department or agency procedures.
(i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes or research activities otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Human Research Protections, Department of Health and Human Services (HHS), or any successor office, and shall also publish them in the FEDERAL REGISTER or in such other manner as provided in department or agency procedures.
Additional Information:
Categories 2 and 3 are not Exempt (Level I) if the research deals with a sensitive aspect of a subject's behavior such as illegal conduct, drug use, sexual behavior, or the use of alcohol.
Surveys and interviews of children are not Exempt (Level I) unless the research satisfies category 1.
Observation of children is Exempt (Level I) if the researcher does not participate in the activities being observed.
Research involving pregnant women and/or fetuses, prisoners, or the institutionalized mentally disabled is not Exempt (Level I).
The research may meet criteria for Exempt (Level I) review if it involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if: these data sources are publicly available or the information is recorded by the researcher in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects (45 CFR 46.101(b)(4)). Note that due to technological advances in data tracking capability, the CPHS rarely approves protocols proposing anonymous data collection.
Two experienced CPHS members must review research that qualifies for a Expedited (Level II) review using criteria listed in 45 CFR 46.110. When conducting a Expedited (Level II) review, the reviewers are authorized to act on behalf of the CPHS with the exception of disapproving the research. During the initial review process, questions may arise that require the researcher to provide additional information or clarification about the protocol. Questions developed during the initial review are communicated to the researcher electronically within approximately three weeks of protocol submission. The researcher is given a 90-day period to respond to modifications necessary to secure approval. Upon receipt and acceptance of the researchers response by the CPHS representative(s), approval to conduct the research is communicated to the researcher through electronic correspondence. CPHS members are informed of initial and continuing review and protocol modifications reviewed using Expedited (Level II) procedures at the appropriate convened committee meeting.
The following criteria are used to determine if the research is eligible for a Expedited (Level II) review (45 CFR 46.110). Research activities that:
Present no more than minimal risk to human subjects, and
Involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.
The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
The categories in this list apply regardless of the age of subjects, except as noted.
The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= 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 expedited review procedure may not be used for classified research involving human subjects.
IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.
Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
Expedited (Level II) Research Categories:
Clinical studies of drugs and medical devices only when condition (a) or (b) is met: (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b)Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 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 subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, 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.
Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) 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; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
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.) Examples: (a) 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 subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
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). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
Collection of data from voice, video, digital, or image recordings made for research purposes.
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 group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
Continuing review of research previously approved by the convened IRB as follows: where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or, where no subjects have been enrolled and no additional risks have been identified; or, where the remaining research activities are limited to data analysis.
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Research not eligible for a Exempt (Level I) or Expedited (Level II) review (e.g., involves more than minimal risk; an experimental design; subjects considered to be vulnerable [children, prisoners, cognitively impaired]; and/or deception) must be reviewed by the convened CPHS membership. Research protocols reviewed during the convened monthly meeting are accessible to the CPHS members approximately 10 days in advance of the meeting. Protocols submitted for convened committee review must be received on or before the posted deadline date, which is usually two weeks before the scheduled convened committee meeting. A primary reviewer is identified to present a specific protocol to other members in attendance. Following presentation and discussion, the committee will vote on a motion to either: 1) approve the protocol as it stands; 2) request revisions to the protocol to secure approval; 3) request that additional information be provided prior to further review by the convened committee; or 4) disapprove the protocol.
“The CPHS shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities (45 CFR 46.109).”
The researcher receives electronic notification from the CPHS stating the approval date and terms of approval.
The researcher receives electronic notification from the CPHS stating the approval date, terms and conditions of approval.
During a protocol review, the CPHS may identify changes that must occur or clarification that is needed prior to approving the protocol. The researcher is notified electronically of the CPHS review stipulations or revisions needed for approval to occur. Research may not commence until the stipulations have been addressed and accepted by a CPHS representative. The researcher is provided with a 90-day time period within which the stipulated conditions must be addressed. The CPHS determines, upon initial review, whether the researcher's response to stipulations will require subsequent review by the convened committee or can be reviewed via subcommittee.
If a determination for approval cannot be made due to pertinent information missing from the protocol, the researcher is notified information is needed by the CPHS to complete the review. Research activity may not commence until the researcher has provided the information and the CPHS has reviewed and accepted the response, as well as reviewed and approved the protocol.
If the research is disapproved, the researcher may not conduct the research. The CPHS will provide the researcher with the reason for its decision. The researcher may resubmit a protocol to the CPHS for review if the reasons given for disapproval can be corrected and addressed.
Protocols are reviewed in the order they are received by the CPHS, unless otherwise noted below.
For research protocols meeting Exempt (Level I) or Expedited (Level II) review (45 CFR 46.101 & 45 CFR 46.110) criteria, the review process typically takes three to four weeks. If the research requires review by the convened committee (Full Board or Convened Meeting Review (Level III)), the researcher will be notified of the review decision within one week following the monthly meeting date. Protocols that require review by the convened committee must be submitted no later than two weeks prior to the scheduled monthly board meeting date. Meeting dates can be obtained by contacting CPHS@csumb.edu or (831)582-5130. Deadline dates pertain only to protocols that require review by the convened committee. Exempt (Level I) and Expedited (Level II) reviews are conducted in the order received.
In certain situations, such as by funding sponsor requirement or external deadline, the CPHS will review a protocol out of submission order. Requests for "out of order" protocol reviews will be assessed by the CPHS prior to assignment for review.
The most common reason for approval delay is due to the submission of an incomplete protocol or an inadequate consent procedure. To avoid unnecessary delay, the CPHS Guidelines and procedure instructions should be followed when writing the protocol, acquiring or assembling supporting documents or developing consent/assent forms.
The second most common reason for approval delay is due to additional research compliance, referred to in 45 CFR 46.107(a) as other "policies and resources, regulations, applicable law, and standards of professional conduct and practice", which applies to the protocol. When review and approval of additional research compliance impacts the protocol's methods or procedures, the CPHS will hold the protocol approval while the ancillary review is processing. A few common (i.e.: not exhaustive) examples of ancillary reviews that typically have an impact on Human Subjects Research protocols are:
Protected Level 1 or Level 2 Data Security and Privacy Protection - administered by IT's Information Security Committee
Student Data Protection (FERPA) - administered by the VP of Student Affairs
Externally Funded Research Requirements - administered by Sponsored Programs Office
Additional research compliance is typically identified during the course of protocol review. So the best practice is always to submit your protocol as cleanly and as soon as possible so that the CPHS can make its determination as quickly as possible.
The researcher must document the proposal record locator number or award tracking number (currently called Kuali Research ID#) to their CPHS protocol (45 CFR 46.103f). If an award is received, the University Corporation at Monterey Bay may withhold funds until CPHS approval is secured.
If the research lacks definite plans for involvement of human subjects, an Approval in Principle may be appropriate (45 CFR 46.118). This process allows for the researcher to disclose plans to conduct research and to demonstrate understanding that human involvement in the research cannot occur until the CPHS approval is secured. This occurs when the research plan has not been completely developed or material development will occur prior to any involvement with subjects.
45 CFR 46.118: Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by the CPHS before an award may be made. No human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the CPHS, as provided in this policy, and certification submitted, by the institution, to the Department or Agency.
Exempt (Level I) protocols may be approved with up to no end date. Expedited (Level II) and Full Board or Convened Meeting Review (Level III) protocols are valid for up to one year from the date of approval (45 CFR 46.109) at which point the researcher may request an extension using the CPHS Project Review (continuing review) form. The length and terms of approval is determined by the CPHS based on project complexity, degree or type of risk associated with participation, and the researcher's history of compliance with ethical practices.
If the researcher is not satisfied with the decision of the CPHS, or with the process by which a decision is rendered, an appeal process may be enacted. To initiate the appeal of a CPHS decision, the researcher must submit a statement to the CPHS noting areas of contention. If the issue is not resolved through the CPHS, the appeal will be forwarded to the Provost for review.
Correspondence and communications between the CPHS and the researcher most often occur through email or by telephone. Formal correspondence regarding the protocol submission and review are through electronic based notifications. Once the researcher has received notification that the protocol is approved, research may begin. If revisions are needed to secure approval, the correspondence will detail the topics that require a response. Upon CPHS review and approval of the response, the researcher will receive correspondence indicating Committee approval. For Expedited (Level II) and Full Board or Convened Meeting Review (Level III) research approximately six weeks prior to the protocol expiration date, the CPHS sends notification to the researcher to complete a ”Report of Progress and Request for Renewal” which must be reviewed and approved by the CPHS prior to the protocol expiration date. It is the researcher's responsibility to submit this report.