Policy for the Use of Human Subjects in Research
Cal Poly, San Luis Obispo is committed to the protection of human subjects in research. To assist with this goal, the University has designated a Human Subjects Committee (also called Institutional Review Board, or IRB) to review proposals for research involving human subjects. The Committee evaluates the research only in terms of its compliance with ethical standards regarding the treatment of subjects. While individual researchers are ultimately responsible for their practices, the Committee's review is designed to provide objective input as an additional protection for the subjects. In addition, the independent review by the Committee is of benefit to those who could be held accountable for the research practices -- the researchers and the University.
Applicability of this Policy
All institutions at which research involving human subjects is carried out are required by law to have an institutional review board (IRB) to oversee those projects when the research is supported by a federal agency. It should be noted that investigators who will carry out federally funded research involving human subjects that is not "exempt" from review under federal guidelines, are required to receive authorized training in the ethical principles and procedures for carrying out such research. Federal funds will not be awarded without proof of this training. Training authorized by the Office of Human Research Protections (OHRP) is available online at the Federal training website. Even if the research is not federally funded, however, it is Cal Poly's policy that a review of compliance with ethical guidelines be completed on all research involving human subjects conducted at Cal Poly. Similarly, reviews must be done of all off-campus research on human subjects carried out by Cal Poly faculty, staff, and students when they are conducting the research as an aspect of their roles as faculty, staff, or students of the University. The Committee is not responsible for reviewing research on human subjects that is conducted by a University employee or student as a function of their independent consulting work or their work with another institution.
In accordance with federal guidelines for the protection of human subjects, research involving human subjects is defined as any systematic investigation of living human subjects or human materials that is designed to develop or contribute to generalizable knowledge. Human subjects research which requires review by the Committee includes faculty research, master's theses, and senior projects as well as research conducted on campus by parties not directly affiliated with the University. While the ethical principles for research are often applicable to classroom activities, demonstrations, and assignments, the Human Subjects Committee does not review classroom activities unless data will be collected and used in a systematic investigation.
The Human Subjects Committee members and chair are appointed by the Dean of Research. The members will include representatives from a range of campus departments involved in human subjects research. Consistent with federal guidelines for IRB membership, the Committee will also include at least one member not affiliated with the University (and having no close relatives affiliated with the University), at least one non-scientist, and individuals of various races, cultural backgrounds, and genders. A list of current Committee members is available from the Dean's Office, Bldg. 38, Rm. 154; (805) 756-1508. Nonmembers may be consulted if additional expertise is deemed useful in evaluating a research proposal; however, nonmembers will not have a vote regarding the approval of the project. Committee members are responsible for removing themselves from reviews of projects for which they may have a conflict of interest (e.g., when he or she is an investigator or advisor for the research).
Types of Human Subjects Review
Some forms of research are considered exempt from further review, others may be given an expedited review, and the remainder are subject to full review. Even when a project falls into one of the categories for exempt status (listed below), researchers are still expected to submit an approval form and a brief research protocol for confirmation of the exempt status to the Dean of Research or the Chair of the Human Subjects Committee via Debbie Hart (Office of Research and Economic Development, (805) 756-1508, email@example.com). Confirmation of exempt status should be received by the researcher prior to initiating the research.
The following categories are typically considered exempt from further review:
- Research conducted in educational settings involving normal educational practices, such as research on instructional strategies, curricula, or classroom management methods;
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey or interview procedures, or observation of public behavior, provided (1) information is recorded in such a way that human subjects cannot be identified, directly or through identifiers, (2) any disclosure of the subjects' responses outside the research could not place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation, and (3) the topic of the research does not involve a very sensitive or emotional issue (e.g., personal experience with family violence, HIV, or sexual assault). Research involving educational tests, survey or interview procedures, or observation of public behavior may be considered exempt even if the provisions (1) through (3) listed above have not all been met if the subjects are elected or appointed officials or candidates for public office, or if federal statutes require without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter;
- Research involving the study of existing data, documents, records, or pathological or diagnostic specimens, if these sources are publicly available or the information is recorded in such a way that subjects cannot be identified directly or through identifiers;
- Research and demonstration projects designed to study public benefit or service programs or changes or alternatives to those programs; and
- Taste and food quality evaluation and consumer acceptance studies, provided wholesome foods are consumed that have no additives or include a food ingredient, agricultural chemical, or environmental contaminant at or below the level and for a use 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.
Research proposals may be given an expedited review if the procedures used involve no more than minimal risk. Minimal risk is involved when the probability and magnitude of anticipated harm or discomfort 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. Examples of research classified as minimal risk in the federal guidelines include: voice recordings of speech defects, moderate exercise by healthy volunteers, research on individual or group behavior or characteristics in which stress to subjects is not involved and the researcher does not manipulate subjects' behavior, and noninvasive procedures such as weighing and testing of sensory acuity.
An expedited review will be conducted by a subcommittee of the full Human Subjects Committee. The subcommittee for each expedited review will typically consist of the Human Subjects Committee Chair, one Committee member with expertise related to the proposed research topic, and one member whose area of expertise is in a discipline other than that of the researchers.
Research projects involving greater than minimal risk to subjects (e.g., studies on the effects of stimulus deprivation, experimental drugs, or physical activities with significant risk of serious injury) will be subject to a full review by the Human Subjects Committee as a whole.
The Review Process
The first step a researcher should take to request approval for a research project with human subjects is to obtain and carefully read copies of the Human Subjects Committee's submission materials, which include: (a) an approval form, (b) a research protocol, (c) a sample consent form protocol, and (d) the Cal Poly Policy for the Use of Human Subjects in Research. The submission procedures, which are outlined in detail below, are slightly different for projects considered exempt from further review, than for those classified as needing an expedited or a full review. Researchers who are uncertain as to whether their project would be categorized as exempt, as opposed to needing either an expedited or a full review, should feel free to consult with the Chair of the Human Subjects Committee or the Dean of Research prior to submitting the research proposal.
In fact, consultations with the HSC Chair or the Dean are encouraged for clarification of any aspect of the review process, both prior to initiating a review and during the review. Advance consultations can often reduce the amount of time needed for the researcher to prepare the submission materials as well as the time for a proposal to receive approval. HSC submission materials are available both from Dean of Research, Bldg. 38, Rm. 154, (805) 756-1508; and from the Chair of the Human Subjects Committee. The name and location of the current HSC Chair can be obtained from the Dean's office.
Proposals for human subjects research that the researcher believes are exempt from further review should be submitted to either the Dean of Research or the Chair of the Human Subjects Committee via Debbie Hart (Office of Research and Economic Development, Bldg. 38, Room 154, firstname.lastname@example.org). Please note that the HSC Chair will typically not be available to review projects during academic breaks and summer quarter; at those times, researchers should submit proposals to the Dean. Only one copy of the HSC approval form and a brief research protocol (including informed consent materials) need to be submitted if you are applying for exempt status as typically only one member of the Committee will need to review the proposal. Researchers should generally allow one to two weeks to receive confirmation of exempt status, although feedback can often be provided within a shorter amount of time if needed and requested.
Proposals for which the researcher anticipates an expedited or a full review should be submitted to the HSC Chair via Debbie Hart (Office of Research and Economic Development, Bldg. 38, Room 154, (805) 756-1508, email@example.com). The submission for an expedited or full review should include a fully completed HSC approval form and a research protocol, including an informed consent form. Every attempt will be made to provide feedback to the researchers as soon as possible but typically no more than two to four weeks following receipt of the submission for expedited reviews. Full reviews may require additional time, a month or longer, to provide the researcher with a response from the Committee. Researchers should not expect to have proposals reviewed by the HSC during finals week, holidays, or quarter breaks. Subject recruitment and data collection should not be initiated prior to obtaining approval from the Human Subjects Committee. The Committee reserves the option of withdrawing approval of a project if circumstances warrant, for example, if the research procedures are found to produce greater risk of harm than previously anticipated. The researcher must promptly report to the HSC Chair or the Dean of Research any alterations in their materials or procedures not addressed in their initial submission materials as well as any unforeseen problems or complaints regarding the research project.
Following the review of the researcher's materials, the Committee may approve the project, deny approval, or request specific clarifications or changes in order for the project to fully comply with ethical guidelines. If clarifications or changes have been recommended, once the Committee receives written verification from the researcher that the clarifications or changes have been made, approval will be granted. Proposals may only be denied by a majority vote of a quorum of the full Committee. (A quorum is defined as a majority of the total membership.) More specifically, if an expedited review committee does not approve a project, the researcher will be notified, and, unless the researcher chooses to withdraw the proposal, it will then be reviewed and voted on by the full committee. A researcher is welcome to submit additional information to clarify the planned research practices at any point during the review process and may request to meet with the HSC Chair, the Dean, or the Committee to discuss the decision on the research proposal.
Overview of the Ethical Principles
Cal Poly's ethical guidelines for the use of human subjects in research are based on the principles and procedures outlined in the Federal Policy for the Protection of Human Subjects and the Office of Human Research Protections (OHRP) Institutional Review Board (IRB) Guidance. The OHRP IRB Guidebook provides a detailed interpretation and discussion of the Federal Policy guidelines. The Federal Policy provides a common policy to be implemented across a broad spectrum of federal agencies including the National Aeronautics and Space Administration, the Environmental Protection Agency, the Consumer Product Safety Commission, the National Science Foundation, and the Departments of Agriculture, Energy, Education, Justice, Defense, Housing and Urban Development, and Health and Human Services. Cal Poly's policy is similarly intended to apply to the range of disciplines represented on campus while at the same time acknowledging the value of the ethical guidelines of individual disciplines' professional associations (e.g., the American Medical Association, the American Psychological Association, the American College of Sports Medicine, the American Association on Mental Deficiencies). Should a specific circumstance not be fully addressed by the Cal Poly policy, the Federal Policy and the OHRP IRB Guidebook will provide the guidelines for the Committee's decision-making. The Federal Policy will be the primary reference for the review of federally funded research.
The Federal Policy and Cal Poly's guidelines draw heavily on the three basic ethical principles laid out in the Belmont Report, a 1979 report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. These three basic principles are: respect for persons, beneficence, and justice. Respect for persons entails treating individuals as autonomous agents who enter into research voluntarily and with adequate information (i.e., informed consent). Those with diminished autonomy, such as children, prisoners, and individuals who are in some way incapacitated, have a right to be protected. The second basic principle, beneficence, refers to the obligation to secure the well-being of research subjects. Possible benefits should be maximized, while possible harms should be minimized. The final principle explicated in the Belmont Report is that of justice. Justice implies that both risks and benefits of research should be distributed equally across various groups. For example, the burden of serving in research should not largely fall on certain groups such as the poor or the imprisoned, while others primarily benefit from the knowledge gained from the research.
Copies of the Belmont Report, the Federal Policy, and the OHRP IRB Guidebook are available in the Office of the Dean of Research, Bldg. 38, Rm. 154; (805) 756-1508.
Specific Ethical Criteria
Consistent with the principles outlined in the Belmont Report, the Federal Policy, and the OHRP IRB Guidebook, the following criteria will be used to evaluate research proposals at Cal Poly:
- Risks to subjects are minimized. Exposure of subjects to unnecessary risks is avoided, and precautions, safeguards, and alternatives are utilized to reduce the probability of harm and limit its severity or duration. An example of an appropriate safeguard is the presence of medically trained personnel during the administration of physical endurance tests. While a degree of risk may be unavoidable in some research, the risks that are present must be reasonable in relation to anticipated benefits of the research, including possible direct benefits to the subjects and the general benefits of the knowledge that may be gained from the research. An adequate research design is implemented to ensure that the results will be meaningful and, therefore, of potential benefit to increasing knowledge. Regarding studies of the direct benefit to subjects of an intervention or treatment method, investigators should offer the treatment or intervention to members of control groups if and when it has been found to produce beneficial results. Similarly, members of groups receiving alternative treatments that are determined to be less effective should be offered the more beneficial treatment as well.
The risks that must be identified and addressed include: (a) physical harm (e.g., pain, discomfort, injury, side-effects of drugs, dizziness), (b) psychological harm (e.g., stress, guilt, depression, loss of self-esteem, confusion, embarrassment), (c) social harm (e.g., the possible stigmatizing effects of diagnostic labels such as "delinquent" or "schizophrenic"), and (d) economic harm (e.g., threats to employment if a subject's involvement in research on HIV carriers or alcohol abusers were revealed). An additional risk involving social, economic, and/or psychological harm could result from having subjects reveal illegal activities. Some of the social and economic risks may be adequately addressed by appropriate procedures for maintaining confidentiality or anonymity. When relevant, referrals for assistance (e.g., counseling or medical treatment) or other appropriate efforts must be made to attempt to ameliorate any type of harm or distress that might be brought on, even in part, by the research.
- Selection of subjects is equitable considering the purpose of the research and the special needs of vulnerable populations. Equitable selection is intended to ensure that the burdens and benefits of research are fairly distributed. Researchers should exercise caution regarding the use of certain groups of subjects who are easily available, in a compromised position, or susceptible to manipulation. Voluntariness of participation could be diminished for prisoners or for students, patients, or employees of researchers, given that there may be an implied, if not overt, indication that grades, employment status, or treatment may be dependent on the individuals' willingness to participate in research. On the other hand, competent adults should not be overprotected and, thereby, excluded from research in which they might wish to participate. Thus, it should be especially clear in research proposals involving easily available subjects or those in a potentially compromised position, that appropriate measures are taken to ensure that their participation is not coerced in any direct or indirect manner. For example, if students constitute the subject pool, extra credit should only be offered for participation in research if at least one other equally attractive option for obtaining extra credit is also offered. Participation as a subject of research may not be a course requirement. In addition, while incentives for participation such as a few extra credit points or small monetary payments are generally allowable with appropriate informed consent, very large inducements may be inappropriate as they could be coercive, blinding prospective subjects to potential risks and reducing the voluntariness of their participation. In studies of interventions for diseases or disorders to which women, minorities, or other specific groups might be susceptible, it is especially important that they not be underrepresented as subjects. In other situations, however, reseachers may need to take steps (e.g., screening interviews or questionnaires) to exclude certain groups of potential subjects if those individuals might be particularly vulnerable to the procedures implemented (e.g., pregnant women in studies of the effects of drugs or individuals with anorexic tendencies in weight loss studies). In the case of studies involving physical exercise, researchers should follow the health screening procedures and other recommendations provided in the current edition of Guidelines for Exercise Testing and Prescription by the American College of Sports Medicine. It is recognized that some studies obviously require selecting prospective subjects only from specific groups that are relevant to the purpose of the study (e.g., children with learning disabilities in a study of the effectiveness of an educational intervention for such children).
- Informed consent is sought from every prospective subject or the prospective subject's legally authorized representative. A legally authorized representative (e.g., a parent or guardian) must provide consent for children under the age of 18 or for individuals with diminished capacity to give their own consent (e.g., developmentally delayed adults). Informed consent should ensure that potential subjects or their legally authorized representatives understand the nature of the study and can knowledgeably and voluntarily decide whether or not to participate. Informed consent may not contain exculpatory language that attempts to waive the subject's or representative's legal rights or to release the investigator, research sponsor, or the institution from liability for negligence.
Section 46.116 of the Federal Policy lists the basic elements that must be included in each informed consent statement. These basic elements are concisely listed in the Guidelines for Human Subjects Research Protocols. Section 46.116 also contains additional elements that may be appropriate to include in informed consent statements in some studies, as well as a brief discussion of exceptions to the need to obtain informed consent or to include all of the basic elements of consent (e.g., a full disclosure of the nature and purpose of the study). Full disclosure of the purpose of the study is not required at the onset of the subject's participation in studies with no more than minimal risk if complete disclosure would render the findings of the research invalid. For example, a researcher could justifiably fail to inform subjects that their attention span will be assessed as a function of the type of background music being played, given that that information could itself produce changes in the subjects' behavior (e.g., greater attempts to focus their attention in spite of distracting music). Deception (e.g., telling students their problem-solving ability will be tested when, in fact, they are being observed regarding their competitiveness), is similarly allowable in research of no more than minimal risk when the deception is methodologically necessary to test the desired hypotheses. In cases of deception or a lack of full disclosure, subjects must be subsequently debriefed regarding this information. An example of an allowable exception to the need to obtain informed consent is research involving only nonintrusive naturalistic observations of public behavior in which data are recorded in such a way that observed individuals cannot be identified.
The informed consent should generally be documented in a written and signed consent form containing the appropriate elements of informed consent. Each potential subject or legal representative should be given adequate time to read the consent form before being asked to sign it. The consent form should be written in language easily understandable to the prospective subject or legal representative. This implies that consent forms should be available in an appropriate language other than English for prospective subjects or legal representatives not fluent in English. It also implies that technical jargon, which may be familiar to the researcher but not necessarily to others, should be avoided or explained in the consent form. A signed consent form may be waived if (a) the only record linking the subject and the data would be the consent form and the principal risk to the subject would be harm that could result from a breach of confidentiality, and (b) no more than minimal risk is involved and the study involves no procedures for which written consent is normally required outside of the research context.
- When appropriate, plans are included for adequately monitoring the data to ensure the safety of the subjects. Researchers are required to monitor their procedures carefully throughout the data collection process to reevaluate the risks to human subjects. If the risks are determined to be greater than initially predicted (e.g., an exercise protocol results in dangerous increases in heart rate), the Human Subjects Committee Chair or the Dean of Research and Graduate Programs should immediately be notified and prompt, appropriate steps should be taken to reduce the risks, obtain additional informed consent, and/or discontinue the procedures.
- The privacy of subjects and confidentiality of data are adequately protected. Privacy refers to the subject's right to have control over the extent, timing, and circumstances of sharing him- or herself with others. Privacy is typically protected by informed consent which ensures that subjects have voluntarily agreed to share themselves with others. More complex privacy issues are involved in studies that use private records (such as medical records) to identify prospective subjects and in some observational studies (e.g., those in "quasi-public" places such as hospital emergency rooms). Individuals conducting research of this nature should consult the discussion of such privacy issues in Part 3 of Chapter 3 in the OHRP IRB Guidebook, available in the Dean's Office, Bldg. 38, Rm. 154; (805) 756-1508.
Maintaining confidentiality requires that researchers take steps to ensure that the information revealed by the subject is not divulged to others without the subject's permission. Information is regarded as confidential when the researcher could identify which data are associated with an individual subject but agrees not to reveal this information to others. Appropriate measures to achieve confidentiality include removing face sheets containing identifying information from questionnaires, substituting code numbers for names or other identifiers, limiting the number of individuals with access to data containing identifiers, and storing data in locked cabinets. If codes are used and a list matching the codes with the identity of the subjects is maintained, the list must be kept in a secure location separate from the data. Anonymity of subjects' responses is the most certain method of ensuring that the identity of a subject will not be associated with his or her data. When data are collected anonymously, even the researchers have no means by which they could identify which data belong to which subjects.
- Additional safeguards have been implemented to protect the rights and welfare of special classes of subjects, particularly subjects who might be vulnerable to undue influence or coercion (e.g., children, prisoners, mentally disabled persons, economically or educationally disadvantaged persons). One safeguard applicable to children and mentally disabled persons is the requirement of obtaining the informed consent of a legal representative of the prospective subject. The legal representative must be a competent adult whose primary concern in the research situation is the best interests of the prospective subject who is the representative's ward. Even when a legal representative gives informed consent for a ward to take part in a research project, the individual subject/ward must still give assent, or agreement, to participate as well.
When applicable, researchers should consult Chapter 6 of the OHRP IRB Guidebook for specific considerations regarding studies of the following groups: fetuses, pregnant women, children and minors, cognitively impaired persons, prisoners, traumatized and comatose patients, terminally ill patients, elderly/aged persons, minorities, students, employees, and individuals in countries other than the United States.
- Adequate debriefing of subjects regarding the purpose of the study and any deception involved in the procedures is included. Subjects are offered a method of obtaining a summary of the research findings when available. For example, all subjects may be given a copy of the informed consent form which includes the name, business phone number, and business address of the researcher or advisor for the project and an invitation for interested subjects to contact that individual when it is expected that the results will be available. Alternatively, a summary of the results might be posted in a location accessible to the subjects, such as an information bulletin board in a gym at which athletes had participated in research on an exercise program. Such summaries, as well as other reports of findings, should, of course, refer to no subjects by name or other information that would indicate individuals' identities.