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Human Subjects Policy

Santa Clara University is committed to a policy of safeguarding the rights and welfare of all human subjects in research. The university accepts the principles set forth by the national Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in its report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (commonly known as the Belmont Report, April 18, 1979). The commitment to these principles includes recognition of the necessity for review of a research project independent of the investigator to ensure optimum protection of human subjects involved in that project. However, this commitment extends beyond the requirements of federal regulations and is not affected by the sources of research funding.

This policy is applicable to all research involving human subjects conducted by an employee or student of the University in connection with his or her university work.   “Research” is specifically limited to “a systematic investigation designed to develop or contribute to generalizable knowledge” (See section II for definitions of research and human subjects). In case of doubt about whether the policy applies to a specific case, the researcher is invited to contact the Human Subjects Committee for an authoritative determination.

Three basic ethical principles cited in the Belmont Report are:

1. Respect for Persons. Human subjects must be treated as autonomous and able to make responsible choices. This principle leads to the requirement of informed voluntary consent.

2. Beneficence. Subjects must be protected from harm and their well-being must be secured. This principle leads to the requirement that the benefits to subjects or to humanity generally must be judged to outweigh the risks to subjects.

3. Justice. The risks and benefits of research must be distributed fairly without creating differences in treatment among ethnic, racial, religious, sexual, or age-defined classes. This principle leads to the requirement that investigators take care not to exploit special categories of persons less able to refuse participation in research such as prisoners, mental patients, and children.

Applications of these principles lead to the standard expectations that investigators will:

 

A. Secure informed consent by (add link: see Federal Guidelines for Obtaining Informed Consent from 45 CFR 116 & 117)

1. making real efforts to see that subjects understand the project

2. providing a "way out" for subjects if they desire one

3. providing a way for questions to be answered.

B. Systematically evaluate risks and benefits of their research.

C. Select subjects in a fair manner that does not exploit some especially vulnerable category of people.

 

These definitions are drawn from 45 CFR 46.102 of the Code of Federal Regulations, and supplemented by other examples.

a. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition may be funded or unfunded, or may be conducted as a component of another program not usually considered research. For example, demonstration and service programs may include evaluation components, which constitute research activities under this definition.

Precedent and practice have established the principle that certain kinds of activities that might be called “human subjects research” do not require review for the protection of human subjects. The following kinds of activities do not require such review: (a) accepted and established service relationships between professionals and clients where the activity is designed solely to meet the needs of the client; (b) research using only historical documents; and (c) research using only archaeological materials or other historical or pre-historical artifacts.

Pilot studies, pre-tests, and other “preliminary” investigations are considered research, and must be reviewed unless they fall into one of the excluded categories listed above.

Some classroom activities and student projects are considered research, while others fall outside of the scope of the policy. See Part V, Section E on student research for more information on the kinds of classroom or student activities that require human subjects approval.

Quality improvement and quality assurance activities conducted solely for the intent of maintaining or improving quality of services provided by an institution, likewise, are not considered research activities. However, if the data collected are generalizable and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research. Sometimes, data from a quality improvement or quality assurance activity become of interest to the external community after they have been analyzed. In these cases, if the research involves human subjects, the research use of the data collected for another purpose must be reviewed.

b. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individually identifiable private information.

c. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

d. Interaction includes communication or interpersonal contact between investigator and subject.

e. 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 that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

f. Minimal risk means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The Human Subjects Committee (HSC), composed of at least five voting members appointed by the Associate Provost for Research and Faculty Affairs, will serve as the Institutional Review Board required by law. In addition, the Director of Research Compliance & Integrity serves in an ex-officio capacity. One of the voting members will not be affiliated with Santa Clara University. The composition of the committee should reflect expertise in the areas in which applications are typically received: the social sciences, business, law, and physical sciences. It will be appointed in accordance with 45 CFR 46.107, which provides guidelines for assuring that the committee is “sufficiently qualified through the experience and expertise of its members...to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.”

The Chair of the Human Subjects Committee will be a tenured member of the faculty. Committee members may be tenured or untenured full-time faculty members. Typically, the Chair and committee members serve terms of three years. All committee members will undergo a certification process administered through the Office of Research Compliance and Integrity.

The Human Subjects Committee will meet at least once per year to review university policies and procedures designed to protect human subjects. It also will meet as needed to review specific projects. When the committee reviews a project, it will act in a thorough, timely and impartial manner. It will have the authority to approve, disapprove or require modifications in projects. The committee can take action on an application to conduct research when a quorum (greater than 50% of voting members) is present. A list of alternative members (former members) may be called upon to review a project if the regular committee is unable to reach a quorum within the period needed for a project to be reviewed in a timely fashion. All decisions will be based on a formal vote and all votes, including dissenting votes, will be recorded. Approval of a proposed project requires a majority vote in favor. In the case of a tie vote, approval is denied. Research covered by this policy may be subject to further review by appropriate university officials. However, if the Human Subjects Committee fails to approve a project its decision may not be overruled. An investigator who is not satisfied with a decision may ask the committee to reconsider.

The Human Subjects Committee will consider all proposals requiring Regular (Full) review. Expedited Review may be carried out by a Committee member as designated by the Chair or one Committee member in conjunction with the Committee Chair.  All members of the HSC must be advised by the Chair of research proposals that have been approved via Expedited review procedures (45 CFR 46.110c). Exempt level proposals may be approved by an Area Representative, the HSC Chair, or a HSC Committee member.

Procedures for Obtaining Approval

  

Refer to the detailed procedures on the application forms. If in doubt about what procedure to follow, or about the applicability of this policy, the researcher should contact the Chair of the Human Subjects Committee. The name of the current chair can be obtained from the Office of the Provost or the Office of Research Compliance & Integrity.

The Chair and the Committee will make every effort to notify the researcher concerning the results of the review in a timely manner. However, the application must be submitted to allow sufficient time for a committee review. Because most federal agencies will not grant funds if human subjects clearance has not been granted, it is important that the application be submitted well before deadlines to allow for committee approval or for making changes recommended by the committee. For projects that require a full review and that will be submitted to Federal funding agencies, a sixty (60) day lead time is recommended. For research that is exempt from full review and that is not funded externally, thirty (30) days lead time will generally suffice. While the committee strives for much faster turnaround times in the case of routine projects, no guarantee is made beyond those just stated. 

All research involving human subjects falls into one of three categories: Exempt Review, Expedited Review, or Regular (Full) Review. Each and every Human Subjects research project conducted at Santa Clara University must be reviewed by someone other than the researcher. All Human Subjects research must have signed documentation that certifies that a review took place.

The placement of a research proposal into Exempt, Expedited or Regular review depends on the nature of the population and the type of research activity proposed. For this reason, researchers are advised to read through all three types of institutional review. Before beginning the research, investigators must determine which category their research falls into and submit the appropriate information to the Human Subjects Committee or one of its representatives. Although the investigator makes the initial category judgment, the committee may require an investigator to change the project’s classification and subsequently request a revised application for committee approval. The three research categories are described below.

1. Exempt from Full Review

An investigator may apply for Exempt Review when human subjects activities involve “no more than minimal risk” as defined in Section II.F. (Definitions) and the research procedures fall into one or more of the categories listed below. Please note that “Exempt” means exempt fromfull review, not exempt from any review. Projects at the “exempt” level may be reviewed by an Area Representative or sent to the Chair of the Human Subjects Committee for review.

Research activities in which the only involvement of human subjects will be in one or more of the following categories may be exempt from full review: (these categories are taken verbatim from 45 CFR 46.101b and each of these is followed by an explanatory paragraph.) On the application form, investigators are asked to indicate under which of the five exemption categories listed below the request for exemption is being based. Applications may be returned to the investigator for further information, if necessary.

a. 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.

The purpose of this category is to exempt research on educational practices, in an educational institution. This category does not extend to research conducted in a school setting but not related to the instruction in that institution. For example, an evaluation of two methods of fourth grade classroom instruction in a local school district would qualify as exempt research. A survey of children’s media use habits conducted at the same school, involving the same children, would not qualify as exempt research.

b. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

“Educational tests” refers to standardized tests used for educational purposes, such as the Scholastic Achievement Test. It does not refer to personality tests or clinical evaluations.

c. Research involving survey or interview procedures, except where all of the following conditions exist:

(i) the researcher records responses in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects,

(ii) the subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability, and

(iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.

If condition 1 and either 2 or 3 apply, the researcher should submit the proposal under the “Expedited Review” category.

All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.

d. Research involving the observation (including observation by participants) of public behavior except where all of the following conditions exist:

(i) the researcher’s observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects,

(ii) the observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and

(iii) the research deals with sensitive aspects of the subject’s own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.

The University interprets “public behavior” to mean behavior that is apparent to an unconcealed observer, without the use of any surreptitious equipment, such as binoculars, special microphones, or recording devices.

e. 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.

“Existing” means that the data are “on the shelf” at the time the researcher develops a proposal for their use. Use of data not already on the shelf is not eligible for exemption

2. Expedited Review

An investigator may apply for Expedited Review when human subjects activities involve “no more than minimal risk” as defined in Section II. F. (Definitions), but involve research procedures including one or more of the following types listed below. A proposal submitted under Expedited Review is reviewed by the HSC Chair or one or more members of the Human Subjects Committee.

Investigators are advised to indicate on the application form the category, listed below, upon which the expedited review request if based. (These categories are quoted from 46 FR .8392, followed by explanatory paragraphs as needed.)

a. Collection of: hair and nail clipping, in a nondisfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.

b. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of ruptured of the membrane prior to or during labor.

c. Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiograph, electro-encephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electro-retinography. It does not include exposure to electromagnetic radiation outside that visible range (for example, x-rays, microwaves).

d. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age and older who are in good health and not pregnant.

e. Collection of both supra- and sub-gingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.

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

Because recordings made of subjects are de facto identifiable, research involving these techniques which would otherwise be exempt are eligible for expedited review. Such studies will be approved if the researcher outlines appropriate mechanisms to minimize the risks of invasion of privacy and breach of confidentiality.

g. Moderate exercise by healthy volunteers.

h. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.

i. Research on individual or group characteristics or behavior (including but not limited to, research on perception, cognition, motivation, identity, cultural beliefs or practices, social behavior, game theory, or test development) where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.

Much behavioral research that does not qualify for exemption may be reviewed as minimal risk using the expedited procedure. This category is designed to accommodate research activities that pose no more than minimal risk to subjects and that are not eligible for exempt review status.

j. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

3. Regular Review

Any research involving human subjects that does not qualify for Exempt Review or Expedited Review will be subject to Regular (Full) Review. Typically, projects that require Regular Review exceed the standard for “minimal risk” and/or involve more vulnerable populations.  Applications requiring Regular Review will be reviewed by the full committee. Thus, researchers need to allow enough time for a full committee review of the application (see Section IV.A. for more details on submission).

The following five categories of research always require Regular review: 1) research involving prisoners; 2) studies of pregnant women where the focus of the research is on pregnancy and/or the fetus; 3) research on fetuses in utero; 4) research on minor children unless the research qualifies as educational research in the sense of IV.B.1a. or IV.B.1b above, or where the research does not involve direct interaction with the child; 5) research using non-public records.

C. DURATION OF APPROVAL

Approval for use of human subjects in research is granted for a period of one year from the date of Committee approval. If a research project continues beyond the year for which it was approved, it is the responsibility of the investigator to request a renewal of the approval. No data collection or interaction with human subjects is allowed after the one-year approval period is over until a renewal has been approved.

If an investigator wishes to renew a project within two years of the original approval, he/she may do so by submitting a renewal application form via eProtocol.  If, however, a renewal of a project’s approval is sought more than two years after the date of the original approval, a new application will need to be completed and submitted for HSC review.

1. Should the researcher wish to make a change in protocol once a study has been approved, he/she must file a “Modification Form” that details the nature of the change. Then, all data collection activities must be suspended until this form has been approved (see eProtocol Renewal and Modification).

2. A report for each approved research project must be filed at the end of the approval period. This report must accompany any requests for approval of a previously approved research project (see eProtocol Renewal and Modification).

Implementation

  

Implementation of this policy is guided by three principles:

1.   Every research project involving human subjects at Santa Clara University must be reviewed by someone other than the researcher;

2.   Every such review must have signed documentation certifying that the review has occurred;

3.   Paperwork and delays are to be minimized, subject to adherence to the first two principles.

In brief, a faculty, staff member, or student desiring to conduct a research project involving human subjects should:

1.   Obtain a copy of the HSC application form (via eProtocol system)from the Santa Clara University web site http://cms.scu.edu/provost/research/hsforms.cfm

2.   Complete the appropriate sections of that form (see instructions on the form itself) and submit electronically to Research Compliance Program.

3.   Wait for approval. Data collection cannot begin until approval is received.

4.   In the event of any confusion at any stage of the process, or uncertainty about any part of this policy, the remedy is always the same:     contact the chair of the HSC.

1.   Area Representatives are appointed by the Associate Provost of Research Initiatives.

2.   HSC Area Representatives are faculty on full-time appointments and who are not on sabbatical or other leave during the year of their appointment.

3.   Each year, the Chair of the HSC will review the list of Area Representatives and suggest additions or deletions as necessary depending on the volume of  applications received.

4.   It is permissible for a member of the HSC to also serve as an Area Representative.
 
5.   The typical term for an Area Representative would be 2-3 years and could be renewable.

The Office of Research Compliance and Integrity (ORCI) will forward the HSC application form and associated documents to the Area Representative.

The Area Representative is to make a determination as to whether the research is, in fact, exempt. This determination should be made within two days (48 hrs).

1. If the Area Representative believes the research to be exempt:

a. He/she reviews the application and, if acceptable, notifies the Office of Research Compliance and Integrity and HSC Chair of the approval for the Faculty member to begin data collection.

2. If the Area Representative believes that the research may not be exempt:

a.  He/she should immediately inform the Office of Research Compliance and Integrity and HSC Chair via e-mail, explain why the research may or may not be exempt, and to instruct the faculty to resubmit the appropriate HS application. If the Chair of the HSC finds it to be exempt, he or she will send it back to the Area Representative. Otherwise, the normal procedures for expedited or full review will then commence.

3. Area Representatives have no authority to approve nonexempt Human Subjects research.

4. The Chair of the HSC will review all forms forwarded by Area Representatives. If s/he disagrees with the decision of the Area Representative, s/he will immediately contact the affected faculty member and instruct them to file for expedited or full committee review, as appropriate.

1. The Director of Research Compliance & Integrity will act as a University Representative to the Human Subjects Committee.

2. This is an ex-officio position; the University representative will not vote on whether or not to approve applications.

1.  This policy distinguishes five (5) kinds of student research:

a. Undergraduate or graduate student thesis research and/or independent study research that involves interaction with human subjects.

b. A class research project involving interaction with human subjects and designed to produce generalizable knowledge.

c. Class assignments primarily intended for educational purposes that involve interaction with human subject(s).

d. Class assignments conducted within research methods classes involving interaction with human subjects with the primary intention of demonstrating how research is done.

e. Students who are utilizing data from a research project that already has HSC approval.

2. All undergraduate or graduate student thesis and independent study research should follow the same procedures as those for faculty research described above.

a. The student’s faculty advisor is responsible for informing the student of the necessary procedures

3. A class research project (e.g., a research project involving interaction with human subjects that is intended to produce generalizable knowledge) is handled via a single submission by the faculty member teaching the class, and directed to the Area Representative or HSC, as appropriate.

a. The faculty member teaching the class or sponsoring the student bears a responsibility to educate students concerning the University policy on Human Subjects Research. Faculty are encouraged to have students read through the Human Subjects Manual on-line as part of the research assignment, and to discuss these points as appropriate while preparing students to do research.

b. In the application, the faculty member should describe the class project and indicate what steps have been taken to inform students about their responsibilities as researchers who will be working with human subjects.

c. The submission by the faculty member should affirm that all student projects fit the definition of exempt research. If the Area representative agrees, blanket approval will be granted for all student research conducted as part of that course delivery.

1. If a faculty member anticipates teaching repeated sections of a course involving class projects during an academic year, blanket approval for the year may be sought.

2. If several faculty are responsible for repeated sections of a course involving class projects, they may jointly apply for blanket approval for that academic year.

3. Separate course numbers, and also substantially different approaches to teaching repeated sections of a course, require separate applications.

d. If the faculty member anticipates, or intends to allow, a student to conduct human subjects research that is not exempt, the student and sponsoring faculty member should jointly apply to the HSC for expedited or full review.

4. Class assignments primarily intended for educational purposes that involve interaction with human subjects are not subject to HSC review provided that they do not place human subjects at more than minimal risk (see Section II. F.) and they do not utilize systematic data gathering procedures with vulnerable populations including pregnant women, prisoners, persons with mental disabilities, minors, or economically or educationally disadvantaged persons. For example, a class assignment that asked students to interview several adults about their impressions of a recent election would not be subject to HSC review. However, an assignment that asked a student to administer a standardized psychological test to a minor or homeless person would require HSC review only if this met the definition of research. Everyday conversations with member of vulnerable populations in the course of Arrupe Center placements would not be subject to HSC review unless students were engaged in systematic data gathering procedures.

5. Class assignments conducted within research methods classes with the intention of demonstrating how research is done are not subject to HSC review provided that they do not place human subjects at more than minimal risk (see Section II. F.) and/or they do not utilize systematic data gathering procedures with vulnerable populations including pregnant women, prisoners, persons with mental disabilities, minors, or economically or educationally disadvantaged persons. Therefore, the administration of a survey to undergraduate students about their use of technology would not be subject to HSC review, provided that there was no intention to produce generalizable knowledge (e.g., to present these results at a conference or within a publication).

6. When a student is working on a project that already has Human Subjects approval, and that student will use some of the data to fulfill a course or degree requirement, such as a senior thesis or master’s degree, the original principal investigator must submit an amendment to the HSC requesting the student be added as a researcher on his/her project for the stated purpose.

Instructors are responsible for making the initial determination as to whether HSC review is required.

Instructors and students are cautioned to consider the implications of not obtaining human subjects approval should they later decide that they wish to present the results in a public manner (e.g., at an academic conference, or through publication). If there is any doubt as to whether the project should be reviewed by the HSC, the Chair of the Human Subjects Committee should be contacted.

In the event that HSC review is not needed for a particular classroom research project, the student researcher and the instructor are not relieved of the obligation for the ethical use of human subjects. Consequently, the researchers should adhere to ethical standards and use informed consent when appropriate.

Human subjects applications involving research with minors are required to go through the Santa Clara University (SCU) standard background check process.  Anyone who is part of the research team conducting studies with children under the legal age (18) is required to have a background check.

The following information and forms are available for the background check process:

(1) A release form (Consent and Authorization to Obtain and Review Records) for each member of the research team to sign and return to the SCU Risk Manager Sam Florio. See Appendix M

(2) A Live Scan Service form with the identifying SCU information included in the form.  Use of any other form could result in the background check not being completed. See Appendix N

(3) A document explains the background check process and the locations where background check can be done (Santa Clara Police Department across the street from the University on Wednesday afternoons with an appointment) or at the Sheriff's Dept in San Jose (one exit north on 880) with a fee ($10-$20).See Appendix O

Research Compliance Program will reimburse the cost of the background check. Provide the Director of Research Compliance and Integrity with receipts for all those who have the background check done and to process a reimbursement. The original receipt is required for reimbursement.

Any questions, contact Sam (sflorio@scu.edu).  Also, please send Sam and Director of Research Compliance and Integrity (protocols@scu.edu) an email when the background checks have been completed so that Sam can review the results.

1. All application forms and reports, along with a record of the decision in each case, will maintain in Research Compliance Program files.  The records will be kept for at least three years after completion of projects, which is in compliance with the applicable federal law.
 
2. Records of applications are normally held in confidence, with the exception that the status of a faculty member’s application (e.g., filed/not filed, approved/not approved) may be ascertained by querying the Chair of the HSC.

1. In the case of externally funded research, the Sponsored Projects Office is charged with the responsibility for providing to the proper sponsoring agency the appropriate certification after the human subjects protocol has been approved by the HSC.

NOTE:  The Research Compliance Program maintains, and makes available upon request, current U.S. Department of Health & Human Services regulations, informational documents, and other relevant literature concerning ethical principles and human experimentation.