I.
The authority under which the Institutional Review Board for Human Subjects
Research (IRB/HSR) at the California State University, Bakersfield (CSUB), is established and empowered to act is based upon the following two federal reports:
A. The Belmont Report: Ethical Principles and Guidelines for Research Involving
Human Subjects. Report of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research, April 18,1979.
[http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm]
B. The Code of Federal Regulations, Title 45, Public Welfare, Part 46, Protection of
Human Subjects (45 CRF 46), Office for Protection from Research Risks (OPRR),
National Institutes of Health (NIH), Department of Health and Human Services
(DHHS), Revised June 23, 2005. [http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm]
The primary purpose of the CSUB IRB/HSR is to ensure the protection of the rights and welfare of human subjects for research. In accord with The Belmont
Report, the general rule [regarding whether or not an activity requires review] is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects (page 3)
This protection of the rights and welfare of human subjects for research is founded on three (3) basic ethical principles, as specified in The Belmont Report:
A. Respect for persons. This principle incorporates two ethical convictions: (a) individuals should be treated as autonomous agents; and (b) persons with diminished autonomy are entitled to protection. The application of this principle requires the following:
1. Informed consent. Subjects, to the degree that they are capable, shall be given the opportunity to choose what shall or shall not happen to them (page 5).
The consent process shall contain three (3) elements:
•
Information. The extent and nature of information includes, as a minimum, the research procedure, their purposes, risks and anticipated benefits, alternative procedures
(where "therapy" is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research (page 5).
•
Comprehension. The manner and context in which information is conveyed i as important as the information itself
(page 6). The researcher has the obligation to adapt the presentation of information to the subject's capacities and to ascertain that the subject has comprehended the information.
• Voluntariness. This element requires conditions free of coercion and undue influence. Coercion occurs when an overt

threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance (page 6).
B. Beneficence. This principle obligates the researcher to make every effort to secure the well-being of the human subject. Two general rules have been formulated as complementary expressions of beneficent actions: (a) do no harm, and (b) maximize possible benefits and minimize possible harms.
The application of this principle involves a thorough assessment of risks and benefits by all parties to the research endeavor—the investigator, the review committee, and the subject. The term "risk" refers to a possibility that harm may occur, and it usually refers both to the chance (probability) of experiencing a harm and the severity (magnitude) of the envisioned harm. The term "benefit" ... refers to something of positive value related to health or welfare
[and] is not a term that expresses probabilities (page 7).
C.
Justice. This principle obligates the researcher to ensure that there are fair procedures and outcomes in the selection of research subjects. This principle applies to the selection of subjects at two levels: the individual and the social. Individual justice in the selection of subjects would require that researchers exhibit fairness: thus they should not offer potentially beneficial research only so some [persons] who are in their favor or select only "undesirable" persons for risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons, (page 7).
Specifically, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied
(page 5).
II. The authority of the CSUBIRB/HSR shall be:
A. To define what it will review, including research conducted by CSUB personnel at other instituti ons or res earch conduct ed at CSUB b y researchers not affiliated with the university.
B. In accord with 45 CRF 46:
1. To approve, modify, or disapprove protocols based upon
consideration of human subject protection aspects;
2.
To place restrictions on a study; and/or
3.
To suspend or terminate a study.
C. To require progress reports from investigators and oversee the conduct of the research study.
III. The relationship of the CSUBIRB/HSR to other units/agencies is as follows:
A. The CSUB IRB/HSR reports directly to the Provost and Vice President for Academic
Affairs and represents the university on all matters associated with the protection of human subjects for research.

B. The CSUB IRB/HSR is expected to work cooperatively and constructively, while carrying out its authority regarding the protection of human subjects for research, with the following persons:
1.
Research Investigator(s);
2.
Thesis chairperson or sponsoring faculty in the case of student projects;
3.
Department Chair and/or Center /Institute Director; and
4.
School/Unit Dean
C. When required, the CSUB IRB/HSR will consult, and work directly, with its counterparts at other institutions.
D. The CSUB IRB/HSR will be responsible for all compliance matters associated with the protection of human subjects for research that are specified by Federal and State regulatory agencies. Therefore, after consultation with the Provost and Vice President for Academic Affairs, the CSUB IRB/HSR is authorized to work directly with the appropriate
Federal and/or State regulatory agency.
IV. Membership of the CSUB IRB/HSR. Membership shall comply with the requirements specified in 45 CRF 46 .
A.
45 CRF 46 requires a minimum number of five (5) members to the IRB/HSR.
However, the CSUB IRB/HSR shall have nine (9) members of which three (3) shall be faculty members at CSUB whose primary concerns are in scientific areas, three (3) shall be faculty members at CSUB whose primary concerns are in nonscientific areas, and three
(3) shall be community members.
B. Membership shall represent a diversity:
1.
Gender
2.
Ethnic/Cultural Background
3.
At least one (1) member whose primary concerns are in scientific areas.
4.
At least one (1) member whose primary concerns are in nonscientific areas.
5.
At least one (1) member who is not otherwise affiliated with CSUB and is not part of the immediate family of a person affiliated with CSUB.
C. Qualifications for membership shall include:
1.
Professional competence necessary to review specific research activities
2.
Knowledge of standards of professional conduct and practice and reputation for professional compliance
3.
Knowledge of institutional commitments and regulations
4.
Knowledge of applicable law.
5.
Sensitivity to community attitudes
V. Management of the CSUB IRB/HSR
A. The Chairperson

1.
In consultation with the Executive Committee of the Academic Senate and the Assistant Vice President for Grants, Research, and Sponsored Programs , the Provost and Vice President for Academic Affairs shall select and appoint the
Chairperson of the CSUB IRB/HSR.
2.
The nominal length of service shall be three (3) academic years. By mutual agreement, the Chairperson may be appointed to additional three-year terms.
3.
The Chairperson may be removed from office by the Provost and Vice President for
Academic Affairs, after consultation with the Executive Committee of the
Academic Senate and the Assistant Vice President for Grants, Research, and
Sponsored Programs, if there are significant and/or repeated "failures" to comply with the policies and procedures outlined in this document by the IRB/HSR.
B. The Committee Members
1.
In consultation with the Executive Committee of the Academic Senate and the Assistant Vice President for Grants, Research, and Sponsored Programs , the Provost and Vice President for Academic Affairs shall select and appoint all the committee members of the CSUB IRB/HSR, in accord with the diversity principles specified above.
2.
The nominal length of service shall be three (3) academic years. By mutual agreement, committee members may be appointed to additional three-year terms.
3.
To insure continuity of "committee history," appointments for the first year shall be staggered, i.e., one -, two-, and three-year terms.
Thereafter, all terms shall be three (3) years. By mutual agreement, a committee member completing a one- or two-year term may be appointed to a full three-year term.
4.
All members are expected to attend all meetings convened by the
Chairperson. Repeated failure to attend meetings shall be grounds for removal from the committee.
5.
Any committee member may be removed from IRB/HSR service by the Provost and Vice President for Academic Affairs, after consultation with the Committee Chair, Executive Committee of the Academic Senate, and the Assistant Vice President for Grants, Research, and Sponsored
Programs, if there are significant and/or repeated "failures" to comply with the policies and procedures outlined in this document by the IRB/HSR.
C. Orientation and Continuing Education of Committee Members
1.
At the beginning of each academic year in the Fall Term, all new and continuing members of the CSUB IRB/HSR shall go through an orientation program regarding the authority, purpose, principles, policies, and procedures of the committee. The orientation shall include, as a minimum, a review of the video tapes developed by the
Office for Protection from Research Risks (OPRR), a discussion of the previous year's review of research proposals, and discussion of any significant developments impacting the consideration of research risks.
2.
At the beginning of the Winter and Spring Terms, there shall be a

specialized training session to cover one or more topics considered by the members of the CSUB IRB/HSR to be particularly significant and timely, especially topics dealing with a "vulnerable" category of subjects, e.g., children, prisoners, pregnant women, or handicapped/mentally disabled persons. In addition, to the degree that the budget will allow it, CSUB shall send at least one committee member to attend regional meetings on the protection of human subjects from research risks, several of which are sponsored annually by the Office for Protection from Research Risks (OPRR), National
Institute of Health (NIH), and the Food and Drug Administration
(FDA).
3.
The Assistant Vice President for Grants, Research, and Sponsored
Programs shall be responsible for coordinating the annual orientation program, the term training sessions, and any travel associated with continuing education for members of the CSUB IRB/HSR.
D. Use of Consultants. In accord with 45 CRF 46 , the CSUB IRB/HSR may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the committee. Such consultants may not vote with the IRB/HSR.
E. Support of the IRB/HSR. The Assistant Vice President for Grants, Research, and
Sponsored Programs shall be responsible for identifying, justifying the need for, and providing/acquiring needed resources to support the functions of the CSUB
IRB/HSR. These resources include, but are not limited to, s e c r e t a r i a l / a d m i n i s t r a t i v e s u p p o r t , c o m p u t e r a c c e s s , reproduction/ duplicating, filing space, and meeting area.
F. Conflict of Interest. No member of the CSUB IRB/HSR may participate in the initial or continuing review of any project in which the member has a conflicting interest, e.g., the member is the principal investigator, the project director or co-director, is the faculty sponsor, is a consultant or subcontractor.
VI. The Functions of the CSUB IRB/HSR
A. Conducting initial and continuing review of research involving human subjects. In accord with 45 CRF 46 , the following definitions apply:
1.
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (page 6).
2.
Human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (page 6). a. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment hat are performed for research purposes.
b. Private information includes information about behavior that occurs in a context in which an individual can reasonable expect that no observation or recording is taking place, and information which has been provided for

specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
B. Reporting findings and actions to the investigator and institution. In accord with 45 CRF 46 , the CSUB IRB/HSR shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB/HSR approval of the research activity. If the IRB/HSR decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
C. Determining which projects require review more often than annually. In accord with 45
CRF 46 , the CSUB IRB/HSR shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
D. Determining which projects need verification from sources other than the investigators that no material changes have occurred since previous CSUB IRB/HSR review.
E. Insuring prompt reporting to the CSUB IRB/HSR of proposed changes in research activities.
F. Insuring that changes in approved research are not initiated without CSUB IRB/HSR review and approval, except when necessary to eliminate apparent immediate hazards to the subject.
G. Insuring prompt reporting to the CSUB IRB/HSR, appropriate CSUB officials, and
Department or Agency heads of unanticipated problems or scientific misconduct involving risks to subjects or others.
H. Insuring prompt reporting to appropriate CSUB officials and Department or Agency heads of any serious or continuing noncompliance with the requirements specified by the CSUB
IRB/HSR or any suspension or termination of approval by the CSUB IRB/HSR.
VII. The Operations of the CSUB IRB/HSR
A. Scheduling of Meetings
1.
For the scheduling of orientation and continuing education meetings for committee members, see Section VII, Management of the CSUB
IRB/HSR, Subsection C, Orientation and Continuing Education of
Committee Members .
2.
Meetings dealing with the review process will be scheduled as deemed necessary by the Chairperson of the CSUB IRB/HSR, the Assistant Vice President for Grants,
Research, and Sponsored Programs, and/or the Provost and Vice President for
Academic Affairs.
B. Pre-Meeting Distributions to Committee Members. The Office of Grants, Research, and
Sponsored Programs, will be responsible for distributing all information and materials in a

timely manner before all scheduled meetings. This will include, but not be limited to, the following: (1) date, time, and place of the meeting, (2) meeting agenda, and (3) materials to be reviewed for the meeting.
C. The Review Process
1. All research protocols which are not specifically exempted in 45 CRF 46 shall be reviewed by the IRB/HSR.
2. The CSUB IRB/HSR shall review and have authority to approve, require modifications in, or disapprove all research protocols (45 CRF 46.109
). a. The CSUB IRB/HSR shall require that information given to subjects as part of the informed consent process is in accord with 45 CRF 46.116
. b. The CSUB IRB/HSR shall require documentation of informed consent in accord with 45 CRF 46.117
.
3.
The CSUB IRB/HSR shall notify the investigator(s) in writing of its decisions to approve or disapprove the research protocol, or of modifications required in the research protocol to secure approval.
If the CSUB IRB/HSR decides to disapprove a research protocol, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
4. The CSUB IRB/HSR shall conduct continuing review of research activities at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the informed consent process and the research activity.
5. The CSUB IRB/HSR shall have authority to suspend or terminate approval of research that is not being conducted in accordance with its requirements or that has become associated with unexpected serious harm to human subjects (45 CRF 46.113
).
Any suspension or termination of approval shall include a statement of the reasons for the action by the CSUB IRB/HSR and shall be reported promptly to the investigator(s), appropriate CSUB officials, and the Department or Agency head.
6. Standard Review Procedure a. Each member of the CSUB IRB/HSR shall have access to all research protocols and be apprised of all ongoing reviews. b. A subcommittee of three (3) members of the CSUB IRB/HSR shall be the
“primary reviewers” for each research protocol. Each subcommittee shall consist of one (1) member whose primary concerns are in scientific areas, one (1) member whose primary concerns are in nonscientific areas, and one (1) member representing the community-at-large. c. The subcommittee shall report to the CSUB IRB/HSR at a scheduled meeting and shall lead the discussion on the protocol.
7. Expedited Review Procedure (45 CRF 46.110
)

a. Research activities in the 10 categories listed on page 17 of 45 CRF 46 which involve no more than minimal risk to human subjects may be approved by the
CSUB IRB/HSR using expedited review procedures. b. Minor changes in previously approved research protocols during a period of one
(1) year or less may also receive continued approval from the CSUB IRB/HSR using expedited review procedures. c. The expedited review may be carried out by the chairperson of the CSUB
IRB/HSR or by one or more experienced members of the CSUB IRB/HSR designated by the chairperson. The reviewer(s) may exercise the full authority of the CSUB IRB/HSR except disapproval. d. No research protocol may be disapproved using the expedited review procedures.
A research protocol which is judged as “questionable” under expedited review shall be referred for standard review. e. Protocol has already gone through another IRB review (e.g. at a hospital, other campus, etc.).
D. Criteria for CSUB IRB/HSR Approval (45 CRF 46.111
)
1. Risks to human subjects will be minimized a. By using procedures which are consistent with sound research designs and which do not unnecessarily expose subjects to physical or emotional trauma, and b. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects will be reasonable in relation to anticipated benefits to subjects.
3. Selection of subjects will be equitable, in terms of the purposes of the research and the setting in which the research is being conducted.
4.
Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.
5. Informed consent will be appropriately documented.
6. As appropriate, the research plan will make provisions for monitoring the data collected to ensure safety of the subjects.
7. As appropriate, the plan will make provision for protecting the privacy of subjects and for maintaining the confidentiality of the data collected.
8. Additional safeguards will be implemented to protect the rights and welfare of subjects from vulnerable populations, such as
prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
E. Voting Requirements for Standard Review Procedure (45 CRF 46.108
)
1. A quorum shall be required for the CSUB IRB/HSR to take formal action at any

convened meeting. At least five (5) members, including at least one member whose primary concerns are in nonscientific areas, must be present for a quorum.
2. Approval or disapproval of a research protocol shall be based upon a majority of those members of the CSUB IRB/HSR present at the meeting.
3. Only members of the CSUB IRB/HSR in attendance of a convened meeting shall have full voting rights for the approval or disapproval of a research protocol, unless a member has a “conflict-of-interest” with a specific protocol.
4. No proxy votes from non attending members of the CSUB IRB/HSR shall be counted in the approval or disapproval of a research protocol.
5. Persons invited by the CSUB IRB/HSR for assistance or consultation or the investigator(s) for the research activity are prohibited from voting on any research protocol.
F. Review of Actions Taken by the CSUB IRB/HSR (45 CRF 46.112
)
1. Research protocols approved by the CSUB IRB/HSR may be subject to further review for approval or disapproval by the Provost and Vice President for Academic
Affairs, or his/her designee(s).
2. Research protocols NOT approved by the CSUB IRB/HSR may not be approved by the Provost and Vice President for Academic Affairs, or his/her designee(s).
G. Communications from the CSUB IRB/HSR
1. To the Investigator a. Requests for additional information regarding a research protocol needed to clarify the process being proposed to protect the rights and welfare of human subjects. b. Decision of the CSUB IRB/HSR regarding the approval or disapproval of a research protocol or modifications required to secure approval of a research protocol. c. Specification of any reporting requirements to the CSUB IRB/HSR, including changes to the approved protocol, progress of the research activity, and adverse reactions from subjects, potential subjects, and/or the public-at-large.
2. To the Provost and Vice President for Academic Affairs. Annual reports summarizing the activities of the CSUB IRB/HSR shall be submitted through the Office of the
Assistant Vice President for Grants, Research, and Sponsored Programs .
VIII. Record Requirements for the CSUB JRB/HSR (45 CRF 46.115
)
A. Listing of the members of the CSUB IRB/HSR identified by:
1. Name
2. Earned Degree(s)
3. Representative Capacity
4. Experience, such as board certifications, licerises,.etc.

5. Employment or other relationship between each member and CSUB.
B. Written procedures and guidelines by which the CSUB IRB/HSR will follow.
C. Copies of all research protocols reviewed, scientific evaluations, if any, that accompany the research protocol, approved consent documents, progress reports submitted by the investigator(s), and reports of injuries to subjects.
D. Minutes of all scheduled meetings, including:
1. Members in attendance,
2. Actions taken by the CSUB JRB/HSR,
3. Vote on the actions, including the number of members voting for, against, and abstaining,
4. Basis for requiring changes in or disapproving a research protocol, and
5. Summary of discussions of controverted issues and their resolution.
E. Copies of all correspondence between the CSUB IRB/HSR and the investigator(s).
F. Records of continuing review activities.
G. Adverse reaction reports, and CSUB IRB/HSR consideration of adverse reaction reports.
H. Statements of significant new findings developed during the course of research which may relate to the subject's willingness to continue participation in the research activity.
I. All records shall be retained for at least three (3) years, and records relating to research activities which are conducted shall be retained for at least three (3) years after completion of the research.
IX. What Information the Investigator Provides to the CSUBIRB/HSR for Review
A. See http://www.csub.edu/grasp/irbhsr for the specific details to be included in the research protocol that is forwarded by the investigator(s) for review by the CSUB IRB/HSR.
B. The Elements of Informed Consent
1. The requirements for informed consent are specified in 45 CRF 46.116
(see also http://www.csub.edu/grasp/irbhsr).
2. The CSUB IRB/HSR may approve a consent procedure which does not include, or which alters, some of the elements of informed consent set forth in 45
CRF 46.116 , or waive the requirements to obtain informed consent provided that the
CSUB IRB/HSR finds and documents the following conditions: a. The research involves no more than minimal risk to human subjects; b. The waiver or alteration will not adversely affect the rights and welfare of the subjects; c. The research could not practicably be carried out without the waiver or alteration; AND d. Whenever appropriate, the subjects will be provided with additional pertinent information after their participation.

C. The Documentation of Informed Consent (45 CRF 46.117
)
1. Primary Procedure a. A written consent document that embodies the elements of informed consent and has been approved by the CSUB
IRB/HSR shall be signed by the subject or the subject's legally authorized representative. b. A copy of the signed written consent document shall be offered to the person signing the form.
2. Alternative Procedure a. A short-form written consent document stating that the elements of informed consent have been presented orally to the subject or the subject’s legally authorized representative shall be signed by the person hearing the oral presentation. b. A written summary of what is specifically said to the subject or the subject’s legally authorized representative shall be approved by the CSUB IRB/HSR. c. When this alternative procedure using oral presentation is used, there shall also be a witness to the oral presentation. The witness shall sign both the short-form written consent document and the written summary. d. The person actually obtaining consent shall also sign the written summary. e. A copy of the signed short-form written consent document and a copy of the signed summary shall be given to the subject or the subject’s legally authorized representative.
3. In certain types of research where anonymity is a concern (e.g. AIDS research, etc.), the CSUB IRB/HSR may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either of the following: a. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; OR b. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

CSUB INSTITUTIONAL REVIEW BOARD FOR HUMAN SUBJECTS RESEARCH
(IRBIHSR)
Research Activities Exempted by 45 CRF 46.101
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: a. research on regular and special education instructional strategies, or b. research on effectiveness of, or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, UNLESS a. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and b. any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph 2 above, IF a. the human subjects are elected or appointed public officials or candidates for public office, or b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, IE 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.
5. Research and demonstration projects which are conducted by or subject to the approval of
Department or Agency heads, and which are designed to study, evaluate or otherwise examine: a. public benefit or service programs, b. procedures for obtaining benefits or services under those programs, c. possible changes in or alternatives to those programs or procedures, d. possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, IF a. wholesome foods without additives are consumed, or

b. 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.
CSUB INSTITUTIONAL REVIEW BOARD FOR HUMAN SUBJECTS RESEARCH
(IRB/HSR)
Research Activities Which May Be Reviewed Through Expedited Review Procedures Authorized in 45
CRF 46.110
1. Collection of hair and nail clippings, in a nondisfiguring manner; deciduous teeth; and permanent teeth I.E patient care indicates a need for extraction.
2. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
3. 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, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, echography, and electroretinography. It does NOT include exposure to electromagnetic radiation outside the visible range, e.g., x-rays and microwaves.
4. Collection of blood samples by 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 or older and who are in good health and not pregnant.
5. 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.
6. Voice recordings made for research purposes such as investigations of speech defects.
7. Moderate exercise by healthy volunteers.
8.
9.
The study of existing data documents, records, pathological specimens, or diagnostic specimens.
Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.
10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.