Institutional Review Board

Central Virginia Community College has adapted the ethical principles for protection of human subjects as stated in the Code of Federal Regulations, 45CFR46. Created by the National Research Act in 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established to enact these regulations. The Commission published The Belmont Report which set forth the following basic ethical principles for the conduct of research involving human subjects:

• Respect for Persons. Acknowledgement of the autonomy of the individual and the responsibility to provide special protection for individuals with reduced autonomy.
• Beneficence. A responsibility to do no harm, to maximize possible benefits, and to minimize possible harm.
• Justice. An expectation of fairness in distribution of benefits realized from research as well as its burdens.

APPLICATION

As stated in the Federal Code of Regulations, 45CFR46, it is the charge of the IRB to ensure that in the conduct of research:

• Risks are minimized and reasonable in relation to anticipated benefits
• Subjects give informed consent
• Rights and welfare of the subjects are maintained

To ensure that adequate safeguards are provided, Central Virginia Community College will follow the principles listed below which apply to all research and student projects involving human subjects:

• Subjects’ legal rights will be respected; their rights to privacy, dignity, and comfort will also be considered in approving proposed research.
• Risks to subjects must be reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.

The purpose of the Central Virginia Community College Institutional Review Board is to ensure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research studies conducted by or with Central Virginia Community College employees or students or on Central Virginia Community College campuses.

The IRB does not assume the role of evaluating the soundness of the proposed research study, the merits of the research design, nor the potential contribution of the research to the scholarly literature. The IRB is charged with evaluating each project’s compliance with ethical standards in regard to issues such as informed consent, confidentiality, and any risk to the participants.

REGULATIONS

1. Federal Register 56 (June 18, 1991): 28002∼28032 [Federal Policy for the Protection of Human Subjects; Notices and Rules] (The Common Rule)
2. Title 45 Part 46 of the Code of Federal Regulations
   1. Codification of the Federal Policy for each of the departments and agencies adopting it is as follows:
      1. CFR Part 1c [Department of Agriculture]
      2. 10 CFR Part 745 [Department of Energy]
      3. 14 CFR Part 1230 [National Aeronautics and Space Administration]
      4. 15 CFR Part 27 [Department of Commerce]
      5. 16 CFR Part 1028 [Consumer Product Safety Commission]
      6. 22 CFR Part 225 [International Development Cooperation Agency] [Agency for International Development]
      7. 24 CFR Part 60 [Department of Housing and Urban Development]
      8. 28 CFR Part 46 [Department of Justice]
      9. 32 CFR Part 219 [Department of Defense]
      10. 34 CFR Part 97 [Department of Education]
      11. 38 CFR Part 16 [Department of Veterans Affairs]
      12. 40 CFR Part 26 [Environmental Protection Agency]
      13. 45 CFR Part 46 [Department of Health and Human Services]
      14. 45 CFR Part 690 [National Science Foundation]
      15. 49 CFR Part 11 [Department of Transportation]
   2. FDA regulations pertaining to research with human subjects are codified at:
      1. 21 CFR Part 50 [Protection of Human Subjects]
      2. 21 CFR Part 56 [Institutional Review Boards]
   3. The Code of Virginia:
      1. 32.1∼162.16 Definitions
      2. 32.1∼162.17 Exemptions
      3. 32.1∼162.18 Informed consent
      4. 32.1∼162.19 Human research review committees
      5. 32.1∼162.20 Applicability of Federal policies

1. The IRB is composed of five full-time employees with varying backgrounds and expertise to comprehend the nature of the research, as well as other competencies necessary to interpret regulations, relevant law, ethical standards, and standards of professional practice.
2. The IRB functions administratively through the Office of Institutional Effectiveness.
3. The IRB Chair is the Dean of Institutional Effectiveness.
4. The IRB Vice Chair is a voting member of the IRB and presides over all convened meetings in the absence of the Chair. The Vice Chair is the Director of Grants Development. The Vice Chair has authority to sign all IRB action items in the absence of the Chair.
5. Members will be invited to join the IRB by the Dean of Institutional Effectiveness for tenure of at least two years. The term of appointment may be terminated by notice of the Committee member to the Chair or by notice from the Chair. If a member is unable to attend meetings for an extended period, the Chair must be informed so that a replacement can be appointed. Tenure may be extended by recommendation of the IRB Chair and agreement by the member.
6. The IRB will include both men and women, at least one member whose primary concerns are in science areas, one whose primary concerns are nonscientific areas, and one at large member.
7. No person will be excluded from serving on the IRB based on sex, race, color, or national origin.
8. No IRB member may participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
9. The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues requiring expertise beyond or in addition to that available on the IRB.
10. A majority of the members must participate in each board action.
11. IRB members do not receive compensation for their service.

EDUCATION AND TRAINING

1. All IRB members are required to undergo formal training at the time of their initial appointment. At a minimum, two group training activities and the National Institutes of Health Human Participant Protections Education for Research Teams online course are required.
   Approved training includes:
   1. The National Institutes of Health Human Participant Protections Education for Research Teams
   2. Office for Human Research Protections (OHRP) Human Research Protection Training
   3. Approved trainings hosted by CVCC or other IRB Institutions.
   4. Other educational materials:
      1. IRB Guidebook and videos/webinars, "Protecting Human Subjects" (Guidebook); Videos and Webinars
   5. Other educational opportunities:
      1. Research Community Forum (RCF’s): http://www.hhs.gov/ohrp/education/conferences/index.html
      2. Conferences: http://www.hhs.gov/ohrp/education/conferences/index.html
2. The IRB Chair will maintain a log of training completion dates.
3. Continuing education of IRB members is accomplished through participation in regional IRB training, review of various online tutorials, and through Central Virginia Community College-­provided IRB training activities.
4. IRB members must complete the Documentation of Training in Human Subject Protection and Documentation of Education on the Protection of Human Subjects forms once every three years (see Appendix 3).

The CVCC IRB is accountable to the U.S. Department of Health and Human Services Office of Human Research Protections for the oversight of all human subject research to ensure the ethical treatment of all human subjects.

The CVCC IRB must review and approve any funded or non-funded research related to human subjects whether or not it is funded internally or externally by private or government funds if the research is

1. sponsored by CVCC;
2. performed by or involves CVCC faculty, staff and/or students regardless of where the study is performed; or
3. conducted using College-owned facilities or equipment.

§46.112 REVIEW BY INSTITUTION

Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.

REPORTING REQUIREMENTS

The institution or, when appropriate, the IRB must prepare and maintain adequate documentation of IRB activities [Federal Policy §.115]. In addition to the written IRB procedures and membership lists required by the assurance process [Federal Policy §.103], such documentation must include copies of all research proposals reviewed, minutes of IRB meetings, records of continuing review activities, copies of all correspondence between the IRB and investigators, and statements of significant new findings provided to subjects (as required by Federal Policy §.116(b)(5)).

REQUIRED ASSURANCES

Research activities involving human subjects may not be conducted or supported by the departments and agencies adopting the Common Rule (56FR28003, June 18, 1991) unless the activities are exempt from or approved in accordance with the Common Rule. See section 101(b) of the Common Rule for exemptions. Institutions submitting applications or proposals for support must submit certification of appropriate IRB review and approval to the department or agency in accordance with the Common Rule.

The Health and Human Safety (HHS) Office of Human Research Protections IRB Guidebook requires that IRBs:

1. Consider the qualifications and professional development of the Principal Investigator and relate them to the degree of protocol complexity and risk to human subjects.
2. Consider requiring that less experienced research investigators be sponsored by seasoned researchers.
3. Consider directing that proposals requiring skills beyond those held by the Principal Investigator be modified to meet the investigator’s skills, have additional qualified personnel added, or be disapproved.
4. Instruct investigators to prepare protocols, with complete descriptions of the proposed research. The research plan must include provisions for the adequate protection of the rights and welfare of prospective subjects and ensure that pertinent laws and regulations are observed. Samples of informed consent must be included with protocols. Investigators are responsible for obtaining informed consent and ensuring that no human subject will be involved in the research before consent is obtained.
5. Ensure that the research plan addresses quality assurance standards set by the institution as well as applicable external standards.
6. Ensure that appropriate reviews for scientific merit be conducted before the research is approved.
7. Ensure that mechanisms be in place for monitoring the progress of the research.

For non-­exempt research, the IRB must:

1. Review the proposal at a convened meeting
2. Evaluate the procedures:
   1. How are subjects recruited?
   2. Are subjects equitably selected?
   3. What are the risks and are they minimized?
   4. Do the benefits outweigh the risks?
3. Evaluate the consent process:
   1. Will subjects be fully informed of procedures and risks?
   2. Is consent written in appropriate understandable language?
   3. Is the subject’s voluntary consent and withdrawal explained fully?
   4. How is informed consent obtained?
4. Evaluate the Informed Consent Form (see Appendix 2, page 42).

TYPES OF IRB REVIEW

Applications will be treated as exempt or non-­exempt. Non-­exempt protocols can be either expedited or Full Board Review. The Principal Investigator or Project Director do not make the determination as to whether a project is exempt or non-­exempt.

1. Exempt Review
   1. A research protocol can be submitted for an exempt review if the Chair deems the project qualified.
   2. If the Chair anticipates that there will be no or few questions about a proposal and that the proposal is appropriate for consideration for exemption, he/she may call for an exempt review.
   3. The IRB Chair will distribute the application materials electronically, via mail, or by fax for each member to review and convene the board.
   4. If a majority of members approve the exempt status, the research is approved as exempt.
   5. If a majority of members have doubts of the project’s qualification as exempt, the Chair may call for full board review of the proposal.
   6. The term “exempt” refers to the requirement for continuing IRB review, but not the general requirements for informed consent and protection of subjects. Thus, even if the project is exempt, the PI must inform potential subjects of the proposed procedures and of their rights as subjects.
   7. Exempted approvals expire one year after board review. The PI must seek review annually for projects that last longer than a year. Additionally, the PI must ensure that progress reports and/or review applications are submitted more frequently if mandated by the IRB.

EXEMPTIONS

Under Federal regulations, certain types of research are exempt from Federal policy unless the appropriate Federal agency heads have determined otherwise [45 CFR 46.101].

Exempt types of research include:

1. 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.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

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) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the Investigator or Project Director 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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

These exemptions do NOT apply when (a) deception of subjects may be an element of the research; (b) subjects are under the age of eighteen; (c) the activity may expose the subject to discomfort or harassment beyond levels encountered in daily life; or (d) fetuses, pregnant women, human in vitro fertilization, children, individuals who are mentally impaired, or individuals involuntarily confined or detained in penal institutions are subjects of the activity.

1. Expedited Review
   1. A research protocol may be considered for expedited review:
      1. if the research has been reviewed and approved by another IRB;
      2. it is a continuation review of research previously approved by the convened IRB as follows:
         1. where
            1. the research is permanently closed to the enrollment of new subjects;
            2. all subjects have completed all research-­related interventions, or
            3. the research remains active only for long-­term follow-­up of subjects, or
         2. where no subjects have been enrolled and no additional risks have been identified; or
         3. where the remaining research activities are limited to data analysis.
   2. An expedited review will be conducted by two board members selected by the Chair. Both reviewers must approve the proposal.
   3. In an expedited review, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-­expedited procedure set forth in 46.108(b).
2. Full Board Review
   1. Protocols that involve more than minimal risk must go to Full Board Review.
   2. All proposed human subject research that does not meet the criteria for exemption or an expedited review must be reviewed by a majority of the IRB members at a convened meeting referred to as a Full Board Review.
   3. Prior to the review meeting, the Full Board Review application is previewed by the Chair or designee to determine if further documentation is needed.
   4. Once all materials are collected, the application is submitted to the full board for review requiring a majority of members to review proposal.
   5. A majority of board members reviewing the proposal must agree on the board’s determination.

REQUIREMENTS

In order to approve research covered by this policy, the IRB shall determine that all of the following requirements are satisfied:

1. Risks to subjects are minimized (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits the subjects would receive even if not participating in the research). The IRB should not consider possible long-­range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibilities.
3. Selection of subjects is equitable. In making this assessment the IRB should consider the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
4. Informed consent is sought from each prospective subject or the subject's legally authorized representative in accordance with and to the extent required by §46.116.
5. Informed consent is documented in accordance with and to the extent required by §46.116.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

1. For any project involved with live human subjects/participants, it is the responsibility of the Principal Investigator (PI) to apply to the CVCC Institutional Review Board for Human Subject Research Determination.
2. Should it be determined that a project meets the Office for Human Research Protections (OHRP) definition of Human Subject Research, no activity with the subjects may begin until IRB approval has been issued.
3. Prior to submission for IRB review, the PI must complete IRB training to include, at a minimum, one Central Virginia Community College IRB Human Subject Protection Orientation and the National Institutes of Health Human Research Participants online course. The online course must be taken each year of the project.
4. The PI must ensure that all researchers working with the subjects and the project director of a human subject research project complete the CVCC IRB Human Subject Protection Orientation. It is at the discretion of the PI as to what other training may be required.
5. No contact with human subjects may be conducted until the PI’s IRB training is complete and the Documentation of Training in Human Subject Protection form has been submitted to the Office of Grants Development (see appendix 3).
6. If it is determined that the study is human subject research, the PI must submit the appropriate applications to the IRB two (2) months prior to the anticipated start date of the project. No contact with human subjects may begin prior to IRB approval.
7. All application materials must be submitted no later than one (1) week prior to the regularly scheduled IRB review meeting to be considered at that meeting.
8. It is the PI’s responsibility to submit the application for IRB continuation review at least two (2) months before the expiration of the existing IRB approval. The IRB can refuse to accept late applications for renewal or continuation.
9. All work on the project must stop on the IRB approval expiration date unless continuation has been formally approved.
10. Records of all PI and researchers’ IRB training must be maintained in the Office of Institutional Effectiveness.
11. The PI must maintain records of all human subject research projects for a minimum of three (3) years after completion of the project.

1. The PI completes and submits electronically the Human Subject Research Determination form and proposal to research@centralvirginia.edu.
   1. These are distributed to the Office of Grants Development and the IRB Chair or their designees.
   2. If it is determined that the project is human subject research, the PI must submit a Documentation of Training in Human Subject Protection form (see Appendix 3) with the certification of completion of the National Institutes of Health course Participant Protections Education for Research Teams. This certification must accompany all IRB applications for review.
2. If the proposal is determined a human subject research project, the PI completes the appropriate IRB review application form:
   1. Application for Exempt Review
   2. Application for Expedited or Continuation Review c. Application for Full Board Revie
3. The PI gathers all required documentation as per the application checklist.
4. The PI electronically submits the application packet to the IRB email address.
5. IRB reviews will be scheduled. Deadline for submission of application and materials is one (1) week prior to the scheduled IRB review.
6. The application packets are sent to the IRB Chair for review and distribution.
7. The IRB takes action within one month of application submission.
8. THE IRB MUST APPROVE THE RESEARCH PROJECT BEFORE THE RESEARCHER MAKES ANY CONTACT WITH THE SUBJECTS.
9. Approval is for a maximum of one year from the date of the IRB meeting considering the application.
10. If any work or data analysis is to continue after the approval expiration date, the PI must submit an application for board review two months prior to the expiration date.
11. A project that requires a Full Board Review for the original application must apply for a Full Board Review for continuation unless it meets the criteria for expedited review.
12. Upon completion of the project, the PI should submit to the IRB the Close Out Report form (see Appendix 3). No approval is required by the IRB.
    CHECKLIST (SEE FORMS):
    1. PI certifications of human subject protection training
    2. Completed and signed application for review
    3. Research plan/proposal
    4. Samples of informed consent/assent forms
    5. Outline of information to be provided prior to subjects’ agreement to participate
    6. Instruments, surveys, questionnaires, etc. g Curriculum vitae

INFORMED CONSENT DEFINITION

Informed consent is a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights or release or appear to release the investigator, the sponsor, the institution, or agents thereof from liability for negligence [Federal Policy §116; 21 CFR 50.20 and 50.25].

IRB CONSIDERATIONS

Investigators may seek consent only under circumstances that provide the prospective subject or his/her representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. Furthermore, the information must be written in language that is understandable to the subject or representative. The consent process may not involve the use of exculpatory language through which the subject or representative is made to waive or appear to waive any of the subject's legal rights or releases or appears to release the investigator, sponsor, institution, or agents from liability for negligence [Federal Policy §116].

FEDERAL REGULATIONS

Federal regulations require that certain information must be provided to each subject: [Federal Policy §116(a)]

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any reasonably foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject or to others which may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights and whom to contact in the event of a research-­‐related injury to the subject.
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

The regulations further provide that the following additional information be provided to subjects, where appropriate: [Federal Policy §116(b)]

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
3. Any additional costs to the subject that may result from participation in the research.
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
6. The approximate number of subjects involved in the study.

As per CFR §46.117 (c), the IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it determines either of the following:

1. 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.
2. 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. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Adverse events are events or circumstances that were unintended and unanticipated at the time the project was approved by the IRB. Any illness, injury, or trauma that requires medical or psychological treatment must be reported to the IRB, to the funding agency, and in the Progress Report (see Appendix 3). Even adverse events that are not related to the project must be reported.

UNANTICIPATED EVENT REQUIRING REPORTING

Is the adverse event an unanticipated problem and therefore must be reported?

1. Is the adverse event unexpected?
2. Is the adverse event related or possibly related to participation in the research?
3. Does the adverse event suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized?

If the answer to all three questions is yes, then the adverse event is an unanticipated problem and must be reported to appropriate entities under the Health and Human Safety (HHS) regulations. 45 CFR 46.103 (a) and 46.1203(b)(5)

SERIOUS ADVERSE EVENT

Any event resulting in death, a life threatening situation, inpatient hospitalization, significant disability, or birth defect must be reported to the IRB within five (5) days of the PI’s knowledge of the event. A physician’s comment is required and must be included with the report.

UNEXPECTED ADVERSE EVENT

Any adverse event not listed in the current consent form must be reported within five (5) days.

NEITHER SERIOUS NOR UNEXPECTED ADVERSE EVENT

Any adverse event which is neither serious nor unexpected must be reported to the IRB within one (1) month.