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SECTION 1200 - INSTITUTIONAL EFFECTIVENESS

 

1210    INSTITUTIONAL REVIEW BOARD (IRB) POLICY AND PROCEDURES

I. Policy

It is the policy of the Institutional Review Board (IRB) to ensure protection of the rights and welfare of human subjects in research, in accordance with Georgia Perimeter College rules and with federal regulations in Title 45, Code of Federal Regulations (CFR), Part 46, "Protection of Human Subjects." This policy applies to research that is:

a.         sponsored by Georgia Perimeter College;

b.         conducted by employees or agents of Georgia Perimeter College; or

c.         conducted using the property, facilities, or non-public information of Georgia Perimeter College

This policy applies only to research with human subjects, defined as follows (CFR 46.102):

a.         "research" is a systematic investigation designed to develop or contribute to generalizable knowledge; and

b.         "human subjects" are live individuals about whom the researcher obtains:

 

1.      data through intervention or interaction, or

2.      identifiable private information.

This policy applies to exempt categories of research (CFR 46.101) only to the extent of ensuring the research is truly exempt. The IRB will audit proposals declared exempt to ensure they fit exempt categories.  If the IRB agrees that a proposal is exempt, it normally will not comment on procedures for the protection of human subjects.

In reviewing proposals under this policy, the IRB will consider the following (CFR 46.111):

a.         Are risks minimized?

b.         Are risks reasonable, relative to the benefits and knowledge expected to occur?

c.         Are privacy of subjects and confidentiality of data protected adequately?

d.         Are subjects adequately informed about the research and their rights?

e.         Is consent appropriately documented?

f.          If subjects are potentially vulnerable (such as children, prisoners, pregnant women, mentally disabled persons, or the economically or educationally disadvantaged), have additional safeguards been taken to protect their rights and welfare?

II. Procedures for researchers

Submitting proposals for initial review: Obtain an application packet from the Office of Institutional Research and Planning (IRP) or download from the IRP website. The packet contains an application form; lists of exempt and expeditable categories of research, a sample consent form, summary sheet and IRB Policy and Procedures. Decide whether the proposal is exempt, expeditable, or requires full review. Submit three copies each of (1) the application form, (2) a one-page summary of the research proposal, (3) the proposal itself, in abbreviated form, and the consent form to be used. Submit these materials to the Grants and Sponsored Programs Office, signed by the researcher and the researcher’s Department Chair. Applications that are completed incorrectly or have insufficient information for review may be rejected. The IRB may be convened on an ad hoc basis; applications requiring full review must be received by IRP at least three (3) calendar weeks before a decision from the IRB is required by the applicant(s).

 

Submitting proposals for continuing review:

Continuing research projects must be reviewed at least once a year. For continuing review, submit three copies each of the following:

a.         a new application form (indicate the project was approved earlier and show the number originally assigned by the IRB);

b.         a one-page summary of activities, including (1) approximate number of subjects that have been studied, (2) any problems involving risks to subjects, withdrawal from participation, or complaints about the research; and (3) any new literature, findings or other relevant information about risks;

c.                     a copy of the current informed consent form; and

d.         any changes in the research procedure, samples, or instruments.

Abbreviated proposals:

In order to reduce paperwork, researchers should submit abbreviated proposals. It is only necessary to submit material dealing with treatment of human subjects, including survey instruments, and consent forms. Include background material only if it is centrally important in justifying the treatment of human subjects. Omit references, literature reviews, and other material not relevant to the treatment of human subjects.

Obtaining informed consent:

Subjects must give their informed consent before participating. Subjects should have the following items of information, so they can make informed decisions about participating (CFR 46.116):

 

a.         a statement that the study involves research, along with information explaining the purpose of the research, describing the procedure, identifying experimental procedures, and saying how long participation will last;

b.         a description of reasonably foreseeable risks or discomforts;

c.         a description of benefits that the subject or others might reasonably expect;

d.         a disclosure of appropriate alternative procedures or treatments, if any, which might be advantageous to the subject.

e.         a statement describing the extent to which confidentiality will be maintained;

f.          for research involving more than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs and, if so, what this consists of or where further information can be obtained.

g.         an explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject; and

h.         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 IRB may waive or modify the above elements of informed consent {CFR 46.116(d)}

Documenting informed consent:

Subjects usually sign consent forms, but written consent is not always required. The IRB may waive the requirement for a consent form if (CFR 46.117):

a.         Signing the consent form itself would put a subject at risk; or

 

b.         the research presents no more than minimal risk and involves no procedures for which written consent is normally required outside the research context.

 

Note that waiving the requirement for written consent does not waive the requirement for consent itself. If a consent form will not be used, the researcher must explain to the IRB how informed consent will be obtained.

Obtaining assent from children:

With children, consent must be obtained from a parent or parents, and assent must be obtained from the child.  "Children" are defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research. "Assent" is defined as an affirmative agreement to participate; mere failure to object is not enough. With older children, assent is usually written; with younger children, assent is usually oral.

III. Administrative procedures within the IRB

Administrative channels:

An IRB member, to ensure that they fit within the letter and spirit of the declared exempt categories, will audit exempt applications.

An IRB member and the IRB Chair will review expeditable applications.  If time is of the essence, or the research appears harmless or involves minor changes to a previously approved proposal, the Chair may review the application alone, in accordance with CFR 46.110.

Applications requiring full review will be sent to all IRB members at least one week before the scheduled IRB meeting. These applications will be reviewed and acted upon on an ad hoc basis, or at regularly scheduled IRB meetings, as warranted by volume of applications.

Notice of approval or disapproval:

For exempt research, approval by the Academic Dean is all the researcher needs to begin research. The IRB will audit all proposals declared exempt to confirm that they fit exempt categories.  If the IRB agrees a proposal is exempt, it will not notify the researcher. If the IRB determines that a proposal should not have been declared exempt, it will ask the researcher to stop until the proposal has been approved.

For research requiring expedited or full review, the IRB will send a notice of approval or disapproval to the researcher within a week of its decision. The researcher will also be notified if modifications will be required to secure approval. If the IRB disapproves a proposal, it will include in its notification a statement of reasons for its decision and will give the investigator an opportunity to respond.

IRB meetings:

A quorum of 4 members must be present for full review of proposals. A majority vote is needed for an application to be approved.

The IRB may invite individuals with special competence to help with the review of proposals. These individuals will not vote with the IRB.

Any member of the IRB who has a conflicting interest in an application under review shall not participate in the review of that application, except to provide information requested by the IRB.

Continuing review:

The IRB shall conduct continuing reviews 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 conduct of the research.

 

The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has led to harm to subjects – Suspension or termination of approval shall be reported promptly to the investigator and to appropriate institutional and OPPR officials.

IV. IRB Files and Records

The IRB shall maintain adequate documentation of IRB activities, including the following:

a.         Written IRB procedures.

b.         Minutes of IRB meetings.

c.         Copies of research proposals received, along with material accompanying the proposals, correspondence, progress reports, records of continuing review activities, and reports of injuries to subjects.

d.         A list of IRB members identified by name, earned degree, and representative capacity, sufficient to characterize the member's chief anticipated contribution to IRB deliberations, and employment relationship to Georgia Perimeter College.

Records of research proposals shall be retained for three years after completion of the research, and all records shall be open for inspection and for copying by authorized representatives of HHS at reasonable times and in a reasonable manner.

The IRB will arrange for annual review of its actions and procedures.

 

Approved by Institutional Effectiveness Policy Council  11/22/02

Approved by CAB 6/23/03