312.02.04 Human Subjects Protection

A. Policy

The Georgia State University Institutional Review Board (IRB) is the official review board for a university projects that involve the use of humans as research subjects. It is the policy of the IRB to ensure protection of the rights and welfare of human subjects in research, in accordance with GSU 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:

1. sponsored by GSU;

2. conducted by employees or agents of GSU; or

3. conducted using the property, facilities, or non-public information of GSU.

This policy applies only to research with human subjects, defined as follows (45 CFR 46.102):

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

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

a. data through intervention or interaction, or

b. identifiable private information.

This policy applies to exempt categories of research (45 CFR 46.101) only to the extent of ensuring that 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 (45 CFR 46.111):

1. Are risks minimized?

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

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

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

5. Is consent appropriately documented?

6. 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?

B. Procedures for Researchers

1. Submitting proposals for initial review: Obtain an application packet from the Office of Sponsored Programs. The packet contains an application form, lists of exempt and expeditable categories of research, and a sample consent form. 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 (4) the consent form to be used. Submit this material to the Office of Research and Sponsored Programs, 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 meets on the third Thursday of each month, and applications requiring full review must be received by the Office of Sponsored Programs one week before the meeting.

2. 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 that 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.

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

4. Obtaining informed consent: Subjects must give their informed consent before participating. Subjects need to be aware of the following items of information, in order to 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, that 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)).

5. 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 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.

6. 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.

C. Administrative Procedures Within the IRB

1. Administrative channels: Exempt applications will be audited by an IRB member and the IRB Chair, to ensure that they fit within the letter and spirit of the declared exempt categories.

Expeditable applications will be reviewed by an IRB member and the IRB Chair. If time is a critical concern, 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 on the Friday before the regular IRB meeting scheduled for the third Thursday of each month. These applications will be reviewed and acted upon at the regular IRB meeting.

2. Notice of approval or disapproval: For exempt research, approval by the Department Chair is all that is needed to begin research. The IRB will audit all proposals declared exempt to confirm that they fit exempt categories. If the IRB agrees that a proposal is exempt, it will not notify the researcher. If the IRB determines that a proposal should not have been declared exempt, the researcher will be asked to cease research activities 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 their decision. The researcher will also be notified if modifications will be required to secure approval. If the IRB disapproves a proposal, they will include in the notification a statement of reasons for the decision and will give the researcher an opportunity to respond.

3. 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.

Members of the IRB who have any conflicting interest with an application under review shall not participate in the review of that application, except to provide information requested by the IRB.

4. 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 the authority to observe or have a third party observe the conduct of the research. The IRB shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has led to harm the subjects. Suspension or termination of approval shall be reported promptly to the investigator and to the appropriate institutional and Public Health Service officials.

D. IRB Files and Records

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

1. Written IRB procedures.

2. Minutes of IRB meetings.

3. 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.

4. 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 GSU.

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

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

(Source: Vice President for Research, August 5, 1996)