312.02.04 Human Subjects Protection

A. Policy

The Georgia State University Institutional Review Board (IRB) is the official review board for 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:

1. Research conducted by or under the direction of any employee or agent of Georgia State University in connection with his or her institutional responsibilities (regardless of the location of the project);

2. Research using any property or facility of Georgia State University;

3. Research involving the use of GSU's non-public information to identify or contact human research subjects or perspective subjects;

4. Research that satisfies a requirement imposed by the University for a degree program or for the completion of a course of study;

5. Is certified by a dean or department head to satisfy an obligation of a faculty appointment at the University, including clinical or adjunct appointments.

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.

In reviewing proposals under this policy, the IRB will consider the following (45 CFR 46.111):

1. Risks to subjects are minimized.

2. Risks to subjects are reasonable in relation to anticipatee benefits, if any , to subjects and the importance of the knowledge that may be expected as a result.

3. Selection of subjects is equitable.

4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative in accordance with and to the extent required by 45 CFR 46.116.

5. Informed consent will be appropriately documents in accordance with and to the extent required by 45 CFR 46.117.

6. When appropriate, the research plan makes adequate provisions 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 the data.

B. Procedures for Researchers

1. Submitting proposals for review.

a. All initial applications must be submitted electronically through the IRB's electronic submission program. More informaiton can be found at the IRB website at www.gsu.edu/irb.

b. Continuing research projects must be reviewed at least once a year. For continuing review the renewal application must be completed in the IRB's electronic submission program.

c. A study closure application must be submitted once the study and data analysis are complete. The study closure can be completed through the IRB's electronic submission program.

2. Informed consent.

a. 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):
i. 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:

ii. a description of reasonably foreweeable risks or discomforts;

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

iv. a disclosure of appropriate alternative procedures or treatments, if any, that might be advantageous to the subject;

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

vi. for research involving more thatn minimal reisk, 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;

vii. 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

viii. 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.

b. The IRB may waive or modify the above elements of informed consent (CFR 46.116(d)).

c. Subjects usually sign concent forms, but written consent is not always required. The IRB may waive the requirement of signed consent. Waiving the requirement for written consent does not waive the requirement for consent itself. If a consent form will not be used, the research must explain to the IRB how infomred consent will be obtained. The IRB may wiave the requirement for signed consent form if (CFR 46.117)):

i. signing the form itself would put a subject at risk; or

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

d. With children, parental permission 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.

(Source: Vice President for Research, October 24, 2006)