Institutional Review Board

What is the IRB?

The Institutional Review Board is a committee of peer faculty/researchers at AUM who are committed to quality research and trained in OHRP (Office of Human Subjects Protections) policy. They review proposals involving any aspect of the university’s involvement in human subject research. Their primary responsibility is protection of the research participant.

What does the IRB do?

It is the responsibility of the IRB to review research protocols involving human participants to ensure that the rights of the participants are protected, that they are not subject to unreasonable harm (physical and emotional), and that information about them is kept confidential.

What is AUM’s policy regarding the use of human participants in research?

All research involving human participants conducted by faculty, staff, or students of the Auburn University at Montgomery (AUM) must be reviewed and approved by the AUM Institutional Review Board (IRB). The IRB operates according to the guidelines in the Code of Federal Regulations (45CFR46) and other state and institutional guidelines.

What is research?

Research means a systematic investigation, including pilot research, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy.

What is a human participant/subject?

Human participant means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or through identifiable private information.

How do I know if I should submit a research protocol to the IRB?

If your research project (including observation, interviews and surveys) involves human participants, you must submit an IRB Protocol Review request.

When should I submit my protocol review request to the IRB?

You may submit your request at any time, but you must receive IRB approval before you begin recruiting participants or collecting data.

What do I submit? What is informed consent?

You will submit a completed Protocol Review Request and all required attachments. Informed consent is generally obtained through a document that fully discloses the nature of the research, explains the risks (both physical and psychological) and benefits and allows the individual to voluntarily decide whether to participate in the research study or not.

To whom do I submit my request?

IRB review requests should be submitted in hard copy to Debbie Tomblin, Research Compliance Manager at the Office of Sponsored Programs (Rm 114 Administration Bldg., AUM) 334.244-3250 dtomblin@aum.edu

or

Institutional Review Board
c/o Office of Sponsored Programs
P.O. Box 244023
Montgomery, AL 36124-4023

What happens after I submit my IRB Review Request?

Protocols are accepted and processed on a continual basis. When a protocol request is submitted, it will be assigned to a subcommittee of the IRB for initial review. The initial review may take 5 to 10 working days to process. The subcommittee will take one of four decisions:

1)   Determine the research project is exempt from further review.

2)   Recommend the research project for a full board review.

3)   Approve as “expedited”.

4)   Return to the researcher with a memo listing revisions and clarifications.

Regardless of the decision, you will receive a memo (email) notifying you of the decision and giving you further instructions.

Feel free to contact the IRB Administrator at 244-3250 or dtomblin@aum.edu to inquire of your project’s status.

What is the best way to prepare my IRB Review request?

You should work closely with your faculty advisor well in advance of beginning the actual research. It will be important for you to apply what you learned in the CITI online training course when you complete your IRB proposal.

You should submit an IRB request that includes the appropriate request form, an informed consent form or survey cover letter, training certifications for all researchers involved, and any tests, surveys, or interview questions you will be using in your study, approval from other institutions (if appropriate). Always carefully proof your entire document for typos and errors before submitting.

Do the human research regulations apply to non-U.S. institutions?

Yes, whenever non-U.S. institutions are engaged in non-exempt HHS-supported or -conducted human subjects research, the regulations apply.

Please see: http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html#sectionb.

What is the historical basis for the current human research regulations 45CFR part 46?

The history of contemporary human subjects protections began in 1947 with the Nuremberg Code developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis. The Code captures many of what are now taken to be the basic principles governing the ethical conduct of research involving human subjects.

Similar recommendations were made by the World Medical Association in its Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects first adopted in 1964 and subsequently revised many times.

Basic regulations governing the protection of human subjects in research supported or conducted by HHS (then the Department of Health, Education and Welfare) were first published in 1974. In the United States, a series of highly publicized abuses in research led to the enactment of the 1974 National Research Act (Public Law 93-348), which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the National Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines to assure that such research is conducted in accordance with those principles. In 1978, the Commission published “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as the Belmont Report, named after the Belmont Conference Center where the Commission met when drafting the report. The Belmont Report identifies three fundamental ethical principles for all human subjects research -- respect for persons, beneficence, and justice.

Based on the Belmont Report and other work of the National Commission, HHS revised and expanded its regulations for the protection of human subjects in the late 1970s and early 1980s. The HHS regulations are codified at 45 CFR part 46, subparts A through D. The statutory authority for the HHS regulations derives from 5 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 289.

The regulations found at 45 CFR part 46 are based in large part on the Belmont Report and were written to offer basic protections to human subjects involved in both biomedical and behavioral research conducted or supported by HHS. In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.” In 1995 the Central Intelligence Agency was required by Executive Order to comply with all subparts of the HHS regulations.

What ethical principles guide the protection of human subjects?

Three basic principles of ethics set forth in The Belmont Report are particularly relevant to

The protection of human subjects in biomedical and behavioral research:

(a) Respect for persons: recognition of the personal dignity and autonomy of persons

and the need for special protection for persons with diminished autonomy, such as

Children or prisoners;

(b) Beneficence: obligation to protect persons from harm by maximizing anticipated

benefits and minimizing possible risks;

(c) Justice: fairness in distribution of the benefits and burdens of research.

These ethical principles are embodied in 45 CFR 46, which mandates institutional research

review and approval mechanisms designed to promote the protection of human research

What is Informed Consent?

Informed consent is a process in which the researcher provides sufficient information, in an understandable format, to the research subjects so that they can make a voluntary decision whether or not to participate in the study. The informed consent process is fundamental in ensuring respect for persons and should serve to educate the subject about the research, the benefits and risks, and the voluntary nature of their participation. The informed consent should be in language understandable by the study subjects. The informed consent should also be revised when deficiencies are discovered or when additional information will improve the process. The regulations under section 28 CFR §46.116 describe the elements or information that must be contained in the informed consent provided to the study subjects.

What should be included in Informed Consent (document)?

1)   A statement that the study involves research.

2)   The name(s) of the funding agency(ies).

3)   An explanation of the purposes of the research.

4)   The expected duration of the subject's participation.

5)   A description of the procedures to be followed and what the subjects will be required to do in the study.

6)   Identification of any procedures which are experimental.

7)   A description of any reasonably foreseeable risks or discomforts to the subject. Risks are not limited to physical injury, but also include psychological, social, financial, legal, and others.

8)   A description of any benefits to the subject or to others that may reasonably be expected from the research; there may be none other than a sense of helping the public at large when balanced by the appropriate level of risk.

9)   A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. In most NIJ studies the alternative will be to not participate in the study.

10)               A statement describing the extent to which confidentiality of records identifying the subject will be maintained. For studies sponsored by NIJ the subject should be informed that private, identifiable information will be kept confidential and will only be used for research and statistical purposes. If, due to sample size or some unique feature, the identity of the individual cannot be maintained, the subjects need to be explicitly notified. If the investigator intends to disclose any information, the subject needs to be explicitly informed what information would be disclosed, under what circumstances, and to whom. The subject must be informed of any potential risks which may result from this disclosure and must explicitly provide prior written consent.

11)               For research involving more than minimal risk [1], 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.

12)               An explanation of whom to contact for answers to questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. This should include name and telephone number or other appropriate methods.

13)               A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

How should Informed Consent be documented?

As a general rule, informed consent should be documented by the use of a written consent form approved by the IRB, and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

An IRB may waive the requirements to obtain a signed consent form as described in section 46.117(c) if it determines:

1.       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

2.       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. In cases in which the written consent documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research and obtain their oral consent to participate.

If I want to do research at a local school, what is the procedure for consent?

 You must obtain the consent of the following individuals:

 ■The Administrator of the school district where the research is to be performed (on letterhead).

 ■The Principal of the school where the research is to be performed (on letterhead).

 ■The Teacher(s)

 ■The Parent(s)/legal guardian(s) – “Informed Consent” – written at a 8th grade reading level

 ■The child – “Assent” – written to the child’s level of understanding

What if I merely want to observe children in a classroom setting?

You must still get parental “Informed Consent” and each child’s “Assent.” For any child who does not obtain parental consent, that child may not be included in the research even if that child assents to participate in the research.

What if I want to have a “focus group” for my research?

 Each person in the focus group must sign an informed consent form that has information that states confidentiality may not be guaranteed once the group disbands.

How long must I store my research data?

Storage of the signed consent forms for three (3) years past completion of the study is required. If you will no longer be at AUM you must work with your advisor or Dept Head to determine where the data will be stored and when it will be destroyed. Signed consent form must be stored at AUM. Transcripts and aggregate data can be maintained indefinitely as long as there is no identifying information.

How long does my IRB approval last?

IRB approval is for a 12-month period from time of original approval.

What is an “adverse event”?

An adverse event is any unanticipated problem involving risk that ultimately results in harm to the subject and is related to a research intervention requires reporting to the Research Compliance Manager/IRB Administrator.

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 What if I have an “adverse event” occur during my data collection?

Adverse events must be reported immediately to the Compliance office/IRB Administrator.

What do I need to do if I need to modify my project?

You must complete a “Request for Continuation or Change” for modifications on approved research involving human subjects.

What if my project is oral history rather than traditional research? Do still have to get IRB approval?

The IRB has determined that studies involving the use of oral histories will be reviewed and determination made on a case-by-case basis, as to whether the research meets the definition of research specified in the federal regulations.

What is the age of majority in Alabama?

19 years old.

Age 18 and under, parental informed consent must be obtained (in addition to the child’s assent or informed consent).

What is the difference in public and private information?

For the purposes of determining whether research involves human subjects, the following definition of "private information" must be used:  "Private information includes information about behavior that occurs in a context in which an individual can reasonably 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."