The experiences with the Institutional Review Board (IRB) at the University of Georgia have been exceptionally positive and helpful as we focus our research in the areas of addiction and psychiatric pharmacy. First, it is easy to be overwhelmed by the daunting challenge of keeping up with the information required for submission to your IRB. Before applying to the IRB, it is necessary to understand what information will be expected and why it is important. The IRB's expectation is that you will provide a detailed explanation of your proposed study such that they will understand and see for themselves what the participants will be exposed to during the course of the study. Furthermore, the IRB will want to see that you have completed a risk assessment for the study, and that you have minimized the possible risks to the participants. This article will serve as an introduction to the basics necessary for a successful IRB application.

The IRB is a research oversight committee charged with ensuring that research involving human subjects is conducted in compliance with the applicable federal, state, and institutional policies and procedures. The members of the IRB are responsible for protecting the rights and welfare of ALL human research subjects. The three areas for protecting human research subjects include respect for persons, beneficence, and justice. These principles are now accepted as the quintessential requirements for the ethical conduct of research involving human subjects. The IRB is not meant to discourage research in any way but rather, to ensure that research is conducted responsibly. All proposed research that involves intervention or interaction with human subjects, the collection of identifiable private data on living individuals, and/or data analysis of identifiable private information on living individuals, requires review and approval by the IRB prior to the initiation of the research.

While preparing to submit an application to the IRB for approval, there are a couple of key points to keep in mind. First of all, ensure that all researchers participating in the study have completed the appropriate level of training. The principal investigator and all personnel engaged in the conduct of research with human subjects are required to complete the training. Each institution may have a different type of IRB training requirement, but all training should be completed prior to submission to the IRB. Proof of completion of training may be required and should be maintained throughout the research study.

After ensuring that all researchers have completed the appropriate level of training, it is important to consider all the components necessary for a complete IRB application. These include but are not limited to:

  • Purpose of research

  • Source of subjects

  • Research procedures, including the text of any survey or interview questions that will be asked of participants

  • Recruitment and eligibility of participants

  • Potential risks and benefits to the research subjects and the community

  • Procedures used to protect the anonymity of subjects

  • Procedures to follow in case of an emergency

  • Forms to be used to obtain consent from research subjects

A detailed description of your research, including your hypotheses, methods or procedures to be used, a description of the population you will be studying, and a description of the steps you will take to minimize risk to participants and to ensure confidentiality will be expected in your application to the IRB. No researcher may involve humans as subjects in research unless the researcher has obtained the informed consent from the subject or from the subject's Legally Authorized Representative (LAR).

Documentation of informed consent is required in all cases, unless the IRB has approved a waiver of consent. A consent form is used to provide information to prospective subjects, which enables persons to voluntarily decide whether to participate as research subjects. Information provided to the subject or representative must be written in simple language, so all aspects of the research (e.g., purpose, risks, benefits) are clearly stated. The researcher must provide the participant with two copies of the consent document to be signed. One signed copy is kept by the participant and the other by the investigator. The IRB has the authority to waive the federal requirements for informed consent in the following instances: (1) research in which the only involvement of human subjects is that of anonymous observation, for example, observational studies of public behavior when obtaining consent would not be practicable and (2) research that is conducted in established educational settings, involving normal educational practices. The applicant may also ask the IRB to waive the requirements for the investigator to obtain a signed consent form for some or all subjects, if it finds either: (1) the only record linking the subject with the research would be the consent document, and the principal risk would be the potential harm resulting from a breach of confidentiality (e.g., an interview or survey that addressed the participant's HIV status). Each subject will be asked whether he or she wants documentation linking him or her with the research, and that 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. If consent forms will not be used, the researcher must explain in the application to the IRB how informed consent will be obtained.

The following points must be provided within an informed consent form in order for it to be considered complete:

  • The purpose of the research

  • The procedures and amount of time required of the participant

  • The discomforts or stresses that may be faced during the research

  • The possible risks to the participant if they participate in the study

  • How the results of the study will be used and if the results will be anonymous or confidential

  • Disclaimer for internet research if applicable

  • Inclusion criteria for participation

Internet Research

Internet data collection via email, LISTSERVs, electronic bulletin boards and web surveys falls under the charge of the Institutional Review Board. For internet research, consider the following:

  • Determine if your study is confidential or anonymous: An anonymous survey is one in which information obtained is recorded in such a manner that human subjects CANNOT be identified directly or through identifiers linked to study participants. In other words, your data is being submitted by unidentifiable sources. Information obtained in confidentialsurveys is recorded in such a manner that researchers CAN identify human subjects directly or through identifiers linked to participants.

  • Design your survey to collect desired type of data: Anonymous: Do not collect participant Internet Protocol (IP) addresses. IP addresses are unique identifiers that some, although not all, electronic devices use to identify and communicate with each other. Ensure that you have disabled this feature when designing your online survey instrument. By designing your survey to block the collection of identifiable data, you are ensuring identities are not compromised in your research. On your consent letter, inform your participants that the online survey program is not collecting identifiable information about them.

  • Confidential: Explain the steps that will be taken to protect the information that will be collected. On your consent form or letter, give complete details about how confidentiality will be maintained, or if necessary, how the information may be disclosed.

Internet consent document should be written like a cover letter and should include all the elements of the regular signed consent, including the confidentiality disclaimer stating “There is a limit to the confidentiality that can be guaranteed due to the technology itself.” The consent document should also include a statement that says “By completing the survey you are agreeing to participate in the research.” The survey instrument should be formatted in a way that will allow participants to skip questions if they wish to or to provide a response like “I choose not to answer.” At the end of the survey, there should be two options for submission of the survey: one to allow participants to discard the data and the other to submit it for inclusion in the study.

Researchers encountering a problem or event that is both unanticipated and indicates that the research places subjects or others at a greater risk of physical, psychological, economic, or social harm than was previously known or recognized, must promptly report such problems or events to the IRB.

  • 1.

    Do I need an IRB to do my research?

    IRB submission is required for all research projects using "human subjects" as defined by the Federal Policy for the Protection of Human Rights 45 CFR 46, the Food and Drug Administration (FDA) regulations 21 CFR 50, 56, and with the Federal wide Assurance granted by the Office of Human Research Protections (OHRP).

  • 2.

    What is research?

    Federal Definitions (from 45 CFR 46): Research is a systematic investigation, including research development, hypothesis testing, and evaluation, designed to develop or contribute to general knowledge.

    The activity is research when the intent is to extend the information gathered beyond the individual or if the intent is to analyze the data to contribute to the knowledge and theory, or to make generalizations.

  • 3.

    What is a human subject?

    A human subject is a living individual about whom an investigator (whether professional, patient or student) conducting research obtains:

    • Primary Data: Data through intervention or interaction with the individual

    • Secondary Data: Previously identifiable private information

  • 4.

    What are the types of IRB Review?

    • Full Board Review: The application will be considered by either the Biomedical (if an intervention is involved) or Social and Behavioral committee. Each committee meets once per month (at most) – so this process takes time! Studies going to Full Board will be those that:

    • Focus on vulnerable population groups (children/prisoners)

    • Include invasive sample collection

    • Pose greater than minimal risk to participants

    • Expedited Review: The application will be passed to a single Designated Reviewer, who then makes a recommendation to the Chair. Studies undergoing Expedited review will be those that:

    • Secondary data that contains identifiers

    • Primary data collection from adults

    • Exempt Review: IRB can determine that an application is exempt from review

  • 5.

    What about pilot studies?

    If a pilot study requires primary or secondary data from human subjects, it requires an IRB.

  • 6.

    Can data collection begin prior to IRB approval?

    The answer is NO! A researcher may design data collection instruments (surveys, questionnaires, etc.) but CANNOT start collecting data using those instruments until they receive IRB approval. If the data is collected prior to IRB approval, the data may NOT be used for any research/publication purposes.

  • 7.

    Does behavioral health research (addiction and psychiatry pharmacy) require an IRB?

    Yes, all research with human subjects that collects primary or secondary data will require an IRB.

  • 8.

    Who is the principal investigator?

    The principal investigator is any individual who is engaged in conducting human subjects research studies. Such engagement would include: obtaining information about living individuals by intervening or interacting with them for research purposes; obtaining identifiable private information about living individuals for research purposes; obtaining the voluntary informed consent of individuals to be subjects in research; and studying, interpreting, or analyzing identifiable private information or data for research purposes.

  • 9.

    What are the training requirements of the principal investigator to submit an IRB?

    According to HHS Regulation 45 CFR 46.101, the principal investigator and all personnel engaged in the conduct of research with human subjects are required to complete the training for all new applications, continuing reviews, or addition of new research personnel on approved studies, regardless of funding status. The training is under the supervision of the Collaborative Institutional Training Initiative (CITI) and is called the CITI Human Subjects Protection Training.

  • 10.

    If I am a student pharmacist or pharmacy resident, do I need to be trained by CITI?

    Yes, everyone who participates in the human subjects research is required to be CITI trained.

Submitting an IRB proposal can be a long and cumbersome process; however, it is important to remember that this process helps ensure the validity of our work as well as ensuring the protection of the human subjects that participate in our research. While in pursuit of IRB approval, always keep in mind that risks to research subjects posed by participation in research should be justified by the anticipated benefits to the subjects or society. This requirement is clearly stated in all codes of research ethics, and is central to IRB approval. Another point to keep in mind during this process is that more than one IRB submission may be required before the application is approved successfully.

Do not allow a resubmission to discourage you, but rather, consider it a challenge to improve your work and further examine whether you adequately communicated all of the components of your study. Remember to use simple, clear language in your study description and avoid using jargon or complex wording on consent forms for the participants. Lastly, always proofread very carefully prior to submission to ensure accuracy and consistency throughout your application. These techniques will ensure a successful IRB submission and will produce human subject research that may have an impact on the practice of psychiatry pharmacy.

1.
Institutional Review Board.
University of Maryland
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Web. 14 March 2012
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2.
The Office of the Vice President for Research.
University of Georgia
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Web. 14 March 2012
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3.
What You Can Do to Facilitate Efficient IRB Review.
Columbia University
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Web. 14 March 2012
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