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Berea College

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Human Subjects are defined by federal law 45 CFR 46 as  “a living individual about whom an investigator (whether professional or student) conducting research:
<ul>
<li>Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or</li>
<li>Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”</li>
</ul>
The National Institute of Health has a great tool to help with decisions about whether research falls under “Human Subjects” research and thus needing IRB approval: <a href="https://grants.nih.gov/policy/humansubjects/hs-decision.htm">Am I Doing Human Subjects Research? Decision Tool</a>

What Constitutes Human Subjects Research and What Research Needs to Be Reviewed?

Protocols fall under 1 of 3 categories for review: full board; expedited; exempt.
To explore categories of research protocols prior to opening Mentor, the NIH has a range of <a href="https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html">decision charts</a>, which generally assess research.  Please be aware that individual projects may be more specific than these charts allow.  If more information is needed, please ask the IRB.

Determining Under What Category of Research A Study Falls

Informed consent is critical to the protection of human subjects. The federal regulations outline the elements of informed consent in section 116 of the Common Rule: <a href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.116">General Requirements for Informed Consent. </a>To view other frequently asked questions about informed consent, <a href="https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html">please refer to this page.</a>
Informed consent is the process of informing potential research participants about the key elements of the research study and what their participation will involve.  The informed consent process is one of the central components of the ethical conduct of research with human subjects.  The consent process should include providing a written consent document, which contains the required information (for example: elements of informed consent) and the presentation of that information to prospective participants.
This <a href="https://www.hhs.gov/ohrp/regulations-and-policy/guidance/checklists/index.html">checklist</a> provides the critical pieces necessary for a successful informed consent.
The IRB offers the following templates as guides to writing your consent forms.  Not all protocols require a consent form and some protocols may only need a very truncated consent form (see below).  We recommend using the templates here when full informed consent is required.  You may still write your own consent form, but be sure to cover all the elements outlined in the template.
Please note:  the IRB does not review the consent process for exempt protocols.  It is up to the investigator to decide if informed consent is appropriate or not.  In most cases, the exemption criteria anticipate that informed consent would not be appropriate.

Informed Consent

Under special circumstances the IRB may permit a modification of the requirements for informed consent or a complete waiver of informed consent.  The criteria for modification or waiver should be reviewed by the investigator.
The IRB may also waive the requirement for documentation of informed consent. The criteria for this waiver are spelled out in section 117(c) of the federal regulations: <a href="http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117">Documentation of Informed Consent</a>
Below, please find more detailed information on select situations that arise or may arise during the length of a protocol, such as annual reporting and adverse effects.  This is not a comprehensive list.

Waiver or Modification of Informed Consent

When research involves particularly sensitive information (e.g., drug use, genetic information, etc.) that is linked to subject identifiers, the IRB may require that the investigator secure a “<a href="https://grants.nih.gov/policy/humansubjects/coc/how-to-apply.htm">Certificate of Confidentiality</a>” from the NIH.

Certificates of Confidentiality

Any changes to existing protocols should first be reviewed by the IRB as they may impact the risk/benefit ratio of the protocol.  To submit an amendment, go to the “view protocol” page and click on the “Amendments” tab at the bottom to find the link to upload the amendment.  Include a summary of the changes.  If the changes require modification of the original consent form, include the updated consent form along with the summary. Use track changes to highlight the changes being made.

Amendments/Modifications

Exempt protocols are not required to file continuing reviews on an annual basis but all protocols approved by expedited or full board review procedures are required to submit a continuing review report or termination.  Mentor will automatically notify you of an impending report due date.  Just go to the view protocol page and scroll down to the set of tabs at the bottom.  The Annual Report tab is the first tab visible.  Click on the Context Menu and select “Edit” and complete the resulting form.

Annual Reports/Continuing Review

In the event that a human subject is harmed as a result of participation in your project, it is necessary that you immediately inform the IRB.  Go to the view protocol page and click on the Adverse Events tab.  There is a button there to upload a description of the event.  You should include in your summary your judgment of whether the harm to the subject was a result of their participation in the project or incidental to it.  You should also indicate if you think that the event warrants any changes to your protocol or consent form.  If so, you should then submit a protocol amendment.  It is best to talk with the IRB chair before submitting your amendment.

Institutional Review Board