Common IRB Forms Explained

Case Reports

Conflict of Interest

  • In order to protect subjects from financial conflicts of interest *or perceived conflicts of interest,* the IRB requires that such potential conflicts be disclosed in the eProtocol application. If the IRB determines that a conflict exists that could influence the research or jeopardize the well-being of subjects, the IRB may require additional information about the conflict or may require that the conflict be resolved before the research is approved.
  • If you or any member of your immediate family (spouse, children, parent, in-laws, and siblings) has a financial interest in either a public or private company whose drug, procedure, technique, device, or software is used or tested in any study, you will need to disclose the conflict in your application.
  • If a COI becomes apparent within the course of your study, you must immediately disclose it to the IRB.

Waivers

  • In some limited situations, obtaining informed consent is not feasible. Be sure to check with the GME Research Staff if you think your circumstance may qualify. When you need a waiver, you will need to complete the Complete Waiver of Authorization or Alteration of the Authorization section of the eProtocol application.
  • You may request either if all five of the following criteria are met:
    1. The research involves no more than minimal risk to the subjects, AND
    2. The research could not practicably* be carried out without the waiver or
      alteration, AND

      *The commonly accepted definitions of the term “practicable” are (a) feasible; (b) capable of being effected, done or put into practice; and (c) that may be practiced or performed; capable of
      being done or accomplished with available means or resources. (Practicable means possible, it does not mean convenient.)
    3. The research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format, AND
    4. The waiver or alteration will not adversely affect the rights and welfare of the subjects, AND
    5. Whenever appropriate, subjects will be provided with additional pertinent information after participation.

Please note:

• If your research requires PHI, you must also complete the Waiver of HIPAA Authorization.
• If consent for your research will be obtained verbally, you must also complete the Waiver of Documentation (Signature) of Informed Consent.

• If you are conducting a case report and the patient is deceased, you will need to seek consent from the patient’s legally authorized representative.
 

  • You may obtain informed consent verbally if you explain all important aspects of the study and allow time for the potential participant to ask questions. After the explanation, you can provide the potential participant with written information about the study (by providing a written consent form or study information sheet), give them time to make a decision, and answer any follow-up questions. At this point, the participant can verbally agree to participate.
  • In some limited situations, it is not feasible to obtain documentation of informed consent for minimal risk research. Verbal consent would be preferable to written consent for online or mailed surveys, telephone interviews, or when anonymous sensitive information is collected to avoid written documentation that links the participant to the research study. In these situations, a Waiver of Documentation (Signature) of Informed Consent may be appropriate.
  • You may complete the Waiver of Documentation of Informed Consent if one of the following criteria is met:
    1. The only record linking the subject and the research would be the consent document, and the principal risk would be any harm from a breach of confidentiality (each subject would be asked whether they want documentation linking them with the research) OR
    2. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the consent OR
    3. The subjects or legally authorized representatives are members of a cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects, and an appropriate alternative mechanism for documenting that informed consent was obtained is available.
  • Please note, when completing the waiver of documentation of consent, you must request a Waiver or alteration of HIPAA Authorization.
  • Pro Tip: be sure to use plain and clear language when communicating with a potential participant during the recruitment and consenting process. This glossary offers a great resource to look up lay language for medical terms. 
  • The Waiver of Alteration of HIPAA Authorization is integrated into the eProtocol application process.
  • When completing the eProtocol application, recognize that in some limited situations, completing Waiver or Alteration of HIPAA Authorization may be appropriate. To apply, all three criteria below must be met:
    1. The use or disclosure of protected health information (PHI) involves not more than minimal risk to the privacy of individuals based on:
      • An adequate plan to protect the identifiers from improper use and disclosure;
      • An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law;
      • Adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research which the use or disclosure of PHI would be permitted by the Privacy Rule.
    2. The research could not be practicably conducted without the waiver or alteration, AND
    3. The research could not be practicably conducted without access to and use of the protected health information.

Please note, when applying for a waiver of documentation of consent, you must complete the waiver or alteration of HIPAA Authorization.

Consent & Assent

  • Complete the template (on the CMHS Institutional Review Board website on the intranet) to create a consent form for patients or authorized representatives when information protected under HIPAA will be used in research. If your study involves one of the 18 HIPAA identifiers known as Protected Health Information (PHI), you may need to obtain HIPAA authorization from each research participant. A helpful primer on HIPAA in Research can be found here and a more comprehensive resource can be found here. GME Research Staff can assist you with this process.
  • Use the template (on the CMHS Institutional Review Board website on the intranet) to create a consent form for patients or legally authorized representatives when you would like to use their data for a case report.
  • The IRB site also provides information on the process for obtaining “remote consent” and the original signature from the patient.
  • Please note that if the potential subject speaks a language other than English, you may need to see that study documents are translated. GME Research Staff can assist you with this process.
  • For studies with children, the eProtocol form will require the investigator to address the requirements outlined in The Code of Federal Regulations for additional protections for vulnerable populations.
  • Use the template (on the CMHS Institutional Review Board website on the intranet) to create an assent form, which is required when research participants are: a) over seven years old but under the age of consent specified in their state or b) an adult is incapable of giving informed consent. In California, individuals can generally consent to treatment at 18 with some exceptions (sensitive treatments, emancipation, self-sufficiency); IRB staff can guide you through these exceptions. In some cases the assent form is needed in addition to the guardian consent form. Because assent can be so nuanced, be sure to discuss your study with GME Research Staff.
  • This template may be helpful for you to: 1) explain the study to a child in developmentally-appropriate ways, 2) explain the voluntary nature of the study, and 3) offer the option to withdraw at any time for any reason. The child’s agreement to participate must be affirmative; a failure to object to participation is not enough. The Office for Human Protections offers a helpful FAQ on conducting research with children here.
  • At times assent may be appropriate for adults. GME Research Staff will help guide you in the appropriate use of assent.
  • Please note that if the potential subject speaks a language other than English, you may need to see that study documents are translated. GME Research Staff can assist you with this process.
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