Consent (Section 2)

2.1 Office of Human Research Protections Resources

• FAQs: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html
• Informed Consent Guidance: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent/index.html

2.2 What is consent?

• Consent is the hallmark of human subjects research. It is an ongoing process of providing an individual with information about a study and is a real world application of the respect for persons principle in the Belmont Report. 
  • The riskier the study, the more intensive the process should be.
  • Provide the subject ample time to read and understand the form.
  • Discuss the form with the subject, don't simply ask them to read and sign it.  
  • The subject must be able to understand the consent form - if they don't, they can't participate. Use lay language and simple writing forms. 
  • Give the subject the opportunity to reaffirm consent and provide the subject with reminders about the procedures, risks, and voluntary nature of participation.   
  • Explain the difference between treatment and research.
  • Encourage the subject to ask questions. 
  • Provide the subject a copy of the consent form.
  • Answer the subject's questions.

2.3 What types of informed consent exist?

• Investigators can seek signed informed consent, a waiver of signed consent (online consent, verbal consent), and waive or alter elements of informed consent.Waiving elements essentially means you are waiving elements of the consent form or the accepted consent process. Only under certain circumstances may the IRB approve a request to waive signed consent or waive or alter the elements of informed consent. Requests must be made by the PI through the IRB application (Section 8) and supported by submitting Appendix M1 or M2. 

2.4 Are there any additional consent requirements when working with children?

• Yes. Generally, prior to consenting/assenting anyone under the age of 18 into a research project, investigators must seek the permission of the child’s parents/guardians through the use of a parental consent form. Assent is required of children age 12 years and younger in additional to parental permission. Assent is a child’s affirmative agreement to participate in research. Informed consent is required for children aged 13 to 18 and is required in additional to parental permissions. Please be aware that you must be in compliance with Kent State University  Policy 5-19, University Policy Regarding On-Campus Activities Involving Minors.

2.5 I am conducting a study in multiple languages. Do I need a consent form for each language?

• Yes.
• I have the English version ready, but do I need the foreign language form ready before I submit to the IRB?
  • In some cases it is acceptable for a delayed submission of a foreign language document. You have to have the foreign language form approved prior to recruiting those subjects; this can occur at initial approval or later on as an amendment. For example, if year one is English speakers only and year 2 is Spanish speakers, you don’t need the Spanish language form until year two. In this scenario the foreign language materials need to be submitted as an amendment prior to use. If foreign language speakers are recruited at the onset of the study both forms are necessary with the initial submission.
  • Our suggestion is to have all relevant language forms prepared at initial submission. If you're conducting grant or contract research that involves the enrollment of foreign language speakers, you will almost certainly need the foreign language documents upon initial submission. 

2.6 Screening, recruitment, and consent? 

• Study screening procedures are frequently confused with study recruitment. Recruitment includes all activities where information is provided to the prospective participant while screening includes obtaining information from prospective participants. Recruitment does not require the consent of the prospective subject whereas screening may.
  • Recruitment is the process of inviting prospective participants to participate by providing them with study information. 
  • Screening is the process of obtaining information from prospective participants to determine eligibility.
    • Only obtain the minimum information necessary should be obtained to determine eligibility.  
    • Screening may occur prior to consent. However, participant information is to be promptly destroyed unless individuals consent to retention.
    • The IRB may approve screening procedures without obtaining prior informed consent only if the solicited information is limited to the minimum necessary for determining eligibility AND if these procedures are limited to:
      • obtaining information through oral or written communication with the prospective subject or legally authorized representative, or
      • obtaining identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
        • Important note, if reviewing identifiable private information without consent, supplemental review processes, such as FERPA or HIPAA review, may be required. 

2.7 Passive  and Opt-Out Consent

• Though this phrase (also sometimes referred to as “implied consent”) is commonly used in research, the federal regulations do not reference this process. In reality, when the research participant or parent does not affirmatively indicate consent/permission, then consent/permission is not being obtained. It cannot be assumed that a failure to opt out equals consent to participate. Therefore, researchers seeking to use passive/implied consent/permission will need a waiver of informed consent/parental permission from the IRB.