Process of informed consent

• the location or setting for providing information or obtaining consent. Investigators should describe the location or setting as completely as possible. For example, the location might be a private examination room in a county health department clinic. Or the location might be a public beach or other public place, like a health fair. Or the location might involve a combination of one location where information is provided, and then another location where consent is obtained. For example, investigators might provide some information at a mobile HIV testing clinic, and then obtain consent later in a private room in a county health department clinic.
• who would provide consent or permission. Investigators should explain whether the participant will provide consent, or whether the person providing informed consent is the participant’s legally authorized representative, such as a parent or guardian or other individual.
• whether there would be a waiting period between providing information and obtaining consent. In greater than minimal risk studies, particularly complex studies where the procedures may be difficult to understand or where participants might want to consult with their families or their physician, then a waiting period might be appropriate. A waiting period can provide the investigator an opportunity to review information provided and to re-assess participant understanding.
• the steps taken to minimize coercion or undue influence. The IRB needs to assess the experience of investigators in working with populations (such as prisoners or cognitively impaired individuals) who may be vulnerable to coercion or undue influence. Examples include, but are not limited to steps like
  • requiring participants to discuss the consent document with their physician and whoever else they may turn to for advice, like family members or close friends
  • involving participant advocates
  • for studies involving prisoners, making sure that individuals such as prison guards are not present for the consent process
  • making sure that participants understand that no services or treatments or benefits would be withheld if they do not participate in research.
• the languages used by individual obtaining consent. List the languages (English, Spanish, Creole etc) in which the individual obtaining consent is fluent. The IRB needs to asses the languages used by those obtaining consent, to determine whether as part of the process of consent, those individuals would be capable of answering questions about the research. For example, in an immigrant population with little or no English, the investigator or member of the research team would need to demonstrate competence in the language of the participant population.
• the languages understood by participants or legally authorized representatives. List languages (English, Spanish, Creole etc) that participants can read or speak, and languages the legally authorized representative can read or speak. For example, children participating in research might be fluent in both English and Spanish, but their parents or legally authorized representatives may only be fluent in Spanish, so the researcher would need to make sure a member of the study team is fluent in Spanish
• the information to be communicated to the participant or legally authorized representative. Explain the information that will be provided to participants. (Investigators may reference an attached document in the Documents section of the application--not in the “Upload Consent Documents section). The IRB must have sufficient understanding of the information provided to participants to know whether the information includes exculpatory language (where the investigator releases, or appears to release the institution from liability or claims of negligence)

Waiver or alteration of the consent process

In certain situations the IRB may waive or alter the consent process in accordance with federal regulations. The research must not be subject to FDA regulations, because FDA does not permit any waiver of the consent process.

• When the DOH IRB waives the requirement to obtain informed consent, it waives the entire requirement for consent--both the attributes of consent (described in the first
  paragraph of 45 CFR §46.116 and 21 CFR §50.20) and the elements of disclosure (described in 45 CFR §46.116(a)-(b) and 21 CFR §50.20.)
• When an IRB alters the consent process, consent is still obtained, but the consent does not follow regulatory requirements.
• In both cases the IRB must determine that all regulatory criteria authorizing a waiver or alteration are met, and must document its rationale.
• Waiver or alteration of the consent process is different from waiver of the requirement to document the consent process (see help on documenting the consent process).

• Element II.7.A: The Research Review Unit evaluates compliance with policies and procedures on seeking informed consent from participants or their legally authorized representatives, and assent, when possible, from participants who cannot give consent.
• Element II.7.B: The Research Review Unit has and follows written policies and procedures requiring that prospective participants whose decision-making capacity is in question be appropriately protected
• Element II.7.C: The Research Review Unit reviews the content of the consent process, including the consent document, and the process through which informed consent is obtained from each participant, focusing on measures to improve participant understanding and voluntary decision-making
• Element III.1.F: The Investigator develops an informed consent process and method of documentation appropriate to the type of research and the study population, emphasizing the importance of participant comprehension and voluntary participation.

• Chapter 3: Basic IRB Review
• Evaluation Instrument for Accreditation, Association for Accreditation of Human Research Protection Program