Special Report: Streamlining IRB Process
IC information sheet can be used with IC waivers
Waiver used with Internet, some other studies
Informed consent discussions and recommendations are important and time-consuming. IRBs continually seek ways to improve the informed consent process while also finding better and more efficient ways of handling them. One way to streamline the IC process could be to make certain IRBs are not inundated with IC forms unnecessarily.
There are times when a waiver of documentation of informed consent is appropriate and in everyone's best interest. One example would be research that is conducted solely through a website, notes Catherine L. Higgins, PhD, manager of the IRB in the office of research compliance and biosafety, division of research, at Texas A&M University in College Station.
"If research is conducted solely online, researchers could have an informed consent information sheet as the first page of the online survey," Higgins says. "Then participants could stop at the end of reading it or they could stop in the survey at any point. If they finish the survey, we view that as their consent."
Texas A&M University uses an informed consent information sheet whenever the IRB determines that a waiver of documentation of informed consent is appropriate, she says.
The informed consent information sheet is three pages, written in a question-and-answer format. It has no place for a study participant's name and signature and is intended only to answer the participant's questions. The template highlights in yellow the words and phrases that could be personalized to a particular study. The sheet meets federal requirements of a consent. (See story on TAMU IC information sheet below.)
The informed consent information sheet is a useful tool in the case of studies that are sensitive and the IRB decides it would be better to have no names in study records. In these cases, the only link between the name of the study participants and the study is the consent document, so if the information sheet is used, no signatures and names will be recorded and stored, Higgins says.
"For Internet-based studies the information sheet generally is used because it doesn't make sense in most cases to have a signed informed consent form," she explains. "And there are some international studies where we might learn from a cultural evaluation that signing a consent document would be outside the acceptable cultural practices; then, we would use an information sheet."
In Texas, an open records law called the Texas Public Information Act gives the public access to government records with no exceptions for research. This posed a challenge in informed consent documents, so the IRB sought guidance from the university's general counsel to see what kind of language would be needed in IC documents and on the IC information sheet, Higgins says.
They decided on IC wording that reads: "Information about you and related to this study will be kept confidential to the extent permitted or required by law."
There have been no issues with the TPIA and the institution's research, Higgins says.
Investigators have responded positively to the information sheet, but some have asked to use it when it is not appropriate. The IRB is careful to watch for studies where the information sheet is proposed as a solution but full informed consent is necessary, she adds.
To obtain a waiver of informed consent, investigators must complete a two-page waiver of consent form that asks for protocol-specific explanations and justifications for these criteria:
- The research involves no more than minimal risk to the participants.
- The waiver or alteration will not adversely affect the rights and welfare of the participants.
- The research could not practicably be carried out without the waiver or alteration.
- Whenever appropriate, the participants will be provided with additional pertinent information after participation.
- And investigators seeking waiver of documented informed consent must provide protocol-specific reasons and justification on how at least one of these criteria is met:
- The only record linking the participant and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern, and/or
- That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research.
Texas A&M IC information sheet template
Sheet addresses purpose, privacy, etc.
The Texas A&M University human subjects protection program uses an informed consent information sheet whenever full documentation of informed consent is waived by the IRB. The information sheet template provides investigators with a simple way to ensure participants are knowledgeable about the research project. It uses bold-faced questions, with answers in regular font. Investigators can adjust the template with the study's information in the areas that are highlighted in yellow or capitalized.
Included in the information sheet's questions are these:
• Why is this study being done?
The purpose of this study is to .
• Why am I being asked to be in this study?
You are being asked to be in this study because [inclusion/exclusion criteria].
• What are the alternatives to being in this study?
If this is not a treatment study: The alternative to being in the study is to not participate. Another activity will be given if you choose not to participate.
For studies that give course credit: The alternative is to sign up for another study or to choose to complete another assignment as described in your syllabus.
If this is a treatment study: The following therapies for treatment of [condition] are available: [treatments]. You should talk to your personal doctor (or study doctor if appropriate) to discuss what would be right for you.
• What will I be asked to do in this study?
You will be asked to [describe task]. Your participation in this study will last up to [length in hours/weeks/months/years] and includes [number] visits.
• Are there any risks to me?
The things that you will be doing are no more/greater than risks that you would come across in everyday life. [Describe risks, including physical, criminal, social, financial, economic, psychological risk as well as risks associated with breach of privacy or confidentiality.]
Suggested wording if applicable: Although the researchers have tried to avoid risks, you may feel that some questions/procedures that are asked of you will be stressful or upsetting. You do not have to answer anything you do not want to. If applicable, add: Information about individuals who may be able to help you with these problems will be given to you.
• Will there be any costs to me?
Aside from your time, there are some/no costs for taking part in the study.
• Will information from this study be kept private?
[If applicable] The records of this study will be kept private. No identifiers linking you to this study will be included in any sort of report that might be published. Research records will be stored securely and only [insert names of individuals who will have access to this data] will have access to the records.
Information about you will be stored in locked file cabinet; computer files protected with a password.
Information about you will be kept confidential to the extent permitted or required by law. People who have access to your information include the Principal Investigator and research study personnel. Representatives of regulatory agencies such as the Office of Human Research Protections (OHRP) or [if FDA regulated] the Food and Drug Administration (FDA) and entities such as the Texas A&M University Human Subjects Protection Program may access your records to make sure the study is being run correctly and that information is collected properly.
[If applicable] The funding agency for this study, [insert sponsor name], and the institution(s) where study procedures are being performed [insert school, hospital, clinic, institution] may also see your information. However, any information that is sent to them will be coded with a number so that they cannot tell who you are. Representatives from these entities can see information that has your name on it if they come to the study site to view records. If there are any reports about this study, your name will not be in them.
Information about you and related to this study will be kept confidential to the extent permitted or required by law.