Feature Article

Consenting Subjects - Looking for Answers

Mary A. Banks, RN, BS, BSN
Director, Office of the Institutional Review Board, BUMC
Issue: January, 2006

Author has nothing to disclose with regards to commercial support.

Educational Objectives:

• Explain a potential risk when survey data is linked to individual subjects
• List the four criteria that a study must meet to be eligible for a waiver of informed consent
• Explain one criteria the IRB may use to grant a Waiver of Documentation of Consent
• State IRB requirements for persons to be allowed to consent subjects at BUMC

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• Introduction
• Required Elements of Consent
• Informed Consent for Survey Research
• Waiver of Informed Consent
• Waiver of Documentation of Informed Consent
• Consent From a Legally Authorized Representative
• Consent Forms From Other Institutions
• Research Staff Consenting Subjects
• Validation Dates on Consent Forms
• HIPAA Authorization Language in Consent Form
• Quiz

On a daily basis the IRB fields a wide variety of questions about research. Without a doubt the most frequently asked questions relate in some way to informed consent. While most investigators clearly understand the basic principles of obtaining informed consent, they often struggle with the details of the consent process. Therefore, we thought it would be useful to publish some of our most frequently asked questions and answers related to informed consent. Perhaps you will find yours among those listed here or perhaps one of these is something that you always wanted to know but were afraid to ask.

Question: An IRB Coordinator said something to me about the "required elements of consent". I hate to admit it but I don't know what the required elements are. How can I be sure I have included them in my ICF?

Answer. You can find a listing of all of the required elements of consent by going to the OHRP website OHRP informed consent checklist. The IRB has tried to help BUMC investigators ensure that all the required elements are included in their ICFs by programming these elements into the INSPIR consent template. For certain elements, the investigator must add details based on the study specifics (e.g., a description of the risks of the study); but for other elements the template language is hard-coded and cannot be modified by the investigator (e.g., compensation for research related injury). This language was purposefully hard-coded so that these required elements could not be unintentionally omitted or modified by the PI. Sometimes the hard-coded language is not applicable to the study. In such instances it can be removed or modified by the IRB staff. The investigator can request that this be done by attaching a document outlining the desired change, as well as a justification for that change, in Section S of the INSPIR.

Question: My study involves only telephone surveys. We are not performing any interventions, so there is no risk to subjects. Why is informed consent necessary?

Answer: Many survey studies do involve some risk to subjects. The level of risk depends on the questions being asked and whether the data is linked to individual subjects. Most often, the risk is the potential for harm due to loss of confidentiality. OHRP and FDA regulations require that, unless research is exempt, informed consent be obtained from each subject or his/her legally authorized representative (LAR). So, when you are doing non-exempt research involving surveys or questionnaires, you must obtain informed consent unless a Waiver of Informed Consent is granted by the IRB.

Question: Okay, but isn't it pretty obvious that I am going to need a waiver of consent for my telephone survey research? What do I need to do for the IRB to grant me this waiver?

Answer: Federal regulations allow for waiver of one or more (or all) of the elements of consent if approved by the IRB. But the IRB cannot approve a waiver of consent for FDA regulated research, except in emergency situations 21 CFR 50.24

For non-FDA regulated studies, the OHRP regulations 45.CFR 46.116 allow the IRB to waive the requirement for informed consent when the IRB determines that the research meets four criteria. These criteria, found in Section J4 of INSPIR, are:
1.) The study involves no more than minimal risk to subjects; 2.) The waiver or alteration will not adversely affect the rights and welfare of the subjects; 3.) The research could not practicably be carried out without the waiver or alteration; and 4.) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

In order for the IRB to approve a waiver of informed consent, investigators must complete ALL FOUR ITEMS in Section J4 of INSPIR and explain specifically how each of these criteria is met for this study. Of these four criteria, often the most difficult to meet is the “practicability standard” (criteria #3). In the case of your telephone survey, it would be unlikely that the IRB would determine that it is impracticable for you to obtain consent since you will be talking directly with subjects. So, in this case the IRB probably would NOT agree to waive all elements of consent.

Question: You're kidding! But I think that the study can not "practicably be carried out" if we have to wait for every subject to mail back his/her signed consent form. Is there anything I can do about this?

Answer: Yes. You can ask for a Waiver of Documentation of Consent. The IRB can waive the requirement for documentation of consent if it determines that the research represents no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context. You must still consent subjects (verbally) prior to doing the survey, but you would not have to obtain a signed consent form from the subjects. To obtain a Waiver of Documentation of Consent, you should:

1. Go to Section J3 of INSPIR and explain how one of the two criteria is met;
2. Go to Section Q and create a consent form that will be read to subjects over the telephone prior to the survey.
3. Do NOT select any signature lines for the consent form.

Question: The regulations require that I obtain consent from the subject or his/her legally authorized representatives (LAR). I could not find in the regulations any information about who can be the LAR. Can only a family member be the LAR?

Answer: Each institution sets its own guidelines in conformity with state laws for who can sign an ICF as a LAR and when. The BUMC IRB recently clarified its standards and created an algorithm to help investigators determine when consent by LAR can be approved and who can be the LAR. This issue was discussed in detail in the November 2005 CR Times Feature Article. The algorithm can also be found on the BUMC IRB website.

Question: I am the PI on a BUMC study and also the PI on the grant. I have co-investigators at the VA Hospital and at UMass. We plan to enroll subjects at each of these three locations. Do all of the subjects have to be consented using the BUMC consent form?

Answer: Under most circumstances the ICF from the institution where the subject is being consented will be used to obtain consent. So, in this situation, the study will probably be reviewed by the BUMC IRB, the VA IRB, and the UMass IRB. A consent form will be created at each institution using their letterhead and their institution-specific ICF wording. The BUMC IRB will be responsible for reviewing, approving and validating only the BUMC consent form. Occasionally the BUMC IRB asks to see the other ICFs (attached in Section S), but the BUMC IRB will NOT stamp other institutions’ consent forms.

Question: I am confused about who is allowed to obtain consent from subjects. Is it only the PI? Can it be any member of the research staff?

Answer: The most important issue here is that any person who is charged with obtaining consent must have the appropriate background, training and understanding of the research to appropriately present the research to subjects and answer their questions. He/she must also have an understanding of human subjects’ rights related to their participation in research.

BUMC has specific requirements for any person who will be consenting subjects. He/she must provide the IRB with documentation of training in human subjects protection. All persons who have provided this documentation are listed on the IRB website. Secondly, he/she must be listed as a co-investigator in Section A4 of INSPIR. Finally, in Section J2 of INSPIR, the PI must explain to the IRB precisely who will consent subjects. The IRB may require specific qualifications depending on the complexities and risks of the study.
Once a study has been approved no one else is allowed to consent subjects until an amendment outlining the changes in study personnel has been submitted and approved by the IRB.

Question: When my protocol was approved last July, the attached consent form had a validation stamp in the footer which said it was valid until July 2006. In November, the IRB approved an amendment that included a modification to the consent form. This consent form also says that it expires in July of 2006. Can you explain this? How I can keep track of which consent form I am supposed to be using?

Answer: First, you must always only use consent forms that have been approved by the IRB. Approved consent forms have a validation date and expiration date in the footer of each page of the consent. Consents that have not yet been fully approved do not have an “approved” footer and have a “NOT CURRENTLY APPROVED” watermark across each page.

When an amendment is submitted, the attached consent automatically contains the “NOT CURRENTLY APPROVED” watermark. Once the amendment is approved, the new version of the consent form becomes the “APPROVED” version. The previously approved version of the protocol is archived and the consent form attached to the archived version then gets the “NOT CURRENTLY APPROVED” watermark. Once it has the “NOT CURRENLTY APPROVED” watermark, it is obsolete and should not be used any longer.

The best way to ensure that you are using the correct version of the consent form at all times is to only print consent forms as you need them. If for some reason you must pre-print consent forms in batches, then each time a new amendment is approved you must print new consent forms and destroy all old printed consents because they are no longer valid.

Question: Someone just told me that BUMC is no longer using separate HIPAA authorization forms and the HIPAA authorization language has been added to the ICF. Is this true? How did I miss this?

Answer: It IS true! This change was announced in last month’s issue of the CR Times (December 2005) Feature Article. HIPAA language will be included in the ICF for new protocols created as of January 9, 2006. If HIPAA authorization is required, the investigator must:

a. Go to Section K2 of INSPIR and answer YES, HIPAA is required for this study.
b. Check the box next to HIPAA authorization language
c. Go to Section Q (consent form) and you will find the HIPAA authorization language in the last section of the consent
d. Modify the templated HIPAA language as appropriate. Only the details of the authorization wording should be modified as appropriate, not the main headings which are required core elements of HIPAA Authorization.
e. When the protocol and ICF are approved, the HIPAA authorization language is also approved. For more details go to the research HIPAA website at www.bumc.bu.edu/hipaa.

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