Human Research Protection Program

IRB Frequently Asked Questions

1. My department chair says that my project qualifies as exempt. Do I still need to submit paperwork to the Human Subjects Protection Program?
   
2. Does our FWA state that all studies (not just federally funded studies) will be conducted according to the code of federal regulations ?
3. My sponsor has said that IRBs are now required to register with the FDA. Has the MCW/FH IRB registered yet with the FDA?
4. What’s the difference between “informed consent” and “HIPAA authorization” for a research study with human subjects?
   
5. Why should I apply to the IRB for both a “waiver of the informed consent process” and “waiver of HIPAA authorization” if I am doing a clinical study of patients and will be using an IRB-approved consent form to enroll subjects?
6. Doesn’t the HIPAA “preparatory to research” provision allow investigators to use medical records to identify potential research subjects without requiring a “waiver of the informed consent process” and “waiver of HIPAA authorization?”
7. Can I save the names and phone numbers of persons who call in response to study recruitment ads, or people who have been screened for a study, so I can offer them a chance to participate in future studies? What if the callers and persons screened tell me they are interested in hearing about future studies?

IRB Frequently asked Questions

1. My department chair says that my project qualifies as exempt. Do I still need to submit paperwork to the Human Subjects Protection Program?
   Yes, your protocol must be submitted through eBridge. A determination of "exempt" does not mean that it does not need IRB review, but that it is exempt from the requirements of 45 CFR 46. The “exempt” determination must be made by the IRB.
    
2. Does our FWA state that all studies (not just federally funded studies) will be conducted according to the code of federal regulations ?
   “FWA” means “Federalwide Assurance,” a promise that the US Department of Health and Human Services (DHHS) requires every institution receiving federal research support to sign. In their FWAs, MCW and Froedtert demonstrate their awareness of the federal regulations, and they promise to follow the regulations. It’s an honor system.
   
   All FWAs also ask the institution: “Do you intend to apply the federal research regulations to 100% of the research you do -- not just to the federally-funded research?”
   
   Both MCW and Froedtert have answered “Yes” to this question in their FWAs. For this reason, DHHS can enforce the federal research regulations for all studies under the jurisdiction of MCW and Froedtert.
   
   Why would any institution volunteer for this extra burden? MCW and Froedtert believe that the ethical principles underlying the regulations should be applied to all studies; the regulations are a reasonable application of those principles. MCW and Froedtert also believe there should be a single standard for research under their jurisdiction, and not different standards for different subjects (depending on who is underwriting the study).
   
   MCW and Froedtert do review this decision periodically, looking for other meaningful and efficient ways to achieve consistency and protect all human subjects.
    
3. My sponsor has said that IRBs are now required to register with the FDA. Has the MCW/FH IRB registered yet with the FDA?
   The FDA does now require that IRBs are registered and the MCW/FH IRB has complied with that requirement. If your sponsor is requesting IRB numbers or an FWA number, these can be found on the IRB website under the Regulations, Guidance, and FWA tab. You or the sponsor can also check the OHRP database for information on the MCW/FH IRB.
    
4. What’s the difference between “informed consent” and “HIPAA authorization” for a research study with human subjects?
   These two overlap in concept in the regulations and in practice; this is why the difference between “consent” and “HIPAA authorization” is confusing for investigators.
   
   Informed Consent
   The definition of "human subjects research” includes any use of "identifiable private information" (DHHS regulation language). So peeking into a patient's medical record to determine whether he/she might be eligible for a study or  clinical trial qualifies as a “human subjects research” activity. As a human subjects research activity, peeking into a medical record requires prior informed and documented consent (by default) unless the IRB has determined that a "waiver of the informed consent process" is appropriate and approved that waiver.
   
   This is puzzling and annoying for clinical investigators, who don’t have to seek consent for comparable clinical activities. A physician is free to use his/her own patients’ charts for research screening purposes, or for deciding which patients to approach about a study. But this right applies only to the physician and other clinicians personally caring for that patient. Other physicians and employees do not have the same right -- even though they may belong to the same practice group, same Division, or same Department as a physician who personally cares for the patient.
   
   HIPAA authorization
   HIPAA regulations use the phrase "protected health information" to refer to the medical chart and all other related health information about a patient. “Protected health information” is a subset of a person’s “identifiable private information,” as defined by DHHS regulations.
   
   For treatment purposes, anyone within a Covered Entity (e.g., MCW or Froedtert Hospital) is allowed to access a patient record. For research or clinical trial purposes, the same is not true. Peeking into a patient's medical record to determine whether he/she might be eligible for a clinical trial requires documentation that the patient gave prior HIPAA authorization (by default), unless the IRB determined that a “waiver of HIPAA authorization” is appropriate and approved that waiver.
    
5. Why should I apply to the IRB for both a “waiver of the informed consent process” and “waiver of HIPAA authorization” if I am doing a clinical study of patients and will be using an IRB-approved consent form to enroll subjects?
   No one except the physician or nurse providing treatment for the individual patient has the right to screen the medical record for study eligibility. When any other persons will be screening charts to identify study candidates, or to abstract clinical information, it is necessary to apply for the two waivers.
   
   The regulatory criteria for the two types of “waivers” are different. Thus investigators who propose peeking into a patient's medical record to determine whether he/she might be eligible for a clinical trial should routinely ask for both kinds of waivers. While the two waivers may refer to the same activity (peeking), they are associated with different regulatory requirements
   
   If the IRB blurs the distinction (procedurally or in our minutes), we lay the MCW IRB open to the charge of "not following the regulations" or "not understanding the difference."
    
6. Doesn’t the HIPAA “preparatory to research” provision allow investigators to use medical records to identify potential research subjects without requiring a “waiver of the informed consent process” and “waiver of HIPAA authorization?”
   IRBs at some other institutions invoke the HIPAA “preparatory to research” provision [45 CFR 164.512(i)(1)(ii)] so that researchers can use medical records to identify potential study or clinical subjects without requiring the two described IRB waiver actions.
   
   MCW/Froedtert Hospital IRB policy takes a different position. The IRB’s perspective is that:
   - Documented informed consent (or waiver thereof) is always necessary for researchers who plan to use medical records to identify potential subjects;
   - HIPAA authorization (or waiver thereof) is required whenever a researcher might remove any protected health information from the covered entity, and whenever a person who is not part of the covered entity might contact prospective subjects; and
   - The “preparatory to research” provision will only be invoked to help a researcher determine whether there are enough potential subjects to propose a study.
   
   Therefore investigators who propose using a patient's medical record to determine whether he/she might be eligible for a study clinical trial should routinely ask for both kinds of waivers.
    
7. Can I save the names and phone numbers of persons who call in response to study recruitment ads, or people who have been screened for a study, so I can offer them a chance to participate in future studies? What if the callers and persons screened tell me they are interested in hearing about future studies?
   Whether the investigator saves a broad diagnosis (e.g., “arthritis”) or more detailed medical information (e.g., medical history, laboratory reports) with the contact information, databases created to help identify potential subjects for future subjects have two qualities that trigger IRB review requirements:
   • the database includes “private identifiable information” as well as “protected health information about each entry; and
   • the “private identifiable information” is being saved for “future unspecified research purposes” (e.g., future arthritis clinical trials).

The first quality (personal identifiable information, protected health information) invokes the requirement for documented informed consent. The second quality (“future unspecified purposes”) invokes the requirement for a banking application to the IRB.

Thus the IRB does not permit an investigator to use contact or health information collected in the course of one study (i.e., subjects screened out of the study, subjects screened into the study) again for any other study, unless that investigator has submitted an application to create a “recruitment database bank” and a banking consent form for IRB review and approval. Once approved, the PI can use the banking consent form to recruit subjects from any study identified in the banking protocol.

The latter policy applies to volunteers who respond to study advertisements by telephone. An investigator has no right to save any contact or screening information about subjects screened by phone or email unless they have enrolled in the study being advertised (then the information may be used only for one study), or unless they have consented to let their contact information be entered into a “recruitment database” by means of an IRB-approved banking consent form.