When you go through the informed consent procedure, do you "talk through" all the material in a face-to-face conversation, or do you just hand the consent form to the patient to read and sign? The latter is not an acceptable consent procedure. The consent form is merely the documentation of the conversation that took place between you and the patient. It cannot be a substitute for that conversation.

After enrolling the patient, do you ensure that she/he receives a copy of the consent form?

The consent form is intended to be a future reference for the subject. It describes the study's schedule, its purpose, and any known side effects. It gives the names and numbers of people or offices to contact if something goes wrong. This information must be available to the subject throughout the study -- without the consent form it will not be.

Do you ensure that a copy of the consent form goes in the patient's medical record?

If another health provider cares for this patient, he or she must know about any research that the person is participating in, especially if investigational drugs or devices are being used.

Do you take sufficient time to answer the patient's questions? Do you try to elicit questions from the patient?

You need to be sensitive to the reluctance of some patients to question an authority figure or to ask questions about a complex topic. It is up to you to make the context as comfortable for questioning as possible.

Do you try to elicit feedback from the patient to see if he or she truly understands what the research entails?

The complexity of the material may be daunting, and may require repetition. If you don't probe respectfully to see if the subject understands, you won't have a chance to go over the unclear parts.

Do you give the patient the opportunity to consult with a family member or friend if he/she is not sure about what consenting to the research means?

This should always be an option, even if it means the patient will take the consent form home before signing it, and come back for another visit to enroll. Lack of time or fear that a patient will be lost to enrollment are never justifications for rushed or uninformed consent.

Do you make sure that the informed consent, and all study procedures, take place in a setting that is respectful of the patient's confidentiality and that permits you to give your full attention to the interaction?

Discussing a complex study in a busy waiting room, or another place where you may be interrupted, is not an optimal context for either effective communication or maintenance of confidentiality.

Do you take steps to ensure that your subjects feel like valued participants?

Such steps include listening respectfully, not interrupting, maintaining eye contact, and avoiding distractions during the interaction. All health care professionals should always do these things, but bad habits arise out of time pressure and other stresses. Making the subject feel valued is essential if you expect the subject to comply faithfully to the protocol, or even if you hope to retain the subject throughout the study.

If someone decides not to participate in a study do you or any member of your research team ask again?

Such repeated requests are considered coercive, especially in a health care system where most patients have few or no other health care options.

When you enroll a patient in research, do you give the impression that the study is primarily a treatment?

Research is done because we don't know which treatment works best. If we knew, there would be no ethical justification for doing research on humans. When people who are ill are asked to participate in research, they often come away with the impression that the research was done primarily for therapeutic purposes. In a phenomenon termed the "therapeutic misconception" the uncertainty connected with research is ignored.

Investigators may compound the problem by presenting the research as primarily something that could help when all else has failed, rather than emphasizing that the effectiveness of the experimental treatment is not known - or that the patient has a chance of being assigned to a control group, and won't receive the experimental treatment at all. A patient whose therapeutic misconception has been boosted this way is not fully informed.

Do you assign the informed consent procedure to someone who is not listed as an investigator and/or is not trained to obtain informed consent for research?

The principal investigator and persons named as co-investigators are the only individuals authorized to obtain consent. The PI is responsible for insuring that all persons who obtain informed consent know what the procedure entails. Clearly, it is not something that may be assigned to whichever resident happens to be on duty.

When you write a consent form do you try to reduce the technical jargon as much as possible?

Remember that the average American has a reading level of not more than eighth grade, and that lower reading levels can be expected in some populations.

When you write a consent form, do you take care not to oversimplify so much that important information is left out?

It's fine line to walk between too much and too little technical language, but walk it we must. For a handy guide to plain language equivalents for medical terms, visit the web site at http://ovcr.ucdavis.edu/hsglossary.htm.

Do you take steps to insure that all members of your research team are carrying out procedures consistently?

Even among a group of investigators committed to a project, lack of sufficient coordination can sometimes lead to inconsistency in interacting with subjects, not to mention possibly invalidating the data. Subjects who receive conflicting messages from study staff may not feel fully confident in the research or the researchers.

When designing a study, or agreeing to carry out a clinical trial, do you realistically evaluate staffing and time needs?

Shortcuts are sometimes made when there is not enough staff or enough time to carry out all the steps required to do good research. Sometimes such shortcuts compromise human subject protections, as when the consent procedure is rushed and perfunctory. The time to avoid this problem is when you plan the study.

When you agree to carry out a multi-site trial, do you learn the protocol in depth?

It should go without saying that a principal investigator who takes on responsibility for a clinical trial should know the protocol in detail, including the entire study schedule, the whole range of possible side effects, and various contingencies for handling problems that arise.

If you use an investigational drug, device or biologic for treatment ("compassionate use" or "emergency drug request") do you always get interim approval from the IRB Chair and written informed consent from the patient or the patient's representative?

All use of investigational drugs, devices or biologics, whether on or off a research protocol, requires IRB approval. In emergency situations, the Chair can give interim approval until the next IRB meeting. Written informed consent is required in all cases except when the patient's condition is life threatening and prior consent can't reasonably be obtained.

When someone not employed by the Bureau is working on site for your study, do you ensure that the person is properly qualified, supervised, and credentialed?

If you take responsibility for a research project, you assume responsibility for the activities of all study personnel on site, including those who may come in from another institution to recruit patients, carry out interviews, or provide interventions. It is not acceptable to rely on "long-distance" supervision or credentialing from the other institution.

When you prepare a presentation or publication based on a case report, a case series or a retrospective chart review, do you always obtain an exemption from review from the Chair of the IRB?

Investigators are not permitted to make the final determination that a study is exempt from review. This must be confirmed in writing by the Chair of the IRB.

This is not only the law, it is also the prudent course. The rules for determining exemptions can be slippery, and not everyone is fully cognizant of them. For instance, many people don't know that no research involving pregnant women, fetuses, prisoners or jail detainees may be exempted from review, even if the research is a report of a single case. No survey, interview or focus group research with minors may be exempted from review, no matter how innocuous the questions. If you don't get confirmation that your research is exempt, you could inadvertently carry out noncompliant research. For the safety of all concerned, you must get written confirmation if you think your research is exempt.

Do you ensure that all the research projects carried out by the residents you oversee have been approved by the IRB?

The rule about always obtaining an exemption applies to residents' projects, even if the project is a small chart review.

Do you always obtain an exemption from review when you write up or present data from the Tumor Registry or other data bank?

The same rule applies to research generated from these sources of data as to research based on medical records.

Are you aware that piloting or pretesting of research techniques with humans needs prior IRB approval?

The subjects' rights are the same, whether you're pretesting one technique or doing the full-scale study.

Do you try to remain visible and available to subjects throughout the study?

Subjects who feel they can reach the person in charge will be reassured, and you will have a better chance of dealing with problems early if they arise.

Do you debrief your subjects when their participation is over?

A conversation at the end of the study provides closure, makes the subject feel that his/her contribution was valued, and maintains the subject's interest in research participation. Such debriefings are also required by the Joint Commission. When results from the study are available, they should be distributed to the people who participated.

Do you record and retain no more confidential information than is necessary to carry out the study?

Some investigators routinely set up data sheets that include the subject's name, address, phone number, medical record number, and even social security number. This much private information is usually unnecessary to do the research, and its presence on data sheets increases the chance that a subject will be harmed by a breach of confidentiality. Standard research procedure should be to employ a code to identify each subject, linked on a master list to basic identifying information (usually a name and medical record number will suffice). The master list is kept in a locked file, and all individual data collected is identified only with the code number assigned for the study.

When enrolling children in research do you make a reasonable attempt to get both parents' permission? Do you get the assent of children aged seven and older?

If both parents are reasonably reachable, both should give permission, especially for studies that might entail some risk to the child. Children old enough to understand at least some aspects of research participation should receive an appropriate explanation and be asked to assent.

Have you actually read the guidelines?

The application used to apply for IRB approval includes an Investigator's Acknowledgment, to be signed by all named investigators. In this acknowledgment, investigators affirm that they have read the IRB guidelines and will abide by them. On occasion, it has been obvious to the committee -- from the content of the application, from the questions asked by the applicant, or by the applicant's own admission -- that he/she has not read the guidelines. Sometimes applicants have obtained a copy of the application forms, but not the guidelines. If you sign the acknowledgment, it is expected that you truly have read the guidelines. (Guidelines are available in the Resource Room, 603 Durand. Call 864-7792 or 572-3506 first to make sure the room is open)