Rights and Responsibilities of Research Participants
Local newspapers and magazines such as Body Positive, flyers distributed at agencies and in clinics, and trials books list multiple opportunities for research participation for HIV-positive men and women. Some are surveys, which are not designed for your individual benefit, and where the main incentive is usually some form of compensation.
Others are treatment studies, where the main incentive is potential relief of symptoms. However, it is important to understand the difference between treatments provided in a research study (whose effectiveness may be unknown and may or may not be helpful for your symptoms) and those provided by your doctor, which are specifically selected for your benefit. In general, research is conducted for the benefit of the general public health, to advance knowledge of how to treat health problems or to change problematic behavior. Participation is a serious undertaking, not to be initiated lightly.
Sometimes it is hard to tell what the studies are meant to discover, whom they want to enroll, what are the risks and benefits, what is expected of those who participate, and what questions it is helpful to ask when seeking information about studies. This article is intended to review the highlights of current federal research guidelines (describing your rights) and to summarize your responsibilities when you do agree to take part in a research study.
Rights of Research Participants
You are entitled to a reasonable amount of information about any study or research procedure you are considering, according to current federal guidelines. Usually you will not learn all of this information when you first call to ask about a study you've heard about, but by the time you actually agree and sign a consent form, these are major questions that should be answered:
Has the study been approved by an established IRB? IRB stands for Institutional Review Board. All agencies and academic institutions that receive federal research funds are required to have an IRB to review proposed research conducted by staff members or students, or research involving their clients or patients. IRB committees include scientists as well as non-scientists who review the proposed study design, determine that the potential benefits to participants outweigh the risks, and approve the methods designed to minimize risk. The IRB also makes sure that the investigators provide sufficient information (in conversation and in the written "consent form") to prospective participants to enable them to make an intelligent choice about whether or not to participate. If any study you are approached to join has not been officially reviewed by an IRB, do not participate in it. (This does not include questionnaires intended to evaluate programs such as those at community agencies or completely anonymous questionnaires, for example.)
What is the purpose of the study? You should be told why the study is being done and what questions it is intended to answer. Is the purpose to collect information about certain groups of people or certain conditions for descriptive purposes only, or is this a treatment study intended to evaluate the effectiveness of a medication or behavioral intervention intended to alleviate particular symptoms or problems?
What are the procedures? What do you have to do in this study? You should have a clear idea of how many visits are required, the expected duration of your participation, what tests will be done and how often, and whether some or all procedures are experimental. You also should know what are the general areas asked about in interviews and questionnaires, and what (if anything) is offered after the study ends (in those designed to treat a medical or psychiatric condition). If audiotaping or videotaping is included, who will hear or see the tapes? When will they be erased?
What are the possible risks? Risks may include medical harm, discomfort, emotional distress, loss of privacy (discussed below) or simply a waste of your time if the study is so poorly designed that it won't provide useful information. You are entitled to be informed of any significant known side effects of medication you might get, or discomfort associated with procedures, with a description of how such risk will be minimized. For example, if a particular medicine may cause anemia, the investigator may perform repeated blood tests to catch early warning signs in terms of declining red blood cell count. If sensitive questions are being asked that may upset some people, what provisions are there for handling such distress?
What are the possible benefits? Direct benefits include improved health and well-being, or relief of distress. Study participation may provide access to a new medication not otherwise available or affordable, or to the care of doctors who are experts in their field. Indirect benefits include increasing knowledge to help investigators develop new treatments or interventions for others, in the future.
What is the compensation? Money or other tangible reward is not a research benefit but is compensation for time and effort. Compensation should never be a major determinant of participation in studies intended to treat a medical or psychiatric problem, although it is reasonable to consider as an incentive. IRBs are responsible for determining whether the amount of compensation is excessive, in effect amounting to exploitation or coercion. This is particularly true when medical procedures are involved and risks are more than minimal.
In addition to explaining if any payment is available for participation, studies involving medical procedures and treatments need to state whether and what provisions are available in case of injury, or where more information about this can be obtained.
How will privacy be protected? Every investigator is required to spell out the extent to which privacy is protected. What information about your identity will be published? Where are the research records kept? Are they in locked files? Who has access? Usually, IRBs and possibly other institutional agencies such as Quality Assurance staff members are entitled to review your records to verify that the research is being carried out as proposed, to ensure the safety of participants. This may include the funding agency as well. As an additional protection against release of sensitive or private information, many studies involving HIV-positive participants as well as other potentially vulnerable groups obtain from the federal government a Certificate of Confidentiality. This Certificate protects investigators from involuntary release of any individually identifying research information about study participants without their written consent even if records are subpoened. Other ways of protecting privacy are to permit participants to use false names or, if this is a one-time survey, not ask for any identifying information.
Are there alternatives to study participation? In treatment studies, investigators should explain your alternatives if you don't choose to be in their study. For example, are they studying a marketed drug which you could get directly from your own doctor? Are other forms of treatment approved and available? Such information is helpful in decision-making.
What are the policies regarding voluntary nonresponse or discontinuation? After you sign a consent form and agree to participate in a study, you still retain the right to refuse to answer individual questions or to discontinue study participation at any time, without jeopardizing any benefits to which you may otherwise be entitled. However, if this is a treatment study, it is very important to tell the doctors that you want to stop treatment, since in some cases sudden discontinuation may be risky, and you should gradually taper the treatment under their supervision. Such changes of mind are hopefully due to a change in circumstance or to your experience in the study, not a premeditated plan.
In summary, there are several regulatory agencies (federal, state and local) concerned about protecting research participants. Your best protection is to participate in research that has been reviewed by Institutional Review Boards (sometimes called "ethics committees") who have ascertained that a given study conforms to these regulations. In addition, you protect yourself by being an informed consumer, asking questions and making sure you understand the purposes, risks and benefits in a given study.
Responsibilities of Research Participants
Participation in a research study should not be undertaken lightly. When you agree to enroll in a study, it really should be with the intention of completing the procedures and visits you have been told about, barring unforeseen events. There are several steps involved in such a commitment.
Screening for research eligibility. You need to be candid during the screening procedure in response to questions being asked. Nearly all studies are designed with specific "inclusion" and "exclusion" criteria which have been approved by the Institutional Review Board, and once the study is given approval these usually cannot be changed easily or quickly. These inclusion and exclusion criteria are designed so that participants are selected to be able to answer a particular question. For example, if the investigator seeks to identify barriers and facilitators for people who are seeking to return to work after a period out of the work force because of HIV illness, people who have absolutely no work history are excluded: they are not "returning" to work and their situation represents a different set of circumstances. Similarly, if an investigator seeks to evaluate a new treatment for depression, the study might exclude active drug users, since such use would likely obscure the effects, if any, of the study treatment. If ineligible patients enroll, the study may fail, which would waste not only the efforts and funding of the investigator, but the time of those eligible participants who enrolled hoping their participation would advance medical knowledge.
In studies that involve medical treatments, the exclusion criteria may be for your own safety. A given study medication, for example, may be risky to administer to people who have liver disease, or it may have negative interactions with another medication you might be taking. So for both your sake and that of the investigator, it is important to be frank when answering screening questions.
Careful selection of the study. Particularly with regard to treatment studies, it is not advisable to compromise on what you're looking for. For example, if you are depressed and want psychotherapy, it is unwise, if you hear of a trial of antidepressant medication, to sign up for that instead. You are likely to be disappointed and to drop out, which will in turn disappoint the investigator because "dropouts" constitute a major problem in all studies. Similarly, if a study is designed to compare two or more different treatments or interventions and you only want one of them, it isn't fair to the investigator for you to sign up and then drop out if you are assigned to the one you didn't want.
Similarly, many studies include a comparison group in which the participants do not get the "active" treatment. In medication studies, this may be a "placebo" (sugar pill). In behavioral interventions, the control group may be "standard of care" which is what you'd get in the absence of the study. In some but not all studies, participants in the control group are offered the active treatment at the end of the research trial. It is prudent to carefully consider whether you really are willing to "take what you get" during the study trial.
Commitment to study completion. If you have a clear idea of what the study is meant to address, and of the relative risks and benefits to your participation, and decide to enroll, then you really need to be realistic about your availability and desire to participate. Once you sign the study consent form, you should be making a commitment in good faith to follow through with the study procedures and visits to the end.
There are exceptions: If, once enrolled in a treatment study, your symptoms get worse, your obligation is to inform the investigator, who must follow rules about withdrawing participants whose conditions worsen. The usual procedure at that point is to offer known effective treatment, if available, for the condition the study was designed to treat. Similarly, if you enroll in a study and develop an unrelated illness, your study participation would necessarily be suspended or terminated without loss of any benefits to which you are otherwise entitled. The general point is that you need to have the intention of following through with the study in the absence of unexpected barriers.
Participating in research can be helpful, interesting and productive both for you and the investigators if there is a good match between your goals and the research goals. Being in research requires a little altruism -- interest in helping doctors learn more about a particular treatment or better interventions such as improving medication adherence or curtailing problem behaviors -- for the sake of future patients or clients. The direct benefits cannot be guaranteed, because if the investigators were certain which of two treatments or interventions is best, they wouldn't be doing the study, so you need to recognize and accept that the treatment you get may not have the desired effect. In many cases, however, investigators offer post-study treatment, as clinically indicated, for those who do not respond to the study treatment.
If you have questions before or during a research study you are enrolled in, feel free to call the investigator for clarification. If you have questions about your rights as a research subject, call the IRB that approved the study. These telephone numbers are required to be in the consent form you signed, a copy of which you were given. It is in everyone's best interest for you to be an "informed" participant.
Judith Rabkin, Ph.D., M.P.H. is an investigator who conducts both descriptive studies and clinical treatment studies. Elizabeth Small is Administrative Director of the IRB at New York State Psychiatric Institute.