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 Illness, absence of health insurance, financial distress, or a deep desire to help others may cause some people to be more interested in possible participation than others. Offers to participate can be read about in the press or made by someone known and trusted by you. How would you decide what to do? Most people are not prepared. Here are a few pointers that may help you sort through the issues and decide what's in your own best interests.
INTRODUCTION - Research can be broadly defined as any interaction, intervention, or acquisition of personally identifiable private information that is designed and carried out for the purpose of answering a question for application beyond those about whom information is collected. Research can be very serious business. When conducted or supported by the Department of Health and Human Services (DHHS), participants are entitled to certain basic protections. In addition to these, there are additional protections for specific vulnerable populations (e.g., the unborn, the pregnant, prisoners, and children) when participating in DHHS research. For DHHS research, protections are spelled out in the Code of Federal Regulations at Title 45 Part 46 (45 CFR 46). Information about participant rights, details of 45 CFR 46, and more, are available from the DHHS Office for Human Research Protections (OHRP) by phone (1-866-447-4777) or on the Internet (http://www.hhs.gov/ohrp).
In addition, when research is sponsored by private sources and designed to test an investigational drug, biologic, or device, certain other protections may also apply. These are administered by the Food and Drug Administration (FDA). Additional information can be obtained from the FDA by phone (301-827-4460) or on the Internet (http://www.fda.gov/oashi/clinicaltrials/default.htm). A number of other Federal departments and agencies (http://www.hhs.gov/ohrp/policy/common.html) share certain basic standards with DHHS for the protection of participants (known as the Common Rule or Federal Policy). Of course, each Federal department and agency may have its own additional protections.
There are two basic ways that the rights of participants are protected, independent review of the research by an ethics and science panel (usually known as an Institutional Review Board [IRB]) and becoming informed about a proposed study before consideration of consent to participate. IRB review is accomplished by evaluation of proposed research by persons who have no personal involvement in it. Consent is sought by informing possible participants, or their legally authorized representatives, about certain aspects of the planned research experience. Although these are the most obvious and essential ways to protect potential participants, they are not the only ways.
Participants and investigators must achieve and maintain mutual respect for each other. Upon this, all else rests. Should concerns arise, it is also important that participants know the name and means by which the IRB Chairperson (or equivalent knowledgeable advisor) may be contacted. There are certain things you should keep in mind when considering participation in a research project. Foremost in a participant's thoughts should be their own safety and privacy, or that of a child or other who they may legally represent.
Please select one or more of the following categories for additional information before making a decision:
- WHY - purpose of the research and possible value to you
- WHO - matters of personal importance to you
- WHAT - different types of research experiences
- WHERE - how location can complicate a decision
- WHEN - timing of an invitation to participate
- HOW - the nature and circumstances of your participation
- CHECKLIST - summary of issues you should understand about an offering before a decision is made
- LINKS - additional sources of Web-based information
WHY - In general, know the purpose of the proposed research and your options; what you may have to give up, and what may be new to you; find out if what you will encounter has ever been done before (how often and with what outcome); how it may impact you (good and bad); and how likely the impact. Has the investigator stated or implied that you may "profit" from participation (e.g., payments)? If so, inquire further and proceed with caution. Guard against promises that can blur your ability to objectively judge the significance of described research risks.
WHO - First of all, think about you. You may be a normal, healthy person who is chosen by chance. You may be under medical treatment but function more or less normally and have referred yourself or been referred because your medical condition and/or circumstances happen to be of scientific interest. You may be sick, possibly hospitalized, and dependent on medical care for management of an acute or chronic condition that is debilitating. If approached, consult with others who may be of assistance to you in understanding, judging, and deciding what to do.
Some people may volunteer to participate because they think they will somehow have an increased chance of improving their situation. They could be very wrong. Others may simply go along when risks are described to be low and the inconvenience minimal. Yet others may see participation as a selfless act for the benefit of others. Often, there may be no single reason. Whatever the reason, or reasons, those thinking about volunteering should be fully informed and continuously alert. It is the responsibility of investigators to satisfactorily inform you. It is in your best interests to ensure that they do. Ask questions! The higher the stakes, the more the questions you should ask.
WHAT - The research may take the form of a survey or interview in which you may be contacted by study staff to obtain sensitive information that identifies you or other identifiable living persons. The research may take the form of a clinical trial in which you may be assigned to a group, on a basis other than clinical judgment to make comparisons between groups. Special terms may be used that you don't understand. Ask when uncertain!
WHERE - The extent to which you depend for services (e.g., social support or clinical care) on those who may approach you for research may make you feel less free to say no. Even if you are comfortable in saying yes under these circumstances, it's easier to lose track of the crucial distinction between health care providers and research investigators when they are one and the same. For example, health care providers make decisions based on management of your clinical condition. On the other hand, research investigators are driven by specific conditions of a study protocol. A study design may determine your management by the flip of a coin. Trust of providers is natural but questioning of investigators is essential. Don't assume anything.
WHEN - Ask if the research requires prior IRB review and, if not, why not. Furthermore, the setting and circumstances under which you will consider consenting should permit thoughtful consideration; allow discussion with family members or significant others (as appropriate); be as free from time and circumstantial pressures as possible; and permit a cooling off period so you have an opportunity to withdraw before starting (e.g., when risk is to be more than minimal). You should know how to consult with someone not involved with the research if you have concerns (e.g., an IRB Chairperson, ombudsman or other suitable person).
 HOW - You should be told the location of participation; for how long it will last; what and how often contacts will occur; whether you can get what's offered from other sources outside the research; how private information can be linked to you; how research information will be protected from others; circumstances under which your information may be shared with others; costs to you and how any injury (i.e., physical, psychological, social, or financial) will be handled (on the spot and long term); what happens after the study; how to get study results; and with whom you can discuss your concerns apart from those running the research. Of course, you have the right to withdraw at any time (subject to your safety), and you should confirm that you may not be penalized in any way for withdrawal.
(04-07-06)
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