Informing and consenting disadvantaged populations for clinical and community-based research studies.

Abstract: Disadvantaged populations, such as racial minorities, low socio-economic and low literacy groups, the very sick, children, pregnant women and the institutionalized are continually sough t after as research subjects, and their capacity for effective informed consent frequently compromised. Justice demands that the basic rights of all human subjects, especially the disadvantaged, be carefully protected and that researchers not involve these volunteers' only because of administrative convenience. Clinical and community- based investigators must assure that human subjects a re always fully informed about the true nature and intent of study protocols.

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The 1979 Belmont Report clearly articulates the desired outcome of informed consent. Research Subjects (volunteers), regardless of background, should be provided information, understand the information, and based on their comprehension of the information, make a voluntary decision to participate in a research study. However, there is still little evidence about how well informed consent works to assure researchers that participants fully comprehend the "what and why" of the research activities for which they have volunteered.

Psychological research on biases and heuristics identifies cognitive biases in information processing (choices and interpretation of risks and benefits) that have implications for improving the informing process. A growing literature on patient decision aids provides evidence for the feasibility of more effectively informing volunteers, and includes examples of "de-biasing" procedures to improve information comprehension and consent. Informing and consenting involve conceptually different challenges when comparing effectiveness versus values. Both include social and individual values and require techniques that de-bias the process as needed. Over the years, many public health education methods and strategies have been tested and used to determine effectiveness in informing volunteers for community-based research. Many researchers are of the opinion that appealing to an individuals' sense of compassion and altruism may increase research participation among the underserved, and does not necessarily violate the voluntary nature of informed consent. (NIH, 1993; Holmes-Rovner, 2002; Tobias and Souhami R.L., 1993; Sharp and Strauss et al., 1992; NCPHSBBR, 1979).

In many cases, the goals, objectives and methodologies included in a research protocol can be hard to explain, thus making comprehension for some individuals difficult at best. In many cases, individuals from many disadvantaged population groups who volunteer for research projects may feel incompetent to make independent decisions. In some cases, they will "opt out" choosing not to be fully informed of the project, abnegating their civil rights and allowing investigators to make choices for them. This is especially true in the case of "proxy consent" (NCPHSBBR, 1979).

Many times research volunteers give their full trust and confidence to the investigator or research staff member, trusting solely in their skills and competencies. Such freedom of trust can be especially likely when members of the research team are of the same cultural group as the volunteer. Some investigators espouse that efforts should not be made at all to inform disadvantaged volunteers about the research in order to avoid stress and confusion on the part of the volunteer. To the contrary, however, most individuals, regardless of socio-economic status, seek more information, not less, about what is happening to them regardless of risk level. (Nuremberg Code, 1949; Levine, 1986; Kim, 2002).

Low literacy levels can also play a major role in how volunteers are able to comprehend information presented to them by researchers. Although the average reading level of adults in the United States is between the eighth and ninth grades, most health care instructions are written at or above the ninth-grade reading level (Doak and Doak et al., 1996). Several researchers have found that the reading levels of educational materials and the intended readers' literacy levels seldom match (Estey and Musseau et. al., 1994; Overland and Hoskins, et. al., 1993).

JUSTICE AND INFORMED CONSENT

Justice is relevant to the selection, informing and consenting of subjects for research at two critical levels: the Individual and the Social. Individual Justice requires that researcher's exhibit fairness; thus, they should not offer information or potentially beneficial research only to those individuals who are in their favor, nor should they select only disparate and vulnerable persons for risky research (NCPHSBBR, 1979).

Social Justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on the potential volunteer. Therefore, it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects, and that some classes of potential subjects may be involved as research subjects, based on certain criteria. (NIH, 1993).

Social Injustices, however, arise from social, racial, educational, economic, sexual and cultural biases institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and although individual institutions or investigators may not be able to resolve a problem that is pervasive in their social setting, they can consider Distributive Justice in selecting research subjects. For example, persons from disadvantaged populations are already burdened in many ways by their infirmities, disparities and environments. When research is proposed that involves high levels of risks and does not include a therapeutic component, other less burdened classes of persons should be selected as volunteers, except where the research is directly related to the specific conditions of the class involved. Also, even though public funds for research may often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public health care constitute a pool of preferred research subjects when more advantaged populations are likely to be the recipients of the benefits. (NIH, 1993; NCPHSBBR, 1979; Levine, 1986).

Certain groups where disparity is high, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, because many times they are geographically accessible in settings where research is being conducted. Given their dependent status and their frequently compromised capacity for free consent, they especially should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness, socioeconomic condition, or actual fear of loss or less effective medical treatment. (NIH, 1993; Levine, 1986; Gezt and Borfitz, 1999).

In the case of research protocols, justice demands that the individual should always be fully informed about the true nature of the research including its goals, methods, benefits and risk. It is a common misconception that receiving treatment in clinical trials is the same as receiving treatment as a patient. In truth, the primary purpose of a clinical trial is designed to answer a scientific question, not to provide medical treatment. Individuals thinking of whether or not to participate in a study should be duly informed and understand the difference between research and medical treatment. In many ways, however, participation in a clinical trial is much like visiting with a doctor to receive medical care. The doctor's primary goal is to help a person to feel better; the Principal Investigator's primary goal is to see how a person will react to a new drug, a new combination of drugs or a procedure in order to determine whether it will be medically useful at a future time. This truth does not change the fact that many people are helped to feel better while participating in research study. For example, many investigational drugs may prove to be far superior to the older drugs they will one day replace. Drugs given in clinical trials have not only improved, but have also saved thousands of lives (Veatch, 1995).

WHY HUMAN SUBJECTS CONSENT

The reasons people choose to participate in clinical trials are compelling. Examples of a few of these reasons include: 1) To gain access to new information and therapies; 2) To help advance science; 3) To help others who are trying to cope with illnesses; 4) To earn extra money; and 5) To receive free medical care. On the other hand, a surprising number of individuals consent to be in studies even if they personally have little, if anything, to gain by doing so. Some volunteers get involved simply out of curiosity or because they believe study volunteers get better medical care. Others participate in research studies because they do not have health insurance and are looking for help covering medical treatment cost. (Veatch, 1995).

When further discussing why individuals consent to participate as human subjects, we must look deeper into what is affected. The information, knowledge, and autonomy of volunteers who consent can be evaluated, in part, by exploring questions directed at their satisfaction with the consent process. Questions include: 1) Was the subject satisfied with the information that was provided during the informed consent process stating what would happen during the research? 2) Was the subject satisfied with the information provided about the safety, risks or potential benefits of the research? 3) Was the subject satisfied with the information provided about the alternative(s) to participation in the research? (Lidz, Appelbaum, et. al., 1988). The overall informed consent process should have a direct relationship on why volunteers make a decision to participate in research, and whether or not they remain or would return to participate in other research studies.

Most persons who participate in a clinical trial have positive experiences. Over 600 volunteers have enrolled in cardiovascular related research protocols conducted at the Morehouse School of Medicine's, Clinical Research Center (MSM CRC). One study, the Telehealth Heart Failure Project to Improve Access and Adherence, recruited high-risk African American patients residing in low-income inner city and rural areas. Inclusion criteria for the protocol required each subject to previously have had a primary diagnosis of congestive heart failure (CHF). The purpose of the study was to minimize emergency room and clinic or hospital visits, by detecting and correcting clinical deterioration and other complications through computer-based telemonitoring system technology.

Study subjects were asked to complete a nine question "Participant Satisfaction Survey" to express their feelings about being involved in the MSM CRC studies. Table 1 shows that a sample taken of 260 satisfaction surveys from participants in two MSM CRC studies, Telehealth and Vascular Compliance, approximately 90% of individuals participating in these studies responded "they did understand the informed consent instrument" administered to them by research staff. Another 10% said they "did not understand or were not sure" about the instrument.

The reasons individuals enroll in a study are not always the same as why they remain in a study, or whether or not they would return for participation in another one. Over a period of time, interest may dim and mixed feelings can emerge about participation. Change in attitude is natural and should not be disregarded by investigators. Volunteers may have good reasons to withdraw their consent, just as they may have good reasons to stay in the study or return to participate in future studies.

As shown in Table 2 below approximately 90% of survey respondents indicated they "would return to the clinical research center to participate in another study". About 10% indicated they "would not or were not sure" about returning for other studies.

The autonomy of the subject's informed consent can also be evaluated in terms of the subject's satisfaction with other specific elements of the process. The evaluation of patient satisfaction also examines other key areas including: how human subjects feel about the first encounter and secondly, the overall research experience relative to the subject's expectations.

The evaluation of patient satisfaction also examines other key areas including: how human subjects feel about the first encounter and secondly, the overall research experience relative to the subject's expectations. Second, overall research experience relative to the subject's expectations. Satisfaction with the consent process does not mean that the subject's expectations of the research were fulfilled, such as expecting a cure of one's diabetes or cancer. Instead, satisfaction with the informed consent process means that the subject believes that this initial process represents the eventual procedural research experience.

The consent process strongly suggests that researchers with positive attitudes, quality and courteous behavior and strong procedural skills remain as critical elements in whether or not participants understand the research, agree to be involved in the research, return to participate in other studies, would recommend others to participate, or are displeased with or mistrustful of research.

Data in Table 3 shows responses to another question asked of volunteers about the attitude, behavior and skills of the research team involved in research protocols at the Morehouse School of Medicine, Clinical Research Center.

An important limitation of the use of satisfaction measurements is the difficulty of assessing satisfaction with rare events. For example, there may be a rare, but serious, adverse event in a research study and the research staff may poorly communicate the possibility and actuality of that event to volunteer subjects. However, measurement of satisfaction may not detect this limitation of the informed consent process, especially if none of the volunteer subjects are ever made aware that they experienced the events.

One common benefit to all who volunteer for research should be that participants get to meet researchers, professionals and scientist who can help them to better understand their medical complications, and who dearly communicate with them about new treatment options under development. Individuals who are diagnosed as being critically ill, for example can sometimes find new hope from participating in a community-based or clinical trial. Such trials, however, can serve only to enhance, and not replace medical treatment and care the individual receives from their physician. (Nuremberg Code, 1949; Gezt and Borfitz, 1999).

An important limitation of the use of satisfaction measurements is the difficulty of assessing satisfaction with rare events. For example, there may be a rare, but serious, adverse event in a research study and the research staff may poorly communicate the possibility and actuality of that event to volunteer subjects. However, measurement of satisfaction may not detect this limitation of the informed consent process, especially if none of the volunteer subjects are ever made aware that they experienced the events. This is where "research ethics" comes into play

ETHICAL PRACTICE AND INFORMED CONSENT

Key to the protection of volunteer human subjects is the explicit concern about ethical standards and guidance involved in informed consent. Webster defines ethics as: "the discipline dealing with what is good and bad and with moral duty and obligation ... a set of moral principals or values." Not obtaining informed consent raises immediate ethical problems, and implies legal and civil rights issues. Individuals must be given the opportunity to abnegate their freedom to make choices and, therefore, the individual who possesses that right can only give abnegation. Many scholars question whether "consent" is even an appropriate concept in medical decision-making, and that in the healthcare delivery system consent should be replaced with a much more radical, robust notion of active "physician patient interaction and participation". For example, the idea of physician-patient pairings based on "deep values" where healthcare delivery systems organize around and announces particular value orientations. The premise being public health and medical information disseminated to participants by persons whose "cultural values" and life experiences are more closely aligned with their own, can result in less conflict and fewer misunderstandings, greater comprehension and a higher likelihood of true comprehension. Thereby, the position of the volunteer as an active participant in the decision making process about the research protocol would be strengthened (Kim, 2002; Guidance for IRB, 1998).

In clinical research, as well as community-based behavioral research, the practice of ethics is nothing more than an expression of the good will, good nature, and good character of the research investigator and the research team. Any ethical behavior and decision-making that is not such an expression soon ceases to function and becomes obsolete. Human ethics is generally the result of ones own experience, but may also be motivated by a desire to impose the will of a superior upon their subjects. In either case, ethics has "will" as a basic factor and is an expression of the will, nature and character of the one in control of the environment or the lawgiver. Ethics, therefore, derives from personality, and defines and reveals that personality (Andreason, Sanctuary, 1990; Guidance for IRB, 1998).

While the ideal circumstances might be that all research volunteers know everything in the informed consent document at the time they sign over their consent, even for the most educated volunteer, this is dearly an unrealistic expectation. Further, even investigators and IRB members cannot retain or recite all information contained in an arbitrary informed consent document.

Ethical practice requires "structural" and "process" change to the tangible aspects of informed consent. Examples of structural change include: 1) the development of a consent template, standardized consent language, or a glossary of lay definitions; 2) increasing or decreasing the amount of information in the consent document and; 3) lowering the reading level of the consent document. On the other hand, change in the process requires that: 1) qualified personnel administer the informed consent process; 2) that subjects are given an adequate amount of time to make a decision regarding participation and, 3) that information is thoroughly reviewed with the subjects and, 4) that subjects discuss the research with their primary care physician (Lidz and Appelbaum, et. al., 1988). An ethical consent process ensures that the volunteer subject consents to the research all the way through, not just at the outset. Research staff must move away from viewing informed consent as a signed off piece of paper. If, at the end of the day, the subjects do not comprehend at least the study objectives, risk and benefits, can the process then be deemed truly ethical and just? This philosophy can help researchers understand that ethical consent is not just about following rules, it's about upholding the principle of giving subjects the information they need to make informed choices, while upholding their rights. (DHHS 21 C.F.R. 50.20; 45 C.F.R. 46.116 (a) (2).)

INFORMED CONSENT: AN ONGOING PROCESS

Universal guidance on informed consent suggests that in order for investigators to fully comply with regulations and policies governing informed consent, researchers should view informed consent as a process rather than just a brief encounter. Knowledge is also time-sensitive in that, subjects may know at the time of a decision the specific information provided to them, but after the decision has been made they may readily forget that information. For example, when decisions are made about which car to buy or college to attend, one may do a great deal of in-depth research and gain a large amount of knowledge that allows one to make an informed decision. However, after the decision is made, one may forget the specific knowledge that was used to make such a decision.

Also, in order to understand and comply with federal regulations, informed consent should be implemented as an ongoing process, rather than just a formality. Essentially, information about the research study must be presented in a manner that empowers and enables volunteers to decide whether or not to participate as a research subject. Respect for a person's ability to make a voluntary and conscious decision to participate in a clinical trial, and remain in that trial, is the key component of informed consent. Therefore, research investigators seeking to obtain informed consent should educate the individual in a method that is culturally relevant and is fully comprehensible. ((NIH, 1993; Gleeson, 2003). To this end, the consent process must involve a written consent document as well as an ongoing oral explanation of the research. Federal guidelines define the process as follows:

The consent process involves giving the subject adequate information concerning the research study, providing adequate opportunity for the subject to consider all options, responding to the subjects questions, ensuring that the subject has comprehended this information, obtaining the subject's voluntary agreement to participate and, continuing to provide information as the subject or situation requires. To be effective, the process should provide ample opportunity for the investigator and the subject to exchange information and ask questions. Federal guidelines go on to say, that: "... the investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion on undue influence. Exculpatory language, through which the subject or the representative is made to waive or appear to waive any of their rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence should never be used in the consent document." The volunteer's signature on that documentation provides an agreement to participate in a study, but represents only one part to the consent process. Many scholars suggest that many criticisms of informed consent stem not from flaws in the doctrine itself, but from the ways in which it is implemented in healthcare settings. (DDHS 21 CFR Part 50; DHHS 45 CFR Part 46; Veatch, 1995; McGuire-Dunn and Chadwick, 1999)

To illustrate the issues with and possibilities for informed consent in this environment, let's look briefly at two models of implementation: the Event Model and the Process Model. In the "event or encounter" model, informed consent is seen as an act of decision-making that occurs at one specific point in time. The investigator or research staff-person sets forth a reasonably comprehensive list of details, risks, and benefits for a particular procedure or; the volunteer signals acceptance by signing a consent form. There are several serious flaws with this model, including: (1) the emphasis is usually on complete disclosure of facts by the investigator/researcher rather than complete understanding of these facts by the volunteer, which means that the volunteers consent may not be a truly "informed" one; (2) because the volunteers understanding of the facts is not emphasized, both volunteer and investigator/researcher may come to view informed consent as a waste of time; and (3) this model makes the investigator/researcher and volunteer relationship seem "more bureaucratic and less humane."

The process model, in contrast, emphasizes continuous and active volunteer participation in decision-making. Various areas must be explored if this can be achieved: First, the investigator and volunteer role expectations must be shifted so that the volunteer is accepted as a valued member of the research team--one with knowledge of important community issues, events and contextual facts that are sometimes unavailable to the investigator/researcher on a day to day basis; Second, differences between investigator/researcher and volunteer, and their ideas and concerns about particular research "myths and truisms" can cause problems and must be more thoroughly addressed and dispelled. Finally, volunteers' beliefs, values and expectations must be thoroughly explored and discussed to ensure that a particular research study will be appropriate. While the process methodology is ongoing, time-consuming and may not be practical in all research situations, it should be offered as, at least, a direction in which to move (Lidz and Appelbaum, 1988).

DISCUSSION

Human Subjects aren't always given the information they need to truly consent to participate in a research study. However, researchers along with the institutional IRB, put an inordinate amount of time into the construction of the consent forms to be used with these volunteers. If the investigator and other members of the research team have ensured that the actual necessary components for a 'true' informed consent are present and, that all information has been communicated appropriately, with a tool in place to verify such, then can it be said that this is truly an informed subject? If not, it communicates the message that the heart and soul of informed consent is just getting the words right and getting the consent form signed.

A good informed consent process should not focus on the form, but on the volunteer and helping him or her understand what participating in the research really means. Gross inefficiency in the consent process can amount to a conspiracy to deceive potential subjects and to thereby allow them to misunderstand what they are consenting to (Lidz, 1988)"

To ensure that the informed consent process is done correctly, researchers must adopt a "subject sensitive culture" that values consent. Volunteers need to be given information clearly, as well as factually, when they are deciding whether to participate in a trial. It can be very difficult to relate, or translate, to a subject who hasn't gone through medical training or doesn't have a clinical research background. Investigators should be taught to look at the consent process from the subject's point of view, especially considering that in some instances, it takes many years of intensive public health and medical training for investigators themselves to understand the research process and the elements of the risk-benefit analysis.

Having someone observe and discuss the informed consent process, perhaps a Research Subject Advocate can assist researchers to receive some guidance on the process. Also, dialogue with a random sampling of subjects to determine the quality of the informed consent process can be one key means of assessing the process. Volunteers won't likely be able to recite back all the information that they have been given, but they must understand exactly what they are getting into. Yet even that can be complicated because human nature tends to forget over time; however, this does not mean they didn't understand when they agreed to participate in the study (McGuire-Dunn, 1999).

In circumstances where individuals are recruited to participate in very "complicated and high risk" studies, researchers may need to consider implementing a second consent or to "re-consent" the volunteer. For example, at the outset of a study many volunteers may not fully realize the kind of discomfort involved in the study, yet they may be hesitant to withdraw from the study after it has begun, despite the discomfort because they feel obligated. Therefore, subjects should be made fully aware throughout the research of their option to withdraw if they so choose. Especially in cases of high risk studies, where discomfort levels are high or extreme, the IRB should consider requiring a second consent process halfway through the trial. This is necessary because the volunteer may not really be able to judge the complex nature of the trial at the beginning.

In conclusion, informed consent is one of the primary ethical requirements underpinning research with human subjects, the starting point on a continuum that reflects the basic principles of respect and social justice for the individual citizen. It is far more than a one-time event or a brief encounter, it is an ongoing process that assures and insures that prospective human subjects will understand the nature of the research in which they are agreeing to take part. In practice, it confirms that the volunteer is knowledgeable respected and protected as fully as possible. This confirmation helps to protect both the subject and the investigator. As stated in the Belmont Report: respect for persons requires that they be given the opportunity too make an informed behavioral choice about what will and will not happen to them. An appropriate process of Informed Consent requires that the information exchanged between researcher and subject warrant just and ethical decision-making. In recruitment of disadvantaged populations, such as persons of low literacy levels, this exchange may call for a variety of methods to be used throughout the informed consent process. Investigators have an ethical responsibility to encourage dialogue, and to probe research subjects to test and ensure that the person has some level of understanding concerning the research. (NIH, 1993; Estey, 1994; McGuire-Dunn, 1999).

Although the elements of informed consent are easy to enumerate, in practice they are not always so easy to achieve. Even in the best instances, there are no definitive remedies against failure to communicate. Information may be poorly translated or individuals may forget that they are even involved in a research study.

The manner and context in which information is conveyed are as important as the information itself. An individual's ability to understand is directly linked to intellect, rationality, maturity, language and cultural background. Thus, it is imperative that investigators adapt and translate the information for consent to the individual's capabilities. Educational pamphlets and brochures, videos, verbal dialogue, written materials and ongoing question and answer sessions between the researcher and subject all must be used.

The principle of justice must be honored in research ethics. "Social Justice" requires fairness. In the words of the Belmont Report: "An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly...justice demands that research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research" (NIH, 1993).

ACKNOWLEDGEMENTS

We also wish to thank the National Institutes of Health and RCMI Grant for the funding (Grant Number: 5P20RR11104-9) provided to the Morehouse School of Medicine, Clinical Research Center, to conduct both the Vascular Compliance and TeleHealth research studies.

REFERENCES

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Levine, R.J. (1986). Ethics and regulations of clinical research. 2nd ed. Baltimore, MD. Urban and Schwarzenberg, 1986.

Lidz C.W, Appelbaum P.S., Meisel A.(1988) Two Models of Implementing Informed Consent. Archives of Internal Medicine, Vol. 148, 1385-1389.

McGuire-Dunn C., Chadwick G.L. (1999). Protecting Study Volunteers in Research: A Manual for Investigative Sites. Ethics and Federal Regulations p.30-35.

National Institutes of Health, Office of Extramural Research. (Sept, 1993). Informed Consent Manual. Available from the Office for Protection from Research Risk, U.S. Government. Washington, DC.

Nuremberg Code. Trials of war criminals before the Nuremberg military tribunals under control council law: (1949). No. 10, Vol. 2, p 1891-1892, U.S. Government. Washington, DC.

Overland, J.E., Hoskins, P.L., McGill, M.J., Yue, D.K. (1993). Low literacy: a problem in diabetes education. Diabetic Medicine, 19, 847-850.

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Tobias, J.S., Souhami R.L. (1993). Fully Informed Consent can be needlessly Cruel. British Medical Journal, 307(6913): 1199-201.

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Frederick G Murphy, MSPH, MPIA

Patricia A. Jackson, RN

Priscilla S. Johnson, RN, PhD

Elizabeth Ofili, MD, MPH

Alexander Quarshie, MD, MS

Casmir Nwigwe, MD

Frederick G. Murphy, MSPH, MPIA, Patricia A. Jackson, RN, Priscilla S. Johnson, RN, PhD, Elizabeth Ofili, MD, MPH, Alexander Quarshie, MD, MS, and Casmir Nwigwe, MD are affiliated with the Clinical Research Center of Morehouse School of Medicine (MSM). Frederick G. Murphy is also an Adjunct Faculty member in the Department of Community Health and Preventive Medicine at MSM. Address all correspondence to Frederick G. Murphy, MSPH, MPIA, Research Subject Advocate, Morehouse School of Medicine, Clinical Research Center, 4112 Fieldway Rd., Rex, Ga 30273, Phone: [phone], E-MAIL: [e-mail].

Table 1. Did you read and understand the Informed Consent?

           Freq.   Percent   Cum.

No            25      9.62     9.62
Not Sure       1      0.38    10.00
Yes          234     90.00   100.00
Total        260             100.00

Source: Morehouse School of Medicine, Clinical Research
Center, 2003

Table 2. Would you come back for another study?

           Freq.   Percent   Cum.

No            23      8.85     8.85
Not Sure       1      0.38     9.23
Yes          236     90.77   100.00
Total        260             100.00

Source: Morehouse School of Medicine, Clinical Research
Center, 2003

Table 3. Was research staff helpful and friendly?

           Freq.   Percent    Cum.

No            37     14.23    14.23
Not Sure       1      0.38    14.62
Yes          222     85.38   100.00
Total        260             100.00

Source: Morehouse School of Medicine, Clinical Research Center, 2003