Executive Summary
With all of the new advances and developments in the world of biobanking, continual assessment of biobanking best practices is encouraged. It is more important than ever, especially with the new opportunities for genetic research by way of biorepositories, to ensure that patient concerns are being heard, understood and resolved. Ultimately, biorepositories cannot exist without the donation of specimens from patients, therefore it is vital that potential biobank candidates be understood regarding their motivations for participation in biobanking. This study will attempt to identify the motivations that surround a participant’s decision to be a part of clinical research, particularly biobanking. This study will examine the impact that sociodemographic factors may have on one’s decision to participate, and will draw comparisons between two populations: a hypothetical population and an actual patient population. As the majority of studies that have previously been performed have failed to access patients who are being consented for biobank participation in real life, this study will provide a method to draw comparisons and conclusions between these groups and identify any factors that might be subconsciously affecting the participant’s decision making.
Background and Significance
Biorepositories, or biobanks, have quickly gained popularity and the attention of the scientific community in the last 10-15 years. The buzz surrounding biorepositories has been both positive and negative. New scientific discoveries are being made as a result of tissue and blood procured from biobanks, this gains the national spotlight and is results in positive publicity for the biobanking community. On the other hand, at times the focus shifts to the negative, revealing issues such as ethical use of specimens, the adequacy of biorepository informed consent practices, biospecimen ownership issues, data sharing and confidentiality, to name a few (L’Heureux). The informed consent process is at the cornerstone of all negative issues surrounding the use of biobanks. Decades of research has revealed that consent forms are often too long and complex, and that participants do not understand the key aspects of the information that is disclosed during this informed consent process (Beskow).
As biobanks have only been in the public eye for about the past 15 years, the biobanking community is continually attempting to improve the use and development of best practices for biorepositories. According to Bledsoe, the International Society for Biological and Environmental Repositories (ISBER) was the pioneer in this initiative, developing the first publication of best practices in 2005 (Bledsoe). Additional editions have been published since that time, however the struggle to ensure the protection of the participants and their medical information is ongoing. With the onset of the broad consent model, a form of consent which requires the patient to consent to use of their specimens in multiple potential research studies rather than a single project, there have been increasing concerns that the informed consent process as it stands is insufficient and fails to safeguard the patients interests (Chin).
Another issue that surrounds biobanks and the Informed Consent process is the use of blanket consenting processes and the inability to provide patients with a clear picture of how their biospecimens will be utilized in research studies. According to Rothstein, this form of “blanket consent” is sufficient for biobanks as many steps are taken to de-identify samples and ensure that all health information is protected. Since the research conducted on the patient’s specimen has no effect, neither positive nor negative, on the patient it is thought that this consent model is adequate to ensure the protection of participants and maintain the integrity of the informed consent process (Rothstein). However, De Vries et al. found that non-welfare interest influence the willingness of individuals to participate in biobank donation (De Vries). The idea is that while patients are willing to consent to research about which they have no information, they still feel strongly about the methods that will be used to conduct the research. The study conducted by De Vries et al. examining the effect non-welfare interests has on willingness to participate in biobanking activities found that these non-welfare interests are very important to individuals, and could ultimately result in their unwillingness to donate to the biobank (De Vries).
While a vast amount of research has been centered around the patient’s understanding of the informed consent, the development of an ethical informed consent form and the patient’s awareness of biobanking and its place in scientific research, little to no research has been done on what motivates individuals to participate in biobanking – both hypothetically and when approached in real-life by a Biorepository staff member. It is important to understand these motivations for participation, as it has been found that of the biobanks in the United States, 75% utilize direct contribution while 57% of the biobanks utilize residual specimens. Additionally, 41% of the biobanks in the United States utilize specimens from both sources (L’Heureux).
Another concern that often arises when considering the Informed Consent process utilized by biobanks are the ideas of altruism and the sense of duty that patients might feel. According to a study conducted by Spruill examining the attitude of focus group participants regarding participating in biobanking, a common theme in the reasoning for agreeing to participate in research was the idea of “I can help someone” (Spruill). Additionally, Pellegrini et al. conducted a study in which they interviewed cancer patients regarding their motivations to participate in biobanking. Pellegrini reported that the two main motivating factors that caused them to be agreeable to participation were making a contribution to scientific research and the opportunity to help others (Pellegrini). However, there is also the concern that the patient is reluctant to decline participation when consented in-person. This presents a current gap in literature, as many of the studies that have been performed investigating this topic of interest are conducted in hypothetical situations. It is possible that a patient might be more likely to state that they would decline participation when they are not actually being asked to participate and therefore do not feel the pressures that could possibly occur in a real-world situation.
The ProMedica Biorepository (PBR), located in Toledo, Ohio, is a hospital-integrated biorepository without an academic affiliation. The PBR, like many other biorepositories, functions in two ways. First, through the collection of expired tissue and specimens that are past their retention period. The use of these specimens does not require the informed consent process. The other function of the PBR is to actively identify patients who are having tissue removed that is of interest, obtaining the patient’s consent and ultimately collecting tissue and blood from that patient for the sole purpose of participating in clinical research. It is often found that patients have concerns regarding the informed consent process, are unwilling to participate or are simply not interested in learning more about the ProMedica Biorepository. In order to grow, the ProMedica Biorepository will need to continue consenting patients, possibly even move towards consenting more patients than usual in the future. To do this, it is vital to understand the motivations of potential participants, identify possible factors that would increase the patient’s hesitation to participate, and develop plans and/or solutions to improve the transparency between the PBR and the patients that consent to participate in biorepository research.
Specific Aims / Objectives
The purpose of this pilot study is to ascertain the motivations that lead individuals to be willing to participate in the biorepository specimen collection process.
The specific aims of this pilot project are:
1. To ascertain both the willingness of individuals to participate in the ProMedica Biorepository as well as the motivations that lead the individuals to that decision.
2. To ascertain both the willingness of individuals as well as their motivation to hypothetically participate in a biorepository.
3. Establish trends among different sociodemographic factors that could relate to willingness to participate in biobanking.
4. To compare the results of the survey from both population groups and disseminate any possible connections or correlation between the two groups.
Study Design
This study is twofold in that a survey will be utilized to collect data from two different populations to achieve the objectives and aims of this study. The survey used in each of the populations will be identical, containing questions that will allow for the collection of both quantitative as well as qualitative data. In addition, the questions will be composed in such a way to prevent the likelihood of variability in survey responses limiting the data analysis results. This will be accomplished by utilizing a majority of questions which do not allow for an open-ended response. Rather, the participant will be required to select one option from a list of choices. There will be one question that allows the participant to respond freely in an open-ended question format. After consenting to participate, each participant will be given a unique identifier code which will replace their identifying information. No record will be kept of the individual’s personal information including their name, date of birth, medical record number, etc. Additionally, at no time will a PBR staff member enter the participant’s chart for the purpose of gathering personal health information to be used in this study. There will be two arms to this study:
1. Group 1: The Hypothetical Population – these patients who will be surveyed are not actual candidates for the ProMedica Biorepository. When these individuals are surveyed, they will not be asked to actually commit to participation, therefore they will feel free to respond as they wish without feeling any unintentional pressure or sense of duty.
2. Group 2: The Actual Patient Population – these patients are those who will be surveyed at the time of their pre-admission testing appointment, the time at which the ProMedica Biorepository staff will perform their informed consent process for participation in the biobank.
The survey utilized in this study will consist of two parts. The first portion of the survey will be used to collect information relating to various sociodemographic factors. None of the information gathered throughout the survey will contain any identifying information. Furthermore, no records will be kept matching the unique identifiers to the participant’s information. The survey will be anonymous. The second portion of the survey will be used to identify potential motivations for willingness to participate in the biorepository. See Appendix A for a copy of the study survey which will be utilized in this study.
Setting
As mentioned previously, this pilot study will be carried out by the staff of the ProMedica Biorepository, which is located in Toledo, Ohio. The ProMedica Biorepository is a member of the ProMedica Health System, thus granting the biobank access to thousands of patients, surgeries and blood/tissue specimens from within the system. The PBR operates by identifying patients of interest who will be having surgery at ProMedica Toledo Hospital, visiting these individuals at their pre-admission testing appointment prior to the day of surgery to perform the informed consent process. If the patient consents to participate in this process, the PBR staff then is able to collect tissue, blood or both tissue and blood on the day of the patient’s surgery.
This study has two separate groups, the Hypothetical Population and the Actual Patient Population, who will receive an identical survey. For the purposes of this study, the survey will be administered to individuals during their PAT appointment for those who belong to the Actual Patient Population, while those individuals who are part of the Hypothetical Population will be surveyed randomly at various physician offices across the ProMedica Health System. For the surveys that are administered at the physician offices, these surveys will be given after the patient has checked-in but before they see the physician and/or nurse. This will minimize any inconvenience to the selected patients as it will not result in time added to their appointment length or any type of delays.
Population / Sampling Method
This study will consist of two, separate populations. Group 1 will be made up of individuals who are selected randomly. The PBR staff member will connect with 5 different ProMedica physicians from various specialties who are located in Toledo, Ohio. The staff member will arrange to spend the day in each physician’s office, surveying patients as they arrive for their doctor appointments. No information will be known about the type of patients who will be seen at that day’s visit, patients who arrive during the designated time period will be randomly chosen and surveyed as the PBR staff member is available. This process will continue until 30 subjects have consented and completed the survey. The PBR staff member will collect surveys from 30 subjects a day, with surveys being completed for 5 days at 5 different ProMedica Physician offices. There will be a total sample size of 150 subjects for Group 1. For Group 1 the following inclusion/exclusion criteria will apply:
Inclusion Criteria
1. Adults, male or female, 18 years old or greater
2. Able to speak and read English without assistance of a translator
3. Verbally consent to participate in IRB-approved research study
Exclusion Criteria
1. Individuals under the age of 18 years old
2. Individuals who are unable to speak/read English without the assistance of a translator
3. Individuals who are pregnant
4. Individuals who are unable to make medical decisions for themselves
5. Individuals who fail to answer each of the questions listed on the survey
Group 2 will be made up of individuals who have already been identified for participation in the ProMedica Biorepository. The prospective subjects in this group will be the same patients who would normally be selected for biobank consent. The PBR staff will collect surveys during all scheduled Biobank consents until a total of 150 surveys has been collected. For Group 2 the following inclusion/exclusion criteria will apply:
Inclusion Criteria
1. Adults, male or female, 18 years old or greater
2. Able to speak and read English without assistance of a translator
3. Verbally consent to participate in IRB-approved research study
4. Individuals must be under the care of a PBR Approved Physician (Will attach)
5. Individuals must be having a surgery/procedure that will yield blood/tissue specimens that are of interest to the PBR.
6. Individuals must consent to participate in the PBR after the survey has been completed if they indicated willingness to participate.
Exclusion Criteria
1. Individuals under the age of 18 years old
2. Individuals who are pregnant
3. Individuals who are unable to speak/read English without the assistance of a translator
4. Individuals who are unable to make medical decisions for themselves
5. Individuals who are under the care of a non-PBR Approved Physician
6. Individuals who fail to answer each of the questions listed on the survey
7. Individuals who elected to decline participation in the PBR, but who have completed the survey and indicated a willingness to participate.
Procedures
Group 1 – The Hypothetical Patient Population
PBR staff member will greet the patient, introduce themselves and give the prospective subject a copy of the Informed Consent Form (Appendix B). The PBR staff member will then obtain the patient’s verbal consent for participation in the study. Each patient who consents will be given a unique identifier which will be used in place of any protected health information throughout the study. The PBR staff member will not record any identifying information from the patient, only the unique ID number will be used and recorded on the survey. After consent has been obtained, the PBR staff member will provide the subject with instructions and a basic summary of the biobank. Next, the PBR staff member will provide the subject with the PBR Biobank Brochure and Informed Consent Document (Appendices E-F), giving the subject ample time to read all of the included information. Once this is finished, and the subject has verbally signaled that they are ready to proceed, the PBR staff member will then provide the subject with the study survey seen in Appendix A. Again, the subject will be given ample time to read and complete the survey. Upon the completion of the survey, the subject will return the materials to the PBR staff member, who will conclude the interview.
Group 2 – The Actual Patient Population
The PBR staff member will make their way to the Pre-Admission Testing department when called, to speak with the patients who are scheduled to be consented that day. Upon entering the room, the PBR staff member will greet the patient, introduce themselves and provide the patient with the purpose of the meeting and the events that will occur. Of note, the PBR staff member will explain to the patient that the survey and the actual biobank consent are two separate processes, and that the survey must be completed prior to the biobank consent. The PBR staff member will give the prospective subject a copy of the Informed Consent Form (Appendix C) and obtain the patient’s verbal consent for participation in the study. Each patient who consents will be given a unique identifier, different from the one assigned by the PBR, which will be used in place of any names or other PHI throughout the study. After consent has been obtained, the PBR staff member will provide the subject with survey instructions as well as a basic summary of the biobank. Next, the PBR staff member will provide the subject with the PBR Biobank Brochure and Informed Consent document, giving the subject ample time to read all of the included information. Once this is finished, and the subject has verbally signaled that they are ready to proceed, the PBR staff member will then provide the subject with the study survey. Again, the subject will be given ample time to read and complete the survey. Upon the completion of the survey, the subject will return the materials to the PBR staff member. At this time, the staff member will then proceed with the normally scheduled Biobank consent process. If the participant indicates on the survey that they would be willing to participate in the biorepository, but later decline to participate during the actual biorepository consent, that individual and their survey results will be excluded from the study. This contradiction raises questions concerning the validity of their responses and could potentially harm the quality of the study data.
Post-Survey Procedures
The surveys will be transcribed into an Excel spreadsheet. For Group 1, this process will occur after each site visit, once 30 surveys have been collected. For Group 2, this process will occur on a weekly basis. The PBR staff member will enter the information into the Excel spreadsheet, which will be saved on a secure, private drive specifically for the PBR. A PBR staff member, one who did not perform the consent process, will perform data checks, ensuring that all data points were logged correctly. Once all 300 surveys have been collected (150 from Group 1, 150 from Group 2), the verified spreadsheet containing all of the study data will be sent to a biostatistician for data analysis. The original, hard-copy surveys will be maintained in the PBR office, contained in a locked drawer for the duration of the study.
Institutional Review Board Approval
This study will require IRB approval via expedited review prior to the start of the study. As there is minimal risk associated with this study, the application will request a waiver of the signature on the consent form. Verbal consent will instead be obtained prior to beginning the study, and only those participants who verbally consent to participate will be allowed to answer the survey questions. Group 1 can be considered exempt from IRB approval due to the fact that no identifying information will be recorded regarding the participants and all surveys will be anonymous, coded with a unique ID to prevent data duplication. IRB approval will still be obtained since it is a requirement for the population of Group 2. Expedited review will be requested as the ProMedica Biorepository already operates under a ProMedica IRB approved protocol. A copy of the Informed Consent document which will be utilized for this study can be found in Appendix B.
Measures
This study is examining individual’s motivations to participate in biobanking. The sole instrument for study measurements will be the study survey found in Appendix A. This survey is taken by the participant without assistance from the PBR staff member, assuming no questions arise regarding the wording of the questions. The survey will ask participants to report various sociodemographic factors as well the incidence of cancer in either the individual’s personal or family history. In addition, questions will be asked regarding prior participation in clinical research, as well as willingness to participate in biobanking. Each of these questions will have a limited data set from which the participant will have to make their selection. The final question of the survey will be open-ended, allowing participants to write freely whatever they would like. This survey is taken once, with no follow-up of any kind. To ensure the validity of the data collected from each participant, the PBR staff member will provide the same instructions to each participant. There will be some variations between the population groups due to the need to address the actual biobank consent that will happen after the survey is completed in Group 2. Additionally, the PBR staff member will remain in the room with the participant throughout the duration of the study to ensure that the most accurate answers are recorded.
Data Analysis
Descriptive and correlational statistics will be utilized to disseminate the information contained within the survey, excluding the open-ended questions. In addition, differences between the two population groups will be examined. Particularly, we will draw comparisons between the two population groups regarding their willingness to participate, family history of cancer, personal history of cancer, history of participating in research, income level and education level. The open-ended question of, “What are the reasons that would lead you to agree/ disagree to participate in the biorepository?” will be transcribed word for word into the Excel spreadsheet and then grouped according to similar responses between the participants. After all responses have been entered, a PBR staff member will code the responses in a way that similar responses will be grouped together for better data analysis (Spruill). Once this completed, statistical analysis will be performed on this survey response as well, similar to the statistical analysis conducted for the rest of the survey.
Study Limitations
There are a few potential limitations of this study. First, all subjects are recruited from the same health system in Toledo, Ohio. This creates the possibility that the data collected may be different in other regions of the country and/or world. Another possible limitation is the uncertainty regarding the cause of the differences between the response obtained from the two population groups. It is possible that the participants in the hypothetical population group may have not paid as close of attention or considered it as seriously as the participants in the actual population group might have.
Human Subjects Concerns
This study involves a large number of patients, with 300 total surveys being collected. The population from which these patients are taken do not involve any vulnerable populations such as pregnant women, individuals under the age of 18 or prisoners. This study involves very little concern regarding Human Subject protection and confidentiality. No private health information is collected from the study participants aside from the content collected in the survey. Additionally, no patient identifiers are collected, rather a unique, random identifier code is used to differentiate responses and prevent data duplication. This study will not require the PBR staff to view the patient’s medical information for any purpose pertaining to this specific study.