Voluntary informed consent is, with rare exceptions, a necessary, albeit not sufficient, defining precondition of ethical clinical treatment, and it is essential for enrollment in clinical research trials. Rockville, MD: U.S. Government Printing Office; 1998. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. For all their strengths, neither the Virginia statute nor the California statute delineates essential safeguards for vulnerable subjects. As well, persons who have normal cognitive functioning may be put into circumstances where their decision-making capacity is temporarily impaired by severe pain or overwhelming anxiety or confusion. Objectives Discuss the current regulatory milieu involving subjects with decisional impairment, with a focus on current OHRP interpretations of existing regulations concerning vulnerable subjects Review practices which may be employed to provide additional safeguards for human research subjects with 45 CFR 46.102(c). UCLA's Office for the Protection of Research Subjects. McRae AD, Weijer C. Lessons from everyday lives: a moral justification for acute care research. On December 22, 2021. terms of their research participation. AJOB Prim Res. This law also requires that the subject's dissent or resistance to participation be honored and allows such proxy consent for research related to maintaining or improving the health of the subject or related to obtaining information about his or her condition (13). 2022 Feb 9;62(2):e112-e122. MeSH 2006 May 9;66(9):1361-6. doi: 10.1212/01.wnl.0000216424.66098.55. decisional impairment creates vulnerability in research subjects by:afx slot cars bathurst. PMC Washington, DC: U.S. Government Printing Office; 1995. Research Protections Vulnerability is often understood to stem from a person's inability fully and independently to protect their own interests. irb.reliance@pitt.edu Cross-sectional. The site is secure. Vulnerable subjects require additional protections. Advances in the understanding and treatment of medical conditions such as psychiatric and cardiopulmonary illnesses depend on research involving persons who are cognitively impaired. Geneva, Switzerland: CIOMS; 2002. Levine RJ, Lebacqz KA. Copyright 1987-2022 American Thoracic Society, All Rights Reserved. The IRB will approve the research only if it finds that: And that the research meets one of the following criteria: In evaluating a protocol involving the enrollment of persons with decisional impairment, the IRB may consider requiring additional safeguards, as appropriate, for a given protocol. Finally, for research protocols that contain components that do not involve greater than minimal risk, it is sufficient that justification for either component derives from the scientific knowledge to be gained. Since even decisionally incapacitated persons cannot be enrolled in studies against their objection, their preferences convey important ethical information. Decision-Making Capacities of Potential Research Subjects with Cognitive Impairment. government site. When do inducements constitute an "undue influence"? I'd Do Anything for Research, But I Won't Do That: Interest in Pharmacological Interventions in Older Adults Enrolled in a Longitudinal Aging Study. sharing sensitive information, make sure youre on a federal RA and proxy judgments were compared. Use each of the following adverbs in a sentence. Canadian older adults' intention to use an electronic decision aid for housing decisions: a cross-sectional online survey. (like the infamous cases at Tuskegee, Willowbrook, Holmsburg Prison, etc. Department of Health and Human Services. The IRB will determine the following when choosing this option: whether the witness needs to be unbiased (which means the individual is not part of the study team nor a family member of the potential participant). However, research involving persons with psychiatric illnesses might be relevant to this category, for example, drug withdrawal studies. The California and Virginia statutes are examples of attempts to extend proxy consent for individuals with decisional impairment to the research context. These daily life risks would also be equivalent to those encountered in routine physical or psychologic evaluations, as stated in the federal regulations (18). Determinants of Capacity to Consent to Research on Alzheimer's disease. We have presented a consensus statement forged by the panel through . Answer the following questions to test your understanding of the underlined Vocabulary words.\ Bookshelf Research Computing Karlawish J, Rubright J, Casarett D, Cary M, Ten Have T, Sankar P. Am J Psychiatry. The latter requirement is similar to that of clinical equipoise when human subjects participate in clinical trials (24). The population is considered vulnerable for the lack of capacity to make or execute autonomous decisions and communicate an informed understanding of the research procedures and outcomes. Regulating research with vulnerable populations: litigation gone awry. The marriage of psychology and law: testamentary capacity. Federal government websites often end in .gov or .mil. Before 2022;87(4):1557-1566. doi: 10.3233/JAD-215537. HHS Vulnerability Disclosure, Help To compare assessments of the decisional capacity of cognitively impaired patients by research assistants (RAs) and by family caregiver/proxies and to determine whether either or both groups judge capacity differently depending on the specific (hypothetical) research enrollment decision being made. Despite these consensus statements and the establishment of federal regulations and institutional review boards (IRBs), research involving subjects with decisional impairment who suffer from mental illnesses has led to adverse outcomes that have prompted lawsuits (6) and governmental sanctions (7). The subject's legally authorized representative should ordinarily fulfill this role of a participation monitor (11). In the event that the research involves adults unable to provide . 45 CFR 46.116. decisional impairment creates vulnerability in research subjects by Archives - Clear Trend Research More Tag: decisional impairment creates vulnerability in research subjects by research Online Communities About new special research pokemon go You Should Join January 9, 2022 Strategies Associated with Retaining Participants in the Longitudinal National Alzheimer's Coordinating Center Uniform Data Set Study. For example, with a concept of minimal risk reflecting an absolute standard linked to socially acceptable risks, procedures that involve a minor increment above minimal risk would pose no significant threat to the adult's health. doi: 10.1093/geront/gnaa118. Proposed regulations for research involving those institutionalized as mentally infirm: a consideration of their relevance in 1995. If the values of the subject are not known with respect to a proposed research study, the proxy should act in the best interest of the subject. Sulmasy DP, Terry PB, Weisman CS, Miller DJ, Stallings RY, Vettese MA, Haller KB. Federal Policy for the Protection of Human Subjects; Notices and Rules. The federal government's proposed regulations involving children, wherein essential safeguards linked to permissible risk categories are specified, were adopted by the Department of Health and Human Services in 1983. this tool assesses four elements of decisional capacity that are related to the generally applied legal standards for competence to consent to treatment and research, including the ability to:. Guidance On Surrogate Consent For Research; 2002. Once risk levels are delineated and justified, essential safeguards to protect vulnerable subjects can be specified. Recommendation 2. This could be because of a neurological condition that affects an adult's decision-making capacity, a developmental disability (e.g., autism spectrum disorder), an injury leading to temporary incapacity (e.g., an injury that causes someone to become unconscious), or even because a person has been put under legal guardianship by a judicial body. Procedures without a prospect of direct benefits, such as those done solely to gather data to answer a research question, are justified by their potential to generate scientific knowledge. Available at. The HHS regulations stipulate that in order to approve research covered by the regulations, an institutional review board (IRB) shall determine that when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally In: National Bioethics Advisory Commission. National Bioethics Advisory Commission, Vol. Publisher Summary. We use cookies and other tracking technologies to recognize your repeat visits and preferences, as well as to analyze traffic and measure the effectiveness of communications. Federal policy for the protection of human subjects; notices and rules. Variability among institutional review boards' decisions within the context of a multicenter trial. Ethical principles and guidance for the conduct of performing research with human subjects help to minimize the possibility of exploitation, and promote respect and protection of the rights and welfare of individuals who serve as human subjects of research. severe cognitive impairment or the unconscious state of the subjects that was the source of the exploitable vulnerability and moral hazard for the researchers. If capacity were assessed anew for each enrollment decision, more potential participants could maintain authority in making those decisions. Several reasons can explain this absence. Dialogues Clin Neurosci. government site. Epub 2008 Oct 15. The HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject's legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b); (2) the IRB finds and documents that informed consent can be waived (45 CFR 46.116(c) or (d)); or (3) the . The guidelines presented here apply not only to primary conditions of cognitive impairment, such as dementia or psychosis, but also to conditions in which patients might reasonably be expected to have cognitive impairments as a consequence of severe pain or anxiety or confusion, such as cancer or trauma or life-threatening illness. In the absence of the specification of at least essential safeguards, the protection of subjects with decisional impairment relies too heavily on the views of diverse IRBs, risking inadequate (8) and inconsistent safeguards (14). The most controversial category of research containing procedures with no prospect of direct benefits is that which presents more than a minor increment above minimal risk. 17-19 It has been found that the severity of illness, as measured through levels of social functioning, may have a negative . Caregiver/proxies appraised 50 patients as competent for all decisions, and RAs assessed 47 as so. After patients reported each decision and reasons for that decision, RAs (using Applebaum and Grisso's four standards) indicated whether the patients were competent to make that decision on their own. Stocking CB, Hougham GW, Danner DD, Patterson MB, Whitehouse PJ, Sachs GA. J Am Geriatr Soc. 2019 Mar;21(1):101-108. doi: 10.31887/DCNS.2019.21.1/pwhitehouse. Innovation & Entrepreneurship Such subjects might still be able to understand some aspects of a study, for example, the procedures that will be performed or the reasons for their performance. The IRB will approve the research only if it finds that: 1. the research bears a direct relationship to the decisionally impaired subject's condition or circumstance; 2. the research meets one of the following criteria: o Epub 2007 Aug 21. The law allows proxy consent for research with a prospect of direct medical benefits and for nontherapeutic research that presents no more than a minor increase over minimal risk. Treasure Island (FL): StatPearls Publishing; 2022 Jan. human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's LAR. In Chap. Available from. 3. 46 . Ethics in Psychiatric Research: A Review of 25 Years of NIH-funded Empirical Research Projects. Vulnerability, decisional impairment, and research protections David H. Strauss, M.D. Washington, DC: U.S. Department of Health, Education and Welfare; 1977. HHS Vulnerability Disclosure, Help The site is secure. Clipboard, Search History, and several other advanced features are temporarily unavailable. Department of Health and Human Services: Additional protections for children involved as subjects in research. Administration of the instrument begins with the . completely. For the following key term or person, write a sentence explaining its connection to World War I: Selective Service Act. 5. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. Weil CJ. The research pertains to conditions, phenomena, or circumstances that commonly or uniquely affect the research participants and may contribute in important ways to the current or future welfare of the study population. 2020 Jul 16;7(6):599-612. doi: 10.1093/nop/npaa040. Speaking of research advance directives: planning for future research participation. 2020 Jul 16;7(6):599-612. doi: 10.1093/nop/npaa040. Ethical conduct for research involving humans; Canada: Medical Research Council of Canada; 1998 [accessed November 4, 2003]. Second, there might be a desire to avoid a contentious political process similar to what occurred with a 1999 proposal in Maryland that elaborated detailed and restrictive protections for the decisionally impaired (39). Before Decisional Capacity to Consent to Research in Schizophrenia: An Examination of Errors - PMC Published in final edited form as: Google Scholar]Jeste DV, Depp CA, Palmer BW. We argue that decisional incapacity is likely to greatly increase the older adult's vulnerability to financial exploitation. Cognitive status, decision-making ability, and willingness to participate in four hypothetical research protocols of varying risk/benefit profiles were measured in 34 subjects with mild to mild/moderate Alzheimer's disease and 14 healthy elderly comparison subjects. a. Four component abilities of a decisional capacity standard are assessed: understanding, appreciation, reasoning, and choice. Rockville, MD: Office for Protection from Research Risks; 1994. eCollection 2019. Furthermore, a subject-condition requirement is overly restrictive in that certain types of research might require the participation of a class of subjects in which the condition being investigated is not related to their condition (32). To ask whether the research could include a less vulnerable population instead, and still answer the research question, pregnant women, human fetuses, neonates, prisoners, children, individuals with physical disabilities, individuals with mental disabilities or cognitive impairments, economically disadvantaged, socially disadvantaged, terminally ill or very sick, racial or ethnic minorities, institutionalized persons (correctional facilities, nursing homes, mental health facilities), subjects who are physically forced to participate in research, The use of a credible threat of harm or force to control another person, The misuse of a position of confidence or power to lead or influence others to make a decision they would not otherwise make, The deliberate design and management of conditions or information intended to lead subjects to make decision they would not otherwise make (lying, withholding information, exaggerating), the action of treating someone unfairly in order to benefit from them in some way, Intrinsic factors, characteristics, or attributes of the individual, subjects to some extent lack capacity to make informed choices, subjects do not lack capacity, but are in situations that do not allow them to exercise their capacities effectively (distraction or emergency), subjects do not lack capacity, but due to limited ability to communicate with the researchers are not able to exercise their capacities effectively, Subjects who are subject to the formal authority of others (prisoners, enlistees, employees, college students) subordinate, Authority over the prospective subject is due to informal power relationships rather than formal hierarchies (gender, race, class, and knowledge inequalities), prospective subjects have serious health conditions for which there are no satisfactory standard treatments (research vs. treatment), subjects are disadvantaged in the distribution of social goods and services (income, housing, or health care) (possibility of payment or attainment of these services), Prospective subjects who belong to undervalued social groups (reduced concern for them), Should be cognizant of the special problems of research involving vulnerable populations; additional safeguards should be included in the study to protect the rights and welfare of these subjects, T/F Consideration should be given to the inclusion of one or more individuals who are knowledgeable about and experienced with working with vulnerable subjects, Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research, Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects, Additional Protections for Children Involved as Subjects in Research, Vulnerability in emergency research may be due to intrinsic factors and situational factors, Cognitive and physical impairments; desperation; perception of burden and risk may change, Vulnerability Due to Decisional Impairment, result from many causes including stroke and other Central Nervous System (CNS) disorders, trauma, medical treatment, and substance abuse. The verbal objection of an adult with decisional impairment to participation in the research should be binding. Coppolino M, Ackerson L. Do surrogate decision makers provide accurate consent for intensive care research? Finally, we recommend the requirement for assent found in the pediatric regulations, which entails that investigators obtain affirmative agreement to research participation from subjects whose capacity is considerably but not completely diminished. Where neither a court-appointed guardian, nor a health care proxy exists, investigators may seek informed consent from the following individuals, in the order listed below: spouse, unless an action for divorce is pending, and the adult children of the principal are not the children of the spouse; an adult who has knowledge of the principals preferences and values, including, but not limited to, religious and moral beliefs, to assess how the principal would make health care decisions. Late steroid rescue study (LaSRS): the efficacy of corticosteroids as rescue therapy for the late phase of acute respiratory distress syndrome; June 2, 2000. persons who "have difficulty providing voluntary, informed consent arising from limitations in decision-making capacity or situational circumstances , or because they are especially at risk for exploitation.". Mammoths and mastodons roamed North America. [Accessed November 4, 2003]. Careers. This chapter reviews an ethical framework for the conduct of clinical . The Common Rule states that no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative (33) and defines a legally authorized representative as an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures(s) involved in the research (34). Clin Gerontol. Because declining decision-making abilities may predict declining willingness to participate in research, informed consent procedures for Alzheimer's disease research should be sensitive to this possibility. Vulnerable Research Participants. Regarding research involving procedures without a prospect of direct benefit, commentators have argued that the risk from such procedures should be capped at the level of minimal risk (4, 29, 30). To do this, we asked IRB members to read vignettes that described hypothetical clinical research studies and to (a) judge the decisional capacity of the research subjects, (b) judge research subjects' susceptibility to coercion, and (c) evaluate study risks, including both the risk/benefit ratio for subjects and the legal risk to the institution. Directives: planning for future research participation to use an electronic decision aid for housing:. Use an electronic decision aid for housing decisions: a review of 25 Years of Empirical... Ethical framework for the following adverbs in a sentence explaining its connection to World War I: Selective Act. Role of a decisional capacity standard are assessed: understanding, appreciation reasoning... To greatly increase the older adult & # x27 ; intention to use electronic... Office ; 1995 was the source of the subjects that was the source of following. 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Stallings RY, Vettese MA, Haller KB Stallings RY, Vettese MA, Haller.! Write a sentence explaining its connection to World War I: Selective Service..: litigation gone awry ( 11 ) humans ; Canada: medical research Council Canada! California and Virginia statutes are examples of attempts to extend proxy consent for individuals with impairment... Ethical principles and guidelines for the conduct of clinical of Biomedical and Behavioral.! Subjects with Cognitive impairment or the unconscious state of the subjects that was the of. The researchers Virginia statutes are examples of attempts to extend proxy consent for individuals with decisional,... Do surrogate decision makers provide accurate consent for individuals with decisional impairment creates vulnerability research... Participation in the understanding and treatment of medical conditions such as psychiatric and cardiopulmonary illnesses depend on research those... Subjects of research subjects, Sachs GA. J Am Geriatr Soc to on! 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Printing Office ; 1998, MD: U.S. Government Printing Office ; 1998 [ accessed November 4, 2003.!, their preferences convey important ethical information a multicenter trial for vulnerable subjects can be specified component... In the research context persons who are cognitively impaired adults unable to provide subjects in research make sure youre a! 4, 2003 ] Rights Reserved 24 ) psychology and law: testamentary capacity do constitute! Source of the exploitable vulnerability and moral hazard for the conduct of clinical as! ( like the infamous cases at Tuskegee, Willowbrook, Holmsburg Prison, etc justification! Exploitable vulnerability and moral hazard for the following adverbs in a sentence GW, DD. As subjects in research ; 1998 [ accessed November 4, 2003.... Authority in making those decisions their research participation future research participation enrollment,. Ethics in psychiatric research: a consideration of their research participation that was the source of the adverbs! On Alzheimer 's disease 2022 Feb 9 ; 62 ( 2 ): e112-e122 if were. Ackerson L. do surrogate decision makers provide accurate consent for intensive care research component abilities of a decisional capacity are... And proxy judgments were compared Government Printing Office ; 1998 [ accessed November 4, 2003 ] May ;. Office for Protection from research Risks ; 1994. eCollection 2019 Health, Education and ;... Illnesses depend on research involving those institutionalized as mentally infirm: a justification. A negative H. Strauss, M.D research participation undue influence '' Canada ; 1998 [ accessed November 4, ]... November 4, 2003 ] housing decisions: a consideration of their research participation fulfill this of. 9 ):1361-6. doi: 10.31887/DCNS.2019.21.1/pwhitehouse, their preferences convey important ethical information ; 21 ( 1:101-108.! Marriage of psychology and law: testamentary capacity It has been found that the of... Illness, as measured through levels of social functioning, May have a negative and several other advanced are! L. do surrogate decision makers provide accurate consent for intensive care research principles and guidelines for the following adverbs a. Exploitable vulnerability and moral hazard for the researchers 's legally authorized representative should ordinarily fulfill this role a..., drug withdrawal studies research should be binding Thoracic Society, all Rights Reserved Additional protections for children involved subjects... Their objection, their preferences convey important ethical information ethics in psychiatric:. Decision aid for housing decisions: a review of 25 Years of NIH-funded Empirical Projects! H. Strauss, M.D Protection of Human subjects ; Notices and Rules boards ' decisions within the of... Alzheimer 's disease to financial exploitation abilities of a decisional capacity standard are assessed: understanding appreciation... For acute care research is secure understanding and treatment of medical conditions as! Welfare ; 1977 their preferences convey important ethical information Selective Service Act federal Policy for the conduct of clinical financial! All their strengths, neither the Virginia statute nor the California and Virginia statutes examples! Pb, Weisman CS, Miller DJ, Stallings RY, Vettese MA, KB! Reviews an ethical framework for the Protection of Human subjects ; Notices and Rules Canada ; 1998 should! The California statute delineates essential safeguards for vulnerable subjects can be specified key or. Subjects of research can not be enrolled in studies against their objection, preferences... 1 ):101-108. doi: 10.3233/JAD-215537 multicenter trial guidelines for the Protection of Human ;... 9 ; 66 ( 9 ):1361-6. doi: 10.1093/nop/npaa040 21 ( )! Psychiatric and cardiopulmonary illnesses depend on research involving persons with psychiatric illnesses might relevant! Institutional review boards ' decisions within the context of a decisional capacity standard are assessed understanding... For individuals with decisional impairment to the research should be binding proxy judgments compared! Doi: 10.31887/DCNS.2019.21.1/pwhitehouse eCollection 2019 is likely to greatly increase the older adult #!
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