PEDIATRICS Vol. 110 No. 3 September 2002, pp. 577-582
National Practices Regarding Payment to Research Subjects for Participating in Pediatric Research
* Departments of Pediatric Critical Care, Bioethics, and Education, Cleveland Clinic Foundation, Cleveland, Ohio
University of Texas, M. D. Anderson Cancer Center, Houston, Texas
 |
ABSTRACT |
|---|
 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
|---|
Objective. Payment to subjects for participation in research is reportedly common, but no published data documents the nature of this practice. Institutional review boards (IRBs) are responsible for ensuring both the safety and voluntary participation of research subjects, yet guidance from federal and expert pediatric sources regarding appropriate payment approaches is conflicting. Ethical issues of payment for participation of adult versus pediatric research subjects may differ. This empirical study sought to examine current payment practices for participation in pediatric research as reported by IRBs.
Design. An 18-question survey regarding payment practices for participation in pediatric research was sent to IRB chairs at member institutions of the National Association of Children’s Hospitals and Related Institutions, and to a systematic random sample of IRB chairs listed with the Office for Protection From Research Risks. Descriptive, nonparametric, and qualitative analyses were used to describe institution types, payment practices, and correlations among responses.
Results. Data from 128 institutions that conduct pediatric research revealed that payment for participation in pediatric research was allowed by 66% of responding institutions, and practices varied widely among institutions. Most responding IRBs that allowed payment required disclosure of payment before enrollment (during the consent process), following federal guidelines more closely than American Academy of Pediatrics guidelines. An IRB’s perception of potential benefits or harms of a study correlated with the amount of payment approved.
Conclusions. IRBs must balance the need to recruit pediatric research subjects against the risk of undue influence during the recruitment process. Federal guidelines and expert pediatric opinion differ in recommendations regarding payment; responding IRBs appeared to follow federal guidelines more closely than guidelines proposed by the American Academy of Pediatrics.
Key Words: pediatric research • compensation • institutional review boards • recruitment • payment • ethics
Abbreviations: FDA, Food and Drug Administration • IRB, institutional review board • OPRR, Office for Protection From Research Risks • AAP, American Academy of Pediatrics • NACHRI, National Association of Children’s Hospitals and Related Institutions
|
INTRODUCTION |
|---|
|
TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
|---|
Payment to research subjects is reportedly a common practice in the United States,1–3 although no empirical data have been published documenting the nature and extent of this practice. Thus, little is known about the amount, method, or timing of payment to subjects who agree to enroll in clinical research.
Federal regulations on human subjects research lack specific guidelines regarding payment for participation in biomedical and behavioral research. Food and Drug Administration (FDA) information sheets for institutional review boards (IRBs)2 state that "the IRB should review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence." Guidance from the Office for Protection From Research Risks (OPRR) specifies that IRBs are responsible for ensuring that a subject’s decision to participate in a study is fully voluntary, and that consent will be sought "only under circumstances that provide the prospective subject... sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence."4 IRBs are not given more detailed guidelines for judging what constitutes coercion or undue influence.
Several authors have discussed potential ethical implications of payment for participation in research.5–8 Dickert and Grady8 acknowledge that payment can be coercive to adult research subjects and have outlined possible models of payment that might minimize undue influence of compensation. Experts who have written about enrollment of children in research note that payment may be particularly ethically problematic in this context.5,9 The American Academy of Pediatrics (AAP) states that "serious ethical questions arise when payment is offered to adults acting on behalf of minors in return for allowing minors to participate as research subjects." They recommend that payment be limited to a token gesture of appreciation for participation, and that if payment is for reimbursement for costs of participation, that it is fair and does not become an inducement.9 The AAP further recommends that if a child will be the recipient of payment, discussion of payment should occur after study completion to prevent it from becoming an inducement for the child or parent. The timing of discussion of payment endorsed by the AAP conflicts with federal guidelines, which recommend that compensation should be discussed during the informed consent process.1,2
Our study was designed to provide information about current payment practices for enrollment of children in research. The goals were to 1) document the types of and extent to which formal policies shape payment practices for enrollment of child research subjects, 2) determine general payment practices for IRB-approved research protocols using pediatric research subjects, and 3) determine whether the characteristics of IRBs or their corresponding institutions affect IRB decision-making about payment practices. This study represents the first publication of systematically collected data on payment practices for enrollment of child research subjects, providing a basis for discussion of potential ethical problems in this area. During an era in which federal initiatives encourage the involvement of children in research, our findings highlight the need for additional research and discussion of payment practices that promote the protection of pediatric subjects.10
|
METHODS |
|---|
|
TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
|---|
Questionnaires were addressed to IRB chairpersons at 624 institutions. Each chair was asked to complete the questionnaire, or to have it completed by "the person connected to [the] IRB who [could] best answer the survey questions." One set included IRBs at the 161 member institutions of the National Association of Children’s Hospitals and Related Institutions (NACHRI). A second set of 444 IRBs was obtained by systematic random sampling from a listing of
4000 institutions that had either a Multiple, Single, or Cooperative Project Assurance on file at the OPRR (renamed the Office for Human Research Protections in 2000) as of July, 1999. The third set consisted of 19 commercial IRBs listed on the Health Industry Manufacturers Association Web site.11 The IRBs from NACHRI member institutions were excluded from the OPRR systematic random sample, as were the IRBs of 10 children’s hospitals in Ohio surveyed in a pilot study. The actual number of survey recipients is unknown, because we learned after the study that not all NACHRI members had IRBs, and because at least 7% of addresses obtained from the OPRR were apparently invalid. The questionnaires required forced-choice responses regarding demographic information, the number of new and proportion of pediatric research protocols reviewed annually, and policies and decision-making practices concerning proposed payment for pediatric research protocols. Open-ended questions elicited information about changes in payment required as a condition of IRB approval, and descriptions of guides or formulas used in determining the monetary value of allowable payment practices.
The questionnaires were mailed over a 2-month period beginning in March 2000. Within 2 weeks after the return date marked on the questionnaire, a reminder postcard was mailed. Three months after the first mailing, nonrespondents from the children’s hospitals were telephoned to ask them to complete the questionnaire. This study was approved by the IRB at the Cleveland Clinic Foundation.
Descriptive statistics were used to sum the forced-choice responses. Nonparametric statistics (McNemar, Kruskal Wallis 1-way analysis of variance, Mann Whitney U tests) were used to assess differences between types of institutions. All statistical tests are 2-sided and assessed at the .05 significance level. Qualitative analysis was used to evaluate written policies and responses to open-ended questions.
|
RESULTS |
|---|
|
TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
|---|
IRB and Institutional Characteristics
Of the 624 mailed questionnaires, 207 were returned completed and 46 were returned by the postal system as undeliverable, for a response rate of 36%. Surveys were completed by the current IRB chair (59.5%), an IRB member other than the chair (16.2%), a manager or coordinator for the IRB office (13.1%), or other individual (8.3%). Of the completed questionnaires, 62%(128) were from institutions that conducted some pediatric research; only those 128 questionnaires were analyzed. Of the 128 institutions that conduct pediatric research, 66% (84) reported that their IRB had approved at least 1 pediatric research protocol that offered payment for participation, 10.9% (14) reported not having approved protocols that offer payment, and 22.7% (29) reported never having had pediatric protocols that offer payment submitted to them. Only the 84 surveys from IRBs that reported approving protocols with payment were used in analyses that describe payment practices. Responses were mostly completed by IRB chairs and represented all regions of the country and a variety of institutions. IRB review of pediatric protocols ranged from <10% to over 70% of all protocols reviewed annually. Overall demographics of respondents involved in pediatric research are presented in Table 1.
|
Use of Guidelines and Principles by Institutions That Allow Payment
Ten (11.9%) of 84 of respondents reported that their IRB used a guide or formula in determining the monetary value of allowable payment. Eighty percent (67/84) reported that their IRB had not rejected a protocol on the basis of a proposed payment plan, although 68% (57) said that their IRB had required investigators to revise a payment plan as a condition of protocol approval. Written comments revealed that IRBs required changes when payments were believed to be too high or coercive (most common), when proposed payments were not prorated to the length of time a subject remained in the study, or when the conditions of payment (eg, who is paid) were not clear. Written comments also indicated that IRBs arrive at acceptable payment practices by using strategies such as group consensus; determining what seems "reasonable;" factoring in transportation and time costs, child care fees, or other expenses; or basing payment on lost wages using a formula such as twice the minimum hourly wage.
Only 7% of respondents (6/84) said that their IRB had a written policy pertaining to payment practices; 5 respondents provided a copy of these policies and procedures. All 5 policies allow payment for research participation, connect payment to reimbursement for expenses, time, inconvenience, or burdens related to study participation, and explicitly state that payment should be prorated and not contingent on completion of the study. Two policies rule out payments that are offered as or represent "inducements," but without explicit explanation or examples, whereas another policy lists conditions for payment that are "reasonable but not coercive." One policy mandates inclusion of information about the type of payment in the consent form. Three policies were specific to pediatric participants. Of these, one policy permits "token gifts to be used by the child (eg, toys, diapers, formula, etc)." Another provides researchers with a specific set of recommendations for calculating reimbursement for time and procedures (eg, $10/hour for participation up to 10 hours, $15 for an outpatient 14-hour urine collection).
IRBs review potential benefits, harms, inconveniences, and discomforts of a study itself, but also consider the same information relative to proposed payment for enrollment of subjects. Respondents to this survey were asked to consider if and how the payment allowed was affected by considerations of whether the protocol offered potential benefit, potential harm, inconveniences, or discomfort to subjects (eg, not whether payment itself was considered a benefit). Forty-four percent of respondents who allow payment (37/84) said that they do discuss possible direct benefit to the subject by the study protocol when considering appropriateness of payment, whereas 52% (44) said that payment amount allowed is unrelated to potential benefit of the protocol. Of the 37 IRBs that discussed benefit from a study when judging a proposed payment scheme, 65% (24) said that benefit to the child subject had no effect on allowable payment amount, whereas 27%10 said that benefit would decrease the amount it was felt appropriate to pay.
Likewise, IRBs were asked about the role of possible harms, inconveniences or discomforts of the study when deciding on the appropriateness of proposed payment. 69% of respondents (58/84) reported that potential harms, inconveniences or discomforts of the study are factors when considering appropriateness of payment, whereas 30% (25) report that these considerations do not come into play relative to payment. Of the 58 respondents whose IRB considers harm, inconveniences or discomforts when judging a proposed payment scheme, 50% (29) said these factors have no effect on the IRB’s decision about appropriateness of payment, 43% (25) said the IRB would increase payment in the face of potential harms, inconveniences, or discomforts, and one respondent said their IRB would decrease payment in this setting.
A subset of these 84 respondents (n = 33) reported considering both possible benefit and harms/inconveniences relative to payment appropriateness. Of these 33, 48% reported that neither had an effect on payment amounts in their experience. A significant percentage (33%, 11/33; P =.001) reported that benefit would have either no effect or would decrease payments, whereas possible harm would increase payments. There was no statistical correlation between high and low payors relative to their reported consideration of risk and benefit in determining payment.
Payment practices varied according to certain institutional characteristics. Of the 128 IRBs who do some pediatric research, IRBs that review fewer than 100 new protocols per year and IRBs at private community hospitals are less likely to approve pediatric research with payment (
2 = 20.52; P < .001, 2 = 16.17; P = .003). Ninety-two percent of respondents from institutions that review pediatric research indicated that their IRB has a member who is knowledgeable about and experienced in working with children.
Specific Payment Practices
The most common method of payment was money, though additional payment methods such as gift certificates and saving bonds were also used. Payment amounts varied, from a minimum of $1 in cash to a maximum of $1000 in cash and $500 in savings bonds, as well as "other" forms (16% report giving gifts, goods, or services). (Table 2) Of the 84 respondents that approved payment, 42% (35) reported that payment was approved for both the child and parent/guardian, 31% (21) approved payment for only the parent/guardian, and 19% (16) approved payment only for the child subject. Several respondents explained that payments were given directly to the child if the child was "older" but to the parents if the child was young, or were split with the child receiving a gift and parents reimbursed for expenses. Ninety-three percent of respondents (78/84) reported that payment was discussed before enrollment in the study. Written comments indicated that at some institutions payment for enrollment is disclosed during or immediately after the informed consent process. Only 5% (4) stated that payment was discussed after the completion of the study.
|
|
DISCUSSION |
|---|
|
TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
|---|
This study provides the first empirical data reflecting current payment practices approved by IRBs for enrollment of children in research studies. We found that payment in various forms is allowed by 66% of the responding institutions that conduct pediatric research, that a range of payment amounts and forms were identified among the respondents, and that few IRBs have written policies or guidelines on this issue. Our data suggest that IRB composition and institutional characteristics may influence payment practices, and that an IRB’s perception of potential benefits and harms of a study may influence the amount of payment approved in a minority of instances.
Our response rate is difficult to interpret for several reasons. The proportion of undeliverable surveys on the OPRR list was a concern. Telephone calls to NACHRI institutions that did not return surveys revealed that not all had IRBs, that some used an IRB at another institution, or that the IRB membership was in flux. Because only 4 of 19 commercial IRBs responded, we did not compare this subgroup to the whole sample. However, our data represents a wide geographic range and includes IRBs from a satisfactory range of types of institutions, revealing interesting correlations. Because this study does not differentiate between reimbursement (eg, compensation for parking or time) as opposed to incentive payments, we are not able to define how many institutions allow reimbursement but not incentives. However, the data suggest that some payments approved by IRBs, such as gifts to the child subjects, certain sums of cash, and items of value, fall outside a reimbursement category. Finally, because 64% of respondents said that their answers were derived from memory rather than from a data source, our information is subject to bias in recall. The reliance on memory resulted from a lack of available databases documenting IRB practices and reasoning processes. This is recognized as problematic for this kind of survey, and represents a challenge to designing a more thorough study of these issues. Actual research protocols were not available for review in this overview study; we thus asked respondents to report ongoing practices rather than to describe the reasoning behind these practices, because we believed description of practices would be less likely to be biased by the interpretation of a single reporter.
This study sheds light on the role payment may play in balancing the need to recruit subjects with an IRB’s charge to ensure noncoerciveness. A majority of respondents stated that neither a perception of benefit from a study nor a perception of potential harms, inconveniences, or discomforts were considered when judging the appropriateness of the amount or type of proposed payment. However, in a small subgroup of respondents who reported considering both benefits and potential harms/inconveniences relative to allowable payments, respondents reported considering lower allowable payment if a study was perceived as potentially beneficial, whereas perception of potential harm or inconvenience would sometimes allow a higher payment. Because this study does not differentiate between compensation and inducements, we can not conclude that inducements are either common, or more frequent in settings of potential harm, inconvenience, or discomforts. However, the authors believe that IRBs should take special care to ensure that payment is intended to compensate for inconveniences rather than to influence parental or participant judgment about potential risks or discomforts.
Of note is that nearly 8% of respondents whose IRB reviewed pediatric research protocols said that their IRB does not have a member with pediatric expertise. IRBs that reviewed a low percentage of pediatric research (1%–10% of new protocols) were least likely to have a member with pediatric experience. Conversely, IRBs reviewing a larger percentage of pediatric protocols (>70%) were most likely to have a member with pediatric expertise; it is this group that was also most likely to require change in the proposed payment plan.
These findings have important ethical and policy implications because boundaries between recruitment incentives, inducements, compensation for costs, and undue influence may be unclear. Federal guidelines support the use of recruitment incentives, and acknowledge that inducement may be acceptable as long as undue influence does not occur, but these guidelines do not address pediatric research specifically. Using language identical to that in the OPRR Title 45 CFR 46.116,4 the FDA Protection of Human Research Subjects document 21 CFR 50.2012 offers general advice against coercion by stating that "an investigator shall seek such [informed] 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 or undue influence," without specifically addressing the issue of payment. Somewhat more specific guidance is found in the FDA’s Information Sheets, Guidance for Institutional Review Boards and Clinical Investigators, last updated in 1998.2 This document states:
"It is not uncommon for subjects to be paid for their participation in research, especially in the early phases of investigational drug, biological or device development. Payment to research subjects for participation in studies is not considered a benefit, it is a recruitment incentive. Financial incentives are often used when health benefits to subjects are remote or nonexistent. The amount and schedule of all payments should be presented to the IRB at the time of initial review. The IRB should review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence [21 CFR 50.20].Any credit for payment should accrue as the study progresses and not be contingent on the subject completing the entire study. Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. For example, in a study lasting only a few days, an IRB may find it permissible to allow a single payment date at the end of the study, even to subjects who had withdrawn before that date.
While the entire payment should not be contingent on completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to FDA, providing that such incentive is not coercive. The IRB should determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn. All information concerning payment, including the amount and schedule of payment(s), should be set forth in the informed consent document."
No language specific to payment for involvement in pediatric studies is contained in either federal document, although children are recognized as a vulnerable population of research subjects.
Pediatric guidelines issued by the AAP in 19959 support the use of compensation for costs or token payment as a gesture of appreciation, and warn against inducement without distinguishing between inducement and the federal language of undue influence. This statement from the Committee on Drugs states, in a section entitled "Payment for Participation":
"Subjects: It is in accord with the traditions and ethics of society to pay people who participate and cooperate in activities that benefit others. However, serious ethical questions arise when payment is offered to adults acting on behalf of minors in return for allowing minors to participate as research subjects. The remuneration should not be beyond a token gesture of appreciation for participation. If remuneration is to be provided to the child, it is best if it is not discussed before the study’s completion. This will help assure that the remuneration is not part of the reasons that a child volunteered or is volunteered for a study. The waiver of medical costs associated with treatment under a research study may be permitted in certain circumstances. The IRB should review any proposed remuneration to assure that the possibility for coercion has been avoided.Compensation: The investigator may make funds and facilities available to reimburse the child (or the family) for any direct or indirect costs incurred because of the child’s involvement in the study. The investigators and the IRB must be certain that the compensation offered is fair and does not become an inducement for the participation of a child subject."
Thus, the AAP has published guidelines that accept the use of payment for participation, without directly recognizing it as an incentive. These guidelines differ from federal guidelines in that they recommend not discussing remuneration with the child until study completion, which is not congruent with the federal statement that all information concerning payment should be set forth in the consent document. Although this timing issue might not impact directly on the consent process for studies involving very young children, following the AAP guidelines would become problematic for studies involving pediatric subjects old enough to be involved in an assent process.
Our data suggest that payment for participation in pediatric research, beyond a token of appreciation, is sometimes allowed by IRBs. Because some reported payment amounts are beyond a token level (for example, bonds of up to $500), and most respondents report informing participants of payment during the consent process, IRBs in this study seem to follow federal guidelines more closely than AAP guidelines. It is clear from written comments and from policies submitted by respondents that IRBs do attempt to avoid coercion associated with payment, but only a minority of respondents reported having written guidelines that reinforce this principle.
The differences between federal and AAP guidelines, and between current IRB practices at different institutions, highlight the need for additional consideration of payment issues. Because continued research involving children is needed, there is a concurrent need to determine empirically what recruitment strategies put child research subjects and their adult decision-makers at the least risk of coercion. Such information would allow development of federal and AAP guidelines regarding payment issues that neither inhibit the progress of needed research nor put the vulnerable pediatric population at risk.
Clearly, payment to children or their adult guardians for involvement in pediatric research does occur, though the actual frequency is difficult to determine accurately with current IRB record keeping. Certain types of payment, such as noncoercive tokens of appreciation and noncoercive compensation for inconvenience, seem to be condoned by both the federal government and by the AAP. The difficulty remains in defining what is or is not coercive, to whom, and in what amounts or forms. Children remain vulnerable from at least 2 relevant competing standpoints in the biomedical research arena: through a relative lack of data to guide therapies, which threatens safe progress in pediatric health care; and through the presumed inability of many minors to safely assess risks, benefits, and potential inducements of clinical studies. Thus, adults continue to be responsible both for designing studies to benefit children and for finding safe approaches to enrollment of needed pediatric participants. Additional evaluation of the role of payment in the recruitment process may guide both investigators and IRBs in reaching these noncompeting goals.
|
ACKNOWLEDGMENTS |
|---|
This study was funded by the Research Program Council, the Department of Pediatric Critical Care Medicine, and the F. J. O’Neill Chair in Clinical Bioethics of the Department of Bioethics, Cleveland Clinic Foundation.
We wish to acknowledge the assistance of Barbara J. Daly, RN, PhD; Stephen J. Davis, MD; Johanna Goldfarb, MD; Eric Kodish, MD; Paul Lauritzen, PhD; and George Agich, PhD, in reviewing this manuscript before submission, and to acknowledge David R. Nelson, MS, for his assistance with statistical analysis.
|
FOOTNOTES |
|---|
Received for publication Sep 4, 2001; Accepted May 29, 2002.
Address correspondence to Kathryn L. Weise, MD, Departments of Pediatric Critical Care Medicine and Bioethics, Cleveland Clinic Foundation, Desk S 10-A, 9500 Euclid Ave, Cleveland, OH 44195. E-mail: weisek{at}ccf.org
|
REFERENCES |
|---|
|
TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
|---|
- Penslar RL. National Institutes of Health, Office for Protection From Research Risks. Protecting Human Research Subjects: Institutional Review Board Guidebook, 1993. 2nd ed. Bethesda, MD: Office for Protection From Research Risks, National Institutes of Health; 1993
- Food and Drug Administration, Office of Health Affairs. Information Sheets. Guidance for Institutional Review Boards and Clinical Investigators. Rockville, MD: Food and Drug Administration, Office of Health Affairs; 1998
- Schultz S. Drug trials are clamoring for kids, but scrutinize the study before signing up. US News & World Report. April 17, 2000
- Department of Health and Human Services. Office for Protection From Research Risks (OPRR). Protection of Human Subjects. 45 CFR 46.116
- Glanz LH. Research with children. Am J Law Med.1998; 24 :213 –244[Web of Science][Medline]
- Macklin R. ‘Due’ and ‘undue’ inducements: on paying money to research subjects. IRB.1981; 3 :1 –6[Medline]
- Ackerman TE. An ethical framework for the practice of paying research subjects. IRB.1989; 11 :1 –4[Medline]
- Dickert N, Grady C. What’s the price of a research subject? Approaches to payment for research participation.
N Engl J Med.1999; 341
:198
–203
[Free Full Text] - American Academy of Pediatrics, Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations.
Pediatrics.1995; 95
:286
–294
[Abstract/Free Full Text] - Food and Drug Administration. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients, Final Rule. 21 CFR Parts 201, 312, 314, and 601
- Health Industry Manufacturers Association (renamed Advanced Medical Technology Association). Available at: http://www.himanet.com. Accessed January 17, 2000
- Food and Drug Administration. Protection of Human Subjects. 21 CFR 50.20
PEDIATRICS (ISSN 1098-4275). ©2002 by the American Academy of Pediatrics
CiteULike 
Connotea 
Del.icio.us 
Digg 
Facebook 
Reddit 
Technorati 
Twitter What's this?
This article has been cited by other articles:
|
|
 |
|
  S. J. Bagley, W. W. Reynolds, and R. M. Nelson Is a "Wage-Payment" Model for Research Participation Appropriate for Children? Pediatrics, January 1, 2007; 119(1): 46 - 51. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. S. Iltis, S. DeVader, and H. Matsuo Payments to Children and Adolescents Enrolled in Research: A Pilot Study Pediatrics, October 1, 2006; 118(4): 1546 - 1552. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. B. Kimberly, K. S. Hoehn, C. Feudtner, R. M. Nelson, and M. Schreiner Variation in Standards of Research Compensation and Child Assent Practices: A Comparison of 69 Institutional Review Board-Approved Informed Permission and Assent Forms for 3 Multicenter Pediatric Clinical Trials Pediatrics, May 1, 2006; 117(5): 1706 - 1711. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. A. Kon Assent in Pediatric Research Pediatrics, May 1, 2006; 117(5): 1806 - 1810. [Full Text] [PDF]
|
|
|
|
 |
|
 C L Fry, A Ritter, S Baldwin, K J Bowen, P Gardiner, T Holt, R Jenkinson, and J Johnston Paying research participants: a study of current practices in Australia J. Med. Ethics, September 1, 2005; 31(9): 542 - 547. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Whittle, S. Shah, B. Wilfond, G. Gensler, and D. Wendler Institutional Review Board Practices Regarding Assent in Pediatric Research Pediatrics, June 1, 2004; 113(6): 1747 - 1752. [Abstract] [Full Text] [PDF]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
