Mr. Chairman and Members of the Subcommittee:
Thank you for the opportunity to share with you the concerns of several agencies within the Department of Health and Human Services (HHS) regarding H.R. 1271, the "Family Privacy Protection Act of 1995.11 Included in this statement are the responses of the Administration for Children and Families (ACF) and several agencies of the Public Health Service (PHS) to questions posed by the House Government Reform and Oversight Subcommittee on Government Management, Information, and Technology during the Subcommittee's consideration of the bill.
Before we turn to the responses of individual HHS agencies, we would like to summarize our concerns about the bill's requirement for prior written parental consent, as currently drafted. While we strongly agree that parental involvement and consent are essential in studies that include minors, the Department believes that changes should be made to the procedure in the bill for documentation of this consent. The requirement for prior written consent could seriously jeopardize the ability of these studies to provide Federal, State and local policy makers with useful, quality information. Further, in programs such as those serving runaway youths, the requirement for written consent, prior or otherwise, may be logistically impossible or even may be incompatible with the best interests of the children receiving services.
In carrying out research involving human subjects PHS follows the requirements set forth in the Federal Regulations for the Protection of Human Subjects (45 CFR 46). In addition, study protocols must be approved by the institutional review boards (IRBs) of the research entities and the peer review processes of the agencies, as well as the schools when studies are school-based.
A prior written consent procedure is likely to undermine the validity of study conclusions by negatively affecting participation rates and introducing response bias. Requiring prior written consent will harm the quality of the data because of a likely increase in nonresponse rates. Further, study findings may be significantly biased. There is evidence that parents who return survey consent forms are somewhat different, as a group, from those who do not respond. It is likely that just those children we wish to help, children at high risk, will be those whose parents will lack the motivation to respond.
An alternative would be to provide for parental notification and to afford parents or guardians the opportunity to respond orally or in writing that they do not wish their child to participate in the study. The current procedure of allowing the child to refuse, even if the parent has not refused, should continue.
1.What surveys, analyses, or evaluations of individual minors are currently conducted with Federal funds?
Answer: Program evaluations and other such studies, evaluations of family and youth programs, such as the Runaway and Homeless Youth Act and the Transitional Living Program for Homeless Youth, supported at the Federal, State or local levels routinely ask questions of youth related to the reasons they sought services from the programs and whether these problems have improved as a result of the services received which may relate to "mental or psychological problems potentially embarrassing to the minor or his family.... 11 as a means of determining the effectiveness of the services provided. Similarly, questions related to issues such as sexual behavior may be asked as vehicles for measuring changes in youth's functioning as a result of participation in these programs.
2.What are the current policies and procedures for parental consent with these surveys, analyses or evaluations?
Answer: Participation of youth (and of their parents or guardians, as applicable) is totally voluntary in evaluations of family and youth programs, such as the Runaway and Homeless Youth Act and the Transitional Living Program for Homeless Youth. These programs routinely ask questions of youth related to the reasons they sought services from the programs and whether these problems have improved as a result of the services received. Similarly, questions related to issues such as sexual behavior may be asked as vehicles for measuring changes in youth's functioning as a result of participation in these programs. The data are maintained and reported in such a way that the privacy and confidentiality of the information provided is ensured.
3.Are there circumstances under which parental consent, as required in the legislation would, in your opinion, not be appropriate?
Answer: Abuse and neglect and other "potentially embarrassing" family problems often constitute the reasons that youth run away from home. Obtaining information about these problems is critical in order for service providers to address these problems and to facilitate a youth's return home or placement in an alternative living arrangement.
Since many of the youth served by family and youth programs, such as the Runaway and Homeless Youth Act and the Transitional Living Program for Homeless Youth, have not yet reached the age of emancipation, and because it would be very difficult to obtain the consent of parents or guardians prior to interviewing homeless youth or runaway youth who do not return home, these provisions would preclude the conduct of evaluations of these types of programs.
4.What are the impacts that you foresee as a consequence of this legislation?
Answer: As mentioned above, program evaluations and other such studies, evaluations of family and youth programs, such as the Runaway and Homeless Youth Act and the Transitional Living Program for Homeless Youth, would be impeded. These programs routinely ask questions of youth related to the reasons they sought services from the programs and whether these problems have improved as a result of the services received which may relate to "mental or psychological problems potentially embarrassing to the minor or his family..." as a means of determining the effectiveness of the services provided.
Similarly, questions related to issues such as sexual behavior may be asked as vehicles for measuring changes in youth's functioning as a result of participation in these programs. The participation of youth (and of their parents or guardians, as applicable) is totally voluntary and the data are maintained and reported in such a way that the privacy and confidentiality of the information provided is ensured. Since 'many of the youth served by these programs have not yet reached the age of emancipation, and because it would be very difficult to obtain the consent of parents or guardians prior to interviewing homeless youth or runaway youth who do not return home, these provisions would preclude the conduct of evaluations of these types of programs.
5.Do you have any suggestions for improvements to the legislation?
Answer: To avoid the problems discussed above, youth service programs should be exempt from these provisions.
1.What surveys, analyses, or evaluations of individual minors are currently conducted with Federal funds?
Answer: CDC supports several school-based (The Youth Risk Behavior Study) and home-based (National survey of Family Growth) surveys that determine knowledge, attitudes, behaviors and practices of adolescents concerning various health factors. Public health professionals use these data to determine new patterns of adolescent risk taking behavior and to develop more effective policies and programs to prevent risky behaviors.
All CDC sponsored surveys involving minors are voluntary. Most of our surveys do not collect personal identifying information. However, when personal identifiers are collected, they are only used to contact respondents at future times for follow-up assessment. Some data collections involving the collection of personal identifying information have legal protection of identity through an assurance of confidentiality.
Although CDC data are collected on the individual level, survey results are published and used in the aggregate. Public health interventions are developed based on the needs of the population rather than the individual.
2.What are the current policies and procedures for parental consent with these surveys, analyses or evaluations?
Answer: All national based surveys routinely obtain informed consent from parents of minor children. In most cases, the technique used is to read or show to the parent/guardian a form which explains the content of the survey, its authorizing legislation, and the confidential and voluntary nature of participation. The interviewer fills in the identifying information on the form and upon receiving the parent's permission, the interviewer signs or initials the document. The minor is then allowed to decide whether or not he/or she wants to participate in the survey.
Our school-based surveys are mostly implemented through the States. Therefore, these surveys comply with State laws concerning parental consent as well as protection of respondents in accordance with human subjects review boards.
3.Are there circumstances under which parental consent, as required in the legislation would, in your opinion, not be appropriate?
Answer: While CDC does support obtaining parental consent, it is often the case in survey research that obtaining written consent is logistically unfeasible. The process required to obtain written parental consent for school-based research often places unnecessary burden on school administrators and teachers, detracts from important instructional time, and may produce response that are so low as to threaten the quality and usefulness of the data.
Many surveys are conducted by telephone because that mode is much less expensive to use than in-person interviewing. Obtaining written consent for telephone interviews would be extremely difficult. Frequently the identity and address of the household is unknown prior to the initial call. Obtaining written consent from telephone respondents prior to conducting the interview would involve collecting additional personal identifiers in order to mail consent forms to the household. Valuable time and resources would be lost contacting and encouraging parents to return the signed forms.
As stated in the response to question 2, many of our national surveys involve obtaining verbal consent and documenting such consent. There has been no indication that the witnessed verbal consent technique has been either abused by interviewers or a cause of concern among minor respondents or their parents.
4.What are the impacts that you foresee as a consequence of this legislation?
Answer: If this bill were enacted, it would significantly decrease CDC's ability to generate data on adolescent health.and risk behaviors, thus curtailing the effectiveness of prevention policies and programs for youth.
CDC uses its data to develop and target interventions to minors to prevent them from placing themselves at risk for various adverse health behaviors and effects. The collection of baseline data for risk reduction studies is frequently performed. In this regard, this legislation would be extremely problematic as it would potentially restrict our ability to measure the effectiveness of risk reduction interventions because accurate baseline and intervention outcome data would not be obtainable.
The legislation could also greatly increase the cost of some surveys because in-person interviews would be required in order to obtain written consent. The legislation would preclude the collection of data for anonymous survey, which are often the best way to obtain information on high-risk behaviors, by forcing the survey subject to identify him or herself by name thus losing anonymity.
5.Do you have any suggestions for improvements to the legislation?
Answer: Delete the requirement for prior written consent. The approach to obtaining consent could then be designed as appropriate for each survey and would be included in the review conducted as part of the requirement to protect human subjects. One alternative to requiring written consent would be to obtain verbal informed consent over the telephone, or in person in the home, and allow the interviewer to document the consent.
Background:
SAMHSA is mandated to collect data on the incidence and prevalence of substance abuse and mental illness, characteristics of the alcohol, drug and mental health (ADM) treatment systems and the characteristics of individuals served, and other related information. In addition, SAMHSA must respond to Federal mandates to evaluate its major substance abuse treatment and prevention programs and mental health treatment programs, a number of which have minors as their primary focus. The collection of data on minors from statistical surveys and administrative records and the participation of minors in program evaluations are essential to SAMHSA's mission of providing national leadership in the areas of substance abuse and mental health services through knowledge development and dissemination.
In carrying out this mission, SAMHSA is acutely aware of the need to protect the privacy and confidentiality of the individuals served by SAMHSA funded programs or participating in SAMHSA's statistical data collections. Only the lowest level of identifying information is collected that will allow the study to achieve its analytic or programmatic objectives. For example, in the case of surveys of individuals in which respondents will not be followed up, data are collected anonymously. Similarly, in surveys of administrative records (record abstraction studies) information identifying individuals is not part of the abstracted record.
All regulations concerning confidentiality and privacy of patient records and protection of human subjects, i.e. 42 CFR Part 2 and 45 CFR Part 46, are followed. Where appropriate, SAMHSA funded contractors and grantees apply for Certificates of Confidentiality to further protect the data they collect. In studies where it is necessary to maintain a file of individual identifiers for follow-- up or linkage purposes, the identifying information is kept in a secure place separated from other data about that individual. Identifiers are then destroyed as soon as the tracing or linkage purpose has been accomplished.
Response to Questions:
1.What surveys, analyses, or evaluations of individual minors are currently conducted with Federal funds?
Answer: These projects are listed below. Also listed are projects that collect data via abstraction of existing records. Because the end product of any survey or evaluation is data analysis, all of the projects shown below incorporate analytical activities.
All SAMHSA data collections in which information is obtained directly from minors require parental consent. Consent is obtained either actively or passively. Under active consent procedures, the parent, guardian, or responsible adult must specifically give the data collector permission for the child to participate in the study. In most cases, active consent is obtained in writing from the parent. (For one SAMHSA survey listed below, the NHSDA, active consent is obtained verbally rather than in writing.) Under passive consent procedures, parents are notified in writing that their children will be asked to participate in a study. If parents do not want their children to participate they must return a form. If no form is returned, it is assumed that the parent has no objections to the child's participation in the study.
Whether parental consent is obtained actively or passively, the minor's participation is still voluntary. In no cases are minors required, coerced, or otherwise compelled to participate in the data collection.
National Household Survey on Drug Abuse (NHSDA) -- Anonymous interview survey of persons age 12 and over. Active, verbal consent of parent obtained. Written consent not obtained because survey is anonymous. Data is used for aggregate statistical analysis only.
Drug Abuse Warning Network (DAWN) -- A record abstraction survey of drug-related emergency room episodes and drug-related deaths as reported by selected medical examiners. Minor's records are abstracted, but abstraction is anonymous, i.e. individuals are not identified. Data is used for aggregate statistical analysis only.
Drug and Alcohol Services Information System (DASIS) --The DASIS includes an anonymous record abstraction component, the Treatment Episode Data Set. States forward data on each admission to publicly funded substance abuse treatment units to SAMHSA. Records for minors admitted to treatment are included. Identifying information is not given to SAMHSA. Data is used for aggregate statistical analysis only.
Evaluations of all grants for substance abuse treatment services funded by the Center for Substance Abuse Treatment (CSAT), require written parental consent for the participation of minors. These studies include: Evaluation of the Job Corps Drug Treatment Enrichment Program; Evaluation of the CSAT Adolescent Treatment Programs; and Evaluation of the Program for Pregnant and Postpartum Women and Infants.
Evaluations of all grants for substance abuse prevention services funded by the Center for Substance Abuse Prevention (CSAP) include minors. Many of these evaluations require passive parental consent for the participation of minors. These include: Evaluation of the High-Risk Youth Program; and Evaluation of the Community Partnership Program. Passive consent means that the program sends forms to the parents explaining the study and asking parents to return a form only if they do not want their children to participate. If no form is returned, consent is inferred.
Evaluation of the Comprehensive Mental Health Services Program for Children with Serious Emotional Disorders requires written parental consent.
National sample surveys of substance abuse treatment outcomes that involve interviews with clients, such as the Services Research Outcomes Study; the National Treatment Study; and the Alcohol and Drug Services Survey require written parental consent before sampled minors are interviewed.
In addition, SAMHSA conducts several surveys of treatment facilities in which client data, including data on clients under the age of 18, are collected in aggregate form. These are not listed above.
2.What are the current policies and procedures for parental consent with these surveys, analyses or evaluations?
Answer: Procedures for parental consent for each SAMHSA survey and evaluation are shown above. Parental consent is obtained whenever individuals are asked to provide information about themselves. With the exception of the substance abuse prevention evaluation studies discussed below, all studies listed above require written consent of the parent or guardian for non-emancipated minors, and of emancipated minors for themselves. The evaluations of substance abuse prevention programs frequently rely on passive consent. Participation in all the SAMHSA studies is voluntary.
Parental consent is not obtained for the record abstraction component of treatment outcome studies such as those listed above. 42 CFR Part 2 permits disclosure of patient records for limited and specific purposes, including research and evaluation.
SAMHSA does not obtain parental consent in studies involving anonymous record abstraction, such as DAWN and DASIS. In this case, SAMHSA cannot identify individuals, therefore consent is irrelevant. Also, SAMHSA does not obtain parental consent to conduct "analyses" on databases that contain data on minors. As described above, identifiers are not retained in the analytical databases.
3.Are there circumstances under which parental consent, as required in the legislation would, in your opinion, not be appropriate?
Answer: In the case of evaluation of substance abuse prevention programs, requiring prior written parental consent is likely to have a harmful effect on the minors' participation in prevention programs, and on the agency's ability to collect meaningful data on the effectiveness of the programs. Many of the high-risk youth participating in substance abuse prevention programs may have parents who are unlikely to provide written consent for their children's participation in prevention programs, or in evaluation of such programs. These may include parents who are substance abusers, or who abuse or neglect their children. Requiring written consent for participation in evaluations may prevent such children from participating in the prevention programs, themselves.
Furthermore, requiring written parental consent is likely to harm the quality of the data from such evaluations. If the evaluations only include data from children whose parents provide written consent, it is likely that children at higher risk will be under-represented in the studies. This means that study results will be considerably less accurate in measuring program effectiveness, and in providing information for future policy and program planning.
A requirement for parental consent, in any form, does not make sense in terms of anonymous record abstraction or analysis of aggregated data. In neither case is there any risk to the minor whose information is included in the aggregate data base.
4.What are the impacts that you foresee as a consequence of this legislation
Answer: This legislation . could unnecessarily impede the work of the Agency in carrying out its mandates related to knowledge development and dissemination. Congress would not have the data needed to assess the effectiveness of SAMHSA programs and other Federal efforts related to substance abuse and mental health.
SAMHSA endorses the concept of written parental consent in those cases where the risk of potential harm is present. But it is important for agencies to have some flexibility in determining the appropriateness of written consent, as contrasted to passive consent, procedures. In the case of the prevention studies, the harm done by being unable to assess the impact of prevention programs targeted at youth would outweigh the virtually nonexistent harm that would follow from a passive consent procedure.
The inability to conduct data analysis or administrative record abstraction studies -- a conceivable consequence of the proposed legislation -- would, of course, be extremely damaging and not in the interests of the government or the public.
5.Do you have any suggestions for improvements to the legislation?
Answer: We believe that an exception needs to be made for the abstraction of anonymous records and surveys that do not include identification of individuals. We believe that secondary analyses of data which are not intended to and cannot identify individuals should not be covered by this legislation because it would unnecessarily limit the use of data. For example, recently we prepared analyses of the risks to children from family drug abuse. These were designed to show how many children live in households where their parents use drugs.
The NIH institutes and centers support a variety of research studies that may involve surveys, analyses or evaluations of individual minors. These research studies include, but are not limited to, the following: surveys of children's oral health, studies of children who are considered at high risk for alcohol abuse; research to access school-based interventions which promote healthful behaviors in areas such as cardiovascular disease, obesity, and asthma; research which focuses on the extent and nature of drug use in adolescent populations; and research concerning pregnancy, sexually transmitted diseases, and eating disorders affecting adolescents. Below, as examples, are how title IV would affect two NIH institutes.
NIH/National Institute on Drug Abuse
1. What surveys, analyses, or evaluations of individual minors are currently conducted with Federal funds?
Answer: Data on drug using behaviors among adolescents and other minors provides an indication of a potential "epidemic" in drug use. For that reason, and to collect information to inform prevention activities, the National Institute on Drug Abuse (NIDA) sponsors a number of home- and school-based studies that collect data from minors on drug use and related factors. The most visible of these efforts is the Monitoring the Future (MTF) Study (also known as the High School Senior Survey), which is conducted annually by the University of Michigan under a NIDA grant. MTF is the Government's primary means of tracking drug use among the nation's youth.
Under its extramural program, NIDA also sponsors numerous additional studies that focus on young people in the effort to measure the extent and nature of drug use, to identify its causes, and to develop interventions to prevent or treat the problem. One of these other studies is an ongoing survey of American Indian and Alaskan Native youth, a group at high risk of developing substance abuse problems. These studies are an essential part of the nation's efforts to measure, understand, and combat the drug problem among its youth.
Other examples of Federally funded studies are: one, a study of 3rd-6th graders about their knowledge, beliefs, and attitudes about drug abuse and the relationship of drug abuse to AIDS (Wells, University of Washington); and two, identification of drug and HIV risk factors and assessment of the effectiveness of an intervention to decrease aggression and other antisocial behaviors among a sample of Baltimore City school children (Anthony, Johns Hopkins).
2. What are the current policies and procedures for parental consent with these surveys, analyses, or evaluations?
Answer: Parental consent is a part of the protocol for all NIDA-supported studies that collect data from minors, whether the minors are contacted in the home or the school. Procedures for obtaining and documenting consent vary from one study to another, but protocols for all studies of minors must provide for parental consent as well as addressing other human subjects issues. Protocols must be cleared through Institutional Review Boards (IRBs), the NIH extramural review process, and internal NIH officials. The clearance process considers risks to the child; appropriateness of study content for children of the target ages; informed consent from both child and parent; and other issues.
With school-based surveys, the most common procedure for obtaining parental consent involves giving parents written notification of the survey, including its purpose And contents, and asking them to respond if they object to their child's participation. The notification is either mailed by the school to the parents directly, as in the MTF study, or, more typically, sent home to the parent through the child. Parents can withdraw their children from participation in the study by calling the school or responding in writing. They are not required to justify their objections. Numerous studies using this procedure have been reviewed and approved by IRBs and NIH extramural committees and internal groups. Equally significantly, numerous studies using this parental consent procedure have been approved by school boards and administrators. Approval at the school level is essential, and investigators do everything they can to resolve problems before they reach this stage. In addition to parental consent, minors surveyed in NIDA-sponsored studies also have the option of refusing participation and are so advised.
With home-based surveys of minors, parental consent is always required. Studies vary, however, in whether the parents' signatures are obtained.
3. Are there situations under which parental consent, as required in the legislation would, in your opinion, not be appropriate?
Answer: We believe the requirement for signed documentation of consent would be inappropriate in some situations. In school-based surveys, studies have found that large numbers of parents don't respond when a form is sent to them asking them to approve or disapprove participation. Follow up notifications have shown that the overwhelming majority of these nonresponding parents approve of their child's participating in the survey, but just did not return the form. If parents are required to return a signed document, many children will be excluded from participation simply because the parents who approve their child's participation did not return the form. Home-based surveys have less of a problem dealing with the signed documentation of consent requirement than school-based surveys because interviewers in home surveys have direct contact with the parents.
4. What are the impacts that you foresee as a consequence of this legislation?
Answer: The requirement for signed documentation of parental consent under this legislation will have several adverse effects, particularly on school-based surveys. First, this procedure will create a vast amount of administrative work. More of this administrative work will fall on the schools rather than the researchers, because many schools have policies that restrict outside researchers' access to parents' addresses and phone numbers. This added administrative burden may result in refusal of large numbers of schools to participate.
Second, because of parents not returning forms, the requirement for signed documentation of consent will greatly reduce the available samples of children for these studies. This will result in either reduced reliability and precision of study findings or in greater cost because of the need to increase sample sizes to offset attrition.
Third, and more seriously, study findings may be biased significantly by the nature of the children in the samples available under the new procedure. Regardless of whether parents approve or disapprove of their children's participation, parents who return survey consent documentation forms are somewhat different, as a group, from those who do not. This creates a bias in the sample of children. For example, in a 1983 study of procedural factors affecting an evaluation of an alcohol education curriculum, Kearney, Hopkins, Mauss, and Weisheit (Public Opinion Quarterly) reported that 34 percent of parents did not return the forms that were sent out.
More white than African American or Asian-Pacific Islander parents sent in the forms. Seventy-eight percent of all parents consented to their children's participation, but this rate also was lower for racial/ethnic minorities than for whites. The overall effect of the signed documentation of consent procedure was a sample that overrepresented white students and underrepresented African American and Asian students.
Response rates in many cases may be lower than those achieved in this study. In study of drug use in which signed documentation of parental consent was sought for minors, participation in a survey at an inner city school, the University of Michigan (Johnston, personal communication, 1995) found that only 17 parents out of 100 returned the form, resulting in a 17 percent response rate.
Other factors not considered in this study may influence the likelihood of parents' returning survey consent forms and approving their children's participation, and these other factors may bias the survey sample and the findings. For example, NIDA is concerned that parents who use illicit drugs might be less likely to return a consent form. In 1991, 11.3 percent of parents who live with their children reported illicit drug use in the past year (DHHS, 1994). If situations of this type were common, the resulting bias in survey findings could not be corrected and would not even be known. This would seriously jeopardize the credibility of the survey results.
If written parental consent procedures reduce the feasibility and accuracy of school-based surveys and increases their cost, it may be necessary for more researchers to collect data on children using home-based surveys. This would greatly increase the cost of conducting the necessary research. It also might undermine the validity of self-reports of sensitive behaviors, as children are more reluctant to report such behaviors when surveyed in their homes with their parents present. Although special techniques are available to ensure children's privacy in responding to surveys in the home, these procedures are expensive and may not work with young children.
5. Do you have any suggestions for improvements to the legislation?
Answer: We believe that the signed documentation of parental consent procedure required under H.R. 1271 overcompensates for the current problems and creates numerous additional problems that increase the cost and difficulty of conducting research on minors and reduce the validity of the findings of that research. An additional problem with the proposed legislation is that some of the survey consent forms sent home to parents through their children may not reach the parents; thus, these parents do not have the opportunity to review the issue.
To strengthen the current procedure while avoiding the potential problems associated with the signed documentation of parental consent procedure, we recommend that the legislation be revised to accept a different form of evidence of parental consent. Parental consent would still be required, and signed documentation of consent would still be acceptable. We propose however, to accept for school-based surveys the following circumstances as documentation of parental consent:
(a) Parents have been notified in writing of the intended survey, its purposes and contents, through letters sent directly to them through first class mail. Sending forms home through the children would no longer be acceptable notification. while we feel that it will strengthen current procedures, there will be an increased burden on the schools which will more than likely be responsible for mailing and processing the letters.
(b) Parents who, for any reason, wish to withdraw their child from participation in the study could do so by (i) returning the form with a signature denying permission, (ii) calling the school indicating their desire to withdraw their child, or (iii) calling a toll-free number provided by the researcher (if different from the school district) to withdraw their child. Addressed, stamped return forms shall be provided to facilitate parents' responding.
(c) Notification would be required to be mailed to parents at least two weeks prior to the planned survey date, and parents may register their disapproval of their children's participation at any time prior the survey.
(d) Any child whose parent has been notified as described above and has not registered disapproval will be eligible to being surveyed. As in current procedures, children have the right to refuse regardless of the fact that their parents may not have disapproved of their involvement in the study.
This suggested procedure for documenting parental consent would balance the parents' rights and responsibilities with the need to continue to conduct research on vital issues of child health and well being. Although the suggested changes would require modification of the protocols for numerous planned and ongoing studies and would entail some increase in costs, these changes would avoid needless costs, difficulties, and introduction of bias while improving parents opportunity to review and control the information their children are asked to provide.
1. What surveys, analyses, or evaluations of individual minors are currently conducted with Federal funds?
Answer: The National Institute of Child Health and Human Development (NICHD) supports a range of research, including surveys, analyses, and evaluations, that involve individual minors in both home and school settings. The major topics of that research are adolescent pregnancy, sexually transmitted diseases including AIDS, acquisition of productive skills and behaviors, parent-child relationships, intergenerational family dynamics, and adolescent eating disorders.
The adolescent pregnancy studies look at factors that contribute to unwanted pregnancy and its consequences, for example premarital childbearing, poverty and welfare policy, and the impact of mentoring and stress on pregnant adolescents. The studies concerned with sexually transmitted diseases and AIDS include interventions to decrease risk and to prevent infection. The studies of productive skills and behaviors are used to monitor the transition from minor dependency to independent adult status. The studies of parent-child relationships are used to examine the role of families in the development of successful adults. The studies of intergenerational family dynamics are used to examine the causes of welfare dependency, out-of-wedlock childbearing, and the effect of family turbulence over the life course. Finally, the studies on adolescent eating behaviors include research on anorexia, bulimia, and obesity.
2. What are the current policies and procedures for parental consent with these surveys, analyses, or evaluations?
Answer: As with all NIH-funded research involving human subjects, the NICHD-supported studies described above meet the requirements of the Federal Regulations for the Protection of Human Subjects (45 CFR 46. These regulations require formal written consent by a subject or written permission of the subject's agent, such as a parent of a child (person who has not attained the legal age for consent, as defined by the law of the jurisdiction where the research is conducted), however, the requirement for written consent or permission may be waived if: (1) the research involves no more than minimal risk to the subjects; (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) the research could not practicably be carried out without the waiver or alteration; and (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.
3. Are there situations under which parental consent, as required in the legislation would, in your opinion, not be appropriate?
Answer: There are some circumstances where the written consent requirement in the legislation would create a significant burden, or even make it not feasible to conduct the research. The Federal Regulations for the Protection of Human Subjects, while generally requiring written consent, also recognize that such written consent is not always appropriate, and allow for other forms of consent as long as they afford both the subject and the subject's agent (parent or guardian) the right to be informed about the study before agreeing to participate, as well as the authority to decline to be a subject of the research.
4. What are the impacts that you foresee as a consequence of this legislation?
Answer: Enactment of this legislation as proposed would impact negatively on the research of the NICHD in the following three ways:
Reduce response rates - field research has shown that while very few parents have any objection to their children participating in such research, many more will either not get around to sending in a signed written consent, or will not do so because they are put off by the legal nature of the document. For studies to produce results that are representative of the population being studied, it is essential that high participation rates be obtained.
Increase costs - The extra effort necessary to obtain an adequate response of written consent from parents or guardians is very costly, whether conducted in the home or school. ' It is likely to require several more attempts to reach the parent and persuade them to send in the consent form. Because schools are prohibited, in most cases, from providing researchers with information about parents, this added workload is likely to fall most heavily on school personnel, and, perhaps, result in the school being unable to assume that added expense and declining to participate in the study.
Increase the likelihood of bias in the study result - The extra burdens of requiring "written" informed consent are likely to affect disproportionately certain groups in the study population. Specifically, lower socioeconomic groups, families where English is not the primary language, families under stress, and various minority groups, are the most likely to not return written consent forms and, thereby, decrease, or even eliminate, the necessary inclusion of such groups.
5. Do you have any suggestions for improvements to the legislation?
Answer: If there is found to be a need for such legislation, we would suggest that the narrow requirement for "written" consent be replaced by a provision that is consistent with the provisions of the Federal Regulations for the Protection of Human Subjects (45 CFR 46), which, in 1991, were made the guidelines that are followed by most agencies of the Executive Branch of the Federal Government.
In addition, we would suggest that the consent of the minor, whether emancipated or not, as well as that of at least one of the minor's parents or guardians, be sought. As drafted, only an emancipated minor would have the right to object to participating in the research. The Federal Regulations for the Protection of Human Subjects would urge that the consent of the unemancipated minor be obtained as well.