May 2005

The Common Rule generally requires informed consent from those who participate in research studies.  Although Maryland law specifically addresses consent for medical treatment, it does not separately address consent for participation in a research study that involves medical treatment.  In the absence of specific law or regulations addressing consent for research, Hopkins follows the Maryland law for consent to medical treatment when determining legally effective informed consent for research studies under the Common Rule.

The general rule under Maryland law is that a person eighteen (18) years or older may consent to medical treatment for himself or herself.  If the person is not able to give informed consent due to lack of capacity or unconsciousness, Maryland law provides for surrogate decision making and for the appointment of a guardian or legal representative.

The general rule under Maryland law is that a parent or guardian must consent to medical treatment for a person under the age of eighteen (18) (Please see the IRB Consent Guidelines for further details). Thus, in most research studies, if children under the age of 18 are to be enrolled, the parent or guardian of the child must provide informed consent on behalf of the child.  Following this “local law” satisfies 45 CFR 46 Subpart D -- Additional Protections for Children Involved as Subjects in Research (“Subpart D”).  In addition, under Subpart D, the investigator must obtain the child’s assent in certain circumstances.

There are certain exceptions to this general rule for consent from minors for medical treatment under Maryland law.  Again, in the absence of specific law or regulations addressing exceptions to consent for research, Hopkins follows the Maryland exceptions to consent to medical treatment when determining legally effective informed consent for research.  The exceptions for consent to medical treatment for minors fall into two categories.  The first is for situations where the minor is married or is the parent of a child. The second is for situations where a minor seeks particular types of treatment.  The rules for how minor consent applies in these two types of situations are slightly different and therefore each will be dealt with separately below.

MINORS WHO ARE MARRIED OR THE PARENT OF A CHILD

A minor who is married or the parent of a child has the same capacity as an adult to consent to medical treatment.  We believe this means that in these situations the treatment may not be rendered without the minor’s consent.  Thus, if the parent or guardian says “yes”, but the minor says “no”, the medical treatment, and by parallel application, the research, may not be done.  Likewise, if the parent or guardian says “no”, but the minor says “yes”, the medical treatment, and by parallel application, the research, may be done.  Of course, if the minor is not capable of giving consent, i.e., does not understand, is incompetent or is unconscious, the parent or guardian may generally provide consent.

Accordingly, the rules for consent to research for these minors are as follows:

1. If the minor is married, the minor must consent for all medical treatment, and by parallel application, must consent for all research.

2. If the minor is the parent of a child, the minor must consent for all medical treatment for himself/herself and for his/her child, and by parallel application, must consent for all research for himself/herself and his/her child.

If a research study includes enrollment of minors who are married or the parent of a child, Subpart D does not apply to review of the study for these minors.  However, the IRB may wish to apply Subpart D analysis as a matter of policy.  Also, if a research study includes enrollment of the children of minor parents, Subpart D would apply to enrollment of the children.

Examples of Minors Who Are Married or the Parent of a Child:

Example A: A PI proposes a survey of mothers aged 13-17 to study the relationship of sexual activity, schooling and nutrition.  In this case, the women aged 13-17 must consent to participate in the study.

Example B: Same as Example A, but the PI wants to enroll the children of the mothers aged 13-17 in the study.  In this case, the women aged 13-17 must consent to participation in the study for themselves and for their children.  The infant’s participation would be subject to the protections of Subpart D.

Example C: A PI proposes a phase I study for a new cancer drug in males and females aged 13-17.  Mr. and Mrs. Jones are aged 13 and 14, respectively.  Both Mr. and Mrs. Jones must consent to enrollment in this study.  The Subpart D analysis of direct benefit for greater than minimal risk would not be applicable in these two cases unless the IRB determined to apply the analysis as a matter of policy.  Both individuals would be consenting as adults to participation in the study and would be evaluated as adults on a risk benefit analysis.

Example D: Same as Example C, but the two individuals who wish to enroll are not married, but are the parents of a child.  The analysis for participation of the two individuals is the same as in Example C, i.e., as the parents of a child, each is deemed to be an adult for consent purposes.

Example E: A PI wants to study the effects of nutrition changes in infants 6 months -- 12 months old.  Mr. and Mrs. Jones are 14 and 13, respectively, and are the parents of baby “X”.  Because the individuals are the parents of baby “X”, they must enroll baby “X” in the study.  However, all of the protections of Subpart D would be applicable to baby “X” in evaluation of the enrollment of the child.

MINORS WHO SEEK CERTAIN TREATMENTS

If a minor seeks specific treatment for or advice about certain conditions/issues, the minor has the same capacity as an adult to consent to consultation, diagnosis and treatment for those conditions/issues.  These conditions/issues are as follows:

1. Drug abuse.*
2. Alcoholism.*
3. Mental or emotional disorder.  (16 and 17 year olds)*
4. Venereal disease.
5. Pregnancy.
6. Contraception other than sterilization.
7. Physical examination and treatment of injuries from an alleged rape or sexual offense.
8. Physical examination to obtain evidence of an alleged rape or sexual offense.
9. Initial medical screening and physical examination on and after admission of the minor into a detention center.

*   Maryland law limits a minor’s right to refuse treatment in some situations.  Because this Guidance addresses the right of a minor to consent to treatment and to research related to that treatment, these exceptions do not apply here.

We believe that for these conditions/issues, the minor must give their consent for medical treatment.  However, we do not believe that there is a 100% parallel application of these medical consent rules in the research context.  This is so because these Maryland statutory exceptions for minor consent were intended to allow access by minors to very particular services to which their parents might object.  By parallel thought process, we believe that minors in the research context must be able to join research protocols which offer the prospect of direct benefit to these minors for these very particular services.  We also believe the minors who seek this specialized treatment may join research protocols which involve no more than minimal risk.

Accordingly, we believe the minor must consent for all research that is minimal risk or that offers the prospect of direct benefit to that minor for that specific treatment.  However, we do not believe the minor may consent without parental or guardian consent to research related to the specific treatment if the research involves more than minimal risk and does not offer the prospect of direct benefit to that minor for that specific treatment.

Examples of Minors Who Are Seeking Specific Treatment 

Example A: A PI wants to study the drinking habits of teenagers.  He wants to approach all teenagers being seen in the JHOC outpatient clinic and ask them to join the study.  The PI proposes that only the teenagers’ consent be obtained -- not their parents’ consent.  Teenagers being seen for general medical problems in the JHOC outpatient clinic cannot be assumed to be seeking treatment or advice for alcoholism.  Consequently, this consent procedure would not be consistent with the exception for medical consent under Maryland law, and thus would not be acceptable as an exception to application of Subpart D.  Therefore, the teenagers would need parental consent to join the study.

Example B: A PI wants to study the drinking habits of teenagers who have sought counseling for alcoholism treatment.  The study is deemed to be a minimal risk study.  The PI intends to seek to enroll teenagers without their parents’ consent.  This consent would be consistent with the exception for medical consent under Maryland law and would be acceptable as an exception to application of Subpart D. These teenagers would be deemed to have sought treatment for the specific problem of alcoholism and they must consent to that treatment.  By parallel application, these teenagers may consent to research related to alcoholism that includes no more than minimal risk.

Example C:  A PI wants to study the drinking habits of teenagers who have sought counseling for alcoholism treatment.  The study involves more than minimal risk.  It also offers the prospect of direct benefit to the teenagers who would enroll in the study.  The PI intends to seek to enroll teenagers without their parents’ consent.  These teenagers would be deemed to have sought treatment for the specific problem of alcoholism and, under Maryland law, they must consent to medical treatment.  By parallel application, the teenagers must consent to research related to alcoholism that includes the prospect of direct benefit to those who would enroll in the study.  Subpart D would not apply.

Example D: Same as C, but the researcher wants to study sexual behavior of the teenagers as well as alcoholism.  This study could not proceed without parental consent.  The treatment sought by the teenagers is for alcoholism, not sexual issues.  Accordingly, the minors may not consent as adults for purposes of consenting to a research study relating to both sexual issues and alcoholism. 

Example E: A PI wants to study the physical and mental condition of teenagers admitted to detention centers.  The PI intends to seek to enroll teenagers without their parents consent.  This consent would be consistent with the exception for medical consent under Maryland law and would be acceptable as an exception to application of Subpart D.  However, because the teenagers would be deemed to be “prisoners” under the Common Rule, Subpart C would require approval of OHRP for this study.

SUMMARY CHART

Chart which summarizing the previous two selections.

GENERAL CONSIDERATIONS

Please note that the above examples are intended to illustrate what is allowed under Maryland law, and by parallel analysis, under the Common Rule.  Approval of a particular study or a particular consent procedure is always under the purview of the individual IRB.  Thus even if a particular consent process were permitted under Maryland law, the IRB may not approve it, or may approve it only with more restrictive protections.

For example, although in the situations/treatments noted above the consent of the parents of the minor would have no legal effect, the IRB could, on a protocol by protocol basis, include a requirement for parental consent as a protection for minor participants.  However, two things may be relevant if such a requirement were to be included for a particular protocol.  First, the minor would need to consent to contacting the parent for consent.  Second, due to the possible sensitive nature of the type of treatment the minor is seeking, e.g., for drug abuse, alcoholism, venereal disease, etc., requiring parental consent could negatively impact recruitment.

CONCLUSION

Any study proposing enrollment of minors requires careful study by the IRB.  Using this Guidance, PIs should highlight for IRB staff and explain to the IRB the consent process for minors in their protocols coming within any of the above categories.