Institutional Review Board
Research with Children
The primary ethical considerations concerning research with children are described in the first section of the Belmont Report, respect for persons.Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. (Belmont Report, 1979)
Issues to consider regarding respect for persons in dealing with children is that there are many circumstances in which children are not considered autonomous. Adults make many decisions for children, which is generally very appropriate. With regard to research, however, ethics guidelines explicitly state that investigators must treat children as autonomous and respect their stated wishes whether they choose to participate in research or not.
The second ethical issue related to research with children is that they are considered persons with diminished authority. Because their developmental stage dictates that their decision-making skills are limited by their maturity, they are entitled to protections that are not afforded to adults who participate in research.
These two provisions conflict in very fundamental ways, which makes research with children a challenge. In a study protocol, the investigators should provide sufficient information to help the IRB understand how they plan to both respect the autonomy and protect the wellbeing of the children who participate in their research. Recommendations on developing an assent (permission provided by children) process, in addition to the parental consent, can be found here. The HSPP can provide guidance on the regulatory requirements for inclusion of children in proposed research. Please contact the HSPP with any questions at firstname.lastname@example.org.
Title 19 of the Colorado Revised Statutes (C.R.S.) covers issues relating to the abuse and neglect of children. These statutes include provisions on persons who are required to report child abuse or neglect, which can be very relevant in some proposed research studies with children. Please review:
TITLE 19. CHILDREN'S CODE
ARTICLE 3. DEPENDENCY AND NEGLECT
PART 3. CHILD ABUSE OR NEGLECT
C.R.S. 19-3-304 (2012)
19-3-304. Persons required to report child abuse or neglect
(1) (a) Except as otherwise provided by section 19-3-307, sections 25-1-122 (4) (d) and 25-4-1404 (1) (d), C.R.S., and paragraph (b) of this subsection (1), any person specified in subsection (2) of this section who has reasonable cause to know or suspect that a child has been subjected to abuse or neglect or who has observed the child being subjected to circumstances or conditions that would reasonably result in abuse or neglect shall immediately upon receiving such information report or cause a report to be made of such fact to the county department or local law enforcement agency.
(b) The reporting requirement described in paragraph (a) of this subsection (1) shall not apply if the person who is otherwise required to report does not:
(I) Learn of the suspected abuse or neglect until after the alleged victim of the suspected abuse or neglect is eighteen years of age or older; and
(II) Have reasonable cause to know or suspect that the perpetrator of the suspected abuse or neglect:
(A) Has subjected any other child currently under eighteen years of age to abuse or neglect or to circumstances or conditions that would likely result in abuse or neglect; or
(B) Is currently in a position of trust, as defined in section 18-3-401 (3.5), C.R.S., with regard to any child currently under eighteen years of age.
(2) Persons required to report such abuse or neglect or circumstances or conditions include any:
(a) Physician or surgeon, including a physician in training;
(b) Child health associate;
(c) Medical examiner or coroner;
(i) Registered nurse or licensed practical nurse;
(j) Hospital personnel engaged in the admission, care, or treatment of patients;
(k) Christian science practitioner;
(l) Public or private school official or employee;
(m) Social worker or worker in any facility or agency that is licensed or certified pursuant to part 1 of article 6 of title 26, C.R.S.;
(n) Mental health professional;
(o) Dental hygienist;
(q) Physical therapist;
(s) Peace officer as described in section 16-2.5-101, C.R.S.;
(u) Commercial film and photographic print processor as provided in subsection (2.5) of this section;
(v) Firefighter as defined in section 18-3-201 (1), C.R.S.;
(w) Victim's advocate, as defined in section 13-90-107 (1) (k) (II), C.R.S.;
(x) Licensed professional counselors;
(y) Licensed marriage and family therapists;
(z) Registered psychotherapists;
(aa) (I) Clergy member.
(II) The provisions of this paragraph (aa) shall not apply to a person who acquires reasonable cause to know or suspect that a child has been subjected to abuse or neglect during a communication about which the person may not be examined as a witness pursuant to section 13-90-107 (1) (c), C.R.S., unless the person also acquires such reasonable cause from a source other than such a communication.
(III) For purposes of this paragraph (aa), unless the context otherwise requires, "clergy member" means a priest, rabbi, duly ordained, commissioned, or licensed minister of a church, member of a religious order, or recognized leader of any religious body.
(bb) Registered dietitian who holds a certificate through the commission on dietetic registration and who is otherwise prohibited by 7 CFR 246.26 from making a report absent a state law requiring the release of this information;
(cc) Worker in the state department of human services;
(dd) Juvenile parole and probation officers;
(ee) Child and family investigators, as described in section 14-10-116.5, C.R.S.;
(ff) Officers and agents of the state bureau of animal protection, and animal control officers;
(gg) The child protection ombudsman as created in article 3.3 of this title;
(hh) Educator providing services through a federal special supplemental nutrition program for women, infants, and children, as provided for in 42 U.S.C. sec. 1786.
(2.5) Any commercial film and photographic print processor who has knowledge of or observes, within the scope of his or her professional capacity or employment, any film, photograph, video tape, negative, or slide depicting a child engaged in an act of sexual conduct shall report such fact to a local law enforcement agency immediately or as soon as practically possible by telephone and shall prepare and send a written report of it with a copy of the film, photograph, video tape, negative, or slide attached within thirty-six hours of receiving the information concerning the incident.
(3) In addition to those persons specifically required by this section to report known or suspected child abuse or neglect and circumstances or conditions which might reasonably result in abuse or neglect, any other person may report known or suspected child abuse or neglect and circumstances or conditions which might reasonably result in child abuse or neglect to the local law enforcement agency or the county department.
(3.5) No person, including a person specified in subsection (1) of this section, shall knowingly make a false report of abuse or neglect to a county department or local law enforcement agency.
(4) Any person who willfully violates the provisions of subsection (1) of this section or who violates the provisions of subsection (3.5) of this section:
(a) Commits a class 3 misdemeanor and shall be punished as provided in section 18-1.3-501, C.R.S.;
(b) Shall be liable for damages proximately caused thereby.