Consent for banking	Consenting minor parents
Foster care	Policy for non-English speaking subjects
Record retention	Training
Transfer of material	Shipment of hazardous materials
Consent and assent	Investigator requirements
HIPAA compliance

Foster care

Children in foster care should not be enrolled in clinical research at Children's Hospital of Wisconsin. There are legal requirements for an impartial advocate to represent the child's interests regarding participation in research. Children's Hospital does not have an advocate system in place for this population. Efforts are underway to develop a system that allows children in foster care access to research options.  

Record retention

• All medical and other records* of human research subjects who participate in a clinical research study conducted at Children's Hospital or at another site but approved through the Children's Hospital HRRB must be retained until all subjects are at least 25 years of age or at least 10 years after the subject's last date of study participation, whichever is longer.
• If a study was open but never enrolled any subjects, all study records including HRRB approvals and communications should be kept for six years after termination, due to any potential HIPAA questions regarding recruiting and screening practices. 
• An investigator may be required to retain human research subject records for a longer period of time if required by a research study sponsor, a federal agency (such as the Food and Drug Administration), or pursuant to the terms of a grant or other investigator agreement.
• All records must be retained in a manner that protects patient confidentiality and privacy in accordance with applicable law.
• After the applicable retention period expires, records may be shredded and disposed. However, records should not be destroyed if they are less than 10 years for medical records and study subject records, and never less than six years for study records that never enrolled any subjects.
• Upon study termination, an individualized plan (including specific storage locations) for long-term retention of the study records should be developed by the study team and implemented. Both principal investigators and research coordinators should retain copies of the retention plan.

*Medical and other records refer to all files of the research study that contain any information about the demographics, financial status, health or other personal attributes of human research subjects participating in the study.

Training

Children's Research Institute has established training standards for clinical research in human research protection, biomedical ethics and shipping of hazardous materials. Incomplete training of research staff will delay approval of research projects. Please confirm training of all study staff members prior to submitting your research. See the training policy summary.

Training policy summary

Protection of Human Subjects
The approved training program is the Collaborative Institutional Training Initiative in Human Research. Children's Research Institute and Children's Hospital's IRB require completion of this program for all clinical researchers. Biomedical, social behavioral and community partner tracks all are available to accommodate the best fit for training depending on the research focus. Once initial certification is obtained, the CITI Refresher Course must be completed every two years.

Research Ethics
All new research personnel handling, recording, generating, analyzing or publishing scientific data must complete a one-time training in research ethics. The approved training for research ethics is the Responsible Conduct of Research module developed by CITI. This module focuses on data integrity, authorship, publication rights, mentoring, conflicts of interest and other ethical issues. All research personnel are required to reaffirm their understanding of these ethical standards every two years by reading and signing the Children's Research Institute Code of Ethics. Researchers who previously have completed a code of ethics are not required to complete the RCR module.

Material Transfer Agreements

A Material Transfer Agreement is a contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Materials commonly covered by MTAs include:

• DNA banks.
• Human subject tissue banks.
• Data banks.
• Cell lines.
• Plasmids.
• Chemical compounds.

The process for obtaining an MTA depends upon who owns the material to be transferred. Ownership is determined by where the materials are housed and who financially supported the collection of the research materials up to this point. If it is determined that Children's Hospital has partial ownership of the data due to its support of the research and/or tissue/data bank, please contact the HRRB office for instructions.

Shipment of hazardous materials

Federal law requires specific training for any person shipping or supervising the process of shipping or causing the shipment of biological or hazardous materials. Online training for shipment of noninfectious diagnostic samples is available through Children's University. If researchers are shipping known infectious materials, additional training is required. The preferred training option for shipping known infectious materials is available commercially from Saf-T-Pak. Trainees must sign their certificates and forward the certificate to Children's Research Institute for signature. Training is not valid without an institutional signature. This training is only required for individuals who ship hazardous materials. Researchers not shipping diagnostic or known hazardous materials are not required to complete this training.

Variances

"Exempt" human subjects research protocols
Protocols submitted to the Children's Hospital HRRB which qualify for exempt status require only investigator-level researchers to complete these training requirements.
 
Off-site collaborators
Researchers collaborating with investigators at Children's Hospital but working off campus may substitute local training materials in place of CITI and RCR if the training occurred within the last two years. If no such comparable training has been completed, the researcher will be asked to complete the required CITI and Code of Ethics training. 

Consent and assent for child participation in research policy summary

Definitions

Children
Persons who have not attained the legal age for consent to treatments or procedures involved in research under the applicable law of the jurisdiction in which the research will be conducted. In Wisconsin, the legal age of consent is 18 years.

Guardian
An individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care.

Legally authorized representative
An individual, judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in a research study. Under Wisconsin law, a legally authorized representative may be the parent, guardian or legal custodian of a minor, the person vested with supervision of a child under state law, the guardian of a person judged incompetent, the personal representative or spouse of a deceased subject, or any person authorized in writing by the subject or a health care agent designated by the subject as a principal under state law if the subject has been found to be incapacitated under state law except as limited by the power of attorney for health care instrument.

Parent
A child's biological or adoptive parent.

• One of the responsibilities of the HRRB is to determine that the permission of each child's parent or guardian is granted before research activities begin.
• The general rule is that the minor's parent or guardian must consent before a child may participate in research.
• Consent from the parents or guardians must be sought and obtained prior to assent from the child subject.
• The consent process should include a discussion regarding the purpose, risks, benefits and duration of the research, as defined in the HRRB approved consent form. The consent form should guide the discussion. Parents and guardians must be allowed to ask questions and have time to consider their options.

Minors as parents
Minors may have children of their own and for treatment/care decisions the minor parent may give consent. For research, however, minors generally may not give consent alone for their child to be enrolled in research. The only exceptions are minors who have been emancipated either by marriage (legal in Wisconsin with parental consent) or through a court decision. Other than those circumstances, the mother's parents or the adult father of the child subject (as established by paternity testing and court documentation) also would have to agree to give consent for research. Unwed fathers or fathers without documentation of paternity have no say in research consent processes.
 
Assent
Assent is a child's affirmative agreement to participate in research. Failure to object consent does not constitute assent.

Procedures for obtaining assent

When judging whether children are capable of assent, one must take into account the ages, maturity and psychological state of the children involved. The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are capable, what their participation in research would involve. 

• For children whose age and maturity level limits their ability to fully comprehend the nature of the research activity but who are still capable of being consulted about participation in research, it may be appropriate to focus on conveying an accurate picture of what the actual experience of participation in the study is likely to be (such as what the experience will be, how long it will take, whether it might involve any pain or discomfort). 
• For research activities involving adolescents whose capacity to understand resembles that of adults, the assent procedure should likewise include information similar to what would be provided for informed consent by adults or for parental permission.

Documentation of assent

• For ages 0 to 6, no written assent is required from child (child can still refuse assent and this must be accepted by the researchers).
• For ages 7 to 13, children should sign assent on the separate HRRB approved assent form.
• For ages 14 to 17, children should sign on the assent line of the consent form signed by their parent or guardian.
• For reconsent after age 18, the investigator must seek informed consent when a subject who was enrolled in research with parental permission subsequently reaches the legal age of consent (18 years of age in Wisconsin).

Investigator requirements policy summary 

Only the following individuals may serve as the principal investigator in the conduct of clinical research at Children's Hospital affiliates. 

• Children's Hospital affiliate's Medical/Dental staff members in good standing, Children's Hospital affiliates employees or Children's Research Institute investigators.
• Individuals who are approved by Children's Research Institute may independently serve as a principal investigator on studies that do not involve prospective patient care tests, procedures, investigational medications or investigational devices.
• Individuals approved by Children's Research Institute, including PhD investigators, nurses, students, residents and fellows, may serve as PI for any study. They must have a Children's Hospital Medical/Dental staff member in good standing serving as co-investigator if the study involves prospective patient care tests, procedures, devices or medications and is conducted at a Children's Hospital affiliates site.

HIPAA compliance in research subject screening

Children's Hospital and the Medical College take privacy and HIPAA regulations very seriously. Employees should never access medical records unless job duties require that they do so. The following guidance is intended to help researchers comply with all required reporting of access to patient health information in the conduct of clinical research within Children's Hospital.
 
Incidental contact with PHI is not reportable under HIPAA or Wisconsin State regulations. Incidental contact with PHI includes:

• Viewing clinic and inpatient lists.
• Overhearing conversations concerning patient care.
• Personal observations of patients.
• Other general exposure to PHI not obtained by entering an individual's specific medical record.

Non-incidental contact would include systematic review of individual charts and records to locate eligible subjects. As long as these contacts occurred under a Children's Hospital HRRB-approved HIPAA waiver and do not result in recording of information for the purposes of research, the contact is considered in use and is not required to be reported by HIPAA or Wisconsin regulations. If you disclose any PHI from these records outside Children's Hospital, such as for a clinical trial's screening log with subject initials or dates of birth, these are considered HIPAA disclosures and must be reported to medical records.

Planned Screening Activities

If you plan to prospectively recruit subjects into your research project as they pass through the hospital or clinics for medical care, your best option is to submit a request for HIPAA waiver with your HRRB application. Under this waiver you are permitted to review the charts of prospective study subjects to check for general eligibility as necessary in order to know which protocol, if any, is appropriate to discuss with the subject/family to seek study consent and HIPAA authorization. If you access hospital medical records under this waiver to determine which study to talk to a family about, these are considered uses as the data is not disclosed outside of Children's Hospital. "Uses" are not required to be reported under HIPAA or Wisconsin State regulations.
 
Once HIPAA authorization is signed by the subject or parent, you have full permission to use the subject records and disclose the data to research partners outside Children's Hospital as indicated on the authorization form. No further accounting is required.
 
All accesses to electronic medical records or requests for access to paper records are recorded and can be audited. You may be asked to explain why you accessed certain records at some point in the future. You should log all disclosures of PHI and record the names of all study subjects who have signed HIPAA authorizations for research. You should only access records as required for performance of your job as a researcher.

HIPAA disclosure accounting must be filed in a patient's medical record if the researcher is collecting research data under a waiver or "disclosing" that data to a party outside Children's Hospital.

There are state reporting requirements for all accesses to official medical records. Children's Hospital Medical Records reports these accesses when requested. Data provided to the state is from electronic access and chart requests. Access to PHI not kept online or in official Children's Hospital Medical Records documents currently cannot be effectively tracked for either clinical care or research purposes. As such, reporting currently is not required for these accesses.