Human Research Policies, Guidance and FAQs 

HIPAA | IRB POLICIES| GUIDANCE |FAQs

**PLEASE NOTE**

Effective Immediately: SAEs and Deviations must be reported by completing and submitting the REPORTABLE EVENTS FORM (Please see: IRB POLICIES Section).

HIPAA/PRIVACY

Accounting of Disclosures of PHI

De-Identification of PHI

Uses and Disclosures of PHI for Research Purposes       

Photographing /Videotaping/Other Imaging of Patients and/or Caregivers

• CHHS does not permit parents/legal guardians to photograph caregivers when the caregiver is providing care.  Consent must be obtained prior to any patient photography, videotaping, digital imaging, and/or other visual or audio recordings during patient care or other health system activities.  Specific written authorization must be obtained before any patient photography will be released.

Use and Disclosure of PHI with and without an Authorization

• CHHS provides the notice of our privacy practice to all registering hospital individuals outlining how the facility uses and discloses protected health information. Note: Should any law enforcement officer or individual serving a subpoena, etc. call or present to your department requesting PHI, please refer them to your manager.

INSTITUTIONAL REVIEW BOARD POLICIES

REPORTABLE EVENTS (SAES, DEVIATIONS)

For Researchers:

Adverse Events, Unanticipated problems, Deviations etc. to the IRB 

*New* March 1, 2011

Reportable Events Policy

• Immediately Reportable Events Form
• Reportable Events Log

Federal regulations (45 CFR 46.103(b)(5) & 21 CFR 56.108(b) require written procedures for ensuring prompt reporting of unanticipated problems to the IRB, appropriate institutional officials, any supporting department or agency head (or designee), and OHRP. The purpose of prompt reporting is to ensure that appropriate steps are taken in a timely manner to protect subjects from avoidable harm.

When conducting clinical investigations of drugs, including biological products, under 21 CFR part 312 and of medical devices under 21 CFR part 812, an investigator's responsibilities include preparing and submitting the following complete, accurate, and timely reports (§§ 812.150 & 312.64):

• Any unanticipated problems occurring during an investigation
• Select serious adverse device/drug events occurring during an investigation
• Any deviation from the investigational plan made to protect the life or physical well-being of a subject in an emergency

Events which meet the above prompt reporting criteria must be reported to the IRB within 5 calendar days.

Events which do not meet the prompt reporting criteria may be reported to the IRB with the Continuing Progress Report (CPR).

Conflict of Interest in Human Research/Financial Reporting

Misconduct in Research Practices

Research Noncompliance

Research Revisions and Amendments

GENERAL RESEARCH POLICIES/GUIDELINES

For reference regarding the process of conducting research to be reviewed by the Children's Hospital and Health System Institutional Review Board

Process - Conducting Research on Human Subjects

Grants - Obtaining /Accessing Donated Funds from the Children's Hospital Foundation

Required Researcher Training

• To comply with the terms of our Federal wide Assurance, any person participating in research on human subjects must have training in the Protection of Human Subjects. This policy applies to all "Clinical Researchers", defined as investigators, research or study coordinators/assistants, research nurses, or any employee or member of the research team who has contact with human subjects specifically for research purposes.

Initial Review

Exempt Research

Expedited Review 

Continuing Review

Emergency Use

• Emergency situations may arise in which there will be a need to use a test article in a manner inconsistent with the approved investigational plan or by a physician who is not part of a clinical study. FDA exempts from prospective IRB review the emergency use of a test article so long as the emergency use is reported to the HRRB within five (5) working days of its occurrence.  Except in rare instances, consent must be obtained and the Principal Investigator should make every effort to have emergency use approved by the IRB chair prior to implementation. 

1. Use of Test Articles:The use of an investigational drug, biologic, or device on a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)].
2. Planned Emergency Research: A narrow exception to the Food and Drug Administration's (FDA) requirement to obtain and document informed consent; applies to a limited class of research activities involving human subjects who are in need of emergency medical intervention but cannot provide legally effective informed consent and who do not have a legally authorized representative to represent them. The research plan must be approved in advance by the FDA and the CHW HRRB and publicly disclosed to the community in which the research will be conducted. [21 CFR50.24].

Assent

Billing in Clinical Research Studies

Informed Consent

Non-English Speaking Subjects and/or Legally Authorized Representatives (LAR)

Record Retention

ADMINSTRATIVE RESEARCH POLICIES/GUIDELINES

For reference on the processes by which the Children's Hospital and Health System Institutional Review Board operates

IRB Membership

• The CHW IRB shall be composed of no less than five voting members sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, including considerations of race, gender, and cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for their advice and counsel in safeguarding the rights and welfare of human subjects.

IRB Jurisdiction and Authority

• This policy grants the CHW IRB jurisdiction and authority to the fullest extent needed in order to conduct its reviews and other activities in such a manner as to provide adequate protection to human research subjects. The authority of the CHW HRRB is derived from federal laws, Medical/Dental Staff By-laws and institutional policy.

IRB Voting

• Voting on proposed research may only be conducted when a quorum of the IRB members are present and eligible to vote. In addition, in order for a vote to be conducted, one member whose primary concerns are in a non-scientific area must be present. Members with a conflicting interest in the project under review may not be counted for purposes of determining quorum and may not participate except to provide information requested by the IRB.

IRB Record Keeping

• It is the responsibility of the IRB Coordinator to prepare, and maintain adequate documentation of IRB activities. All IRB activities must be documented and managed in accordance with this policy. All IRB activity, whether at a convened meeting or conducted under expedited review procedures, shall be documented.

IRB Reporting

Policy and Procedure Development and Access

Verification of Clinical Research Personnel

IRB POLICY GUIDANCE

Please note: All IRB policies currently are being reviewed and revised. Please check with the IRB office if you have questions on any policies or procedures.

Foster Care and Wards of the State

Wards of the State in Human Subjects Research (Policy) *new* March 1, 2011

Children in foster care may be enrolled in clinical research at Children's Hospital of Wisconsin only with permission/consent from their legal guardians. Foster parents typically are not the legal guardians. Contact the foster child's case worker to locate the guardian to seek consent. Given the time involved that may be necessary to locate guardians and meet with them, studies that need near immediate consent for participation (short eligibility windows) are not good fits for foster children to participate.

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 IRB 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. 

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 Tom Twinem (ttwinem@chw.org)  or Diane Bauer (dbauer@chw.org) of Corporate Compliance 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 IRB 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 IRB 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 IRB 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).

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 IRB-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 IRB 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. 

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.

FREQUENTLY ASKED QUESTIONS 

The following are FAQs with regards to research at Children's Hospital and Health System.  If there is a question you would like to appear in this section, please send it to Gwen Miner for consideration.

Q:  Should my research personnel complete CITI and Ethics training?

A:  The general rule of thumb is if your team member has patient contact for your research study then CITI and Ethics training is required.  If you are not certain, please contact the IRB office at (414) 266-7454 to verify training requirements. 

Q:  Can a minor parent consent to research for their child?

A:  Minor parents can only give consent for treatment of her child, but they can not consent to research.  Consent must be obtained by one of the maternal grandparents of the infant to be enrolled in a research study, unless the minor mother is emancipated by marriage or court order.

Q: How do I register for IRBnet?

A: Log on to http://www.irbnet.org and click 'New User Registration'.  In order for this application to work properly you must choose Children's Hospital of Wisconsin when asked for your affiliation.  A detailed user guide has been provided in the Toolbox.  It is located on the IRB website homepage.

Q:  What if I forget my user name and/or password?

A:  Next to 'New User Registration' there is a 'Forgot Your Password?" link next to a question mark icon.  You will need to know the e-mail address you registered under.  The CHW IRB office does not have access to any user's account information.

Q:  Who do I call for help with IRBNet?

A:  We now have a dedicated line for IRBNet troubleshooting: 414-337-7818.  This is for help with issues pertaining to working with the IRBnet application. If the website is not functioning properly, you may contact IRBNet Support Desk:  877.261.6461; email: support@irbnet.org

Q: How do I know if my study was submitted properly?

A:  Once you have submitted your study, a confirmation page will appear.  Your status will change to 'Pending Review' and the 'Project Overview' page will display which board has received your study for review. If your status read: "Work In Progress".  Your study has NOT been submitted to the CHW HRRB.

Q:  How do I get my electronic signature on the study?

A:  Required sign-offs are done by clicking on the 'Sign this Package' button.  This will take you to the 'Sign Package' page.  Choose your designation (i.e. Principal investigator) and click 'Sign'.  An e-mail alert will be sent to all members who have access to your study.

Q:  What if I need to amend my study at time of continuing review?  Can I put them both in the same package?

A:  No.  Please use separate packages for your continuing review documents and your amendment submission, as these are separate processes.

Q:  How do I submit an amendment when my study says it is 'Locked"?

A:  Amendments require you to create a new package.  The quickest way to create a new package is to enter the study you wish to amend, click on 'Project History' and then 'Create New Package'.  This will give you an empty designer, with your previously submitted documentation below.  Upload your revised documents and hit 'Submit'.

Q:  Where do I send revised documents for a study that is pending approval?

A:  E-mail the corresponding coordinator, with the revised documents as attachments.  Instructions as to where to send the revisions will be contained in your e-mail notice. DO NOT UPLOAD REVISIONS INTO A STUDY DURING REVIEW UNLESS YOU ARE SPECIFICALLY ASKED TO DO SO.

Q:  What if I can't respond to your request for modifications right away?  How long do I have?

A:  The IRB office policy for receipt of revisions is withdrawal of the corresponding submission after 60 days.  Extenuating circumstances (i.e. PI is out of the country) are gladly accommodated, but you must make contact with an IRB coordinator to prevent withdrawal of your submission.