DAR File No. 39270

Human Services, Administration

Rule R495-820

Institutional Review Board

Notice of Proposed Rule

(New Rule)

DAR File No.: 39270
Filed: 04/14/2015 11:33:33 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this rule is to set forth procedures and standards that are in compliance with the federal requirements for the review and approval of research activities that propose to target or recruit the Department's clients or employees and/or access data from the Department's publicly-funded client population or the Department's employees, including additional requirements specific or unique to the Department.

Summary of the rule or change:

This rule establishes the Department Institutional Review Board (IRB).

State statutory or constitutional authorization for this rule:

• Section 62A-1-111

This rule or change incorporates by reference the following material:

• Adds 21 CFR 56, published by Government Printing Office, 04/01/2014
• Adds 21 CFR 312, published by Government Printing Office, 04/01/2014
• Adds 45 CFR 46, published by Government Printing Office, 01/15/2009
• Adds 21 CFR 50, published by Government Printing Office, 04/01/2014
• Adds 21 CFR 812, published by Government Printing Office, 04/01/2014
• Adds 45 CFR 164, published by Government Printing Office, 10/01/2007

Anticipated cost or savings to:

the state budget:

There will be no increase in cost or savings to the state budget because this proposed rule will not increase workload that would require additional staff or other costs.

local governments:

Local governments have no responsibility for the Department's IRB and are therefore not affected by this rule and will have no fiscal impact.

small businesses:

Small businesses have no responsibility for the Department's IRB and are therefore not affected by this rule and will have no fiscal impact.

persons other than small businesses, businesses, or local governmental entities:

There is no expected fiscal impact for individuals in the category of "persons other than small businesses, businesses, or local government entities."

Compliance costs for affected persons:

There is no cost to affected persons because they will only need to follow the existing guidelines which have no fiscal impact.

Comments by the department head on the fiscal impact the rule may have on businesses:

This rule will have no fiscal impact on businesses.

Ann Williamson, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Human Services
Administration
Room DHS ADMINISTRATIVE OFFICE MULTI STATE OFFICE BUILDING
195 N 1950 W
SALT LAKE CITY, UT 84116

Direct questions regarding this rule to:

• Frank Rees at the above address, by phone at 801-344-4203, by FAX at 801-538-3942, or by Internet E-mail at [email protected]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

06/01/2015

This rule may become effective on:

06/08/2015

Authorized by:

Ann Williamson, Executive Director

R495. Human Services, Administration.

R495-820. Institutional Review Board.

R495-820-1. Purpose.

(1) The purpose of this rule is to set forth procedures and standards that are in compliance with the federal requirements of 45 CFR 46, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812, 45 CFR 164.508, and 45 CFR 164.512 for the review and approval of research activities that propose to target or recruit the Department's clients or employees and/or access data from the Department's publicly-funded client population or the Department's employees, including additional requirements specific or unique to the Department.

(2) The DHS IRB serves as the Institutional Review Board for the Department.

 

R495-820-2. Authority.

(1) This rule establishes procedures and standards for the review of research proposals, as authorized under Section 62A-1-111.

 

R495-820-3. Definitions.

(1) The definitions found in the United States federal regulations at 45 CFR 46(January 15, 2009), 21 CFR 50(April 1, 2014), 21 CFR 56 (April 1, 2014), 21 CFR 312 (April 1, 2014), 21 CFR 812 (April 1, 2014) , and 45 CFR 164 (October 1, 2007) are incorporated by reference, including by not limited to:

(a) "Human subject" defined in 45 CFR 46.102.

(b) "Legally Authorized Representative" defined in 45 CFR 46.102.

(c) "Minimal risk" defined in 45 CFR 46.102.

(d) "Phase I study" defined in 21 CFR 312.21.

(e) "Phase II study" defined in 21 CFR 312.21.

(f) "Phase III study" defined in 21 CFR 312.21.

(g) "Research" defined in 45 CFR 46.102.

(2) The following are defined for purposes of this section.

(a) "Adverse Event" means any unfavorable incident or unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with enrollment in a research study, whether or not considered related to the product, intervention, or treatment being tested. An adverse event also means any emotional distress, psychological trauma, invasion of privacy, embarrassment, loss of social status or employment, or economic impact that may be related to participation in the research.

(b) "Serious Adverse Event" means an adverse event that results in any of the following:

(i) Death, or a life threatening event;

(ii) Inpatient hospitalization or prolongation of existing hospitalization;

(iii) Significant, persistent, or permanent harm or disability either physically or psychologically;

(iv) A congenital anomaly or a birth defect; or

(v) Any medically significant event that may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

(c) "Conflict of Interest" means any situation where the researcher has financial, economic, social, political, familial, legal or other interests which interfere with, or have the potential to interfere with, their judgment in connection with the research.

(d) "Department" means the Utah State Department of Human Services, also referred to as DHS.

(e) "Department's employee" means anyone who has been hired into a full or part-time position whether merit or non-merit with the Department, and for the purposes of this Rule includes any volunteer, student intern, or individual serving a field practicum with the Department.

(f) "DHS IRB" means the Department's Institutional Review Board.

(g) "Division" means any of the Department's divisions, offices, or agencies.

(h) "Foreseeable Risk" means any risk the researcher or sponsor knew, or should have known, would pose a risk to human research subjects.

(i) "Gatekeeper" means the Division Representative on the IRB who serves as the primary reviewer and liaison between researchers and the Department.

(j) "Guardian" means a person who is legally qualified as a guardian of a minor or incapacitated person, but excludes a Guardian ad Litem.

(k) "Less than minimal risk" research refers to research in which the researcher will not contact the human subject in person, but may request access to client or employee data maintained by the Department or its contractors, and the risk of harm or discomfort to the human subject is less than minimal risk as defined in 45 CFR 46.102.

(l) "Serious mental illness" means Major Depression, Bipolar Disorder, Schizophrenia, Dissociative Disorder, other psychotic illnesses, Attention-Deficit Hyperactivity Disorder, Post Traumatic Stress Disorder, Borderline Personality Disorder, Reactive Attachment Disorder, and Panic Disorder.

(m) "Proposal" means the application completed by the researcher and submitted to the division gatekeeper for consideration.

(n) "Publicly-funded client population" means individuals receiving services funded directly or indirectly by the Department, including clients' family members, clients' victims, or local community mental health, substance abuse, and aging and adult service consumers where the local agency receives pass-through funds from the Department to provide services to the community.

(o) "Researcher" means anyone seeking to access data or recruit clients or employees of the Department for research purposes, and anyone proposing or conducting research activities. This may include the researcher's employees, staff, or assistants.

(p) "Review Determination" means the outcome of an IRB review which may be any of the following:

(i) "Final Approval" means the determination of the DHS IRB that the research has been reviewed and may be conducted within the constraints set forth by the DHS IRB.

(ii) "Conditional approval" means the DHS IRB requires specific revisions or verifications before final approval will be granted. Conditional approval does not authorize research activities, including but not limited to subject contact or recruitment, to proceed.

(iii) "Deferred Decision" means the DHS IRB did not have sufficient information to complete a review. The DHS IRB may review the research proposal at a future time after the DHS IRB receives sufficient information.

(iv) "Disapproval" means the DHS IRB denies the proposal and will not approve the proposal, with or without changes.

(v) "Exempt" means the proposal does not qualify as research as defined in 45 CFR 46.102 and in accordance with 45 CFR 46.101 and is not subject to ongoing DHS IRB oversight. Exempt status is determined by the DHS IRB or gatekeeper.

(q) "Vulnerable adult" is as defined in UCA 62A-3-301.

 

R495-820-4. Administrative Support.

(1) The DHS IRB has limited resources and cannot review proposals that are not supported by the facility or program administrators who have authority over the publicly-funded client population or client data. To submit a research proposal, a researcher must acquire:

(a) Prior written approval of the proposal from the facility and program administrator of each program where a member of the client population receives services funded directly or indirectly by the Department;

(i) the proposal must clearly describe what administrative or other support, if any, the facility, program, or staff may be asked to provide;

(ii) approval of a proposal does not obligate DHS to provide a researched with any requested administrative or other support; and

(b) Approval from the applicable division director or gatekeeper. The gatekeepers will only process and submit to the DHS IRB proposals that they have approved.

(2) In the sole discretion of DHS, if the volume of research requests becomes too great for the Divisions to process, the Division directors or designees reserve the right to suspend or postpone their review of study requests. DHS cannot guarantee responses or reviews within any particular timeframe. The Division director or designee also reserves the right, in their sole discretion and based upon their professional judgment, to deny any study request that conflicts or interferes with the best interest of programs or the safety of the publicly-funded client population.

 

R495-820-5. Research Involving Human Subjects.

(1) The requirements of the United States regulations at 45 CFR 46, 21 CFR 50, 21 CFR 56, 45 CFR 164.508, and 45 CFR 164.512 are incorporated by reference.

(2) In addition to the federal regulations incorporated by reference, the Department requires standard procedures for all research involving human subjects. Researchers are required to complete and electronically submit all forms in the application section of the DHS IRB website and to comply with these rules.

(3) Final approval from the DHS IRB must be granted before the researcher begins any research involving human subjects.

(4) Informed consent must follow requirements outlined in 45 CFR 46.116. In addition the researchers must adhere to the following:

(a) The researcher must consult with the division gatekeeper to determine who has legal authority to grant consent for their clients. If a minor's or vulnerable adult's guardianship changes then research shall be suspended until the researcher obtains an updated consent from the new guardian.

(b) The research participant (human subject) must give written informed consent. Depending on the participant population, the DHS IRB may require a written determination by the proposed participant's health care provider of capacity to consent, or require questions to assess comprehension. Where minors or vulnerable adults are involved as human subjects, provisions must be made for obtaining the informed assent of the minors or vulnerable adults, in addition to the written informed consent of their parents, guardians, or legally authorized representatives, in accordance with 45 CFR 46.408.

(c) Utah is a mandatory reporting state pursuant to UCA 62A-4a-403 and 62A-3-305; mandatory reporting requirements must be disclosed to potential participants during the consent/assent process and reflected in consent/assent documents. Mandatory reporting IS NOT REQUIRED when the survey or intervention is done anonymously with no means of identifying the respondent.

(d) The informed consent document must contain the DHS IRB gatekeeper's name and contact information as a person whom the participants can contact to gather more information regarding their rights as research participants.

(e) The informed consent document must contain a statement that the DHS IRB may review the researcher's records as part of the oversight authority referenced in section R495-820-14.

(5) Placebo research is restricted, see Utah Administrative Code R495-820-6.

(6) Remuneration for participation in the study must not be coercive, have the appearance or effect of being coercive, or be offered to entice individuals to participate in the study rather than receive traditional treatment. Compensation to research participants must be restricted to fair and reasonable remuneration. The DHS IRB reserves the right to determine whether proposed compensation is coercive or fair and reasonable.

(7) In addition to the restrictions in federal regulations, the DHS IRB will not approve the following:

(a) Studies which, in the discretion and professional judgment of the DHS IRB, involve a greater-than-minimal risk, and provide no benefit to the human subject, or provide no generalizable or program knowledge.

(b) Phase I and II studies.

(8) The DHS IRB will not review or approve medical research that includes pregnant women or fetuses as part of its target subject population where there is any foreseeable risk to a pregnant woman or her unborn fetus. Medical research studies shall include precautions to avoid enrollment of pregnant women, including requiring a pregnancy test prior to enrollment and requiring that women have a birth control plan they will follow while enrolled in the study.

(9) The DHS IRB shall require a written assurance from the researcher that upon completion of the study, the researcher will provide final closure information and findings to the DHS IRB. Study results shall be provided to DHS IRB and shall either be in a written report, an electronic format, or in a Clinical Trial Registration, and must have data analyzed and presented in a comprehensible and meaningful manner.

(a) Industry sponsors of and researchers involved in research studies, must commit in writing to publicly sharing final study results on or before the date that all sites have been closed, or all data analysis and report writing is completed.

(b) If a researcher or sponsor fails to make the study results public, the DHS IRB may refuse to consider future proposals from that researcher or sponsor.

(c) If a researcher or sponsor fails to provide study results to the DHS IRB, the DHS IRB may refuse to consider future proposals from that researcher or sponsor.

(10) Greater than minimal risk studies must address requirements outlined in 45 CFR 46.405 and 45 CFR 46.406.

 

R495-820-6. Research Involving Placebos.

(1) When the use of placebos is proposed, the Department imposes the following restrictions to protect participants from studies that would withhold active treatment:

(a) The DHS IRB shall not approve placebo studies that target individuals having:

(i) Any pending criminal case;

(ii) Who are incarcerated or in detention; or

(iii) Who have a pending competency evaluation or commitment procedure.

(iv) No minor or vulnerable adult under the guardianship or custody of any division of the Department may be recruited, enrolled, or participate in any research study that involves the use of a placebo.

(v) A serious medical or mental illness.

(b) If an individual has entered a study prior to involvement with civil or criminal legal proceedings, and subsequently becomes involved in any such action, the researcher shall report the event to:

(i) The DHS IRB;

(ii) The agency or entity that has assumed guardianship or responsibility for that person, if any.

(ii) If a minor or vulnerable adult has entered a study involving placebos prior to entrance into state guardianship or legal custody, then a referral will be made to the division gatekeeper or entity that has guardianship or custody, to determine whether the minor's or vulnerable adult's continued participation in the study is appropriate. That determination shall consider:

(A) The opinions of medical or psychological experts who have provided care for the minor or vulnerable adult prior to and during the study;

(B) If the placebo research involves a minor in the custody of the Division of Child and Family Services, the minor's Guardian ad Litem, if one has been appointed, shall be notified and that notification shall be documented in Department records and sent to the DHS IRB.

(C) If the minor's parent(s), prior to the minor's entrance into state custody or guardianship, had agreed to and signed an informed consent form prior to the minor's participation in the study.

(D) If the placebo research involves a vulnerable adult who is a ward of the Office of Public Guardian, the Office of Public Guardian shall be notified and that notification shall be documented in Department records and sent to the DHS IRB.

(c) Placebos may only be used in studies where no proven or known effective standard of care, prophylactic, diagnostic, or therapeutic method exists. If a proven or known effective standard of care or treatment exists, whether or not the standard of care has been subjected to empirical testing, that treatment shall not be withheld unless the participant is also receiving another known effective standard of care or treatment during the duration of his/her study participation. The IRB may consider for review placebo studies as long as participants continue to receive a known pharmaceutical and/or psychotherapeutic standard of care.

(d) Recruitment for the placebo study shall not be limited exclusively to subjects who are receiving services that are either partially or fully funded by monies allocated through the Department.

(e) If the minor or adult has a current diagnosis of serious mental illness at the beginning of a proposed study, the individual will be excluded from participation in placebo studies, unless the participant is also receiving, and continues to receive during the study participation, another active known effective standard of pharmaceutical or non-pharmaceutical care or treatment intervention.

(f) Frequent and close clinical monitoring, as dictated by the medical need of each client, is required in order to assure the ongoing safety and well-being of each human subject. Monitoring shall be documented by the researchers and medical personnel in each client's clinical record.

(g) Any individual with active homicidal or suicidal ideations, or who poses a foreseeable threat to themselves or others, is prohibited from participation in any study that involves the use of a placebo.

 

R495-820-7. Pre-Review.

(1) All research proposals submitted for DHS IRB review must first be reviewed by the division gatekeeper and have all concerns addressed and resolved to the satisfaction of the division gatekeeper no later than the last business day of the month preceding the DHS IRB meeting.

(2) Some research may be exempt from DHS IRB review as provided in 45 CFR 46.101(b). Division gatekeepers, alone or in consultation with the IRB chair, shall determine if the proposed research is exempt from DHS IRB review. If proposed research is exempt, the division gatekeeper or chair will issue an exempt letter to the researcher. If the research is not exempt, the research proposal will be submitted for either expedited review or full board review by the DHS IRB.

 

R495-820-8. DHS IRB Reviews.

(1) DHS IRB reviews may be expedited in accordance with 45 CFR 46.110, in which case the division gatekeeper, alone or in consultation with the DHS IRB chair, may find research to be exempt, may defer a decision, grant conditional approval, or grant final approval of the research.

(2) Mandatory review by a convened quorum of the DHS IRB is required for the following:

(a) Research involving any interaction or intervention as defined in 45 CFR 46.102 with minors.

(b) Research involving any interaction or intervention as defined in 45 CFR 46.102 with vulnerable adults.

(c) Research involving prisoners or detainees.

(d) Research that is greater than minimal risk.

(e) Research involving the use of pharmaceuticals or biomedical devices.

(3) The DHS IRB meets on a monthly basis to review proposed research.

(4) The determinations of the DHS IRB will be submitted to the researcher in writing and may include the following:

(a) Final Approval for a timeframe not to exceed 12 months.

(b) Conditional Approval, including conditions that must be met to get final approval.

(c) Deferred decision including the information that will be needed in order to complete the review.

(d) Disapproval, including reasons for the disapproval.

(e) Exempt from DHS IRB review

(5) DHS IRB review may make recommendations on research methodology that is unlikely to yield clear results.

(6) In accordance with 45 CFR 46.109 it is the IRB that has authority to approve, require modifications to, or disapprove research. As stated in 45 CFR 46.112 agency officials may not approve research that has not been approved by the IRB. Researchers who disagree with the IRB determination may submit a revised protocol to address the IRB concerns or ask to meet with the IRB for further discussion.

 

R495-820-9. Ongoing Review.

(1) The DHS IRB has the authority to set the timeframe for ongoing review of research. The timeframe will be no greater than 12 months from the date of approval.

(2) The researcher is responsible to submit the ongoing review request form 60 days prior to the DHS IRB approval expiration date.

(3) The researcher cannot continue with any research activities past the approval expiration date unless renewal is granted as the result of an ongoing review, in which case a new expiration date will be given.

(4) Data collected after expiration of DHS IRB approval may be required to be destroyed.

 

R495-820-10. Amendments.

(1) If the researcher desires to deviate from the approved research proposal, including but not limited to changes in research design, procedures, or instruments, the researcher must submit an amendment request form to the DHS IRB detailing the proposed changed to the research proposal.

(2) The DHS IRB will review the proposed changes and send a determination to the researcher. The researcher may not proceed with the proposed change unless final approval of the amendment is granted.

(3) Data collected from a proposal change that was not approved by the DHS IRB may be required to be destroyed.

 

R495-820-11. Research Misconduct.

(1) Allegations of research misconduct by researchers shall be reported to the DHS IRB chair or the DHS Deputy Director. Upon receipt of research misconduct the DHS IRB chair may initiate an investigation which includes:

(a) Request a report of related adverse events.

(b) Request an audit of the research by the Department of Human Services Bureau of Internal Review and Audit.

(c) Review research records.

(d) Suspend or terminate DHS IRB approval during investigation in accordance with 45 CFR 46.113.

(e) Review findings with DHS IRB board at which time approval may be revoked.

(f) Report research misconduct to the U.S. Department of Health and Human Services, Office of Human Research Protections.

(g) Set up more frequent ongoing reviews.

(h) Require changes to the protocol.

(i) Suspend research until changes have been made, approved, or determination that research is following approved proposals.

(2) Research misconduct by the Department's providers is also subject to Rule R495-876, Provider Code of Conduct.

 

R495-820-12. Conflicts of Interest.

(1) Conflicts of interest by the researcher shall be reported to the DHS IRB in the proposal forms.

(2) Any concerns of conflicts of interest by DHS IRB members shall be reported to the DHS IRB chair.

 

R495-820-13. Oversight.

(1) Researchers must report Serious Adverse Events immediately to the DHS IRB. The DHS IRB will review and may impose additional conditions for continued approval of the research.

(2) Adverse events must be reported during ongoing review.

(3) In accordance with 45 CFR 46.103 (4), the DHS IRB is responsible to ensure research is being conducted as written in the proposal and that material changes have not occurred since previous DHS IRB review. To do this the DHS IRB may:

(a) Conduct an audit of the research with the assistance of the Department of Human Services Bureau of Internal Review and Audit.

(b) Inspect research records.

(c) Visit research site.

(d) Observe consent process or research.

(e) If any of the above activities indicate research has deviated from the approved proposal the DHS IRB may suspend or terminate DHS IRB approval. Researchers would be required to submit an updated proposal and received final approval of the updated proposal before continuing their research.

 

R495-820-14. Records Management.

(1) IRB records are kept in accordance with 45 CFR 46.115 and Utah State Archives retention schedule series 27250.

(2) Records have a primary designation of public and a secondary designation of protected under UCA 63G-2-305 (1) and (4) or controlled under UCA 63G-2-304.

 

KEY: Institutional Review Board, research

Date of Enactment or Last Substantive Amendment: 2015

Authorizing, and Implemented or Interpreted Law: 62A-1-111