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Office for Human Research Protections Office for Human Research Protections (OHRP):(OHRP):(OHRP):(OHRP):

Prisoner Certification and Engagement in ResearchPrisoner Certification and Engagement in Research

Presented on March 23, 2011 by: Jack Chally, MBARobert Lindblad, MD

"This training has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No.HHSN271200522081C."

Produced by Liz Buttrey, NIDA CTN CCC Training Office

Training Outlineg

ff f h ( )Office for Human Research Protections (OHRP) Prisoner certification overviewOHRP’s definition of a prisonerProcess for obtaining prisoner certificationSOPs to determine participant’s legal statusSOPs to determine participant’s legal status

Engagement in research

2

History P isone s in Resea chPrisoners in Research

Prisoners abused in research Roman age through WWIIg g• Undue coercion to participate

• Parole consideration• Special treatment

Lack of informed consent

4

CCTN Guidance

CCTN encourages studies/sites to obtain OHRP prisoner certification

If particular trial or site chooses not to seek this certification—need to create an SOP to ensure no prisoners are recruited or retained in the research trial

5

How Do the Regulations Define “Prisoner”?Define “Prisoner”?

Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or j il ff d f ilit d th i bilit tjuvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons or may be untriedmay be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial.*, p , g

*Prisoner Research – FAQ http://answers.hhs.gov/ohrp/categories/1568 6

Defining PrisonerS ifi Sit tiSpecific Situations

Individuals who are in:A residential facility for court-ordered substance abuse

treatment as a form of sentencing or alternative totreatment as a form of sentencing or alternative to incarceration are prisoners

Non-residential court-ordered substance abuse treatment and are residing in the community are not prisonersand are residing in the community are not prisoners

Many residential CTPs within the CTN will have clients who meet this prisoner definition



Parolees Detained in a treatment center as a

condition of parole are prisonersLiving in the community and sentenced

to community-supervised monitoring, including parolees, are not prisoners



Probationers, individuals on house arrest, or those awaiting trialRequiring an escort are prisonersNot requiring an escort are not prisonersq g p

9


Individuals with psychiatric illnesses who have been committed involuntarilyto an institution as an alternative to a criminal prosecution or incarceration are prisoners

Individuals who have been voluntarilyd dua s o a e bee o u a yadmitted to an institution for psychiatric illness or civilly committed to non-penal y pinstitutions are not prisoners

10Prisoner Research – FAQ http://answers.hhs.gov/ohrp/categories/1568

Bottom Line

Determining client prisoner status will be challenging and labor intensiveDetermining status will vary by county

and state lawsClient’s legal status may not be clearClients may not be a reliable resource for

this information

11

Obtaining Prisoner CertificationCertification

1) Request a prisoner review from site’s1) Request a prisoner review from site s IRB

1 Requirements vary1. Requirements vary1. Memo2. IRB application checkbox3. Formal request with IRB Chair4. Other

2) The IRB reviews protocol and consent2) The IRB reviews protocol and consent with a prisoner representative member*member*

13*45 CFR 46.304

Obtaining Prisoner CertificationCertification (continued)

3) Th IRB tifi t OHRP th t3) The IRB certifies to OHRP that a proper review occurred by submitting package

di t 45 CFR 46 305 6according to 45 CFR 46.305-64) OHRP issues a prisoner certification to

the site Typical turn around time is ~2 weeks after

i t f kreceipt of package

Note: All subsequent IRB approvals, including amendments and q pp , g

continuing reviews must have a prisoner representative.

14

Alternate Certification RequestsRequests

In circumstances where the IRB will not certify to OHRP on behalf of the site. A grantee may request certification directly from OHRPMore complex, time consuming processIRB cooperation is requiredp qCCC is available to assist

15

Prisoner Status SOPSOP

SOPs must be created for sites without prisoner certificationEach SOP must clarify how they will not engage

in any research activities with any individual who may be classified as a prisonermay be classified as a prisoner

All site SOPs pertaining to prisoner status must be approved by the Leadstatus must be approved by the Lead Team and the CCC prior to site endorsementendorsement

17

Without Prisoner CertificationCertification

Prisoner status determination must occur prior to any research assessment or activityEnrollmentSubsequent visitsFollow up visitsp

18

Enrollment

Recruiting from inpatient populations Recruiting from inpatient populationsDid the court send you to treatment? Yes – determine prisoner status according to OHRP p g

definitions and local laws and regulations No – continue to outpatient questions

Recruiting from outpatient populations Recruiting from outpatient populationsAre you currently awaiting trial, on probation, or

under house arrest? Yes – Do you have to be escorted to the treatment

facility?o Yes – meets the definition of a prisonerp

No – not considered a prisoner at this time

19

Subsequent Visitsand Follow up Visitand Follow up Visit Has there been any change in your Has there been any change in your

legal status since your last visit?H th ti i t b d itt d t Has the participant been admitted to a residential treatment program or

hi t i h it l i th l t i it?psychiatric hospital since the last visit?Yes – follow enrollment guideline and

OHRP P i d fi itiOHRP Prisoner definitionsNo – not considered a prisoner at this time

20

SOPIn Simple TermsIn Simple Terms

Prepare a step-by-step guide Someone could step in for youSomeone could step in for you Guide to keep study

processes goingprocesses going KISS (Keep it simple sweetheart)

Enable someone to walk right in the door and be able to do the work by following

your SOPyour SOP.

21

Defining Researchg

Research means a systematic investigation, including research development, testing and evaluation designed to develop or contribute toevaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy whether or not they are conducted orpolicy, whether or not they are conducted or supported under a program which is considered research for other purposes.

2445 CFR 46.102(d)

Clinical Research

Research conducted on human subjects or on material of human origin identifiable with ththe source person.

Clinical research includes large and small-scale exploratory and observationalscale, exploratory, and observational studies. There are three types: 1 Patient-oriented research1. Patient oriented research2. Epidemiologic and behavioral studies3. Outcomes and health services research

25

HSP and GCP

Human Subjects Protection (HSP) training Human Subjects Protection (HSP) training has been required by the NIDA CTN*Education on the requirements of the U.S.Education on the requirements of the U.S.

federal regulations at 45 CFR 46, Protection of Human Subjects.

d l l ( ) h Good Clinical Practice (GCP) training has also been required by the CTN for those individuals conducting clinical trialsindividuals conducting clinical trials.

* Source: CTN Policies and Procedures Guide v 1.3 (p. 25-27) http://ctndisseminationlibrary.org/PDF/policiesprocedures2009.pdf 27

Engaged in ResearchT i i & R l t R i t

Store HSP & GCP completion certificates

Training & Regulatory Requirements

Store HSP & GCP completion certificates Site regulatory binder CCC RTS system

o IRB required HSP training is acceptableq g po Accredited GCP training is acceptable

Training resources (two-hour, web based)HSP htt // h iht i i /HSP course http://phrp.nihtraining.com/GCP course from http://gcp.nihtraining.com

28

HSP and GCP

Local institutions &/or IRB’s have their own requirements which may differ from NIDA CTN policies

Training has a cost of money and time a g as a cost o o ey a d t eassociated with it

Benefits the individual and the Benefits the individual and the research site as a whole

29

Key personnel y p

Individuals involved in the design and conduct of NIH-funded human subjects’ clinical research, including all individuals named on the Form FDAincluding all individuals named on the Form FDA 1572/IA and any clinical research site personnel who have more than minimal involvement with the conduct of the researchconduct of the research More than minimal involvement - performing study

evaluations or procedures or providing interventionMore than minimal study conduct - contact with study

subjects or confidential study data, records, or specimens.

30

http://www.hhs.gov/ohrp/policy/engage08.html 31

OHRP Institutions Engaged in ResearchEngaged in Research

An institution is automatically considered to be An institution is automatically considered to be “engaged” in human subjects research whenever it receives a direct HHS award to support human subjects research. The awardee institution bears ultimate responsibility for

protecting human subjects under an HHS award. p g j

An institution becomes “engaged” in human subjects research when its employees or agents: I t i t t ith li i i di id l f h Intervene or interact with living individuals for research

purposesObtain individually identifiable private information for

hresearch purposes

32Source: http://www.hhs.gov/ohrp/policy/engage08.html - section III

Institutions Engaged in Human Subjects ResearchHuman Subjects Research

In general, institutions are considered engaged in an HHS-conducted or -supported non-exempt human subjects research project (and therefore would needsubjects research project (and, therefore, would need to hold or obtain OHRP-approved FWAs and certify IRB review and approval to HHS)

Institutions that receive an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research (i.e. p j (awardee institutions), even where all activities involving human subjects are carried out by employees or agents of another institutionemployees or agents of another institution.

33Source: http://www.hhs.gov/ohrp/policy/engage08.html - section III A

Engaged Institutiong g

Receive an award through a grant contract or Receive an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research, even where ll ti iti i l i h bj t i d tall activities involving human subjects are carried out

by employees or agents of another institution. Employees or agents intervene for researchEmployees or agents intervene for research

purposes with any human subjects of the research by performing invasive or noninvasive procedures.E l t i t t f h Employees or agents interact for research purposes with any human subject of the research.


Engaged Institutiong g

Obtain the informed consent of human subjects for the research.

Obtain for research purposes identifiable private information or de t ab e p ate o at o oidentifiable biological specimens from any source for the research. a y sou ce o e esea c


Not Engaged InstitutionInstitution

The services performed do not merit professional recognition or publication privileges

The services performed are typically performed by The services performed are typically performed by those institutions for non-research purposes

The institution’s employees or agents do not p y gadminister any study intervention being tested or evaluated under the protocol.

36Source: http://www.hhs.gov/ohrp/policy/engage08.html - section III B

Not Engaged InstitutionInstitution

Institutions (including private practices) not selected Institutions (including private practices) not selected as a research site whose employees or agents provide clinical trial-related medical services that are dictated by the protocol and would typically be performed as part of routine clinical monitoring and/or follow-up of subjects enrolled at a study site by clinical trialsubjects enrolled at a study site by clinical trial investigators (e.g., medical history, physical examination, assessment of adverse events, blood test chest X ray or CT scan)test, chest X-ray, or CT scan).

37Source: http://www.hhs.gov/ohrp/policy/engage08.html - section III B

Who Needs HSP?

Engaged in the researchConsenting, conducting assessments, g, g ,

recording information, counseling, interpreting results for the research

Not engaged in researchThose that are performing tasks or p g

medical services that are standard within their institution or practice and they are

t i t ti th t k f thnot interpreting those task for the research project

38

Who Needs HSP/GCP??HSP/GCP??

39

Upcoming WebinarsUpcoming Webinars Participant Walkthrough Findings and Trends May 18p g g

Strategies to Improve Treatment Adherence June 1in CTN Research Protocols

R l P ti Relapse Prevention July 20

Certificate of Confidentiality (CoC) Aug 10

Integrated Treatment of Co-Occurring Disorders Sept 14

Informed Consent Oct 12

A New Look at Manual of Procedure (MOP) Development Dec 7

“Web Seminars are funded in whole or in part with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No.HHSN271200522081C."

Produced by Liz Buttrey, NIDA CTN CCC Training Office

Clinical Trials Network · Dissemination Library

NationalNational DrugDrug AbuseAbuse TreatmentTreatment

A f hi i ill b il bl A copy of this presentation will be available

electronically after the meeting from:

http://ctndisseminationlibrary org

CTN Dissemination Libraryhttp://ctndisseminationlibrary.org

and

NIDA Livelink

https://livelink.nida.nih.gov

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