Human Subjects Research at UCAR Overview of the Process September 9, 2014 Meg McClellan UCAR Chief Legal Officer

OVERVIEW

       UCAR HSC HSC Approval Process How do I comply? . . . Procedures Important Concepts - Informed Consent - Confidentiality & Privacy - Risk Exceptions Manual NIH Training/Certification

UCAR HSC

 UCAR Human Studies Committee (HSC) is UCAR’s IRB  Goal: researchers follow the regulations  Goal: protect interests and well-being of research participants

HSC

       Michael Thompson, NCAR Deputy Director & COO – [email protected]

Katy Schmoll, VP F&A/Ethics Officer – [email protected]

Meg McClellan, General Counsel – [email protected]

Greg Byrd, UCP Rep. – [email protected]

Mary Hayden, NCAR Rep. – [email protected]

Kathleen Miller, NCAR Rep. – [email protected]

Lecia Barker, University of Texas at Austin, Outside Rep. – [email protected]

HSC Administrator: Cindy Worster

HSC AT UCAR

https://ncar.ucar.edu/human-subjects-committee/ human-subjects-research

PROCEDURES

  Protocol form and submission (HSC website)  The “protocol” is the researcher’s response to specific questions about the human subjects research HSC reviews online   HSC primary contact (rotates based on the month) Review and communicate electronically     Approval Provisional approval with required changes List of required changes and request for resubmission After approval: submit final electronic copies

WHAT NEEDS TO BE REVIEWED?

  Any

research

(as defined in the regulations) that involves

human subjects

A

living individual

about whom a researcher conducting research obtains:

- data

through

intervention

or

interaction

with the individual

Or - identifiable private information

BASICS OF THE REGULATION

     Based on federal regulation known as the Common Rule (45 CFR part 46) NSF Regulation 45 CFR part 690 Research Human subjects Ethics, values and respect

HUMAN SUBJECTS

   When people are not identified (are anonymous) research may not fall within the regulations Collecting data with no personally identifiable information   No names No audio, video recording Privacy and other confidentiality concerns

may

still exist

THE ETHICS OF HUMAN RESEARCH MEANS SUPPORTING SUCH VALUES AS . . .

      Respecting people and their communities Protecting research participants Benefiting individuals and society Valid design, sampling, data collection, analysis, interpretation, and presentation Disseminating findings effectively, including data sharing Facilitating the application of findings

INFORMED CONSENT

 What is it?

- Consent to participate in research that is voluntary, made by the person (or one with authority to decide for that person), and informed It is voluntary, when it is not coerced Informed – you need to tell them in plain language what you are doing (but there’s more . . .)

INFORMED CONSENT

 When is it required?

- All research involving human subjects requires informed consent from participants - Exception is for exempt research (more on this to follow)

HOW TO: ELEMENTS OF INFORMED CONSENT        No “Legalese” Identification of Researcher Explanation of the purpose of the research Duration of research participation Request for participation, including the right to withdraw at any time Explanation of research procedures Description of how confidentiality will be maintained

ELEMENTS OF INFORMED CONSENT (CONT.)       Right of refusal without penalty Risks - explain Benefits - any feedback or benefits to participants How to contact persons designated to answer questions the participants (or guardians) might have Participants (or guardians) may keep copy of consent Written (or oral where appropriate)

DOCUMENTATION OF INFORMED CONSENT       Written form approved by HSC Verbal consent approved by HSC Signed and dated by person or legally authorized representative Signed and dated by researcher obtaining consent Copy given person/representative Checklist, sample forms

CONFIDENTIALITY & PRIVACY

   

Confidentiality

is about data, agreements and procedures for limiting access of others to data

Privacy

refers to persons and their interest in controlling access of others to themselves.

Neither term is defined in the regulations Both terms have legal definitions depending on the context

MORE ON CONFIDENTIALITY

  Don’t assure confidentiality unless you can really keep it To maintain confidentiality:  Anonymity in data collection  Procedures that eliminate linking data to unique identifiers  Data sharing techniques  Data storage (electronic and hard copy)

CONFIDENTIALITY IN THE DIGITAL WORLD

   GIS   Exempt, confidential or anonymous data, becomes discernable Industry standards in reporting out data Social media Third party survey services    One step removed from researchers Online Contractual obligations

MORE ON PRIVACY . . .

  Be sensitive to the “privacy” expectations of the people that you are studying by asking:  Someone who works with the population (teachers, doctors)   An investigator who has research experience with the population Members of the population what group consider private

others

in their  Embarrassment Understand privacy requirements of any institution, laws

RISKS

  Researchers and the HSC must assess the risk involved Minimal risk?

 Minimal risk occurs when the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or test.

RISKS



Psychological Risk

distress – mental stress and/or emotional 

Sociological Risk

distress – relational stress and/or positional 

Physiological Risk

– bodily harm to self and/or others 

Spiritual Risk

– individual faith/work stress and/or religious community distress

3 CATEGORIES OF REVIEW

   Exempt*   Only HSC can determine (not researcher) Review by HSC on call and/or experienced member Expedited*  Review by HSC Chair and experienced member Full Review  Review by entire committee *Entire HSC is informed, may weigh in; only full committee can disapprove

EXEMPT RESEARCH

  Conducted in established or commonly accepted educational settings Use of educational test, survey procedures, interview procedures or observations of public behavior if:    Anonymous, or unidentifiable; and Exposure of responses outside research does not pose risk of civil or criminal liability, or damage to subject’s financial standing, employability or reputation; and Not under 18, or vulnerable class

EXEMPT RESEARCH (CONT.)

  Use of educational tests, survey or interview procedures or observations of public behavior that is not otherwise exempt (as outlined above), if:   Elected or appointed public officials or candidates for public office; or Federal statutes require that the confidentiality of the personally identifiable information will be maintained throughout the research.

Agency program manger or director may waive some or all requirements (rarely happens)

EXPEDITED REVIEW

   Research that is exempt, involves minimum risk, minor changes in prior approved research HSC chair or experienced member may review and approve (without full HSC) HSC reviewer may exercise all the authority of the full HSC, except to disapprove the protocol; that must be done by full HSC

FULL REVIEW

  Requires Full HSC review and formal meeting Researcher can attend and present

HSC REVIEW

       Risks to subjects are minimized Risks to subjects are reasonable in relation to benefits and importance of knowledge to be gained Selection of subjects is equitable Informed consent is adequate Informed consent will be documented Research plan adequately monitors, collects and stores data to protect privacy and confidentiality Additional safeguards are included for vulnerable populations, situations

RESEARCHER BEST PRACTICES

      PI certification http://phrp.nihtraining.com/users/login.php

Plan ahead – timing is important Involve an HSC member early Consider all aspects of study Data access, transmission, storage are important Record Keeping http://www.ucar.edu/hsc/RFK.htm