Human Subjects Research at UCAR

Overview of the ProcessSeptember 9, 2014

Meg McClellanUCAR Chief Legal Officer

UCAR HSC HSC Approval Process How do I comply? . . . Procedures Important Concepts

- Informed Consent- Confidentiality & Privacy- Risk

Exceptions Manual NIH Training/Certification

UCAR Human Studies Committee (HSC) is UCAR’s IRB

Goal: researchers follow the regulations

Goal: protect interests and well-being of research participants

Michael Thompson, NCAR Deputy Director & COO – mjt@ucar.edu

Katy Schmoll, VP F&A/Ethics Officer – kschmoll@ucar.edu Meg McClellan, General Counsel – mmcclell@ucar.edu Greg Byrd, UCP Rep. – byrd@ucar.edu Mary Hayden, NCAR Rep. – mhayden@ucar.edu Kathleen Miller, NCAR Rep. – kathleen@ucar.edu Lecia Barker, University of Texas at Austin, Outside Rep. –

lecia@ischool.utexas.edu

HSC Administrator: Cindy Worster

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

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

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 individualOr- identifiable private information

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

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

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

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 . . .)

When is it required?- All research involving human subjects

requires informed consent from participants

- Exception is for exempt research (more on this to follow)

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

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)

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 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

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)

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

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 others in

their group consider private Embarrassment

Understand privacy requirements of any institution, laws

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.

Psychological Risk – mental stress and/or emotional distress

Sociological Risk – relational stress and/or positional distress

Physiological Risk – bodily harm to self and/or others

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

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

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

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)

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

Requires Full HSC review and formal meeting

Researcher can attend and present

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

PI certificationhttp://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