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Requirements for Research Requirements for Research on Human Subjectson Human Subjects

QEM Network

June 12, 2009

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OverviewOverview

Basic Principles of Human Subjects ProtectionBasic Principles of Human Subjects Protection -Persons should not be subjects of research without -Persons should not be subjects of research without

their informed consenttheir informed consent -Subjects should not incur increased risk of harm -Subjects should not incur increased risk of harm

from their research involvement, beyond the normal from their research involvement, beyond the normal risks inherent in everyday life risks inherent in everyday life

What are the regulations regarding research What are the regulations regarding research involving human subjects?involving human subjects?

Who decides what is appropriate?Who decides what is appropriate?

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What are the rules around What are the rules around research involving human research involving human subjects?subjects?

““The Common Rule” is used by 18 US federal The Common Rule” is used by 18 US federal agencies to govern research involving human agencies to govern research involving human subjectssubjects

The Common Rule has 4 subpartsThe Common Rule has 4 subparts Subpart A – all research governing human subjectsSubpart A – all research governing human subjects Subpart B – research on fetuses, neonates, and Subpart B – research on fetuses, neonates, and

pregnant women pregnant women Subpart C – research with prisonersSubpart C – research with prisoners Subpart D – research with childrenSubpart D – research with children

Your institution may adhere to subpart A or all Your institution may adhere to subpart A or all of the other subpartsof the other subparts

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Goals of the Common RuleGoals of the Common Rule

RESPECT FOR PERSONS’ AUTONOMY RESPECT FOR PERSONS’ AUTONOMY adequate and comprehensive information about the adequate and comprehensive information about the

research and any risks likely to occur, research and any risks likely to occur, understandable to the participant, and allows them understandable to the participant, and allows them to voluntarily decide whether to participate. to voluntarily decide whether to participate.

BENEFICENCEBENEFICENCE the research is designed to maximize benefits and the research is designed to maximize benefits and

minimize risks to subjects and society. minimize risks to subjects and society. JUSTICEJUSTICE

the research is fair to individual subjects and does the research is fair to individual subjects and does not exploit or ignore one group (e.g., the poor) to not exploit or ignore one group (e.g., the poor) to benefit another group (e.g., the wealthy). benefit another group (e.g., the wealthy).

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Purpose of RegulationsPurpose of Regulations

The regulations balance the risks of harm to The regulations balance the risks of harm to individuals with the possible benefits from the individuals with the possible benefits from the research results. research results.

Level of risk is determined not by how likely the Level of risk is determined not by how likely the risk is to occur, but the amount of harm likely risk is to occur, but the amount of harm likely from the riskfrom the risk Minimal Risk - “The probability and magnitude of Minimal Risk - “The probability and magnitude of

harm or discomfort anticipated in the research are harm or discomfort anticipated in the research are not greater in and of themselves than those not greater in and of themselves than those ordinarily encountered in daily life or during the ordinarily encountered in daily life or during the performance of routine physical or psychological performance of routine physical or psychological examinations or tests.” (§ 690.102 (i)) examinations or tests.” (§ 690.102 (i))

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Types of Harm Types of Harm

There are several types of “harm” that are more than minimal that There are several types of “harm” that are more than minimal that can occur in social science and education research.can occur in social science and education research. Emotional or psychological harmEmotional or psychological harm, for example when a research , for example when a research

interaction causes upset, or worry about breach of confidentiality. interaction causes upset, or worry about breach of confidentiality. Social harmSocial harm due to stigma or other negative social outcomes of due to stigma or other negative social outcomes of

breach of confidentiality. breach of confidentiality. Physical harmPhysical harm if revelations about others get back to those persons, if revelations about others get back to those persons,

particularly when researchers study domestic violence, gang activity, particularly when researchers study domestic violence, gang activity, political activity in a conflict zone, or other phenomena concerning political activity in a conflict zone, or other phenomena concerning violence-prone individuals. violence-prone individuals.

Financial harmFinancial harm if revelations result in loss of employment or insurance if revelations result in loss of employment or insurance coverage. coverage.

Legal harmLegal harm when illegal activities are disclosed. when illegal activities are disclosed. Moral harmMoral harm when participation in research strengthens subjects' when participation in research strengthens subjects'

inclinations to behave unethically. inclinations to behave unethically. (NSF FAQ)(NSF FAQ)

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What types of research What types of research are exempt?are exempt?

Research in educational settings involving educational practices. (§ 101 Research in educational settings involving educational practices. (§ 101 (b) (1)) (b) (1))

Research involving educational tests (cognitive, diagnostic, aptitude, Research involving educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or observations of public behavior, achievement), surveys, interviews, or observations of public behavior, unless subjects are identified and disclosure of responses would involve unless subjects are identified and disclosure of responses would involve more than reasonable risk. (§ 101 (b) (2)) more than reasonable risk. (§ 101 (b) (2))

Research involving educational tests (cognitive, diagnostic, aptitude, Research involving educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or observations of public behavior not achievement), surveys, interviews, or observations of public behavior not exempt under preceding exemption if human subjects are elected public exempt under preceding exemption if human subjects are elected public officials, and if federal statutes require confidentiality of identifiable officials, and if federal statutes require confidentiality of identifiable information. ((§ 101 (b) (3)) information. ((§ 101 (b) (3))

Research involving the collection or study of existing data if publicly Research involving the collection or study of existing data if publicly available or unidentifiable. ((§ 101 (b) (4)) available or unidentifiable. ((§ 101 (b) (4))

Research and demonstration projects designed to study public benefit or Research and demonstration projects designed to study public benefit or service programs. ((§ 101 (b) (5)) service programs. ((§ 101 (b) (5))

Taste and food quality evaluation and consumer acceptance studies. ((§ Taste and food quality evaluation and consumer acceptance studies. ((§ 101 (b) (6)) 101 (b) (6))

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YOU DO NOT DECIDE IF YOUR YOU DO NOT DECIDE IF YOUR RESEARCH IS EXEMPT!!!!!RESEARCH IS EXEMPT!!!!!

You must still submit an application to You must still submit an application to your Institutional Review Board (IRB) your Institutional Review Board (IRB) claiming it is exempt. The IRB makes claiming it is exempt. The IRB makes the final determination. Having your the final determination. Having your research classified as exempt relieves research classified as exempt relieves you of further oversight from the IRByou of further oversight from the IRB

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Institutional Review Institutional Review BoardBoard

Each institution is responsible for convening a Each institution is responsible for convening a committee that will execute the Common Rule committee that will execute the Common Rule for that institutionfor that institution

The application and review procedure is The application and review procedure is different at each institution but includes different at each institution but includes common elementscommon elements

NSF will not release funding to your institution NSF will not release funding to your institution without confirmation of IRB approval of the without confirmation of IRB approval of the research/evaluationresearch/evaluation

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Expedited ReviewExpedited Review

Many IRBs offer expedited review, Many IRBs offer expedited review, particularly for social science and non-particularly for social science and non-medical research with less risk of medical research with less risk of physical harm. physical harm.

Contact your IRB to determine if there Contact your IRB to determine if there are different requirements for expedited are different requirements for expedited reviewreview

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IRB RequirementsIRB Requirements An application describing the general process An application describing the general process

for data collection and analysisfor data collection and analysis How participants will be recruited, including How participants will be recruited, including

compensationcompensation How informed consent will be obtained from adults How informed consent will be obtained from adults

and children, including the level of risk to and children, including the level of risk to participants and potential benefits to participants participants and potential benefits to participants and societyand society

A copy of all data collection instruments (tests, A copy of all data collection instruments (tests, surveys, interview questions, observation surveys, interview questions, observation instruments, etc.) and description of proceduresinstruments, etc.) and description of procedures

How data will be stored and who will have access to How data will be stored and who will have access to itit Anonymity in data collectionAnonymity in data collection Confidentiality of identifiable dataConfidentiality of identifiable data

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Recruitment and Recruitment and CompensationCompensation

How will you get participants to participate in your How will you get participants to participate in your research? research? Advertising, direct invitationAdvertising, direct invitation Many IRBs discourage use of your own studentsMany IRBs discourage use of your own students

Who will be included and who will be excluded? Is this Who will be included and who will be excluded? Is this process fair?process fair? Will particular groups be excluded and why?Will particular groups be excluded and why? Will this research include protected populations (including Will this research include protected populations (including

children)?children)? Will there be any compensation for participation?Will there be any compensation for participation?

If so, is the amount offered coercive?If so, is the amount offered coercive? If a person drops out during the study, will they still be If a person drops out during the study, will they still be

compensated?compensated?

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Risks and BenefitsRisks and Benefits

What are the risks to the participant and What are the risks to the participant and how will they be mitigated?how will they be mitigated? Minimal risk or greater than minimal risk?Minimal risk or greater than minimal risk? If greater than minimal risk, how is the If greater than minimal risk, how is the

investigator going to attempt to prevent any investigator going to attempt to prevent any risk?risk?

What are the benefits of this research?What are the benefits of this research? To the participant, if any?To the participant, if any? To society in general?To society in general?

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Informed ConsentInformed Consent

How will you inform the participants and obtain How will you inform the participants and obtain consent for their participation?consent for their participation? Notify them of their commitmentsNotify them of their commitments Notify them of any risks and how you will address Notify them of any risks and how you will address

themthem Notify them of any benefitsNotify them of any benefits Describe any compensation and what is necessary Describe any compensation and what is necessary

to receive compensationto receive compensation Who to contact if they have any questions, including Who to contact if they have any questions, including

contact information for the IRBcontact information for the IRB NOTIFY THEM THAT THEY MAY STOP AT ANY NOTIFY THEM THAT THEY MAY STOP AT ANY

TIME WITHOUT REPERCUSSIONSTIME WITHOUT REPERCUSSIONS

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Data Collection and Data Collection and AnalysisAnalysis

What data are you collecting?What data are you collecting? Copies of all tests, surveys, interview questions, Copies of all tests, surveys, interview questions,

observation instruments, and other data collection observation instruments, and other data collection toolstools

Who will be collecting the data?Who will be collecting the data? Where are you collecting data? How are you Where are you collecting data? How are you

collecting data? collecting data? How are these procedures going to ensure How are these procedures going to ensure

confidentiality or anonymity?confidentiality or anonymity? How will compensation be made?How will compensation be made?

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Data Storage and AccessData Storage and Access

Where will the data be stored? How will Where will the data be stored? How will confidentiality be ensured?confidentiality be ensured?

How long will the data be kept?How long will the data be kept? Who will have access to the data?Who will have access to the data? How will the data be disposed of when the How will the data be disposed of when the

study is complete?study is complete? Note: Federal funding agencies have requirements Note: Federal funding agencies have requirements

that data be kept for a period of time after the end of that data be kept for a period of time after the end of funding (currently 3 years)funding (currently 3 years)

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Other Information the Other Information the IRB May RequestIRB May Request

Approval from cooperating institutions:Approval from cooperating institutions: School districtsSchool districts Other universitiesOther universities

Evidence that the investigators have had Evidence that the investigators have had training in the ethics of research involving training in the ethics of research involving human subjectshuman subjects Many institutions have online examinations Many institutions have online examinations

or coursesor courses

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Other Issues that AriseOther Issues that Arise

International ResearchInternational Research Many other countries do not have IRBs and review Many other countries do not have IRBs and review

procedures. Consult with your IRB about how to procedures. Consult with your IRB about how to handle international research.handle international research.

DeceptionDeception There are situations in which you may wish to tell There are situations in which you may wish to tell

the participants untruths in the course of the the participants untruths in the course of the research (e.g., stereotype threat research). How will research (e.g., stereotype threat research). How will you handle debriefing of the participants once the you handle debriefing of the participants once the research is complete?research is complete?

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THANK YOU!

Vignette – “Private” Vignette – “Private” InformationInformation

Studyphud showed her research protocol to a colleague who is on Studyphud showed her research protocol to a colleague who is on the IRB to inquire whether the format was correct. She was the IRB to inquire whether the format was correct. She was surprised when her colleague objected to her obtaining a list of surprised when her colleague objected to her obtaining a list of students admitted to the Ph.D. program. Her colleague claimed students admitted to the Ph.D. program. Her colleague claimed that Studyphud has no right to that list since the fact of students' that Studyphud has no right to that list since the fact of students' admission to Ph.D. programs is a private event. The colleague admission to Ph.D. programs is a private event. The colleague said that the only way Studyphud could contact the students is by said that the only way Studyphud could contact the students is by placing a more general solicitation in all doctoral students' placing a more general solicitation in all doctoral students' mailboxes asking them to contact her if they qualified (as new mailboxes asking them to contact her if they qualified (as new students) and were interested in participating. Was Studyphud's students) and were interested in participating. Was Studyphud's colleague right?colleague right?

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Do I Need IRB ApprovalDo I Need IRB Approval

(d) Research means a systematic investigation, (d) Research means a systematic investigation, including research development, testing and including research development, testing and evaluation, designed to develop or contribute to evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this definition, constitute research for purposes of this policy, whether or not they are conducted or policy, whether or not they are conducted or supported under a program, which is considered supported under a program, which is considered research for other purposes. For example, some research for other purposes. For example, some demonstration and service programs may include demonstration and service programs may include research activities. research activities.

Researchit's project in fact fits the criteria for Researchit's project in fact fits the criteria for exemption, because it uses interview procedures that exemption, because it uses interview procedures that involve no risk of harm.( § 690.101.b.2)involve no risk of harm.( § 690.101.b.2)

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Human Subjects Certification Human Subjects Certification TrainingTraining

National Institute of Health Office of National Institute of Health Office of Extramural Research Extramural Research http://phrp.nihtraining.com/users/login.php

New York UniversityNew York University

www.nyu.edu/ucaihs/tutorial

University of WashingtonUniversity of Washingtonwww.washington.edu/research/hsd/training_citi.html

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Questions?Questions?