![Page 1: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/1.jpg)
Recognizing and Minimizing Risks in VA Research
Kevin L. Nellis, M.S., M.T. (A.S.C.P.)
Program Analyst
Program for Research Integrity Development and Education (PRIDE)
March 28, 2011
![Page 2: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/2.jpg)
Overview
•Regulatory background
•Individuals or populations vulnerable to risks
•Types of risks in research
•Minimizing risks
•Potential risks based on types of research
2
![Page 3: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/3.jpg)
Minimization of Risks
• Risks to human subjects are minimized by using procedures that:
• Are consistent with sound research design
• Do not unnecessarily expose subjects to risk
• Are already being performed for diagnostic or treatment purposes
3
![Page 4: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/4.jpg)
Risks and Benefits Analysis
• Risks to subjects must be reasonable in relation to
• Anticipated benefits (outcome or advantage)
• Importance of the knowledge that is expected as a result of the research
• When analyzing the risks to benefits ratio
• Consider only risks and benefits of the research
• Do not to consider possible long-range effects of applying knowledge gained in the research
4
![Page 5: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/5.jpg)
Categorically Vulnerable Populations
• Additional protections required in VHA Handbook 1200.05, for research involving:
• Persons who lack decision-making capacity
• Prisoners
• Pregnant Women
• Children
5
![Page 6: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/6.jpg)
Factors Contributing to Risk
• Complicated lives or time constraints
• Exposure to safety issues
• The immature or emotionally fragile
• Societal judgment
• The financially insecure
• Illegal behaviors
• Legal actions
• Certain populations6
![Page 7: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/7.jpg)
Factors Contributing to Risk
• Employees
• The homeless or displaced
• Language or educational challenges
• Mental or physical disabilities
• Socio-economic disadvantages
• Poor access to healthcare
7
![Page 8: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/8.jpg)
Third Parties at Risk
• Bystanders (family, community,
social groups, caregivers, etc)
• Consumers
• Institutions
8
![Page 9: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/9.jpg)
Possible Types of Risks
• Physical (direct and indirect)
• Psychological or emotional
• Social or cultural
• Economic
• Legal
9
![Page 10: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/10.jpg)
Physical Risks
• Injury
• Pain
• Fatigue
• Side effects of drugs
• Assault
• Death
10
![Page 11: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/11.jpg)
Protections From Physical Risks
• Appropriate study design with appropriately trained individuals
• Appropriate recruitment, advertising, and informed consent process
• Careful monitoring of subjects
• More frequent IRB review
• Providing first aid or clinical care
• Compensate for harms
11
![Page 12: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/12.jpg)
Psychological Risks
• Getting upset or worried
• Anxiety or depression
• Feelings of stress or guilt
• Confusion or hallucination
• Embarrassment or shame
• Loss of self-esteem or self-confidence
12
![Page 13: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/13.jpg)
Protections From Psychological Risks
• Adequately and sensitively administered informed consent
• Respectful treatment
• Remind participants of their right to withdraw or to limit their participation
• When appropriate:
• Provide psychological support or counseling
• Thoroughly debrief subjects after participation
• Assure anonymity
• Provide contacts for suicide hotline
13
![Page 14: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/14.jpg)
Social Risks
• Embarrassment
• Stigma (ostracism)
• Conflict
• Scapegoating
• Resentment
• Discrimination
14
![Page 15: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/15.jpg)
Protections From Social Risks
• Adequately and sensitively administered informed consent
• Assure privacy, confidentiality, and data security
• Assure anonymity, when appropriate
• Ensure researchers follow professional codes
15
![Page 16: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/16.jpg)
Economic Risks
• Loss of a money
• Loss of financial opportunity
• Loss of credit
• Identity theft
• Loss of insurability
• Loss of wages
• Loss of job or advancement
16
![Page 17: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/17.jpg)
Protections From Economic Risks
• Compensate for harms
• Assure of privacy, confidentiality, and data security
• Keep research data separate from medical records to prevent employers and insurance companies from obtaining information
17
![Page 18: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/18.jpg)
Legal Risks
• Lawsuits
• Disclosure of illegal activities
• Conviction of crime
• Subpoena of damaging data
18
![Page 19: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/19.jpg)
Protections From Legal Risks
• Assure anonymity, when appropriate
• Assure of privacy, confidentiality, and data security
• Obtain Certificate of Confidentiality, if appropriate
19
![Page 20: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/20.jpg)
Certificates of Confidentiality are Obtained From the NIH
• Helps researchers protect the privacy of human research participants
• Protect against compulsory legal demands (e.g., court orders and subpoenas)
• Does not protect against voluntary disclosures by the researcher (as specified in the informed consent form)
• Subjects are protected permanently- even if the subject gave the researcher data before the Certificate is issued
• NIH: http://grants.nih.gov/grants/policy/coc/
20
![Page 21: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/21.jpg)
Examples of Research Areas Eligible for Certificates of Confidentiality
• HIV, AIDS, and other STDs
• Sexual attitudes, preferences, or practices
• Alcohol, drugs, or other addictive products
• Information on illegal conduct
• Studies that gather sensitive or risky information
• Mental health
• Behavioral interventions and epidemiologic studies
• Genetic studies
21
![Page 22: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/22.jpg)
22
![Page 23: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/23.jpg)
Potential Risks of Clinical Studies
• Drugs and devices
• Treatment-withholding studies
• Placebo-controlled clinical trials
• Phase I clinical trials in healthy subjects
• Phase I oncology trials
• Confusing language in informed consent
• Conflicts of interests
• High risk radioactive or other materials23
![Page 24: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/24.jpg)
Potential Risks of Genetic Testing
• Psychological impact – emotions aroused by learning that one is (or is not) likely to develop a serious disease
• Change in family dynamics
• Involving minors or incapacitated
• Privacy – will a predisposition remain a secret or slip out?
• Incidental findings about paternity
• Risks of sharing information
• Impact on medical choices
24
![Page 25: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/25.jpg)
Potential Risks of Focus Groups, Questionnaires, or Surveys• Breach of confidentiality or violation of privacy
• Inadvertent disclosures of media (audio, video, or photos)
• Validation of inappropriate or undesirable behaviors
• Presentation of results in a way that does not respect (or agree with) subjects’ interests
• Damage to dignity, self-image, or innocence
• Possible harm to secondary subjects
• Reportable situations (e.g., elderly or child abuse, threats, infectious disease, criminal activities)
25
![Page 26: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/26.jpg)
Potential Risks of Focus Groups, Questionnaires, or Surveys
• Three weeks after answering the questionnaire for a cancer study; a man in his early 20s committed suicide, leaving a note stating that until he answered the questionnaire he did not really realize all of the experiences he had missed.
• A survey researcher was investigating attitudes toward rape. When filling out questionnaires, several subjects became visibly emotionally distressed and asked the investigator for help.
Ref: IRB Forum (January 2001)
26
![Page 27: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/27.jpg)
Potential Risks of Focus Groups, Questionnaires, or Surveys
• A study involving adolescents with emotional difficulties included a few questions about sexual preferences. One subject interpreted the questions as if the researcher were suggesting she or he was a homosexual. The subject became very upset, attacked the researcher, and had to be restrained.
Ref: IRB Forum (January 2001)
27
![Page 28: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/28.jpg)
Key Points
• All those involved in research must understand various risks of research
• Investigators must design the study to minimize risks
• IRBs must ensure that risks are minimized and reasonable in relationship to anticipated benefits before approving the research
28
![Page 29: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/29.jpg)
Key Points
• Both the investigator and the IRB must ensure protections are specific to:
• Nature of the risks
• Individuals involved
• Type of research
• Location and culture
• Monitor and modify the research to minimize risks
29
![Page 30: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/30.jpg)
References
• Bankert and Amdur. IRB Management and Function. (2006) http://books.google.com/books
• Risk and Harm: Social and Behavioral Sciences Working Group on Human Research Protections. (2004)
http://www.aera.net/humansubjects/risk-harm.pdf
• National Research Council. Protecting Participants and Facilitating Social and Behavioral Sciences Research. (2003) http://www.nap.edu/catalog.php?record_id=10638
• OHRP. IRB Guidebook. (1993) http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
• Clayton. Incidental Findings in Genetics Research Using Archived DNA. J. Law. Med. Ethics. 2008: 36(2):286-212 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2576744/
30
![Page 31: Recognizing and Minimizing Risks in VA Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education](https://reader035.vdocuments.us/reader035/viewer/2022062309/56649e9f5503460f94ba1d84/html5/thumbnails/31.jpg)
31