are your participants at increased risk? keren nicole insalaco, ms, cip phone: 617.432.5174 email:...

ARE YOUR PARTICIPANTS AT INCREASED RISK?

Keren Nicole Insalaco, MS, CIPPhone: 617.432.5174

Email: [email protected] Office of Human Research Administration

OVERVIEW

The Basics

Beyond The Regs

Juggling Act

Let’s Practice

Resources Questions

Helpful Tips

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Human Subjects (HS) Research

Governed by several statutes and norms.

Common Provisions: 45 CFR 46 (DHHS) 21 CFR 50 and 56 (FDA) Privacy Rule (HIPAA) Belmont Report (Ethics Code) State and/or Local Laws Institutional Policies

THE BASICS3

THE BASICS (CONT.)4

Key issues when evaluating a study

Risks to subjects are minimized.

Risks to subjects are reasonable.

Subject selection is equitable.

Informed consent will be adequately sought or waived.

Federal regulations risk level classification.

THE BASICS (CONT.)

Minimal Risks Greater Than

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How do the federal regulations define ‘minimal risk’?

The probability and magnitude of harm or discomfort anticipated in the research that 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 tests.

THE BASICS (CONT.) 6

THE BASICS (CONT.)

Prisoners have their own ‘minimal risk’ definitionStandard Definition Prisoner’s Definition

Refers to harm or discomfort

Refers to physical or psychological harm

Compares the probability and magnitude of harm in the research to those encountered in daily life or “routine physical or psychological examinations or tests.”

Compares the probability and magnitude of harm in the research to those encountered in daily life, or in “routine medical, dental, or psychological examinations.”

Unspecified comparison group against which the risks of the research should be measured.

‘Healthy persons’ are identified as the comparison group against which the risks of the research should be measured.

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BEYOND THE REGS

But wait a minute, how are ‘risks’ defined?

Federal regulations define only "minimal risk.“

Risk: The probability of harm or injury occurring as a result of participation in a research study.

So a risk is a ‘stressor’ associated with a study-related activity.

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BEYOND THE REGS (CONT.)

The risk definition can be confusing because:

Risk can refer to probability.

Chances a person might be willing to take to achieve a desired goal.

Risk can also refer to a condition or situation that is potentially dangerous.

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About Risks:

Real or perceived Differ in nature May vary in frequency, probability

and/or magnitude Extent may be transitory, long-term,

or permanent Could impact more than one

individual10


‘Risks’ include but or are not limited to: Anxiety or Distress (e.g., recalling trauma)

Discrimination Issues of Self Esteem

Congenital Anomaly Birth Defect

Embarrassment Life Threatening (e.g., organ failure)

Controversial Fatigue (Mental or Physical)

Loss of Time

Criminal/Civil Liability Financial Standing Perceived Exploitation

Damage Reputation Harassment/Conflict Side Effect (e.g., allergic reaction)

Damage to Financial Standing

Impact Relationships (e.g., with family

members)

Stigmatization

Death Inconvenience or Expense (e.g., travel, babysitter,

etc.)

Therapeutic Misconception

Deprivation (e.g., abstinence, fasting)

Inequality in Power Undue Influence

Disability or Incapacity Invasion of Privacy Unpleasant Emotions(e.g., guilt, fear,)11

JUGGLING ACT (CONT.)

How do we place risks in perspective?

Anonymous Survey Adults Sexual

Practices.

Anonymous Survey

Kids age ≥ 16 Sexual Practices.

Identifiable Survey

Kids age ≥ 11 Sexual

Practices, Abortion,

Abuse, Use of Illicit Drugs

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Minimal Risks Greater Than


Balanced Risk:Benefit Analyses

IRBs can only approve research when risks are judged reasonable in relation to

benefits.

Potential Risks

ExpectedBenefits

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Conducting a project is like cooking…

Research Team

Study Plan Study Materials

Resources Desired Outcome

We should be able to replicate

your project with the

info provided!

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HELPFUL TIPS

Study Population

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HELPFUL TIPS (CONT.)

Vulnerable Populations with Specific Regulatory Requirements

Pregnant Women

Human Fetuses

Neonates

Children | Wards of State

Prisoners 16


Economically Disadvantaged

Employees

Terminally Ill

Homeless

Illiterate | Low Literate

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Special Classes of Participants

Involuntarily Confined

Non-English Speakers

Refugees

Soldiers | Veterans

Students


Factors that can increase participants risks

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Addictions

Adversity and Trauma

Diminished Quality of Life

Discriminated Against

Extreme Poverty

Illicit Markets

Mental Illness

Mistrust of Outsiders

Natural Disasters

Political Conflict

Reduced Access to Care

Socially Marginalized

Stigmatized Conditions

Violence


Including a ‘vulnerable population’ does not necessarily or automatically increase the overall study risk level.

19


‘Healthy’ participants may be considered ‘vulnerable’ within the context of your research.

20


Address any aspects of the research that may raise specific cultural issues (e.g., local context and values).

21


When necessary, consult with experts (e.g., local IRB, mentor,

etc.).

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Research Application

(Plan + Materials)

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The greater the risk(s) posed in the study, the more information we’ll need.

24


For every study task, list any potential or expected risks or

discomforts.

Whenever applicable describe the steps to mitigate risks.

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Be clear on the logistics of the study!!

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Use plain language!

Not everyone knows as much about your research field as you do!

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Submit all materials that participants will hear, see, or

receive.

28


Please make sure your Research Protocol is consistent with your study materials and

grant, if applicable.

29


Piggyback!

Whenever appropriate, use procedures already being performed on participants for diagnostic or treatment purposes.

30


Remember to explain how you are going to identify prospective participants and how they are going to be invited.31


Avoid excessive contact to persuade prospective participants to take part in your research.

32


Do you really need to collect personally identifying info?

33


Don’t confuse confidentiality with anonymity.

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Compensation is not a study benefit.

35


Some studies may need a Certificate of Confidentiality. We’ll let you know.

36


Consider providing participants a separate ‘contact info card’ in addition to the consent form if the consent form includes sensitive information.

37


A flawed research plan can increase the study’s inherent

risks.

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Team Expertise

39


Make sure your staff has adequate training and any applicable current licensure.

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Study-Related Resources

41


It is important that you submit information about your

funding.

42


Be specific about which practices and methods will be

used to protect privacy and confidentiality.

43


Do you have adequate resources to comply with

Harvard’s Data Security policy?

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LET’S PRACTICE

Congratulations!

You are now ready to serve as an IRB Review Specialist at the very prestigious G. Gryffindor School of Public Health (formerly Hogwarts School of Public Health). The School is still known as HSPH.

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LET’S PRACTICE

Case 1: Dr. Flitwick (also the chair of the department of social health) would like to recruit her students and the technicians of her lab to participate in a study about the School’s sexual harassment and drug-free polices.

Participants will be asked about their experiences with the topics in question and be compensated $150 for taking part in a 1hr audio-recorded focus group that would take place during lunch time in the conference room near the cafeteria. 46

LET’S PRACTICE

Case 2: Dr. Flitwick would like to conduct a study about the School’s sexual harassment and drug-free polices. She is planning to post fliers to invite the School’s

students, faculty, and staff. Participants will be asked to complete a paper-

based questionnaire which may have some sensitive questions, but will not ask for identifying information.

Dr. Flitwick is hiring an independent group to conduct the interviews.

Participants will not need to sign the consent form No compensation will be offered to participants.

However, participants will be provided with information from the Ombudsman and other resources available in/outside of the School on the topics in question.

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LET’S PRACTICE

Case 3: Dr. H. Potter conducted a study that involved data on maternal vitamin supplementation. All participants have completed all research-related activities and the data have been stripped of all personally identifying information.

Dr. Potter has received additional funding to conduct research specifically on the effect of maternal B12 supplementation so he would like to submit a new study to the HSPH IRB to conduct this analyses. 48

LET’S PRACTICE

Case 4: You received a call from an investigator that would like to conduct a study that involves asking participants to (i) participate on an exercise program; (ii) complete several questionnaires; (iii) body measurements; and (iv) provide blood (while fasting) and urine samples on multiple occasions.

The study requires 12 study visits in addition to the time necessary to take part in the exercise program. 49

LET’S PRACTICE

Case 5: A PI would like to conduct a study aimed at the design and implementation of a tool for the assessment and management of pain in elderly with a diagnosis of dementia. The study will include hospitalized patients.

Qualitative data will be collected with a mix methods including audio-recorded interviews with participants and family caregivers, focus groups with clinical staff and observation of care at this multi-site study. The investigators are also planning to collect image data (e.g., photographs) from participants as well as the hospital settings to use in presentations. 50

RESOURCES

The Office of Human Research Administration (OHRA) website has many useful links (including to regs, etc.)! http://www.hsph.harvard.edu/ohra/

The OHRA Quality Improvement Program (QIP) offers many services to the Longwood research community. http://www.hsph.harvard.edu/ohra/qip/

ESTR (HU’s IRB online submission system) has a ‘library’ page in which you can see the worksheets and checklists that the IRB uses to evaluate studies. http://irb.harvard.edu

Harvard T. H. Chan School of Public Health Research Ethics Guidelines International Online Navigation Map (Region) http://www.hsph.harvard.edu/region-map/

IRB Forum www.irbforum.org

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QUESTIONS?

OHRA Leslie Howes, Director | [email protected] Delia Wolf, Institutional Official, Associate Dean Regulatory

Affairs & Research Compliance | [email protected]

QA/QI Specialists Stanley Estime | [email protected] Lisa Gabel | [email protected] Alyssa Speier | [email protected]

IRB* Julie Kaberry, IRB Administrative Chair |

[email protected]

*See OHRA website for department-assigned IRB Review Specialists. (http://www.hsph.harvard.edu/ohra/department-

assignments/)

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mailto:[email protected]






Helpful Tips (CONT.)

‘If in the field there is no time to think, reflecting on events and thinking about ethics whilst outside of the field can better prepare the researcher for the next ethical ‘snap decision’ to be faced. It can help the researcher gain ‘a way of thinking’, an ‘alertness’ to situated moral dilemmas.’

M. Guillemin, L. Gillam, Ethics, reflexivity, and “ethically important moments” in Research, Qualitative Inquiry 10 (2004), 261-280.53

are your participants at increased risk? keren nicole insalaco, ms, cip phone: 617.432.5174 email:...

Documents

study risks

minimal risks greater

daily life

psychological examinations

increased risk

minimal risk spectrum

magnitude of harm

everyday life