Biomed refresher 1 CITI Already Verified A+
Research Ethics and Risks of Harm
1. Informed Consent and Questionnaire Risks - Statement about Consent Form: - ️ False - It is not okay to omit potential risks of harm from the quality of life questionnaire in the
consent form. - Rationale: - Dep...
Biomed refresher 1 CITI Already Verified A+
Research Ethics and Risks of Harm
1. Informed Consent and Questionnaire Risks
- Statement about Consent Form:
- ✔️ False - It is not okay to omit potential risks of harm from the quality of life questionnaire in the
consent form.
- Rationale:
- Depending on the nature of the questions posed, significant risks to privacy and confidentiality
could arise, making it necessary to inform participants.
2. Research on Domestic Violence and Children
- Risk Statement:
- ✔️ Research risks of harm exist for both the mothers and children; the type of potential harm is
different for each group.
- Details:
- Both mothers and children face unique risks; mothers may fear further domestic violence through
disclosed participation, while children may experience intensified fears and emotional distress from
discussing sensitive topics.
3. Survey Research and Potential Harm
- Risk Scenario:
- ✔️ A survey about sexual attitudes, beliefs, and practices, mailed by an HIV/AIDS prevention study
poses potential harm to subjects.
- Reasons for Risk:
- Participants may feel alarmed by the study's focus, face confidentiality risks, and experience stigma
associated with HIV/AIDS.
4. Using Publicly Available CDC Database
- Consent Requirement:
- ✔️ Consent from the patients is not required because the database is publicly available.
, - Regulatory Guidance:
- Secondary research on publicly available data without identifiers is exempt from certain regulatory
requirements, including consent, under 45 CFR 46 Exempt Category 4.
5. IRB Waiver or Alteration of Consent Requirements
- Criteria for Waiver:
- ✔️ The research could not practicably be carried out without the waiver of consent.
- Other Criteria:
- Additional criteria include minimal risk to subjects and protection of their rights and welfare.
### Risks in Genetic Research
6. Evaluating Subject Risk in Genetic Studies
- Accurate Statement:
- ✔️ Understanding the purpose and context of a specific study is critical in determining the risk
involved.
- Contextual Importance:
- Each genetic study must be evaluated individually to assess risks accurately.
7. Types of Risks Associated with Genetics Research
- Risk Description:
- ✔️ Physical, social, and psychological risks are present.
- Details on Risks:
- Physical risks are typically minimal (e.g., blood draw), but significant social and psychological risks
may arise from the nature of genetic information, affecting anxiety, employment, and insurability.
Additional information associated with genetics research that should be disclosed to subjects during the
consent process includes: ✔️Plans and options for re-contacting the subjects with results. -
It is important for researchers to discuss any plans or options for re-contacting the subjects with genetic
results. The IRB may also require a description of whether the samples are linked or anonymous, how
they will be stored and who will have access to them or the information they contain, and whether the
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller CertifiedGrades. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $9.99. You're not tied to anything after your purchase.
