Ethics in Research

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Prepared by: Dan Masiga and Nicki Tiffin
Module name: Ethics in Research
Contact hours (to be used as a guide): Total (12 hours), Theory (50%), Practical (50%)

SPECIFIC OUTCOMES ADDRESSED

On completion of this module, students should:

  1. Understand and be able to list the key tenets of participant protection for research
  2. Be aware of ethics review boards and how to apply for ethics approval of research
  3. Understand how to ethically access, manage, and use data
  4. Understand what it means to have scientific integrity
  5. Have a general overview of local legislation about participant protection, data governance and material transfer.

BACKGROUND KNOWLEDGE REQUIRED

H3ABioNet bioinformatics modules as pre-requisites: None required

Additional: None required

BOOKS AND OTHER SOURCES USED

1. Hayden EC. Privacy protections: The genome hacker. Nat News. 2013;497: 172. doi:10.1038/497172a

2. Santos L. Genetic Research in Native Communities. Prog Community Health Partnersh Res Educ Action. 2008;2: 321–327. doi:10.1353/cpr.0.0046

3. He W, Neil S, Kulkarni H, Wright E, Agan BK, Marconi VC, et al. Duffy Antigen Receptor for Chemokines Mediates trans-Infection of HIV-1 from Red Blood Cells to Target Cells and Affects HIV-AIDS Susceptibility. Cell Host Microbe. 2008;4: 52–62. doi:10.1016/j.chom.2008.06.002

4. Ethics for participant participation lecture: Lecture developed by Nicki Tiffin: Ethics_informed_consent_health_genomics

COURSE CONTENT

A)    Theory lectures

1. Ethics for participant protection

1.1 Key tenets of participant protection for research (2 hours)

  • Stakeholders
  • Risks
  • Beneficence
  • Informed consent
  • Vulnerable populations
  • Distinction between primary and secondary use of data and samples
  • Anonymisation, and re-identification risks.
  • Risk of stigmatisation of population subgroups:
  • Specific challenges for genome research
    • Respect for individuals and communities
      • Community engagement and permissions
      • Respecting values and seeking voluntary participation of individuals
        • Informed consent models and process
      • Addressing needs of people with limited decision making capacities
    • Research risks and protection of participants from harm
      • Risks
      • Potential benefits
      • Balancing risks and benefits
    • Fairness in research collaboration

1.2 Ethics review boards and applications for ethics approval of research (1 hour)

  • Overview of necessary processes and documentation.
  • Identification of all stakeholders and review of beneficence/risk for each group of stakeholders.
  • Key issues around tiered consent, secondary use consent, timeline for destroying data/samples after projects are over, return of results, return of incidental findings, particular sensitivities in Africa.
    • Why ethics review boards – ethics review boards as partners in research and not police.
    • Risk based review of research studies – minimal risk and greater than minimal risk studies and types of corresponding reviews.
    • Record keeping and material/data transfer requirements.
    • Community and participant feedback and return of results.

2.     Ethics for data governance, management and use 

2.1  Data governance (1 hour)

       a. Procedural data access controls:

  • Application process for data access.
  • Importance of standard operating procedures (SOPs) and clear documentation of processes to check ethics clearance.
  • Comprehensive memoranda of understanding (MOU) for data access and terms of data usage.
  • Principle of the minimal possible dataset – ensure that access granted only for the actual data required.
  • Aggregation and de-identification of data wherever possible.
  • Layers of checks and balances, standardised checklists for completion prior to data release.
  • Distinction between primary and secondary use of data and samples.
  • Anonymisation, and re-identification risks.
  • Risk of stigmatization of population subgroups.

     b. Logistical data access controls:

  • Physical and electronic protection of data.
  • For physical data such as paper forms, this includes locked filing cabinets and offices, controlled access to storage facility.
  • For electronic data, this includes data access controls, password protection, firewalls, separation of clinical and identifying databases, encryption.

 2.2  Legislation (1 hour)

  • Review and discussion of local legislation, including:
    • Acts for Protection of Personal Information, Promotion of Access to Information.
    • Legislation around movement of data and samples outside country borders (location of “cloud” servers and local legislation around this, Material Transfer documentation).

3. Ethical and Responsible Conduct for Research (2 hours) 

3.1 Scientific Integrity

  • Plagiarism.
  • Good research design and execution.
  • Publication and authorship.
  • Peer review process.
  • Thorough documentation of all research and findings, publication or dissemination of results.

3.2. Responsibility to funders

  • Budgets, financial transparency and audits, conflicts of interest.
  • Sustainability plan, succession plans, disaster recovery plan.
  • Potential for exploitation through unequal or unethical collaboration; risks and responsibilities relating to foreign collaborations (“Helicopter Science”).

4. Collaborative research

  • MOUs, research agreements, good practice in establishing all of the above.
  • Effective governance for Consortia and Networks, necessary documentation and SOPs to ensure effective functioning, for: governance and management structure, administrative protocols, collaborations within the network, data and sample sharing within the network, intentions to publish, publication process.
  • Mentorship, skills sharing and upskilling of students and junior researchers.

B)    Practical component

1. Ethics for participant protection (follows lecture 1; 2 hours)

1.1  Participant protection: Complete the online Ethics training provided by the NIH, at https://phrp.nihtraining.com/users/login.php (follows lecture 1.1)

1.2  Discussion groups with focused questions posed by the presenter (follows lecture 1.1).

Examples:

  • Risks of re-identification of individuals using genetic data: Discussion, Nature article doi:10.1038/497172a
  • Vulnerable populations doi:10.1353/cpr.0.0046
  • Risk of stigmatisation: e.g. Duffy antigen variant confers resistance to malaria and is more common in Africans; also associated with increased susceptibility to HIV infection doi:10.1016/j.chom.2008.06.002

1.3  Prepare participant information/informed consent template/ethics application documents for a given research project.  (follows lecture 1.2) 

2. Ethics for data governance, management, and use (follows lecture 2; 2 hours)

2.1  Construct/review a standard operating procedure (SOP) for data access requests; construct/review a memorandum of understanding (MOU) for data-sharing. (follows lecture 2.1.a)

2.2  Construct a flow chart showing data movement from data collection in the field to data dissemination to primary and secondary end users. Mark all the possible places in the flow chart where data access can be controlled. (follows lecture 2.1.b)

2.3  Identify and review local legislation around data protection, access to information, material transfer. (follows lecture 2.2)

3.     Ethical and Responsible Conduct for Research (follows lecture 3; 2 hours)

ASSESSMENT ACTIVITIES AND THEIR WEIGHTS

Some of the described exercises from above could be used to generate a mark for the module. As there are often no ‘right or wrong’ answers in ethics issues, the aim of the module is more to get the student thinking more widely about what is or isn’t ethical (rather than just about how to get ethics clearance for a project). There could be an assessment exercise with an ethical dilemma presented as a text, with some questions/short essay question, or similar.

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