Web activities

These activities include brainstorming activities, further reading, weblinks to external sites, and enable you to examine and relect upon the methods of both real-world studies and the methods chosen by fictional nursing and midwifery students introduced in chapter one.

Activity 18.1: Identifying Ethical Conundrums

Access the following video clip about a cancer trial conducted in 1957 in which prisoners were injected with living cancer cells:

Britishpathe.com/video/heroic-convicts-aid-cancer-tests

What are the ethical issues arising from this study?

Activity 18.2: Nuremberg Code and Declaration of Helsinki

In order to access the Nuremberg Code and the Declaration of Helsinki see:

Nuremberg Code:

BMJ 1996; 313 doi: http://ezproxy.bcu.ac.uk:2068/10.1136/bmj.313.7070.1448a (Published 7 December 1996)

Declaration of Helsinki:

JAMA. 2013;310(20):2191-2194. doi:10.1001/jama.2013.281053. 

Activity 18.3: Research Governance and Addressing Client Needs

See the following sources for additional information about research governance and addressing the needs of specific client groups:

http://www.hra.nhs.uk/resources/research-legislation-and-governance/research-governance-frameworks/

Shaw, C. Brady, L-M. and Davey, C. (2011) Guidelines for Research with Children and Young People. London: National Children’s Bureau Research Centre.

Mental Health Research Network (2013) Good Practice Guidance for Involving People with Experience of Mental Health Problems in Research. London: Mental Health Research Network.

Royal College of Nursing (2011) Research Ethics; RCN Guidance for Nurses. London: RCN.

http://www.hse.gov.uk

http://www.ec.europa.eu/euraxcess/index.cfm/rights/europeanCharter

Activity 18.4: Ethical Approval Applications and Resources 

For more information about National Research Ethics Service (NRES) and the Integrated Research Application System (IRAS), see:

http://www.nres.nhs.uk

This website includes a range of useful resources such as templates for consent forms and participant information leaflets.

Activity 18.5: Good Clinical Practice Training 

For details about GCP course content and training see:

http://www.crn.nihr.ac.uk/learning-development/good-clinical-practice/

Activity 18.6: Ethics Surrounding Research with Children

For more detailed information about factors to consider when conducting research involving children see:

http://childethics.com/

Kumpunen, S. Shipway, L. Taylor, R.M. Aldiss, S. and Gibson, F. (2012) Practical approaches to seeking assent from children, Nurse Researcher 19(2): 23–27.

Shaw, C. Brady, L-M. and Davey, C. (2011) Guidelines for Research with Children and Young People. London: National Children’s Bureau Research Centre.

Activity 18.7: Should Minors Have to Give Consent? 

Read the following paper:

Cheah, P.Y. and Parker, M. (2014) Research consent from people in resource-poor settings. Archives of Disease in Childhood. doi:10.1136/archdischild-2014-307121

The authors suggest there is an argument for taking consent from children under the age of 16 for their participation in research; particularly children from low-income countries.

What do you think?

What do you think are the risks and benefits of adopting this strategy?

Activity 18.8: Ethics Surrounding Research with Participants Who Have Learning Disabilities

The following paper describes a study involving participants with learning disabilities and the strategies used in order to obtain ethical approval for the study. This included involving people with learning disabilities on the research team:

Northway, R. Howarth, J. and Evans, L. (2015) Participatory research, people with intellectual disabilities and ethical approval: making reasonable adjustments to enable participation. Journal of Clinical Nursing 24(3-4): 573–581.

The following paper gives further insight to the Mental Capacity Act and its application to practice:

Andrews, A. (2015) In whose best interests? Midwives 19, Summer: 64–65.

Activity 18.9: Strategies for Working Alone

For guidance on lone working see:

http://www.suzylamplugh.org

Activity 18.10: Strategies for Working in Partnership with ParticIpants

For guidance on working in partnership with research participants see:

http://www.invo.org.uk

http://www.lindalliance.org

Activity 18.11: Planning an Ethical Study

Jasmine and Charles from the class of 2016 are continuing to plan their studies and are now considering the ethical issues that they must address.

Jasmine is going to recruit newly delivered mothers and plans to ask them to complete two questionnaires; the first at one week after delivery and the second two weeks after delivery to measure participant perineal discomfort Jasmine hopes to recruit newly delivered mothers from one maternity hospital. What ethical factors should Jasmine address before she can begin her study?

Ethical considerations will include:

  • Securing indemnity insurance approval from the academic institution.
  • Securing ethics committee approval for the study. This should probably be provided by NRES using the IRAS system. If the study site suggests this is not required, Jasmine will need to secure ethics committee approval from the academic institution.
  • Obtain permission from the study site to access participants.
  • Establish participant inclusion and exclusion criteria; this will determine whether Jasmine needs to put strategies in place that would be necessary if participants will include girls under the age of 16 or vulnerable adults.
  • Decide who will obtain participant consent and ensure they have appropriate training and permissions for access.
  • Decide when participants will be approached to obtain consent.
  • Establishing strategies to obtain informed consent from participants. This will include the production of participant information leaflets and consent forms.
  • Ensure appropriate strategies are in place to securely store participant identifiers such as names and contact details.
  • Ensure appropriate strategies are in place to securely store participant data.
  • Develop strategies for the delivery and return of questionnaires.

Charles is going to conduct semi-structured qualitative interviews with teenage girls about their anorexia. They will be recruited via an out-patients clinic at a local hospital.

Ethical considerations will include:

  • Securing indemnity insurance approval from the academic institution.
  • Securing ethics committee approval for the study. This should probably be provided by NRES using the IRAS system. If the study site suggests this is not required, Charles will need to secure ethics committee approval from the academic institution.
  • Obtain permission from the study site to access participants.
  • Establish participant inclusion and exclusion criteria. If Charles plans to include teenagers under 16 he will need to ensure appropriate strategies are put in place.
  • Decide who will obtain participant consent and ensure they have appropriate training and permissions for access.
  • Decide when participants will be approached to obtain consent.
  • Establishing strategies to obtain informed consent from participants and their parents if appropriate. This will include the production of participant information leaflets and consent forms.
  • Consider where the interviews will take place. Permission will be required to access facilities with in the study site. If in the participant’s home, Charles will need to implement lone worker policies/guidelines. There may also be an issue regarding Charles interviewing girls on their own. Charles may need to consider involving a chaperone or asking someone else to conduct the interviews.
  • Ensure appropriate strategies are in place to securely store participant identifiers such as names and contact details.
  • Ensure appropriate strategies are in place to securely store participant data.
  • Ensure strategies are in place to support participants who become distressed as a consequence of the interviews.