Informed consent is a process where individuals voluntarily agree to participate in research after understanding its purpose, risks, and benefits. It involves several key principles: consent should be informed, voluntary, and ongoing throughout the research. Researchers have a duty to properly convey information, avoid coercion, and allow participants to withdraw at any time. While written consent is ideal, oral or other culturally appropriate methods may also be used if properly documented. Exceptions to consent may be made only in minimal risk research where consent would make the study impossible. Challenges like lack of capacity, language barriers, or vulnerabilities require extra precautions to ensure proper informed consent.

1. Informed Consent in
Qualitative Research
THURAYA ELNAIEM
UNIVERSITY OF GUELPH
QUALITATIVE ANALYSIS - EDRD 6000

2. “
”
Informed consent describes an interactive process in
which individuals or their surrogates voluntarily agree to
participate in a research study after the purpose, risks,
benefits and alternatives have been thoroughly
described and understood.
(Marshall, 2007)
What is informed consent?

3. Principles of Consent
 Consent should be informed
 Researchers should provide enough time for potential participants to consider whether or
not to partake in the research.
 Efforts should be made by researchers to ensure that the information they are conveying is
understood by prospective participants
 Participants should be informed of any incidental findings during the research
process.
 Consent should be received from participants prior to the
collection of any research data.

4. Principles of Consent
 Consent should be given voluntarily
 The process of recruiting participants is important for researchers to consider, in order to
ensure that undue influence, coercion or incentives are not undermining participants
voluntariness.
 Participants should be free to withdraw consent and request their data to be withdrawn at
any point in time, without reprisal.
 Consent is an Ongoing process
 In qualitative research, information may emerge during the data collection or analysis phase
which changes the research project in a way that affects participants. Researchers have a
duty to disclose this information and allow participants the opportunity to reconsider their
consent based on this new information.

5. Obtaining and
documenting Consent
 There are several equally ethical ways to obtain
consent;
 In written form, where participant sign a consent
form.
 Orally, where the researcher and participants make
a verbal agreement or shake hands.
 Gift exchange, in some cultures gift exchange
establishes a relationship equivalent to consent.
 Researchers should document the process used to
obtain free and informed consent in cases where
written consent is not obtained.

6. Exceptions
Research might be approved without the consent of participants in some
situations. For example if;
 The research involves minimal risk to participant
 The research will not adversely impact the welfare of participants
 Consent will make it impossible for researchers to answer the research question
 If at a later point in time participants will be debriefed and provided with the
opportunity to refuse consent
During Medical emergencies
 If a participant has lost capacity or consciousness and delaying response to obtain
third party consent may compromise their health

7. Challenges:
Lack of capacity of potential participant
 Obtain consent from an authorized third party.
 Researchers and authorized third parties should be aware of legal requirements in
relation to capacity.
 Assess the participants level of capacity. Participants should be included in the decision
making process whenever possible.
 If a participant gains capacity during the research project, then the researcher must
immediately obtain their consent.
 Individuals who lack capacity to consent should have the opportunity participate in the
research that may potentially benefit them. At the same time an individual’s lack of capacity
should not be used to include them in research inappropriately.

8. Challenges:
Language barriers
 Use plain language to ensure participants understanding.
 Avoid technical terminology
 Make adequate translation services available for participants if there is a language
barrier.
Vulnerable communities
 Be mindful of power dynamics
 Consider and communicate specific risks that participants might be subject to
because of their vulnerability
 Make every effort to develop methods of obtaining consent that are appropriate to
the group being studied
 Use expert advice, support and training where necessary.

9. The Tuskegee Study
 Which principles of
consent did the
Tuskegee study
researchers fail to
uphold?
 Why is it important to
receive informed
consent in research?

10. References
 Angell, M. (1997). The Ethics of Clinical Research in the Third World, 337(12), 847–849. Retrieved from
http://www.columbia.edu/itc/hs/pubhealth/p9408/readings/angell_1997.pdf
 Byrne, M. (2001). The concept of informed consent in qualitative research. AORN Journal, 74(3), 401–403. Retrieved from
https://journals-scholarsportal-info.subzero.lib.uoguelph.ca/pdf/00012092/v74i0003/401_tcoiciqr.xml
 Canadian Institutes of Health Research , Social Sciences and Humanities Research Council of Canada, N. S. and E. R. C. C. (2010). Tri-
council policy statement: ethical conduct for research involving humans. Ottawa. Retrieved from
http://books1.scholarsportal.info.subzero.lib.uoguelph.ca/viewdoc.html?id=/ebooks/ebooks1/gibson_chrc/2011-05-
24/1/10456514#tabview=tab1
 Economic and Social Research Council. (n.d.). Research with potentially vulnerable people - Economic and Social Research Council.
Retrieved March 9, 2018, from http://www.esrc.ac.uk/funding/guidance-for-applicants/research-ethics/frequently-raised-
topics/research-with-potentially-vulnerable-people/
 Marshall, P. A. (2007). Ethical challenges in study design and informed consent for health research in resource-poor settings WHO
Library Cataloguing-in-Publication Data Ethical challenges in study design and informed consent for health research in resource-poor
settings. Retrieved from http://apps.who.int/iris/bitstream/10665/43622/1/9789241563383_eng.pdf
 Nijhawan, L. P., Janodia, M. D., Muddukrishna, B. S., Bhat, K. M., Bairy, K. L., Udupa, N., & Musmade, P. B. (2013). Informed consent:
Issues and challenges. Journal of Advanced Pharmaceutical Technology & Research, 4(3), 134–40. https://doi.org/10.4103/2231-
4040.116779