Human Subjects Research

Ethical interaction with Human Participants ROLE OF THE DATA COLLECTOR You are the ambassador for the study You may be the only person related to the study that a person meets

Make a good impression Make certain they know what they are agreeing to do Make certain that the information you collect is accurate Protect the data from getting lost Carefully follow the research plan and instructions from SWACEDA

Ethical interaction with Human Participants SHOW RESPECT FOR The goals of the research project The leaders of the project The individual study participants The communities you are working in The data that you are collecting What else should be respected? Culture Gender Age Social Status Religion This project has the potential to benefit the community, but only if it is done respectfully and completely.

Ethical interaction with Human Participants What does it mean to show respect? Be polite- even if they do not want to participate in the study Ask question in a clear voice and with attention to the participant Record information in neat handwriting Always answer questions that participants ask honestly If you do not know the answer to a question and it is possible to obtain it from a supervisor, tell them that you will get the answer and let them know what you find out Thank participants upon completion WHAT ARE SOME OTHER SIGNS OF RESPECT?

Ethical interaction with Human Participants RESPONSES TO QUESTIONS Be prepared: You may be asked questions in field, not just by participants, but also by onlookers or other people Never answer a question if you do not clearly know the answer! Giving the wrong information can be worse than giving no information. Tell the person that you will ask one of your supervisors and get back to them. When you think the participant has no more questions, you may ask, “Do you have any other questions?” to make sure that all questions have been addressed

Ethical interaction with Human Participants VOLUNTARY PARTICIPATION No individual person is required to participate in this project: they should not feel forced or afraid not to participate People can refuse to participate, or even refuse to hear about the study People may participate in the study, but refuse to answer specific questions People may withdraw from the study at any time

Ethical interaction with Human Participants INFORMED CONSENT- what is it all about? Ensure that the individual understands what the study is about Ensure that they truly agree to join the study IMPORTANT NOTES: The discussion around consent should give the participant time to ask questions and think about their decision to study. DO NOT rush participants through the initial informed consent process Informed consent does not end after the first permission is given. It is ongoing. Participants may ask you questions at any time and may withdraw their consent at any time.

Ethical interaction with Human Participants INFORMED CONSENT AS A PROCESS Ask if they have questions at every visit Notice body language- if they look uncomfortable pay attention to that (in the case of the interview you may want to ask if they would rather move on to another question) Let your supervisor know if there is discomfort with the study or issues with consent in the field

EXERCISE: Informed Consent IN THIS STUDY YOU WILL Introduce yourself to the participant(s) Read the informed consent document to them Ask if they have any questions Ask if they agree to participate If yes, ask if you may begin audio recording the interview Copy of informed consent for this study is in your binder Get into pairs and practice getting consent from each other Try modeling BOTH respectful and disrespectful ways of interacting

What did you learn? Any questions? Informed Consent What did you learn? Any questions?

Ethical interaction with Human Participants VULNERABLE POPULATIONS Some people need extra attention and care, they may have difficulty understanding, therefore difficulty in providing informed consent What are some examples? Children Adults with dementia What should you do? Tell a supervisor and ask how to proceed

Ethical interaction with Human Participants PERSONAL PRIVACY – Every individual has the right to privacy May you enter a person’s home without being invited in? Are other people aloud to “listen in” on the interview? If a participant is feeling embarrassed or uncomfortable about a subject do they have to continue talking about it? Is it alright to leave the information you collect about participants’ personal lives and feelings where other people can see it?

Ethical interaction with Human Participants PROTECTING PEOPLE’S PERSONAL INFORMATION Between the study and the participants there is CONFIDENTIALITY All data collected will be DE-IDENTIFIED to ensure confidentiality If personal information becomes public this could put the participant at RISK Have them define the underlined words one at a time Confidentiality= an expectation that what has been shared with the study will not be shared with the public

Ethical interaction with Human Participants How To PROTECT PEOPLE’S PERSONAL INFORMATION Keep all documents and materials(camera/audio recorder) safe No one without proper authority should see or have access to it If on paper: must be kept in a secure location (locked cabinet). Must only be seen and processed by study staff If electronic: precautions should be take that no unauthorized person can access it Use a number to identify records, never use the participant’s name

Data Integrity At all times data must be: Collected properly Recorded properly Stored properly If you make a mistake in any of these things it is important that you tell your supervisor right away

Data Management Details on how data will be managed SWACEDA team member provides details on where data will be stored and under what file names