APPENDIX 2-1
Key Considerations for Writing and Reviewing Research Proposals
TOPIC | RELEVANT QUESTIONS |
Background and Rationale |
To ensure that the study is important, merits participants’ time, and generates important knowledge. | • Is there evidence that the study is necessary and important? • Is there evidence that the right questions are being asked? • Is there evidence that the approach used is appropriate? |
Study Objectives |
To ensure that the study is feasible and reasonable. | • Are the objectives of the study reasonable and manageable given previous work in the area? • What are the expected outcomes and knowledge of the study? |
Methods |
To ensure that the study is scientifically sound and results are likely to be valid and meritorious. | • Do the research methods seem appropriate to the question? • Is the study likely to produce valid results? • What, where, how, on whom, and when will the study take place? • What types of biological samples will be collected, and will genetic testing be conducted? • How will samples/data be used and analyzed? |
Sample and Recruitment of Human Participants |
To ensure that there is justice or fairness in selection of participants, and participants are recruited appropriately. | • Is the sample appropriately delineated? • Are appropriate inclusion criteria present? • Is any population excluded inappropriately (e.g., based on sex, gender, age, ethnicity, language)? • Are people in the sample vulnerable in any way? • What has been done to protect potential participants from harms? From feeling coerced? • Is there evidence of undue inducement to accept more than minimal risk? • What recruitment strategies and materials are to be used? |
Informed Consent/Assent |
To ensure that there is an adequate process for informed consent (assent where applicable), and that consent/assent is free, informed and ongoing. | • Is there evidence that elements of informed consent /assent (voluntariness, capacity, and comprehension) will be present? • Are alternatives to participation outlined (for therapeutic studies)? • Are consent and assent documents written in plain language? • Are the required elements of consent (as outlined by TCPS 2 and institutional policy) present? • Will consent be oral or written? • Is there a justified request for authorized representatives if appropriate? • Is there a justified request for waiver of consent if appropriate? |
Potential Harms and Benefits |
To ensure that the potential benefit significantly outweighs the potential for harm, and that harms and benefits are considered in terms of participants, their families, and communities. | • Are potential (known and reasonably anticipated) harms and discomforts adequately described? • Are possible benefits described appropriately (in other words, not overstated)? • Have appropriate measures being taken to maximize benefit and minimize harm? • What happens if participants become injured or get sick as a result of being in this study? • Have any rights to legal recourse been waived? |
Privacy and Confidentiality |
To ensure that participants’ privacy and confidentiality will be protected. | • What types of personal information about participants will be collected (e.g., highly sensitive information, identifying information, biological samples)? • What personal information about participants will be disclosed, to whom (e.g., study sponsor, Health Canada, REB), and why? • How will personal information be protected (e.g., coded), how long will information be kept, and how/where will it be stored? • What happens to information/samples if participants wish to withdraw their consent? |
Knowledge Translation and Dissemination |
To ensure that the results of the research will be shared. | • Will participants and their communities receive and benefit from the results of the research? |
Budget |
To ensure that there is adequate funding to conduct the research and potential biases and limitations are identified. | • Is the budget appropriate? Are expenses of the study clearly laid out? • Are expenses to be assumed by appropriate bodies? For example, who pays for extra diagnostic tests? • Are participants to be compensated for out-of-pocket expenses? • Is there evidence that the investigator might benefit inappropriately (i.e., i there a suggestion that the researcher is being paid to recruit participants, and could this then lead to inappropriate recruitment?) • Are there any real, apparent or potential conflicts of interest that may affect how the research is conducted? |
Other Considerations |
| For some research studies, other areas may need to be addressed, such as: • Multicentre or multijurisdictional research • Sex and gender • Official languages • Indigenous research • Community engagement • Legislation and regulations |
Note. Appendix 2-1 is largely adapted from Research ethics and nursing, by K. Oberle and J. L. Storch (2013, Table 14-1, p. 287), in J. L. Storch, P. Rodney, & R. Starzomski (Eds.), Toward a moral horizon: Nursing ethics for leadership and practice (2nd ed., pp. 282–301). © 2013 by Pearson Canada. Additional information from Research Protocol Instructions by Health Canada’s Research Ethics Board (Health Canada, 2022). © 2021 by Health Canada.