Frequently Asked Questions

 

  1. How long does it take for a protocol to be reviewed and approved?
  2. If I am applying for a grant, when should I submit my ethics application?
  3. I’m not sure which board to send my application to for review?
  4. I have read the Tri-Council Policy Statement but it doesn’t anticipate the kinds of research that I am doing. Will my research be approved?
  5. Do I need an information letter or a consent form?
  6. I am instructing a class who will be doing a research project with humans. Can I submit one application for the entire class?
  7. How can I make a revision or an addendum to my approved research?
  8. I have been awarded a grant and need to obtain ethics approval for the funds to be released. However, I will not be doing the research with humans component for another year. Is there anyway I can obtain conditional approval so the administrative funds can be released?
  9. I am an undergraduate doing research. Which SREC (Student Research Ethics Committee) do I submit my application to?
  10. How can I write a successful application?
  11. Where do I get the forms for the application and who do I submit it to?
  12. How long does the review process take?
  13. I will only be doing naturalistic observation or interviewing close friends or family. Do I need ethics review?
  14. I am doing research with a small group of students. Do we use the individual application forms or can the instructor submit a course application on our behalf?
  15. Do I need to read the Tri-Council Policy Statement?
  16. I would like to do a research project in the local district schools but I don’t know the procedure for doing so.
  17. As a researcher, I would like to know how best to obtain consent to tape record an interview?
  18. I have been awarded a grant, but I won't be doing research involving humans until a year later. Is there any way I can access any of the funds for administrative start-up costs before then?

 

1. How long does it take for a protocol to be reviewed and approved?

The McMaster Research Ethics Board meets once a month but most protocols are sent for expedited review. Only protocols that are more than minimal risk are reserved for full board review. Generally speaking it takes an average two to three weeks for your protocol to be reviewed by the expedited review process. A research ethics application that is completed correctly might take less time, because there will be less back and forth between the chair and the researcher to clarify questions or concerns. Applications can be submitted anytime in advance of a meeting date. Please leave enough time for review prior to your anticipated starting time. The McMaster Research Ethics Board approves research for four to five years before the application must be resubmitted.

2. If I am applying for a grant, when should I submit my ethics application?

If you are applying to a funding agency like NSERC, SSHRC, CIHR, you don’t need to submit an ethics application until you have been awarded the grant. However, if you submit an application before you are awarded the grant, and have been approved by the ethics board, your account may be opened right away. After you have won an award the councils have set a six month deadline in which to obtain ethics approval or the funds will be returned to the councils. If you are applying to a different council, even if it is basically the same project, you must reapply for ethics approval.

3. I’m not sure which board to send my application to for review?

NEW PROCEDURES FOR HEALTH SCIENCE RESEARCH

  • All faculty members and PhD students, whose affiliation is with the Faculty of Health Sciences must submit their protocols to the HHS/FHS Research Ethics Board using the application forms found < Here >
  • All research by FHS undergraduate and Masters students must be submitted to the Student Research Ethics Committee (a sub-committee of the joint HHS/FHS REB) c/o Committee on Scientific Development (CSD) office as per instructions for student applications< Here >
  • All quantitative or qualitative research conducted by faculty or students at the St. Joseph Healthcare Hamilton (SJHH) site must still be submitted to the SJHH board for review.

To consult with the coordinator of the medical board (HHS/FHS REB), please contact , Deborah Mazzetti, 905-521-2100 ext. 42013 (mazzedeb@hhsc.ca). There is also a new process and forms for research involving human tissues, so please contact medical ethics board Research Ethics Officer, Alison van Nie at 905-525-9140 ext. 22057 (vanniea@mcmaster.ca) for more information.

The McMaster Research Ethics Board reviews all research that is not from the Faculty of Health Sciences, Hamilton Health Sciences, St. Joseph's Healthcare, but does not review any research proposals that involve human or other resources in the McMaster affiliated hospitals.

4. I have read the Tri-Council Policy Statement but it doesn’t anticipate the kinds of research that I am doing. Will my research be approved?

It isn’t mandatory to read the Tri-Council Policy Statement (highly instructive and educational though) but if you have any doubts that your research requires ethics review, you should contact the chair of the MREB, or the Research Ethics Officers. The Tri-Council Policy Statement is in a state of evolution under the stewardship of the Panel on Research Ethics. Changes to the policy will be made that will account for the varieties of research that are used for example in social sciences and qualitative research. Almost all research submitted for review to the research ethics board is approved. If there are concerns, the board and the chair will work with the researchers in order to resolve any problems, such as, reducing risk of harms to the participants in the research.

5. Do I need an information letter or a consent form?

There are many kinds of research methodology, and not surprisingly, ways of obtaining the free and informed consent of participants. If you are a political scientist with interview questions for a high level government or public official, you do not necessarily need a signed consent form. An official can be sent a letter of information, with your contact information, rights to withdraw, assurances in regards to publication of statements, contact information for the ethics board and the date and time for the meeting. If the official agrees to the interview, that is the same as consent. You still need to document theconsent process--that you sent a letter of information with all the details on the consent form checklist and the official agreed to the interview. That's what you can do with a log book or taped consent. Survey research that is mailed sometimes doesn’t require written consent as completing and returning the survey is the same as consent. Participants need to know that they do not have to answer all the questions or return the survey, with no consequences to themselves, and that their responses be kept confidential or their name anonymous. The Tri-Council Policy clearly outlines that written consent is not necessary for aboriginal peoples who do not have a culture of the written word. Researchers however need to document how consent is obtained in such cultures. Often an information letter and consent form work very well together. The information letter informs participants about the research, in easy to understand language, what will be required in the research, and has contact information. The consent form can be kept by the participant for future contact information and as proof of having understood and participated in the research.

6. I am instructing a class who will be doing a research project with humans. Can I submit one application for the entire class?

Yes, there are course applications for instructors. An entire class can be covered by one application form, completed by the instructor, if the research is minimal risk, and if the research methodologies employed by the students are basically the same. The instructor should study the instructions for instructor’s guidelines on course projects on the webpage. The guidelines indicate the criteria by which instructors may review and approve more individualistic projects within the class. Sample consent forms or questionnaires, if used, should also be submitted. Course approvals are good for three years before having to resubmit.

7. How can I make a revision or an addendum to my approved research?

The research ethics webpage has a change form for revisions or addendums to the originally approved protocol. The change form is a one page checklist to determine the scope of changes to the original protocol. The researcher must submit a copy of the original approval protocol and has a choice of either writing a one page description of the scope of the changes, or highlighting on a revised application form the changes that are proposed. Depending on the significance of the changes, the addendum will either be reviewed and approved by the chair or sent for expedited review.

8. I have been awarded a grant and need to obtain ethics approval for the funds to be released. However, I will not be doing the research with humans component for another year. Is there anyway I can obtain conditional approval so the administrative funds can be released?

According to the Tri-Councils, (SSHRC, NSERC, CIHR), funds for research grants that involve human subjects can’t be released until human ethics approval has been obtained. This would apply even if the researchers won’t be doing the research with humans component until one or even two years later. Sometimes research grants are more for larger scope programs that involve training and other institutions and the research with humans component is not clearly defined. The researcher in this case should submit an ethics application, outlining the scope and nature of the project and the possible research with human components. According to the Tri-Council’s Memorandum of Understanding, approval and release of funds for such projects can be made conditionally on a per annum release of funds basis, and on condition of submitting ethics applications whenever human participants are engaged in research. In very special circumstances that would put the research project in dire straits, a conditional release of funds has been allowed for start up costs for research that does not initially involve the human subject component. Please contact the research ethics officers or the chair of the ethics board for more information.

9. I am an undergraduate doing research. Which SREC (Student Research Ethics Committee) do I submit my application to?

Most departments have a faculty/student committee that reviews undergraduate research. If there isn’t one for your department or program your project will be reviewed by the main McMaster Research Ethics Board. If you are in a program and not sure which department committee to submit your application to, consult the research ethics officer.

10. How can I write a successful application?

If you are writing an independent thesis or honours paper the research ethics application can help organize and improve the quality of your research. You should try to complete the application yourself but ultimately you are obligated to work with a supervisor to refine your application for ethics review. If you don’t have a supervisor, you cannot submit an application. Your supervisor can be from another department and in some circumstance, even from outside the university. Some familiarity with the Tri-Council Policy Statement is a definite help. Attending workshops given by the department or taking courses on research methodology that have research ethics sections are very useful. There are many research ethics online tutorials to choose listed in the resource area of the ethics website. Reading the application carefully is vital in order to complete an application. Consent forms, questionnaires, surveys, and interview questions must all be included with the application. You can also book an appointment with the Ethics staff who are more than happy to help you complete your application.

11. Where do I get the forms for the application and who do I submit it to?

The forms can be downloaded from the Office of Research Services, Ethics in Human Research webpage.

12. How long does the review process take?

If you are in a department that has a Student Research Ethics Committee (SREC), the chances of your protocol being approved quickly are very good, especially if it is a complete application. If your department does not have a SREC, your research will be reviewed by the main research ethics board (MREB) which might take two to three weeks for approval.

13. I will only be doing naturalistic observation or interviewing close friends or family. Do I need ethics review?

If you are doing naturalistic observation in a public place ethics review is not normally required. If you are interviewing friends and family as part of a course research you may need ethics review, unless your course instructor has approval for the course application, in which case the instructor will determine the level of review required. Consult with the ethics office when in doubt.

14. I am doing research with a small group of students. Do we use the individual application forms or can the instructor submit a course application on our behalf?

The instructor can submit a course application for groups of students but if the project is a “one-off” and the instructor won’t be supervising a similar project again, it is better for the group of students to complete an individual application.

15. Do I need to read the Tri-Council Policy Statement?

Unless you were a student sitting on a Student Research Ethics Committee (SREC), there is no need to have great knowledge of the Tri-Council Policy Statement. However, a familiarity with the policy will not only improve the overall quality of your research application, it can also ultimately save your participants, and McMaster University, any chance of harms from risks inherent in research.

16. I would like to do a research project in the local district schools but I don’t know the procedure for doing so.

Before you can do research in the local district schools, you need ethics approval at McMaster. Once obtained, you must contact and apply to the research review committees at the schools. The school boards must review and approve all research before you are allowed into the schools. Contact the research ethics office for assistance. The office can help you apply to the school boards and give you an indication how long the process might take.

17.As a researcher, I would like to know how best to obtain consent to tape record an interview?

There are other ways to lay this out, and the exact wording doesn't have to be adopted here, but the choice to have the interview taped or not should be offered explicitly. This is designed to assure that the interviewee takes a moment to think about the choice and that you have documentation of their consent to be taped. On the consent form, just before of after the place for the signature of the participant, you can ask two questions:

I agree to participate in the research study by participating in a research interview. Further,
A) I agree to the taping of the inteview _______
B) I prefer that the inteview not be taped _______

18. I have been awarded a grant, but I won't be doing research involving humans until a year later. Is there any way I can access any of the funds for administrative start-up costs before then?

Yes, there is the conditional "In Principle" Approval for the Release of Funds - Tri-Council MOU If you are a researcher with Tri-Council funded research (other research sponsors may have a similiar policy) you may apply for an "in principle" conditional release of funds for administrative start up costs only, usually on a pro-rated basis. [Schedule 2.1(f)]This still involves completing as much of the application form as possible and submitting it to the ethics office. Please contact the ethics office (ethicsoffice@mcmaster.ca Tel: 905-525-9140 ext. 23142) if you would like to learn more.