IRB application, q. 46-48

Questions 46-48 of the IRB application relate to including minors (under 18 years of age) in a study.  

q. 46 asks if you will have minors in the study, if yes go on to q. 48. If no skip to q. 49 

q. 47 asks you to read the federal regulations (I could not get the link to work in the application; however, there is another link to it on the IRB website).

Here is an explanation of the regulations 

Minimal risk – when "adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians" (section 46.404) 

Greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds that:

(a) The risk is justified by the anticipated benefit to the subjects;

(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians (Section 46.405) 

Greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition

an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that:

(a) The risk represents a minor increase over minimal risk;

(b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

(c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and

(d) Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians (Section 46.406) 

You need to indicate the level of risk in your study.  

q. 48 asks you to explain how your study meets the level of risk that you identified in q. 47. 

Next time we will continue examining the IRB application, with q. 49-50. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu

 

Happy Valentine's Day!

Today is Valentine's Day and a great opportunity to honor those individuals who have loved and supported you on your dissertation journey. Family and friends give up so much so that you can follow your dreams, it is important to take the time occasionally to let them know how much you appreciate them and their daily sacrifices of time and money.  

I encourage you to do two things today. First, close your eyes and think of each of the people in your life who have supported you, consider what they have done to help you. Send them warm and kind thoughts of gratitude. Second, write a brief note to each saying thank you and letting him or her know how important he or she is in your life and in reaching your dream. 

My thanks go out to each of you, who read my blog; I am so very grateful for your ongoing support and encouragement. I greatly appreciate all of the notes and comments I receive on the blog, it helps me to know that I am not just talking to myself! 

Wishing you a lovely Valentine's Day with your loved ones! Next time we will continue examining the IRB application, with q. 46-48. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu

IRB application, q. 44-45

Questions 44-45 of the IRB application ask you to go into more detail on the issues that you listed in q. 43. 

q. 44 asks you to justify the inclusion of each vulnerable group you identified in q. 43. If you are targeting one of the vulnerable groups, then explain that they are essential for your study. For other groups that you have marked as possible, indicate that you won't know if they are members of the groups and/or that it would be unethical to exclude them. 

q. 45 asks that you consider whether competency might be an issue and how you will deal with consent with these individuals. Let's take a step back and consider who might have questionable competency: the elderly, homeless individuals, mentally handicapped, and people who are seriously ill are common groups of concern. While some of these individuals are competent, there is also a percentage that may not be. You need a way to make sure that your sample is competent to give consent; a common method is using the Mini Mental Status Exam (look it up in the library). You will also need to determine how you will tell volunteers that they do not qualify for the study if you determine they are not competent. A method that I have used is to have them complete a couple of questions from the study and then thank them for participating (not telling them that I feel that they are not competent, and not using their data). 

It is possible that you want to target one of the groups that I mention above; another option is to get consent from their guardian (if they have one). However, you will still need to get assent from the participant. 

If competency is not a possible issue in your study, then enter N/A. 

Next time I will have a Valentine's Day message for you. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu 

IRB application, q. 43

q. 43 of the IRB application asks you to recognize what vulnerable groups may be present in your study and how you will protect them. First, recognize that you may have some of these vulnerable people in your study and not be aware of it (and that is fine, as long as you recognize it). 

q. 43A Minors (17 and under). Generally, you will only have minors if you are targeting that age group. Protections are parental consent, child assent, and they will be told that they can stop being in the study at any time. 

q. 43B Residents of any facility (prison, treatment facility, nursing home, assisted living, group home for minors). Carefully think about this one, even if you aren’t targeting on of the groups. If you are doing some kind of general survey, is it possible that someone from a facility might be included? Some possible protections are they will be told that they can stop being in the study at any time, if appropriate, they can skip questions, and they will self-select whether to participate. 

q. 43C Mentally disabled individuals. Same issues as above, could they participate and you not know it? Protections are same as q. 43B. 

q. 43D Emotionally disabled individuals. This is possible for virtually all studies, there is no way to really know. Some possible protections are they will be told that they can stop being in the study at any time, if appropriate, they can skip questions, and they will self-select whether to participate. 

q. 43E. Pregnant women. If you are doing a study that may include women of childbearing age (13-50), this is always possible. Protections are the same as in q. 43D. 

q. 43F Subordinates of the researcher. Think this one through carefully – because it raises red flags. The best protection is anonymity. 

q. 43G Students of the researcher. Think this one through carefully – because it raises red flags. The best protection is anonymity. 

q. 43H Clients or potential clients of the researcher. Same issues as q. 43F & G. 

q. 43I Individuals who might be less than fluent in English. This is a tough one, if you require that they read, write or speak extensively you may want to make being a Native English speaker an inclusion criteria. If you are doing an anonymous survey, it is probable possible that they may e in the study. You may want to consider having alternate versions of written materials available in different languages if you are looking at say, an immigrant population, but check with the IRB as there very specific requirements for doing this. 

q. 43J Individuals who are in crisis (such as natural disaster victims or persons with an acute illness). This one is generally possible with any study. Some possible protections are they will be told that they can stop being in the study at any time, if appropriate, they can skip questions, and they will self-select whether to participate. It is also a good idea to provide frequent breaks and offer to come back if they are fatigued. 

q. 43K Economically disadvantaged individuals. Again usually possible in any study. See protections in q. 43D. 

q. 43 Elderly individuals (65+). Another one to carefully think about, is it possible that someone of this age group might participate? If so, protections such as those in q. 43J may be appropriate. 

Next time we will continue examining the IRB application, with q. 44-45. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu 

IRB application, q. 40-42

Section VII of the IRB application, which is comprised of q. 40-42, is on your research participants. This information is in your c. 3, let's work through what is expected. 

q. 40a asks that you provide the number of participants needed, including any pilot participants you will have. 

q. 40b asks that provide a rationale for the number(s) you gave in 40a. This should be from a power analysis for a quantitative study (provide how you calculated it) and from the literature for qualitative studies. 

q. 40c describe how you will find your participants. Typical responses include flyers or advertisements. 

q. 40d describe the sampling strategy selected and a rationale for why it was selected. Since there is often confusion about this. I will give you a few common examples. 

In random sampling, all members of a population have an equal probability of participating. An example of this might be a large scale survey. 

In stratified sampling, specific categories ("strata") are used. So for example, you may decide that you want to represent the population in your geographic area, with a specific percentage of males and females, and different races/ ethnicities.  

Convenience sampling is a type of nonprobability sampling which involves the sample being drawn from that part of the population which is close to hand. That is, a sample is selected because it is readily available and convenient. It may be through meeting the person or including a person in the sample when one meets them or chosen by finding them through technological means such as the internet or through phone. The researcher using such a sample cannot scientifically make generalizations about the total population from this sample because it would not be representative enough. For example, if you were to conduct such a survey at a shopping center early in the morning on a given day, the people that you could interview would be limited to those there at that given time, which would not represent the views of other members of society in such an area. 

Snowball sampling is commonly used in qualitative research. In this method, a few individuals from a known group are asked to recruit or suggest possible participants form their social network. 

q. 41 asks that you list all of your inclusion criteria, these are your list of who can participate in your study (be specific- able to read and write English? Belonging to certain groups, etc.). 

Then list all of your exclusion criteria, this is who cannot participate, again be specific. 

Finally, describe how you will identify who needs to be excluded. Typically, there is some self-selection involved, for example, able to read English in an ad and to complete survey. You also should ask a few questions to determine if they fit your criteria, such as their gender, membership in certain groups, etc. 

q. 42 asks that you describe how the participant demographics will be relevant in obtaining an appropriate sample. So for example, let's say you are interested in interviewing only women who work in a male dominated profession, it would be important to know their gender and their job title. You may choose to only interview the first few women who volunteer with certain key job titles, for example, truck driver, dock worker, etc. 

Next time we will continue examining the IRB application, with q. 43. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu

IRB application, with q. 37-39

Questions 37-39 of the IRB application relate to your data collection tools. This information should be in your proposal, but let's work through the questions. 

q. 37 asks if you are using any published measurement tools (e.g., a survey). If yes, you must complete q. 38, if no you skip to q. 39. 

q. 38a Here you name the copyright holder of each instrument that you are using. Typically, it is the author of the instrument.  

q. 38b you need to indicate if you have purchased the instrument for research use or if you have gotten permission for its use. If it was published in a journal or the full instrument is available online it is typically considered in the public domain. 

How do you get permission from an author? Write to them on email; try googling them and finding out their current employer and tracking them down. If you have no success at that try contacting the co-authors. 

q. 38c asks you to list any modifications you are making to the original instruments. Keep in mind that if you make major changes you will need to validate the new measure, which requires additional time and statistics.  

q. 39a asks you to list any instruments that you have designed. Typical ones are demographics surveys and interview questions. 

q. 39b asks if you had an expert panel (outside of your committee) review your self-designed items. This is a good idea, particularly for your interview questions. You and your chair can ask a few faculty members to offer their opinions on them. 

q. 39c asks if you piloted the items already (you would have needed to have IRB approval to do this) 

q. 39d asks if you plan to pilot them in the future. If you are a regular reader of the blog, you know that I strongly recommend this! See my post on 10/16 for more info it. 

Next time we will continue examining the IRB application, with q. 40-42. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu 

IRB application, q. 34-36

Questions 34-36 of the IRB application address any possible conflicts of interest.

q. 34 This question asks you to disclose information relevant to separating your multiple roles as clearly as possible, with the goal of ensuring authentically voluntary participation in your study. Doctoral research directly benefits the student (allowing him or her to obtain a degree), and so the researcher should minimize the potential for either (a) conflict of interest or (b) perceived coercion to participate. Researchers who are in positions of authority must take extra precautions to ensure that potential participants are not pressured to take part in their study. Data collection should be as detached as possible from the researcher’s authority.

 

Examples:

-a professor researcher may recruit students AFTER grades have been assigned

-a psychologist researcher may recruit clients from ANOTHER psychologist’s practice

-a manager researcher may conduct ANONYMOUS data collection so that subordinates do not perceive their responses or [non]participation as being associated with their job standing

 

At the time of study recruitment, are the potential study participants aware of any of the researchers’ other professional or public roles? (Such as teacher, business owner, community leader, supervisor, etc.?) 

You are given two choices – No- they will know about any of your roles.

The alternative is yes, and you must clearly state what your role is how you will make sure people do not feel obligated to participate. Anonymity is the best choice whenever possible. 

q. 35 asks you to disclose any financial conflicts, such as you (or your family) having contracts, clients, etc. that could influence the research or who participates. (This is a common issue in medical drug studies in which the drug company is sponsoring the research).

Again you have two choices, no, there is no financial conflicts or yes. If you answer yes you must indicate how you will manage that conflict. 

q. 36 asks if you will be giving any form of gifts, payments, compensation, reimbursement, free services, or extra credit to participants. In general, the IRB discourages any payment to participants. You can however, provide refreshments to a group or individuals who participate. 

Providing compensation is a tricky area and if you are considering this, I suggest discussing it with the IRB. Payment can be very expensive and you have to give it to everyone who volunteers, whether they complete the study or not. 

Next time we will continue examining the IRB application, with q. 37-39. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu