IRB application: secondary or archival data

If you are using secondary or archival data, completing the IRB application can be tricky. However, the secret to this is remembering that you are not actually having any contact with participants, so keep this in mind as you go through the application. Make sure that the data you will be using has been "deidentified," meaning that no names or identifying info will be included. Let's go through some of the trickier questions. 

q. 11. List your research questions, in the section where it asks the data source give the name of the archival data set. 

q. 12. Discuss how you will get permission to use the data set, how you will access and analyze it. Don’t mention anything about participants. 

q. 13. Your stakeholder may be where you get the data, see if they want a summary of your results. 

q. 16 indicate not applicable for all items. 

q. 25. Indicate that your data will be anonymous. 

q. 26. Indicate no, there will not be a link 

q. 28 n/a 

q. 37-39. Regardless of what instruments were used in the original study, you are not administering them. So indicate n/a for these. 

q. 40-42. List the number of participants in the original study; just say that it is the data set total. For the rest of this section say n/a. 

q. 43. Answer No to all questions. 

q. 44-45 n/a 

Next time I will address a student question on covariates, mediators, and moderators. 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. 51-52

Question 51 of the IRB application is concerning the consent form, it is checklist of the various required elements. Also, be aware that there is a template for the consent form available on the IRB website. The consent form is a very important document, so it is important to follow the template and instructions as closely as possible. 

One thing to consider, is there a possibility that your population may not have a high level of literacy? Keep in mind that the population in general, is estimated at a 10^th grade reading level. Could your population be lower? You can check the readability of your documents in Word- go to the help menu in Word and get the instructions for your version. If you think it is too high, you can lower the level by simplifying words and reducing the number of passive sentences. 

Question 52 is a final checklist to make sure you remember to send everything needed to the IRB, these include all documents the participant may see such as flyers, ads, surveys, interview questions, consent and assent forms. Also send any confidentiality agreements, permission letters, a clean copy of your proposal and the IRB application. 

Finally, make sure your chair signs off on the last page. We have completed our review of the IRB application. Would you like to learn more? Do you have questions? There is a group IRB advising session online on Wednesday February 26 at 1pm eastern (noon central, 11 am mountain, 10 am pacific). For more info and the link to join go to: http://researchcenter.waldenu.edu/Institutional-Review-Board-for-Ethical-Standards-in-Research.htm#sthash.cikjCBco.dpuf   

Next time we will consider how you complete the IRB application if you are secondary or archival data. 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. 49-50

Questions 49-50 ask about whether you are including prisoners in your sample.  

q. 49. Will you be including prisoners? If yes indicate and go on q. 50. If no, indicate it and skip to q. 51. 

q. 50. Enrollment of prisoners requires that the IRB is able to document that the seven conditions under federal regulations 45 CFR 46 Subpart C are met.  If you plan to recruit individuals who are at high risk of becoming incarcerated in a penal institution during the research (e.g., participants with substance abuse history, repeat offenders, etc.), it is best that the IRB can address the Subpart C requirements at the time of initial review.  Otherwise, if a participant becomes incarcerated during the course of the research and the IRB has not previously reviewed and approved your research for enrollment of prisoners, all research activity must immediately cease for that individual until review and application of Subpart C regulations occurs by the IRB.

Understand that prisoners are a very protected population, if you want to do a study on them, there are many issues ahead. Start with reading the info provided on the IRB web site, talk to the warden of the facility and see what they require. There are a number of extra protections that can be done for prisoners, check the IRB site on this- look for info related to Federal certificate of confidentiality (to shield data from subpoena). 

Each of the following are yes/ no questions. 

q. 50a. asks whether the study will examine causes, effects, or processes of incarceration 

q. 50b. asks if this study examine the facility as an institutional structure? 

q. 50c. asks if this study specifically examine the experience of being incarcerated? 

q. 50d. asks if this study examine a condition(s) particularly affecting these prisoners? 

q. 50e asks if this study examine a procedure, innovative or accepted, that will have the intent or reasonable probability of improving the health or well-being of the participants? If yes, it asks that you describe if you will assign them to groups. 

Next time we will finish examining the IRB application, with q. 51-52. 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. 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