October 24, 2016 - University of Michigan

S. Jack Hu, Ph.D.
Vice President for Research
University of Michigan
Office of Research
4080 Fleming Building
Ann Arbor, MI 48109

RE: Human Research Protections under Federalwide Assurance -4969

Research Project: Health and Retirement Study (HRS) 
Principal Investigator: David R. Weir, Ph.D. 
HHS Protocol Number: U01AG009740 

Dear Dr. Hu:
Thank you for your January 23, 2015, as well as your March 11 and 18, 2016, responses to our December 15, 2014 request that the University of Michigan (UM) evaluate allegations of noncompliance with the Department of Health and Human Services regulations for the protection of human research subjects (45 CFR part 46).  
The complainant alleged that in the research noted above, the retention procedures do not ensure both that participation is voluntary, and that study subjects may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled, which, if proven, would represent a violation of HHS regulations at 45 CFR 46.116(a)(8).  Specifically, the complainant alleged the following:
Field interviewers were told to repeatedly call respondents, and if they gave a reason why they could not continue to participate (e.g., too ill, too old, caring for a dying family member, etc.), interviewers should explain to them how important they are to the study, and mark down the results in the case file.  Eventually, the rejected cases are handed over to someone else who will continue to call potential subjects to attempt to get them to participate.  There is no limit on how many times interviewers may call resistant respondents.  Subjects are offered gifts and increasing monetary prizes for continued participation when they express a desire to discontinue participation in the study. 
A. Background: 
On January 23, 2015, we received your correspondence in which you summarized the institutional review board’s (IRB) investigation findings and UM’s response to the allegations.  You indicated in your response that the IRB interviewed the principal investigator, survey manager, and other study team members.  The IRB also reviewed the full IRB application file and requested additional documentation from the Health and Retirement Study (HRS) team.  You indicated that the HRS interviewers underwent extensive training and had guidelines on how, when, and how often to reach out to prospective subjects for study recruitment.  The detailed training materials provided to the IRB as part of its investigation stated that an interviewer may reach out to a prospective subject multiple times before they make contact with them.  For the purpose of this letter, the use of “prospective subjects” refers to already-enrolled subjects who are approached to continue participation in the next wave of data collection. 
Once contacted, the interviewer may call the prospective subject multiple times if he or she expresses reluctance to participate, in an attempt to answer questions and to gain the prospective subject’s participation.  This may include cases where the prospective subject is ill or caring for someone who is ill.  The interviewer may propose ways that will make it easier for a prospective subject to participate, such as breaking the survey up into several sessions or asking a proxy to respond to the survey on their behalf.  If the prospective subject has a caretaker due to illness, the interviewer may offer to have the caretaker complete the interview as a proxy.  As part of this process, the interviewer may tell subjects “how important they are to the study.”  As the project reaches the end of a survey period (also referred to as a wave), interviewers may offer additional compensation to subjects to secure an interview.
In the letter and data you provided on March 11, 2016 regarding the number of contacts per subject for the 2012 and 2014 waves of HRS interviews, it shows that 90% or more of the subjects completed the interview process within five contacts and 50% completed the interview process within two contacts.  Of the subjects that did not complete the HRS interview process, 25% were never contacted and an additional 45% were “finalized” within three contacts.  The HRS team noted that while they may have used the terms “soft refusal” and “hard refusal” internally, specific definitions were not documented and technical systems for management of fieldwork and data tracking did not classify cases in this way.  Cases were coded as “interim refusal” and “final refusal.”  The terms “reluctant respondent”, “resistant respondents”, “resistant cases”, “uncooperative respondents”, “refusal conversions” and a reference to the 4300 code representing a reluctance to participate were used throughout the training materials.  The HRS team made decisions on a case-by-case basis regarding pursuing of respondents.  
The IRB investigation focused on “a detailed review of the refusal conversion procedures used by the HRS.”  This included a copy of IRB and study team correspondence regarding subject complaints submitted to the IRB from 2012 through 2014.  According to the information provided on March 11, 2016, for the 2012 and 2014 waves, there were four subject complaints documented in the correspondence between the IRB and HRS study team.  Of the four complaints, three were requesting to withdraw from the study and one was a repeat request to withdraw from the study.  
The HRS interviewers were paid an hourly rate for the time they spent interacting with subjects and administrative tasks associated with HRS.  During the 2014 data collection, an “interviewer recognition bonus” was implemented.  The bonus was based on the number of production weeks it took an interviewer to meet set “production” thresholds.  The study thresholds were of 100, 150, and 200 interviews completed in the shortest time.  According to the study team, in 2014, these bonuses represented about 6% of total interviewer compensation.  The interviewers were assigned an interview caseload via the study case management system.  This case management system is what was used to track attempted and actual contacts with all subjects, prospective and otherwise.  
The interviewers consulted with the field manager throughout the process to determine what, if any, additional contacts might be appropriate for an individual prospective subject that was reluctant, had given a soft refusal, or had given a hard refusal.  As the end of a survey period approached, case records for subjects who had not been contacted or who had not agreed to participate were referred to a different team of experienced interviewers to evaluate the likelihood that a particular prospective subject might agree to be interviewed.  These experienced interviewers would, in some cases, again reach out to prospective subjects until the survey period ended.  According to your March 18, 2016 response, in retrospect, some of these prospective subjects were those that had given “hard refusals,” based on the definition provided below in the Corrective Action. 
You indicated in the January 23, 2015 response that survey researchers typically make a distinction between “soft refusals” – such as “I’m too busy right now” or “I’m not sure” or people who never pick up their phone – versus “hard refusals” such as “DON’T CALL ME” or “I don’t want to participate.”  You also indicated that it is standard survey practice, as described in the American Association for Public Opinion Research (AAPOR) September 8, 2014 report “Current Knowledge and Considerations Regarding Survey Refusals,” for an interviewer to continue to reach out to a “soft refuser” to see if he or she will later be willing to answer questions in order to gain an interview.  This is part of the “refusal conversion” process.  However, you noted that the AAPOR report states on page 20 that in the case of a “hard refusal,” the survey research team should not contact the respondent again, the respondent should be placed on a do-not-contact list, and “refusal conversions” should not be attempted.  Yet, contrary to the 2014 AAPOR recommendations you reference, HRS interviewers still contacted those subjects who had expressed a clear intent not to participate in the research or a desire to be removed from the research. 
We acknowledge and appreciate the IRB’s initiative in working with the principal investigator to improve the criteria for interviewers regarding “hard refusal”; that is, at what point no additional contact would be made with prospective subjects.  Based on review of your responses and all the supporting information provided regarding the above-referenced research, we make the following determination: 
B. Resolved concern: 
We determine that there is no violation of the regulations regarding this allegation.  Although the previous subject withdrawal practices were not clear regulatory violations, those practices were less than ideal.  The University of Michigan has adequately addressed our concern that is described below.  
The information provided to us demonstrates that the University of Michigan Health and Retirement Study (HRS) team continued to reach out to subjects after they had given a hard refusal to participate, or to continue to participate, in the study.  A subject’s right to refuse participation in a study or request to leave a study without penalty or loss of benefits is protected under 45 CFR 46.116(a)(8).  OHRP’s Withdrawal of Subjects from Research Guidance (2010) provides that “subjects have the right to withdraw from (i.e., discontinue participation in) research at any time (45 CFR 46.116(a)(8)).” (http://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-withdrawal-of-subject/) 
Corrective Action:  The IRB at its June 18, 2015, meeting accepted the following definition of “hard refusal” and the follow-up action proposed by the HRS team: 
Hard refusal: Any unqualified statement by a participant declining to participate. 
If a participant specifically states that they do not want to participate (either in the current wave or in the overall study) the response should be considered a hard refusal. 
Threats of legal action and allegations of harassment should also be considered hard refusals. 
Hard refusals that do not make clear whether the refusal is for the entire study or just the current wave may be treated as hard refusals for the current wave of data collection. 
If the participant specifically asked never to be contacted again or asked to be removed in the study entirely, those responses should be classified as hard refusals to participate in the overall study. 
Actions to take with hard refusals:  Subjects who issue a hard refusal will be removed from the wave or study after one final contact to confirm a respondent’s desire to be removed or to answer any remaining questions. 
To operationalize this agreed-upon definition and process, the HRS team undertook a review of past-wave refusal interactions, identified key elements of interactions corresponding to the above definition, and developed a coding framework that has been implemented for the 2016 data collection wave in order to formally document interactions and guide follow-up procedures.  Interviewers will record information and responses by subjects and use code 4300 for refusals.  All cases meeting the criteria of a hard refusal are immediately taken from an interviewer’s workload for in-depth review by senior staff to confirm the respondent’s request to not be contacted again and placed on a do-not-contact list.  The intent is to improve consistency in how hard refusals are handled and to respect the right of a subject to refuse participation. 
All the corrective actions identified above adequately address the concern underlying the allegation presented to our office.  At this time, there should be no need for further involvement by our office in this matter.  We appreciate the continued commitment of your institution to the protection of human research subjects.  Please do not hesitate to contact me should you have any questions. 
Alfredo R. Sancho, Ph.D., MPH 
Commander, U.S. Public Health Service 
Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland  20852
Telephone: 240-453-8132
FAX:    240-453-6909
Mr. James Ashton-Miller, Associate Vice President for Research, UM
Dr. Alan Sugar, Chairperson, IRB #1 & #6, UM
Dr. Thad Polk, Chairperson, IRB #2 & #3, UM
Dr. Robert Hymes, Chairperson, IRB #4, UM
Dr. Marianne McGrath, Chairperson, IRB #5, UM
Dr. Michael Geisser, Chairperson, IRB #7, #8, #9 UM
Dr. David R. Weir, UM
Dr. Richard J. Hodes, Director, National Institute on Aging, National Institutes of Health (NIH) 
Dr. Sherry Rodgers, Director, Office of Extramural Programs, NIH
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, NIH
Ms. Sarah Carr, Office of Science Policy, NIH 
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